4.1. Therapeutic indications

For the symptomatic relief of acute chesty coughs and catarrh associated with influenza, colds and mild throat infections.

4.2. Posology and method of administration

Glass bottle - Adults and children 12 years and over:

One or two 5 ml spoonfuls to be taken and swallowed slowly every four to six hours.

PETE plastic bottle - Adults and children 12 years and over:

5 ml (fill the measure cup to 5 ml) or 10 ml (fill measure cup to 10 ml) every 4 – 6 hours. To be taken every 4 – 6 hours up to a maximum of 4 doses in any 24-hour period. Rinse the measure cup after use.

Children aged 6 to 12 years: Not recommended.

Children under 6 years: This product is contraindicated in children under 6 years of age.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4. Special warnings and precautions for use

Ask your doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash, or persistent headache.

Do not take with a cough suppressant.

Use with caution in patients suffering from porphyria.

Not suitable for children under 12 years of age.

This medicine contains less than 1 mmol sodium (23mg) per dose, that is to say essentially 'sodium-free'.

This medicinal product contains 9.0% v/v of ethanol, i.e., this medicine contains 0.38 mg of alcohol (ethanol) in each 5ml dose, the amount in a 5ml dose of this medicine is equivalent to less than 1ml of beer or 1ml of wine.​ The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 2.5mg sorbitol in each 5ml dose.​ Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.​ Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

4.5. Interaction with other medicinal products and other forms of interaction

Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.

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

No known contraindications.

There is limited amount of data from the use of Guaifenesin in pregnant women.

There is no information on use in lactation.

Therefore, it should not be used during pregnancy or breastfeeding unless advised by a doctor or a pharmacist.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Adverse events which have been associated with guaifenesin and cetylpyridinium chloride 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

Immune system disorders

Not known

Hypersensitivity reactions

Gastrointestinal disorders

Not known

Abdominal discomfort, nausea, vomiting and diarrhoea.

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 or search for the MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Very large doses may cause nausea and vomiting. Prolonged use of guaifenesin may result in urolithiasis. It is however, rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.