Climara Pro topical patches

Generic Name: estradiol and levonorgestrel (topical patches) (ess tra DY ol and LEE vo nor JESS trell)

Brand Names: Climara Pro

What are estradiol and levonorgestrel?

Estradiol is a form of estrogen, a female hormone involved in the development and maintenance of the female reproductive system. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and levonorgestrel is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women. This medication will not prevent dementia, heart attack, heart disease, or stroke.

Estradiol and levonorgestrel may also be used for purposes other than those listed here.

What is the most important information I should know about estradiol and levonorgestrel?

This medication should not be used to prevent heart disease or dementia. Using estrogens long-term may actually increase your risk of heart attack, stroke, dementia, breast cancer, blood clots.

To be sure this medication is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

What should I discuss with my healthcare provider before using estradiol and levonorgestrel?

You should not use estradiol and levonorgestrel if you have had a hysterectomy, or if you have any of the following:

• 
  

  a history of stroke, heart attack, or blood clots;

  
  


• 
  

  liver disease;

  
  


• 
  

  unusual vaginal bleeding; or

  
  


• 
  

  a history of breast, uterine, or hormone-related cancer.

  
  

Before using estradiol and levonorgestrel, tell your doctor if you have:

• 
  

  high blood pressure, angina, or heart disease;

  
  


• kidney disease;


• a history of gallbladder disease;


• 
  

  asthma;

  
  


• 
  

  epilepsy;

  
  


• 
  

  migraines;

  
  


• 
  

  a thyroid disorder; or

  
  


• 
  

  endometriosis.

  
  

If you have any of the conditions listed above, you may not be able to use estradiol and levonorgestrel, or you may need a dosage adjustment or special tests during treatment.

You may need to stop using estradiol and levonorgestrel for a short time if you will have surgery or you become ill and must stay in bed for any length of time. Tell any doctor who treats you that you are using this medication.

This medication should not be used to prevent heart disease or dementia. Using estrogens long-term may actually increase your risk of heart attack, stroke, dementia, breast cancer, or blood clots. This risk is higher if you are overweight, if you smoke tobacco or have diabetes, high blood pressure, systemic lupus erythematosus, high cholesterol or high triglycerides. Talk with your doctor about your individual risks and benefits if you plan to use estradiol and levonorgestrel long-term.

Estradiol may increase your risk of developing endometrial hyperplasia, a condition that can lead to cancer of the uterus. Using levonorgestrel (a progestin) with estradiol can lower the risk of developing this condition.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and levonorgestrel. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

FDA pregnancy category X: This medication can cause birth defects. Do not use estradiol and levonorgestrel if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Estradiol and levonorgestrel may cause problems with breast-feeding and can affect breast milk. Do not use estradiol and levonorgestrel without telling your doctor if you are breast-feeding a baby.

How should I use estradiol and levonorgestrel?

Use the estradiol and levonorgestrel patches exactly as your doctor has prescribed them for you. Do not use more patches than recommended or use them for longer than your doctor has prescribed.

If you have been using another form of estrogen and progestin and are switching to estradiol and levonorgestrel skin patches, finish your current cycle of treatment first. If you are not already using an estrogen or progestin, you may begin using the skin patches at any time.

To use estradiol and levonorgestrel patches:

• 
  

  Apply each patch to a clean, dry, and smooth (fold free) area of skin on the lower stomach (below the belly button). Do not use the patch on your breasts or at your waistline, where tight-fitting clothing may interfere with its use. Do not apply to broken or irritated skin.

  
  


• 
  

  Open the pouch and take out the patch. Remove one side of the protective liner, trying not to touch the sticky part. Apply the patch and then remove the second side of the liner. Press the patch firmly in place with your hand for at least 10 seconds, making sure there is good contact, especially around the edges.

  
  


• 
  

  If a patch falls off, reapply it to another place on your lower abdomen. If it will not stick, apply a new patch.

  
  


• 
  

  The patch should be worn around-the-clock for one week. Replace the patch on the same day each week as directed by your doctor. Use only one patch at a time.

  
  


• 
  

  Choose a new place on your lower abdomen each time you apply a patch. Allow at least 1 week to pass before applying a patch to the same place.

  
  


• Do not cut the patches.


• 
  

  After one week, remove the patch and fold it in half so that it sticks to itself. Used patches still contain active hormones and should be discarded out of the reach of children and pets.

