1. Name Of The Medicinal Product
Lemsip Max Day & Night Cold & Flu Relief Capsules.
2. Qualitative And Quantitative Composition
Red and yellow Day capsule:
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Red and blue Night capsule:
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For full list of excipients see section 6.1.
3. Pharmaceutical Form
Capsule, hard.
Day capsule:
Red/yellow hard gelatin capsules containing a white free flowing powder.
Night capsule:
Red/blue hard gelatin capsules containing a white free flowing powder.
4. Clinical Particulars
4.1 Therapeutic Indications
Day Capsule:
For the relief of symptoms associated with the common cold and influenza including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and lowering of temperature.
Night Capsule:
For the relief of symptoms associated with colds and influenza including relief of aches and pains, sore throat, headache, lowering of temperature and the symptoms associated with nasal congestion to help allow sleep through relief of nasal congestion.
4.2 Posology And Method Of Administration
Adults and children 12 years and over:
Two red and yellow capsules every 4-6 hours during the day to a maximum of 3 doses.
Do not exceed 6 red and yellow capsules in any 24 hours.
Two blue and red capsules to be taken at night.
Do not exceed 8 capsules in total in any 24 hours.
Do not give to children under 12 years.
Swallow whole with water. Do not chew.
4.3 Contraindications
Hypersensitivity to any of the other constituents.
Phenylephrine hydrochloride: Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Use with caution in patients with Raynaud's Phenomenon and diabetes mellitus.
Caffeine: Should be given with care to patients with a history of peptic ulcer.
Phenylephrine
Phenylephrine should be used with care in patients with cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Paracetamol
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Medicinal products which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose.
Phenylephrine hydrochloride
Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).
Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).
Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine (see section 4.3).
Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.
Caffeine
Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450, factors known to alter the activity of this enzyme system may influence caffeine clearance. Thus, caffeine elimination is enhanced in cigarette smokers and inhibited by cimetidine, disulfiram, and oral contraceptive steroids.
4.6 Pregnancy And Lactation
Paracetamol
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
Caffeine
Taken during pregnancy it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum.
Phenylephrine hydrochloride
The safety of this medicine during pregnancy and lactaction has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.
4.7 Effects On Ability To Drive And Use Machines
Lemsip Max Day & Night Cold & Flu Relief Capsules has no or negligible influence on ability to drive or use machinery.
4.8 Undesirable Effects
Paracetamol
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Acute pancreatitis after ingestion of above normal amounts.
Phenylephrine hydrochloride
High blood pressure with headache and vomiting, probably only in overdose. Rarely palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.
Caffeine
The most commonly reported adverse events following dosing with caffeine are GI irritation and CNS stimulation. Adverse CNS effects include insomnia, restlessness, nervousness and mild delirium; adverse GI effects include nausea, vomiting and gastric irritation.
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g of more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient:
(a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
(b) Regularly consumes ethanol in excess of recommended amounts.
Or
(c) Is likely to be glutathione depleted, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines. See BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms - emesis and convulsions may occur. No specific antidote. However, treatment is usually fluid therapy. Fatal poisoning is rare. If symptoms become apparent or overdose is suspected, consult a doctor immediately.
Phenylephrine hydrochloride
Features of severe overdose of phenylephrine include haemodynamic changes and cardio-vascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent.
Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).
Additional symptoms may include, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicinal products such as phentolamine.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code: NO2B E51
Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.
Caffeine: Caffeine is a central nervous system stimulant. It inhibits the enzyme phosphodiesterase and has an antagonistic effect at central adenosine receptors. Its action on the central nervous system is mainly on the higher centres and it produces a condition of wakefulness and increased mental activity.
Phenylephrine hydrochloride: Phenylephrine is a post-junctional alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.
5.2 Pharmacokinetic Properties
Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.
Caffeine: Caffeine is absorbed readily after oral, rectal or parenteral administration, but absorption from the gastro-intestinal tract may be erratic. There is little evidence of accumulation in any particular tissue. Caffeine passes readily into the central nervous system and into saliva. Concentrations have also been detected in breast milk. It is metabolised almost completely and is excreted in the urine as 1-methyluric acid, 1-methylxanthine and other metabolites with only about 1% unchanged.
Phenylephrine hydrochloride: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SmPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Day & Night Capsule
Capsule contents:
Maize starch
Croscarmellose sodium
Sodium laurilsulfate
Magnesium stearate
Sterilised talc
Capsule shell:
Gelatin
Titanium dioxide (E171)
Quinoline yellow (E104)
Patent blue V (E131)
Erythrosine (E127)
Printing ink:
Shellac
Aluminium hydroxide.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
250 micron opaque uPVC/20 micron aluminium foil, heat-seal coated, with a perforated "push-through" Pill Protect (TM) self-adhesive paper label applied to the foil side, contained in an outer cardboard carton.
Pack sizes: 24 capsules.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom.
8. Marketing Authorisation Number(S)
PL 00063/0529
9. Date Of First Authorisation/Renewal Of The Authorisation
13/10/2009
10. Date Of Revision Of The Text
10/08/2011
