Lemsip Cough Max For Mucus Cough And Cold Oral Solution

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lemsip Cough Max for Mucus Cough and Cold Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 20ml dose contains:

Paracetamol 1000mg Phenylephrine Hydrochloride 12.18mg Guaifenesin 200mg Cetylpyridinium Chloride 3.0mg

Each 20ml dose also contains potassium 23mg, sodium 19mg, propylene glycol 4300mg, sorbitol 3000mg, maltitol liquid 2000mg and ethanol 3000mg.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral Solution

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the short term symptomatic relief of the symptoms of colds and influenza,

including aches and pains, headache, nasal congestion, tickly sore throat and chesty coughs.

4.2 Posology and method of administration

For oral administration.

It is important to shake the bottle for at least 10 seconds before use.

Adults (16 years and over).

Fill the measure cup to the 10ml or 20ml mark and take one dose.

Wipe the neck of the bottle clean and replace the cap securely, without overtightening it. Rinse the measure cup after use.

Leave at least 4 hours between doses, and do not take more than 4 doses in any 24 hours.

For short term use only.

If symptoms do not go away talk to your doctor.

Do not exceed the stated dose. Do not give to children under 16 years of age_

4.3 Contraindications

Hypersensitivity to any of the active substances or any other ingredients. Contra-indicated during pregnancy.

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

The label should contain the following statements:

• Contains paracetamol.

• Do not give this medicine with any other paracetamol-containing product.

• For oral use only.

• Never give more medicine than shown in the table.

• Do not overfill the measuring cup

• Always use the measuring cup supplied with the pack.

• Do not give more than 4 doses in any 24 hour period.

• Leave at least 4 hours between doses.

• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

• Do not store above 25°C. Store in the original package.

• Keep out of the reach and sight of children.

• 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 (leaflet).

• This product is not suitable for long term use.

• Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

• Do not take with other cold or decongestant medicines or any other paracetamol-containing products.

• Use with caution in patients with Raynaud's phenomenon.

• Phenylephrine should be used with care in patients with, diabetes mellitus, closed angle glaucoma and prostatic enlargement.

• Do not exceed the stated dose.

• If symptoms persist consult your doctor.

Each 20ml dose contains 2g Liquid Maltitol and approximately 3g of Sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This product may have a mild laxative effect.

This product contains 19% (v/v) ethanol. Each 20ml dose contains up to 3g of ethanol (alcohol) equivalent to 32ml of wine or 76ml of beer. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high-risk groups such as patients with liver disease, epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines. The amount of alcohol in this medicinal product may impair the ability to drive or use machines.

This product contains propylene glycol, which may cause alcohol-like symptoms.

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 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.

Guaifenesin

Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid.

4.6 Fertility, 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.

Phenylephrine hydrochloride

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 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.

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. The product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects on ability to drive and use machines

Lemsip Cough Max for Mucus Cough and Cold Oral Solution 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, 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, vomiting probably only in overdose. 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: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of five 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

Symptoms:

Symptoms of paracetamol overdosage 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 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.

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.

Guaifenesin: Very large doses may cause nausea and vomiting. The drug 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: R05X

Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis. It is effective against pain of mild to moderate severity, but is less successful against chronic pain.

Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effect on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. It may be given orally to relieve nasal congestion.

Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.

Cetylpyridinium Chloride is a cationic disinfectant with properties and uses similar to other cationic surfactants. These surfactants have bactericidal activity against Gram-positive and, at higher concentration against some Gram-negative organisms. Cetylpyridinium Chloride may be used in a variety of preparations for the local treatment of minor infections.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 4 hours.

Phenylephrine hydrochloride is irregularly absorbed after oral administration and undergoes first-pass metabolism by monoamine oxidase in the gut and liver, resulting in reduced bioavailability. Peak plasma concentrations are achieved in 1 to 2 hours. It is excreted in the urine mainly as the sulphate conjugate, with less than 20% as unchanged drug.

Guaifenesin is rapidly absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to P-(2 methoxy-phenoxy) lactic acid, which is excreted in the urine.

Cetylpyridinium Chloride has only a local effect.

5.3 Preclinical safety data

There are no preclinical safety data on these active ingredients in the literature of relevance to the prescriber or to the recommended dosage and use of the product which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Maltitol (E965) Sorbitol (E420)

Ethanol

Propylene Glycol (E1520) Glycerol (E422)

Saccharin Sodium (E954) Sodium Cyclamate (E952) Acesulfame Potassium (E950) Sodium Citrate (E331) Anhydrous Citric Acid (E330) Xanthan Gum (E415) Levomenthol Eucalyptus Oil Quinoline Yellow (E104) Patent Blue V (E131)

Purified Water

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

2 Years.

6.4 Special precautions for storage

Do not store above 25°C.

Keep the container in the outer carton.

Keep the container tightly closed.

6.5 Nature and contents of container

Clear type III glass bottle and polypropylene child resistant closure with aluminium foil film liner containing 160ml.

Clear PET bottle and polypropylene child resistant closure with aluminium foil film liner containing 160ml.

Graduated polypropylene measuring cup

6.6 Special precautions for disposal

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0712

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/01/2015

10 DATE OF REVISION OF THE TEXT

29/01/2015