  
  


• 
  

  Remove the patch carefully and slowly to avoid irritating your skin. Any adhesive remaining on the skin can be removed with baby oil.

  
  

To be sure this medication is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

If you use this medication to prevent osteoporosis, your doctor may also recommend weight-bearing exercise, calcium and vitamin D supplements, and dietary changes. Follow these directions carefully and ask your doctor before using any supplements.

Store the patches in their sealed foil pouches at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

Apply the next patch as soon as you remember. Continue to follow your regular schedule for changing the patch. Do not use extra patches to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a estradiol and levonorgestrel overdose may include nausea, vomiting, and withdrawal bleeding in females.

What should I avoid while using estradiol and levonorgestrel?

Avoid exposing the patch to sunlight or tanning beds while you are wearing it on your skin.

Estradiol and levonorgestrel side effects

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of the following serious side effects:

• 
  

  signs of a blood clot (sharp chest pain, coughing up blood, shortness of breath, pain in your calf);

  
  


• 
  

  signs of a heart attack (crushing chest pain, left-arm numbness);

  
  


• 
  

  signs of a stroke (sudden severe headache, problems with vision or speech, weakness, numbness);

  
  


• 
  

  nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  new or changing breast lumps.

  
  

Other less serious side effects are more likely to occur, such as:

• 
  

  nausea and vomiting;

  
  


• 
  

  tender or swollen breasts;

  
  


• 
  

  swelling of the hands or feet;

  
  


• 
  

  darkened spots on the skin of your face;

  
  


• 
  

  contact lens discomfort;

  
  


• 
  

  vaginal irritation or discomfort;

  
  


• 
  

  headache, depressed mood;

  
  


• 
  

  a skin rash or reaction where the patch is worn; or

  
  


• 
  

  changes in your menstrual periods.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect estradiol and levonorgestrel?

Before using estradiol and levonorgestrel, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to use estradiol and levonorgestrel, or you may require a dosage adjustment or special tests during treatment.

There may be other drugs that can affect estradiol and levonorgestrel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Climara Pro resources

• Climara Pro Side Effects (in more detail)
• Climara Pro Use in Pregnancy & Breastfeeding
• Climara Pro Drug Interactions
• Climara Pro Support Group
• 4 Reviews for Climara Pro - Add your own review/rating

Compare Climara Pro with other medications

• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist has additional information about estradiol and levonorgestrel written for health professionals that you may read.

See also: Climara Pro side effects (in more detail)

Factive

Pronunciation: JEM-i-FLOX-a-sin
Generic Name: Gemifloxacin
Brand Name: Factive

Factive is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years old, patients who take corticosteroids (eg, prednisone), or in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle area is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, or hand). Problems may occur while you take Factive or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Factive or within several months after you stop taking it.

Factive may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Factive if you have a history of myasthenia gravis.

Factive is used for:

Treating infections caused by certain bacteria.

Factive is a fluoroquinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Factive if:

• you are allergic to any ingredient in Factive or to any other fluoroquinolone antibiotic (eg, ciprofloxacin)


• you have uncorrected blood electrolyte levels (eg, low potassium or magnesium)


• you have a history of myasthenia gravis or of a certain type of irregular heartbeat (eg, QT interval prolongation)


• you are taking certain medicines for heart rhythm problems (eg, amiodarone, procainamide, quinidine, sotalol)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Factive:

Some medical conditions may interact with Factive. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of diabetes, severe or persistent diarrhea, skin sensitivity to the sun, heart problems (eg, abnormal heart function tests, congestive heart failure, a heart attack, slow or irregular heartbeat), heart blood vessel problems, or low blood potassium or magnesium levels


• if you have a family history of irregular heartbeat (QT prolongation)


• if you have a stomach infection, brain or nervous system problems, increased pressure in the brain, Alzheimer disease, or brain blood vessel problems


• if you have a history of seizures or you are at risk of seizures


• if you have a history of joint or tendon problems; rheumatoid arthritis; liver problems; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant


• if you take hormone replacement therapy (HRT) or if you participate in strenuous physical work or exercise

Some MEDICINES MAY INTERACT with Factive. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Arsenic, astemizole, azole antifungals (eg, ketoconazole), cisapride, diuretics (eg, hydrochlorothiazide, furosemide), droperidol, haloperidol, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), certain medicines for heart rhythm disturbances (eg, dofetilide, quinidine, procainamide, amiodarone, sotalol), phenothiazines (eg, thioridazine), pimozide, terfenadine, tricyclic antidepressants (eg, amitriptyline), ziprasidone, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) because side effects, such as racing heartbeat, dizziness, fainting, or life-threatening irregular heartbeat leading to unconsciousness, may be increased by Factive. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat


• Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased


• Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Factive


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) or probenecid because they may increase the risk of Factive's side effects


• Sulfonylureas (eg, glyburide) because the risk of side effects, including low blood sugar, may be increased by Factive

This may not be a complete list of all interactions that may occur. Ask your health care provider if Factive may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Factive:

Use Factive as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Factive comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Factive refilled.


