LEMSIP COUGH MAX FOR MUCUS COUGH & COLD 500 MG / 100 MG / 6.1 MG CAPSULES, LEMSIP MAX ALL IN ONE COLD & FLU CAPSULES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Lemsip Max All in One Cold & Flu Capsules

Lemsip Cough Max for Mucus Cough & Cold 500mg/100mg/6.1mg Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains paracetamol 500mg, phenylephrine hydrochloride 6.1mg and guaifenesin 100mg

Excipient with known effect:

Sodium, 1.4428 mg (0.063555 mmol) per capsule

For a full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM

Capsule, hard

Capsules with a red cap and green body, printed ‘Lemsip’ on the cap in white ink, containing white, free flowing powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or worsen.

Posology

Adults, the elderly and children aged 16 years and over: Two capsules every 4–6 hours, as required.

Do not take more than 8 capsules (4 doses) in 24 hours.

Do not give to children under 16 years of age.

Elderly Population: No dosage adjustment is considered necessary in the elderly.

Method of Administration

For oral administration. Swallow whole with water. Do not chew.

4.3 Contraindications

Hypersensitivity to any of the active substances or any of the excipients listed in section 6.1.

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 (MAOI).

Concomitant use of other sympathomimetic decongestants.

Avoid in patients with prostatic enlargement.

Contraindicated in patients with phaeochromocytoma

4.4 Special warnings and precautions for use

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

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 noncirrhotic alcoholic liver disease. Do not take with any other paracetamol-containing products.

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

This medicine contains less than 1 mmol sodium (23mg) per capsule, essentially “sodium free”.

4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol

The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption may be reduced by cholestyramine.

Medicinal product which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

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.

Guaifenesin

Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid. If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6 Fertility, Pregnancy and Lactation

Pregnancy

The product should not be used during pregnancy unless recommended by a healthcare professional.

The safety of this medicine during pregnancy and lactation 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 preeclampsia.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage.

There are limited data on the use of guaifenesin in pregnant women. Guaifenesin has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy.

Breast-feeding

The product should be avoided during lactation unless recommended by a healthcare professional. There are limited data on the use of phenylephrine in lactation.

Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

There is no information on the use of guaifenesin in lactation.

Fertility

There are no available data regarding the effects of the active ingredients on fertility.

4.7 Effects on ability to drive and use machines

Lemsip Max All in One Cold and Flu 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 reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, nutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Phenylephrine hydrochloride: High blood pressure with headache, vomiting, Rarely, palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.

Guaifenesin: Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses. Also, hypersensitivity reactions may occur.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes, or

(b) Regularly consumes ethanol in excess of recommended amounts, or

© 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 to 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.

Phenylephrine hydrochloride

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alphareceptor-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, 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.

Guaifenesin

Very large doses may cause nausea and vomiting. The active substance is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: N02B E51

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 hydrochloride: 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.

Guaifenesin: Guaifenesin is an expectorant which increases the volume and reduces the viscosity of tenacious sputum.

5.2 Pharmacokinetic properties

Paracetamol: Paracetamol is absorbed rapidly and completely 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 T^ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

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.

Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

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 excipientsCapsule contents:

Maize starch

Croscarmellose sodium

Sodium laurilsulfate

Magnesium stearate

Talc

Gelatin

Titanium dioxide (E171)

Yellow iron oxide (E172)

Red iron oxide (E172)

Brilliant blue – FD&C blue 1 (E133)

Shellac (E904)

Titanium dioxide (E171)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 Years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

250 micron opaque uPVC blister with foil/paper laminate, 35 gsm paper/9 micron soft-temper foil and heat-seal coated, contained in an outer cardboard carton.

Pack sizes: 2, 4, 6, 8, 10, 12, 14 and 16.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS,

East Yorkshire, UK.

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0551.

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

10/09/2009/

01/12/2013