1 NAME OF THE MEDICINAL PRODUCT

Lemsip Max All In One Breathe Easy Powder for Oral Solution Lemsip Cough Max for Chesty Cough & Cold Powder for Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet (4.8g) contains:

Paracetamol 1000mg Guaifenesin 200mg Phenylephrine Hydrochloride 12.2mg Excipients:

Each sachet of this product contains:

61.5mg Aspartame - a source of phenylalanine

1973.3mg of sucrose

129.0mg (5.6mmol) of sodium

Also contains lactose and sulphite

For full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution Pale yellow powder.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of symptoms of colds 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

Oral administration after dissolution in water.

Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweetened to taste.

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

Not to be given to children under 12 years of age without medical advice.

Contraindications

Hypersensitivity to any of the ingredients

Severe coronary heart disease and cardiovascular disorders

Hypertension

Hyperthyroidism

Concurrent use of monamine oxidase inhibitors (MAOI)

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 non-cirrhotic alcoholic liver disease.

Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

This product contains 1973.3mg sucrose per dose (total sugars 2g). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains 129.0mg (5.6mmol) sodium per dose - to be taken into consideration for patients on a controlled sodium diet.

The following warnings will appear on the package label and/or leaflet:

Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

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 NOT EXCEED THE STATED DOSE.

CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Keep out of the reach and sight of children.

If symptoms persist, consult your doctor.

DO NOT TAKE IF: allergic to any of the ingredients, if you have heart disease or high blood pressure.

Do not store above 25^oC Store in the original package.

This medicinal product contains 129.0mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Contains sulphite; may rarely cause severe hypersensitivity reactions and bronchospasm.

If you are pregnant or are being prescribed medicine by your doctor, seek

his advice before taking this product.

Also includes aspartame, sucrose, lactose, sulphite and sodium.

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.

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.

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 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 breast-feeding.

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 preeclampsia. 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

This medicine 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 and vomiting, probably only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and 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.

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

(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 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 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.

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.

5.1    Pharmacodynamic Properties

Pharmacotherapeutic group: Analgesics, Anilides;

ATC Code: N02B E51. Paracetamol, combinations excl. psycho leptics

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 sympathomimetic post-synaptic a1-adrenergic receptor agonist with low cardioselective beta receptor affinity and minimal central nervous stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

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

The active ingredients are not known to cause sedation.

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'A 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 rapidly metabolised by oxidation to l-(2 methoxy-phenoxy) lactic acid; which is excreted in the urine. Within 3 hours, approximately 40% of a single dose is excreted in the urine as this metabolite. The half-life in plasma is approximately 1 hour. Guaifenesin may increase the rate of absorption of paracetamol.

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

Ascorbic acid Sucrose Citric acid Sodium citrate Lemon flavour no. 1 Aspartame (E951)

Saccharin sodium

Curcumin WD (curcumin (E100), Lactose, Polysorbate 80 (E433) and Silica (E551)).

6.2 Incompatibilities

None known.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Heat-sealed sachet of paper/polyethylene/aluminium foil/ polyethylene laminate in an outer cardboard carton.

Packs: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 sachets.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0538

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/09/2008

10    DATE OF REVISION OF THE TEXT

19/04/2016

11    DOSIMETRY (IF APPLICABLE)

N/A

12 INSTRUCTIONS FOR PREPARATION OF

RADIOPHARMACEUTICALS (IF APPLICABLE)

N/A