• Take Factive by mouth with or without food.


• Swallow Factive whole. Do not break, crush, or chew before swallowing.


• Take Factive with a full glass of water (8 oz/240 mL).


• Factive works best if it is taken at the same time each day.


• Drinking extra fluids while you are taking Factive is recommended. Check with your doctor for instructions.


• Avoid taking Factive with dairy products (eg, milk, yogurt) or calcium-fortified juices by themselves. However, taking Factive as part of a full meal that contains these products is permitted.


• If you are also taking aluminum or magnesium (eg, certain antacids), calcium, iron, zinc, multivitamins, or certain forms of didanosine (chewable/buffered tablets, pediatric powder for oral solution), do not take it within 3 hours before or 2 hours after you take Factive.


• If you are also taking sucralfate, take Factive at least 2 hours before taking sucralfate.


• To clear up your infection completely, take Factive for the full course of treatment. Keep taking it even if you feel better in a few days.


• Do not miss any doses of Factive. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in the same day.

Ask your health care provider any questions you may have about how to use Factive.

Important safety information:

• Factive may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Factive with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Factive only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Factive for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Factive may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you take the antibiotic or within several months after you stop taking it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Tell your doctor right away if you experience pain or swelling of a tendon, or weakness or loss of use of a joint area. Rest the area and avoid exercise until your doctor gives you instructions.


• Factive may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Factive. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Some patients taking Factive have developed a rash. This may be more likely if you are younger than 40 years old, are a woman, are taking hormone replacement therapy, or take Factive for longer than 5 days. Contact your doctor if you develop a rash.


• Diabetes patients - Factive may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Factive with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).


• Factive should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. They may also be more sensitive to the effects of Factive, including bone and joint problems.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Factive while you are pregnant. It is not known if Factive is found in breast milk. If you are or will be breast-feeding while you take Factive, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Factive:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain or pounding in the chest; decreased urination; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; fruit-like breath odor; hallucinations; inability to move or bear weight on a joint or tendon area; joint pain; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, nervousness, paranoia, restlessness); muscle pain or weakness; nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, headache, or light-headedness; shortness of breath or trouble breathing; sleeplessness; stomach pain or cramps; suicidal thoughts or actions; sweating; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual swelling or weight gain; unusual weakness or tiredness; vaginal odor or discharge; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Factive side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Factive:

Store Factive at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Factive out of the reach of children and away from pets.

General information:

• If you have any questions about Factive, please talk with your doctor, pharmacist, or other health care provider.


• Factive is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Factive. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Factive resources

• Factive Side Effects (in more detail)
• Factive Use in Pregnancy & Breastfeeding
• Drug Images
• Factive Drug Interactions
• Factive Support Group
• 5 Reviews for Factive - Add your own review/rating

• Factive Prescribing Information (FDA)


• Factive Concise Consumer Information (Cerner Multum)


• Factive Monograph (AHFS DI)


• Factive Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Factive with other medications

• Bronchitis
• Pneumonia
• Strep Throat

Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets

Pronunciation: klor-fen-EER-a-meen/dex -troe-meth-OR-fan/fen-ill-EF-rin
Generic Name: Chlorpheniramine/Dextromethorphan/Phenylephrine
Brand Name: ED DM

Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets are used for:

Relieving sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets are a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking histamine, which helps reduce symptoms, such as watery eyes and sneezing, while the cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets if:

• you are allergic to any ingredient in Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets:

Some medical conditions may interact with Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, intestines, or bladder; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets may be increased


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets


• Guanadrel, guanethidine, methyldopa, mecamylamine, or reserpine because their effectiveness may be decreased by Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets:

Use Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets may be taken with or without food.


• Chew thoroughly before swallowing.


• If you miss a dose of Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets.

Important safety information:

• Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets. Using Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets without checking with your doctor.


• Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets.


