Lemsip Max Blackcurrant Flavour Tablets

1. Name Of The Medicinal Product

Lemsip Max Blackcurrant Flavour Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 500 mg of paracetamol and 6.10 mg of phenylephrine hydrochloride.

Excipients:

Each tablet contains 40 mg of aspartame.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Tablet.

A convex pale purple oval shaped tablet with blackcurrant odour.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Adults (16 years and over): Two tablets every 4-6 hours to a maximum of four doses in any 24 hours.

Do not exceed eight tablets in any 24 hours.

Children 12-15 years: One tablet every 4-6 hours to a maximum of four doses in any 24 hours.

Do not exceed four tablets in any 24 hours.

Swallow whole with water. Do not chew.

OR

Oral administration after dissolution in water.

Adults 16 years and over: Two tablets dissolved by stirring in half a mug of hot, not boiling water and sweetened to taste.

Dose may be repeated in 4-6 hours. No more than four doses (eight tablets) should be taken in 24 hours.

Children 12 – 15 years: One tablet dissolved by stirring in half a mug of hot, not boiling water and sweetened to taste.

Dose may be repeated in 4-6 hours to a maximum of four doses in any 24 hours. Do not exceed four doses (four tablets)

Once prepared the drink should be taken as soon as possible and should not be stored.

Not recommended for children under 12 years of age.

4.3 Contraindications

Paracetamol : Hypersensitivity to paracetamol or any 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

Use with caution in patients with Raynaud's phenomenon or diabetes mellitus.

Patients with prostatic hypertrophy may have increased difficulty with micturition.

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.

Label: Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do no exceed the stated dose. Keep out of the reach and sight of children. Contains paracetamol (panel). If symptoms persist consult your doctor. If you are pregnant or are being prescribed medicine by your doctor, seek their advice before taking this product. Do not take with any other paracetamol-containing products. The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes, i.e. orally and topically (nasal, aural and eye preparations).

Due to its aspartame content this medicinal product should not be given to patients with phenylketonuria.

Phenylephrine should be used with care in patients with closed angle glaucoma and prostatic enlargement.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers. Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxity of paracetamol, particularly after overdosage. Not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

4.6 Pregnancy And Lactation

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 breast feeding.

Due to the vasoconstrictive properties of phenylephrine, the product should be used in caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh the risk. There is no information on use in lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Phenylephrine hydrochloride: High blood pressure with headache, vomiting and rarely, palpitations. Also, rare reports of allergic reactions.

4.9 Overdose

Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or 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, primadone, 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 of paracetamol overdosage 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5 g or more of paracetamol in the proceeding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcystine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code

N02BE51 – paracetamol, combinations excluding psycholeptics

Paracetamol: 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.

Phenylephrine: phenylephrine is a post-synaptic 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 readily after taking the product and is detected in the plasma within 5 minutes or oral dosing. The pharmacokinetic model shows faster absorption seen over the first 30 minutes for the product compared to a standard does of two paracetamol tablets, however, the overall extent of absorption of both products remains the same. Actual mean plasma levels at each time point show the time to achieve a level of 5 µg/ml is less than 14 minutes, compared to 22 minutes for standard paracetamol tablets; the speed to achieve 10 µg/ml being 19 minutes versus 30 minutes.

The median time to maximum plasma concentration (t_max) was 35 minutes which was the same as a standard dose of two tablets of 500 mg paracetamol.

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.

Phenylephrine: Phenylephrine is absorbed from the gastro-intestinal 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 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 findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose

Crospovidone

Citric acid

Aspartame

Enocyanine

Blackcurrant flavour

Magnesium stearate

Povidone

Pre-gelatinised maize starch

6.2 Incompatibilities

None known

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

Tablets are packed in blister trays of cold-form aluminium base and peelable paper/aluminium laminate lidding.

Pack sizes: 6 tablets and 12 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, East Yorkshire

8. Marketing Authorisation Number(S)

PL 00063/0553

9. Date Of First Authorisation/Renewal Of The Authorisation

04/06/2010

10. Date Of Revision Of The Text

04/06/2010