It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 1/12/2016

Lemsip Max Cough & Cold, Powder for Oral Solution, Paracetamol 1000mg, Guaifenesin 200mg

1. NAME OF THE MEDICINAL PRODUCT

Lemsip Max Cough & Cold

Powder for Oral Solution

Paracetamol 1000mg

Guaifenesin 200mg.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

mg/sachet

Paracetamol

1000.0

Guaifenesin

200.00

Excipients with known effect:

Also contains sucrose 1,985mg, sodium 129mg, aspartame 61.5mg, and lactose <11.4mg per sachet.

For the full list of excipients, see Section 6.1.

3. PHARMACEUTICAL FORM

Powder for oral solution. Pale yellow powder with the odour and taste of lemons.

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, chesty coughs and lowering of temperature.

4.2 Posology and method of administration

Duration of treatment should be limited to a maximum of 3 days. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days.

Should not be used with other paracetamol-containing products, decongestants, or cold and flu medicines.

Posology:

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 without medical advice.

Hepatic Impairment: Patients with hepatic impairment should seek the advice of a doctor before taking this product (see Section 4.4)

Renal Impairment: Patients with renal impairment should seek the advice of a doctor before taking this product (See Section 4.4)

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

Method of Administration:

For oral administration after dissolution in hot water.

4.3 Contraindications

Hypersensitivity to paracetamol, guaifenesin or any of the excipients listed in Section 6.1

4.4 Special warnings and precautions for use

Serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported very rarely in association with paracetamol. These severe hypersensitivity reactions are potentially life threatening. The product should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Use with caution in patients with diabetes. Each sachet contains approximately 2 g of carbohydrate.

Patients with hepatitis, non-cirrhotic alcohol liver disease, hepatic insufficiency or renal insufficiency are at an increased risk of adverse reactions associated with paracetamol use. These patients should seek the advice of a doctor before taking this product.

Should not be taken with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage (see section 4.9).

Contains paracetamol (panel). Total sugars 2 g.

Contains aspartame (E951, sweetener); patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. Contains a source of phenylalanine which may be harmful for people with phenylketonuria.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains a source of phenylalanine. May be harmful for people with phenylketonuria. This medicinal product contains 129mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

Anticoagulants: 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.

Guaifenesin may increase the rate of absorption of paracetamol.

Antiemetics: The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.

Cholestyramine: The speed of absorption of paracetamol may be reduced by cholestyramine.

Laboratory Interference: 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 Use in pregnancy and lactation

Pregnancy

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

There are limited data on the use of guaifenesin in pregnant women.

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

Breast-feeding

Available published data does not contraindicate breast-feeding, however the product should be avoided during lactation unless recommended by a healthcare professional.

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

Paracetamol is excreted in breast milk, but not in a clinically significant amount.

Fertility

No know effects.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Adverse effects of paracetamol are rare.

Adverse events which have been associated rarely with paracetamol and guaifenesin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Blood and Lymphatic System Disorders

Not known

Thrombocytopenia a

Agranulocytosis a1

Gastrointestinal Disorders

Not known

Abdominal discomfort b

Nausea b

Vomiting b

Skin and Subcutaneous Tissue Disorders

Not known

*Steven-Johnson Syndrome a

*Toxic Epidermal Necrolysis a

*Acute generalised exanthematous pustulosis a2

Skin rash a

Description of Selected Adverse Reactions

1 There have been occasional reports of blood dyscrasias, including thrombocytopenia and agranulocytosis

2 Very rare cases of serious skin reactions have been reported (see Section 4.4)

*Severe Cutaneous Adverse Reactions (SCARs) including the 3 hypersensitivity skin disorders: Steven-Johnson Syndrome, Toxic Epidermal Necrolysis and Acute generalized exanthematous pustulosis.

Active Ingredients

a Paracetamol

b Guaifenesin

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

4.9 Overdose

The main cause for concern in overdosage with this product is paracetamol intake.

Paracetamol: There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition. Overdosing may be fatal in these cases. Symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor and abdominal pain.

Overdose of paracetamol in a single administration in adults or in children causes liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration.

Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity.

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 deplete, e.g. eating disorders, cystic fibrosis, HIV infections, starvation, cachexia.

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration

Gastric lavage

IV (or oral if possible) administration of the antidote N-acetylcysteine as soon as possible and before the 10th hour of the overdose in accordance with National guidelines.

Symptomatic treatment should be implemented.

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

Pharmacotherapeutic group: Analgesics, Anilides

ATC Code: N02BE51

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.

Guaifenesin: Guaifenesin is an expectorant which increases the volume of mucous that can be expelled by mucocilliary action due to a reduction in the adhesiveness and 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 T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract after oral administration and rapidly metabolized by oxidation to beta-(2-methoxyphenoxy)-lactic acid. 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

None available specific to the product.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ascorbic acid

Sucrose

Citric acid anhydrous

Sodium citrate

Lemon flavour no. 1

Aspartame (E951)

Saccharin sodium

Curcumin WD powder

Lactose

Polysorbate 80

Silica

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

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

Packs: 5 sachets.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited,

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland.

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/28/1.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22/06/2007

Date of last renewal: 22/06/2012

10. DATE OF REVISION OF THE TEXT

November 2016

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.