• Use Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets, discuss with your doctor the benefits and risks of using Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets during pregnancy. It is unknown if Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets.

Possible side effects of Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Chlorpheniramine/Dextromethorphan/Phenylephrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; severe dizziness, lightheadedness, or headache; severe drowsiness; seizures; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets:

Store Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Chlorpheniramine/Dextromethorphan/Phenylephrine Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlorpheniramine/Dextromethorphan/Phenylephrine resources

• Chlorpheniramine/Dextromethorphan/Phenylephrine Side Effects (in more detail)
• Chlorpheniramine/Dextromethorphan/Phenylephrine Use in Pregnancy & Breastfeeding
• Chlorpheniramine/Dextromethorphan/Phenylephrine Drug Interactions
• Chlorpheniramine/Dextromethorphan/Phenylephrine Support Group
• 6 Reviews for Chlorpheniramine/Dextromethorphan/Phenylephrine - Add your own review/rating

Compare Chlorpheniramine/Dextromethorphan/Phenylephrine with other medications

• Cough and Nasal Congestion

Malaria Medications

Definition of Malaria: A parasitic disease characterized by fever, chills, and anemia.

Drugs associated with Malaria

The following drugs and medications are in some way related to, or used in the treatment of Malaria. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Malaria

• Malaria Prevention (16 drugs)

Learn more about Malaria

Medical Encyclopedia:

• Malaria

Harvard Health Guide:

• Symptoms and treatment for Malaria

Drug List:

Aralen

Aralen-Phosphate

Cardioquin

Cleocin

Cleocin-Hcl

Cleocin-Pediatric-Suspension

Cleocin-Phosphate-Iv

Coartem

Doryx-Delayed-Release-Capsules

Doxy-100

Doxy-200

Fansidar

Gantrisin-Suspension

Gantrisin-Pediatric

Halfan

Lariam

Malarone

Malarone-Pediatric

Mepron

Monodox

Ocudox-Convenience-Kit

Oraxyl

Plaquenil

Qualaquin

Quin-G

Quin-Release

Quinaglute-Dura-Tabs

Quinidex-Extentabs

Truxazole

Vibra-Tabs

Vibramycin

E-Z-Paque oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

• 
  

  asthma, eczema, or allergies;

  
  


• 
  

  a blockage in your stomach or intestines;

  
  


• 
  

  cystic fibrosis;

  
  


• 
  

  a colostomy;

  
  


• 
  

  rectal cancer;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  Hirschsprung's disease (a disorder of the intestines);

  
  


• 
  

  a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

  
  


• 
  

  a recent history of surgery on your esophagus, stomach, or intestines;

  
  


• 
  

  a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

  
  


• 
  

  if you have recently had a rectal biopsy;

  
  


• 
  

  if you have ever choked on food by accidentally inhaling it into your lungs;

  
  


• 
  

  if you are allergic to simethicone (Gas-X, Phazyme, and others); or

  
  


• 
  

  if you are allergic to latex rubber.

  
  

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe stomach pain;

  
  


• 
  

  severe cramping, diarrhea, or constipation;

  
  


• 
  

  sweating;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  confusion, fast heart rate; or

  
  


• 
  

  pale skin, weakness.

  
  

Less serious side effects may include:

• 
  

  mild stomach cramps;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  loose stools or mild constipation.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More E-Z-Paque resources

• E-Z-Paque Side Effects (in more detail)
• E-Z-Paque Use in Pregnancy & Breastfeeding
• E-Z-Paque Support Group
• 0 Reviews for E-Z-Paque - Add your own review/rating

Compare E-Z-Paque with other medications

• Computed Tomography

Where can I get more information?

• Your doctor or pharmacist can provide more information about barium sulfate.

See also: E-Z-Paque side effects (in more detail)

Boots Dry Cough Syrup 6 Years +

Boots Dry Cough Syrup 6 Years +

(Pholcodine)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice


• The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

What this medicine is for

This medicine contains Pholcodine which belongs to a group of medicines called cough suppressants, which act to reduce coughing.

It can be used to relieve dry and tickly coughs. Dry coughs do not produce phlegm or mucus on the chest.

Simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children" is provided at the end of this leaflet.

