Expectorant for the treatment of coughs.

Oral administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under12 years: Do not use.

Hypersensitivity to any of the constituents.

Use in children under 12 years.

.

Should not be used with other cough and cold medicines.

Patients should consult a doctor if they are suffering from a chronic cough such as the one that occurs with smoking, asthma, chronic bronchitis or emphysema. Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

- This medicine contains 242 mg of alcohol (ethanol) in each 10 ml dose which is equivalent to 24 mg/ml (2.30% w/v). The amount in 10 ml of this medicine is equivalent to less than 6 ml beer or 3 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

- This medicine contains 12.0 mg sodium benzoate in each 10 ml dose which is equivalent to 1.2 mg/ml.

- This medicine contains 15.2 mg propylene glycol in each 10 ml which is equivalent to 1.5 mg/ml.

- This medicinal product contains 23.9 mg sodium per 10 ml, equivalent to 1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

- This medicine contains 2675 mg sorbitol per 10 ml dose which is equivalent to 267.5 mg/ml. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Alcohol

A dose of 10ml of this medicine administered to an adult weighing 70 kg would result in exposure to 3.0 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.5 mg/100 ml.

A dose of 10ml of this medicine administered to a child over 12 years of age and weighing 40 kg would result in exposure to 5.4 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.9 mg/100 ml.

For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

If pregnant or breastfeeding, consult a healthcare professional before use.

The safety of guaifenesin when used during pregnancy has not been established. Medical advice should be sought before using guaifenesin during pregnancy and it should not be used unless the potential benefit to the mother clearly outweighs the possible risk to the developing foetus.

Breastfeeding

Guaifenesin is excreted in breast milk in small quantities.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.

No or negligible influence.

Adverse reactions identified during post-marketing use are listed below by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown.

Immune System Disorders

hypersensitivity reactions, anaphylactic reactions, angioedema.

Respiratory, Thoracic and Mediastinal Disorders

Dyspnoea*

*dyspnoea has been reported in association with other symptoms of hypersensitivity.

Gastrointestinal Disorders

Nausea, vomiting, abdominal discomfort.

Skin and Subcutaneous Tissue Disorders

Urticaria, rash.

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.

In case of overdose, discontinue use and seek professional assistance immediately.

Signs and Symptoms associated with an overdose of Guaifenesin:

Nausea and vomiting

Treatment:

Appropriate supportive therapy dependent upon individual response to the preparation. Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated. Further management should be as clinically indicated or as recommended by the national poison centres where available.

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite

No relevant information additional to that already contained elsewhere in the SPC.

Glycerol

Carmellose Sodium

Sodium Benzoate (E211)

Sodium Cyclamate

Ethanol (96%)

Levomenthol

Maltitol (E965)

Sorbitol Solution 70%

Natural Cherry Flavouring

Citric Acid Anhydrous

Caramel (E150)

Acesulfame Potassium

Purified Water

Not applicable

100ml bottles: 27 months

200ml bottles: 36 months.

Do not store above 25° C.

Keep out of the sight and reach of children.

Brown glass bottle, hydrolytic class 3, containing 100 ml or 200ml with child resistant caps.

A transparent polypropylene measuring cap is also included.

No special requirements