Before you give this medicine

This medicine can be given to children from the age of 6 years. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

Do not give:

• 
  If your child is under 6 years
  


• 
  If your child is allergic to any of the ingredients in this medicine (see "What is in this medicine")


• 
  If your child has liver or kidney failure
  


• 
  If your child has difficulty breathing
  


• 
  If your child has long-term lung problems or an infection which produces lots of phlegm on the chest


• 
  If you are giving your child monoamine oxidase inhibitors (for depression), or have given them in the last 14 days


• 
  If you are giving your child any other cough and cold medicines
  


• 
  If your child has an intolerance to some sugars, unless their doctor tells you to (this medicine contains maltitol liquid)

Talk to your doctor:

• If your child has a long-term cough or asthma (do not give this medicine to your child if they are wheezing or if they are having an asthma attack)


• If your child has a cough which produces lots of phlegm

Talk to your pharmacist or doctor:

• If your child has other liver or kidney problems (see "Do not give")

Other important information

If your child goes into hospital for an operation, tell the doctor that you are giving this medicine.

Information for people with diabetes: This medicine contains 1.6 g of maltitol per 5 ml spoonful. This provides 4 kcal per 5 ml spoonful.

Information for adults intending to take this medicine

All of the information in this leaflet will apply to you as well.

Driving and using machines: This medicine may make you feel dizzy or drowsy. Do not drive or use machines until you are sure you are not affected.

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.

Pregnancy and breastfeeding: Do not take this medicine, unless your doctor tells you to.

If your child takes other medicines

Before you give this medicine, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

• Water tablets (diuretics) and medicines to treat high blood pressure


• Medicines that may make your child sleepy or feel drowsy such as strong painkillers or medicines for epilepsy


• Medicines for depression or other mental health conditions

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

How to give this medicine

Check the seal is not broken before first use. If it is, do not give the medicine.

Use the measuring spoon provided (the small end measures 2.5 ml and the big end measures 5 ml).

Children of 6 to 12 years

Give two 5 ml spoonfuls three times a day.
Don't give more than six 5 ml spoonfuls in 24 hours.

Give this medicine to your child to swallow.

Do not give to children under 6 years.

Do not give more than the amount recommended above.

Do not give this medicine for more than 5 days, unless your child's doctor tells you to.

If your child's symptoms worsen at any time, talk to a pharmacist or doctor.

If your child's symptoms do not go away, talk to your child's doctor.

If you give too much: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother your child talk to a pharmacist:

• Other allergic reactions such as skin rash


• Feeling sick, being sick, constipation


• Feeling drowsy, dizzy, excited or confused


• Phlegm on the chest

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 30°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the bottle label or the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each 5 ml of oral solution contains Pholcodine 2 mg, which is the active ingredient.

As well as the active ingredient, the solution also contains purified water, maltitol liquid (E965), glycerol (E422), citric acid, sodium citrate, hyetellose, sodium benzoate (E211), acesulfame potassium, flavours (blackcurrant, vanilla).

This pack contains 100 ml of colourless blackcurrant flavoured syrup.

Who makes this medicine

Manufactured by the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

P

Leaflet prepared May 2009

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Treating coughs and colds in children

It's normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

• 
  
  1. If your child is hot or has a fever:
  Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).


• 
  
  2. For coughs:
  Although it may be distressing to hear your child cough, the coughing itself serves an important purpose. It helps to clear phlegm on the chest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may help loosen the phlegm and relax the airways.


• 
  
  3. To help with breathing:
  Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Dry Cough Syrup 6 Years Plus

Reference number: 00014/0523

This is a service provided by the Royal National Institute of Blind People.

BTC44841 vF 29/06/09

Human Albumin Biotest 20%

Human Albumin Biotest 20%, solution for infusion

Human albumin

Read this entire leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Human Albumin Biotest 20% is and what it is used for

2. Before you are given Human Albumin Biotest 20%

3. How you are given Human Albumin Biotest 20%

4. Possible side effects

5. How to store Human Albumin Biotest 20%

6. Further information

What Human Albumin Biotest 20% Is And What It Is Used For

Human Albumin Biotest 20% is a solution for infusion (into a vein). 1000 ml solution contains 200 g human plasma protein of which at least 95% is human albumin.

Human Albumin Biotest 20% is used to restore and maintain circulating blood volume where there is a low blood volume and the use of a colloid, such as albumin, is required.

Before You Are Given Human Albumin Biotest 20%

You will not receive Human Albumin Biotest 20% if:

• you are allergic (hypersensitive) to albumin preparations or to any of the other ingredients (these are listed in section 6 of this leaflet).

Special care will be taken with Human Albumin Biotest 20%:

Suspicion of allergic or anaphylactic type reactions requires immediate stopping of the injection. In case of shock, standard medical treatment for shock should be applied.

The infusion will also be stopped if you develop any of the following conditions as a sign of cardiovascular overload (hypervolaemia):

• headache


• dyspnoea (difficulties in breathing)


• jugular vein congestion (a build up of fluid in a neck vein)


• increased blood pressure


• raised venous pressure (increased pressure in the veins)


• pulmonary oedema (water on the lungs)

You should tell your doctor if you suffer from any of the following conditions:

• Decompensated cardiac insufficiency (heart failure)


• Hypertension (high blood pressure)


• Oesophageal varices (enlarged veins in the gullet)


• Pulmonary oedema (water on the lungs)


• Haemorrhagic diathesis (tendency to abnormal or spontaneous bleeding)


• Severe anaemia (reduced red blood cells)


• Renal and post-renal anuria (decreased or absent urine production)

He/She will take the appropriate precautions. You will also be monitored by your doctor to check your circulatory situation with the electrolyte balance and blood volume.

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time you receive a dose of Human Albumin Biotest 20% the name and batch number of the product are recorded in order to maintain a record of the batches used.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines including any that you may have bought without a prescription from a chemist or supermarket.

Pregnancy and breast-feeding

If you are pregnant, planning a family, or breast-feeding ask your doctor or pharmacist for advice before taking any medicine. If you have already told your doctor then follow any instructions that may have been given to you.

Driving and using machines

Human Albumin Biotest 20% has no known effects on the ability to drive or use machines.

How You Are Given Human Albumin Biotest 20%

Human Albumin Biotest 20% treatment will usually be given in hospital by a doctor or a nurse.

Human albumin can be given directly into a vein or diluted in 0.9% sodium chloride.

Dosage and Frequency of Administration

The amount of Human Albumin Biotest 20% you receive depends on your size, the illness, and on fluid or protein losses.

Your doctor will calculate the dose of Human Albumin Biotest 20% and how often you will receive it to obtain the correct levels in your blood.

If you are given more Human Albumin Biotest 20% than you should

This is very unlikely but your doctor will know what to do if this happens.If you have any further questions on the use of the product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Human Albumin Biotest 20% can cause side effects, although not everybody gets them.

The following side effects have been reported:

• flush,


• urticaria (nettle rash),


• fever and nausea (feeling sick).

These occur rarely.

Very rarely, severe reactions such as shock may occur. If this happens the infusion will be stopped and the appropriate treatment will be started.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Human Albumin Biotest 20%

Human Albumin Biotest 20% should be kept in the outer carton to protect it from light.

Human Albumin Biotest 20% should not be stored above 25ºC.

Do not freeze. Keep out of the reach and sight of children.

Do not use Human Albumin Biotest 20% after the expiry date which is stated on label and outer carton. The expiry date refers to the last day of that month.

The product, once opened, should be used immediately.

Immediately before administration, check that the solution is clear. The product must not be used if any cloudiness or particles are visible.

Medicines should not be disposed of via wastewater or household water. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Human Albumin Biotest 20% contains:

Each vial with 50 ml solution contains 10 g of human plasma protein.

Each vial with 100 ml solution contains 20 g of human plasma protein.

It also contains the other ingredients caprylate, N-acetyl-DL-tryptophanate, sodium ions, and water for injections.

What Human Albumin Biotest 20% looks like and contents of the pack

A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

Glass vial with 50 ml

Glass vial with 100 ml

Marketing Authorisation Holder and Manufacturer

Biotest Pharma GmbH

Landsteinerstraße 5

63303 Dreieich

Germany

Tel.:+49 6103 801-0

Fax:+49 6103 801-150 und -727
mail@biotest.de

For any information about this medicine, please contact your local representative of the Marketing Authorisation Holder:

Biotest (UK) Ltd.

28 Monkspath Business Park

Highlands Road

Shirley

Solihull

West Midlands

B90 4NZ

Tel:+44(0)121 733 3393

Fax:+44(0)121 733 3066

biotestuk@biotestuk.com

PL 04500/0012

POM

This medicinal product is authorised in the Member States of the EU under the following trade names:

Austria: Albiomin 200 g/l

Bulgaria: Albiomin 20% (200 g/l)

Germany: Albiomin 20% (200 g/l)

Greece: Albiomin 20% (200 g/l)

Hungary: Human Albumin Biotest 200 g/l

Italy: Albiomin 20% (200 g/l)

Malta: Albiomin 20% (200 g/l)

Poland: Albiomin 20% (200 g/l)

Portugal: Albiomin 20% (200 g/l)

Romania: Albiomin 20% (200 g/l)

Spain . Albiomin 20% (200 g/l)

UK: Human Albumin Biotest 20%

This leaflet was last approved in February 2009.

Depixol Tablets 3 mg

Depixol Tablets 3 mg coated tablets

Flupentixol

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again


• If you have further questions, please ask your doctor or pharmacist


• This medicine has been prescribed for you. Do not pass it on to others
  
  It may harm them, even if their symptoms are the same as yours


• If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1. What Depixol Tablets are and what they are used for

2. Before you take Depixol Tablets

3. How to take Depixol Tablets

4. Possible side effects

5. How to store Depixol Tablets

6. Further information

What Depixol Tablets Are And What They Are Used For

How do Depixol Tablets work?

Depixol Tablets belong to a group of medicines known as antipsychotics (also called neuroleptics). These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

What are Depixol Tablets used for?

Depixol Tablets are used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Depixol Tablets for another purpose. Ask your doctor if you have any questions about why Depixol Tablets have been prescribed for you.

Before You Take Depixol Tablets

Do not take Depixol Tablets if you

• are allergic (hypersensitive) to flupentixol, other thioxanthine drugs or antipsychotic drugs or any of the other ingredients of Depixol Tablets (see What Depixol Tablets contain). Consult your doctor if you think you might be


• are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation


• are excited or agitated

Take special care with Depixol Tablets if you

• have a heart condition, including an irregular heart beat (such as a


• slower heart beat); have had a recent heart attack or have problems


• that cause ankle swelling or shortness of breath


• have severe breathing problems (such as asthma or bronchitis)


• have liver, kidney or thyroid problems


• suffer from epilepsy, or have been told that you are at risk of having fits


• (for example because of a brain injury or because of alcohol withdrawal)


• suffer from Parkinson's disease, or myasthenia gravis (a condition causing severe muscular weakness)


• have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)


• suffer from glaucoma (raised pressure within the eye)


• have risk factors for stroke (e.g. smoking, hypertension)


• have too little potassium or magnesium in your blood or a family history of irregular heart beats


• use other antipsychotic medicines


• suffer from diabetes


• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

Please talk to your doctor, even if these statements were applicable to you at any time in the past.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself


• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.

You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Taking other medicines

The following medicines should not be taken at the same time as Depixol Tablets:

• Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)


• Other antipsychotic medicines

Medicines may affect the actions of other medicines and this can sometimes cause serious adverse reactions. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

• Tricyclic antidepressants


• Barbiturates or other medicines that make you feel drowsy


• Anticoagulant drugs used to prevent blood clots (e.g. warfarin)


• Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines)


• Metoclopramide (used to treat nausea and other stomach conditions)


• Piperazine (used to treat worm infections)


• Levodopa or other medicines used to treat Parkinson's disease


• Sibutramine (used to reduce appetite)


• Digoxin (to control heart rhythm)


• Corticosteroids (e.g. prednisolone)


• Medicines used to lower the blood pressure such as hydralazine, alpha


• blockers (e.g. doxazosin) beta-blockers, methyldopa, clonidine or guanethidine


• Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)


• Medicines known to increase the concentration of flupentixol in your blood


• Medicines used to treat epilepsy


• Medicines used to treat diabetes

Depixol Tablets can reduce the effect of adrenaline (epinephrine) and similar drugs.

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Depixol Tablets can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

Do Depixol Tablets interact with alcohol?

Depixol Tablets may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Depixol Tablets.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or think you might be pregnant, tell your doctor. Depixol Tablets should not be used during pregnancy unless clearly necessary.

Your newborn baby might show side effects if this medicine is used.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. If you are breastfeeding, ask your doctor for advice. Depixol Tablets should not be used when breast-feeding, as small amounts of the medicine can pass into the breast milk.

Driving and using machines

There is a risk of feeling drowsy and dizzy when being treated with Depixol Tablets, especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way.

Do not drive if you have blurred vision.

Important information about some of the ingredients in Depixol tablets

This product contains lactose and sucrose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Depixol Tablets

Always take Depixol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose varies and depends on the severity of the illness.

Adults

The usual dose is 1 to 3 tablets, twice a day. The maximum daily dose is 6 tablets (18 mg).

If you have liver problems, the level of flupentixol in your blood may be checked.

Elderly patients (above 65 years)

The initial dose is between a quarter and a half of the adult dose.

Children

Depixol Tablets are not recommended for children.

It may take between four and six months before you feel better. Your doctor will decide the duration of treatment.

If you feel that the effect of Depixol tablets is too strong or weak, talk to your doctor or pharmacist.

It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well, because the underlying illness may persist for a long time. If you stop your treatment too soon your symptoms may return.

Effects when treatment with Depixol Tablets is stopped

When you have completed your course of treatment, the dose of Depixol is usually reduced gradually.

Stopping this medicine quickly may cause symptoms such as dizziness, nausea, vomiting, sweating, difficulty in sleeping or unusual muscle movements.

If you take more Depixol Tablets than you should

If you think that you or anyone else may have taken too many Depixol tablets contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning.

Take the Depixol container with you if you go to a doctor or hospital.

Symptoms of overdose may include:

• Drowsiness


• Unconsciousness


• Muscle movements or stiffness


• Fits


• Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness


• High or low body temperature


• Changes in heart beat including irregular heart beat or slow heart rate

If you forget to take your Depixol Tablets

If you forget to take a dose, take the next dose at the right time. Do not take a double dose to make up for the missed tablets.

Possible Side Effects

Like all medicines, Depixol Tablets can cause side effects, although not everybody gets them. Elderly patients tend to be more likely to suffer from some of these effects than younger patients and this may mean your treatment is supervised more closely.

Serious side effects

Stop taking Depixol and seek medical advice immediately if you have any of the following allergic reactions:

• Difficulty in breathing


• Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or breathing


• Severe itching of the skin (with raised lumps)

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

• High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and fast heart rate.
  
  These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Depixol and similar medicines


• Unusual movements of the mouth and tongue as these may be early signs of a condition known as tardive dyskinesia


• Unusual muscle movements (such as circular movements of the eyes), stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called "extra-pyramidal" reaction


• In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death


• Any yellowing of the skin and the white in the eyes jaundice); your liver may be affected

Other side effects

Side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment.

• Throbbing or fast heartbeats


• Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes


• Drowsiness


• Loss of co-ordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)


• Tremor


• Stiff or floppy muscles


• Dizziness


• Headache


• Poor concentration or confusion


• Rigidity of the whole body


• Speech problems


• Fits


• Blurred or abnormal vision


• Shortness of breath


• Dry mouth or increase in saliva


• Feeling sick or vomiting


• Indigestion or stomach pain


• Flatulence (wind), constipation or diarrhoea


• Abnormal urination (such as decrease in the frequency or amount)


• Increased sweating or greasy skin


• Itching, rashes or skin reactions (including sensitivity to sunlight)


• Muscle pain


• Raised blood levels of glucose or the hormone prolactin


• Loss of control of blood sugar levels


• Changes in appetite or weight


• Low blood pressure


• Hot flushes


• General weakness or pain, tiredness or feeling unwell


• Abnormal liver function tests


• Unexpected excretion of breast milk


• Insomnia


• Depression


• Nervousness or agitation


• Reduction in your sex drive


• Men may experience breast enlargement or problems with ejaculation or erections


• Women may experience an absence of menstrual periods

As with other medicines that work in a way similar to flupentixol (the active ingredient of Depixol Tablets), rare cases of the following side effects have been reported:

• Slow heartbeat and abnormal ECG heart tracing


• Life threatening irregular heart beats

In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Depixol Tablets

• Keep Depixol Tablets in the original container out of the reach and sight of children


• Do not use these tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month


• Store Depixol tablets below 25°C and protect them from light and moisture

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Depixol Tablets contain

The active substance is flupentixol dihydrochloride.

Each tablet contains 3 mg of flupentixol.

The other ingredients are potato starch, lactose, gelatin, talc, magnesium stearate, sucrose and the yellow colour E172 (iron oxide).

What Depixol Tablets looks like and contents of the pack

Depixol Tablets are round, yellow, sugar-coated tablets and are available in grey plastic bottles containing 100 tablets.

The tablets are manufactured by:

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Copenhagen

Denmark

For any information about this medicine, please contact the Marketing Authorisation holder:

Lundbeck Limited

Lundbeck House

Caldecotte Lake Business Park

Caldecotte

Milton Keynes

MK7 8LF

UK

This leaflet was last approved in January 2010.