BUTAMIRATE Syrup Ref.[9890] Active ingredients: Butamirate

Source: European Medicines Agency (EU) 

4.1. Therapeutic indications

Symptomatic treatment of dry, irritant cough of any aetiology.

4.2. Posology and method of administration

Posology

Children 3-6 years: 5 ml 3 times daily.

Children 6-12 years: 10 ml 3 times daily.

Adolescents over 12 years: 15 ml 3 times daily.

Adults: 15 ml 4 times daily.

The maximum duration of treatment without medical advice is 7 days (see section 4.4).

Method of administration

This product should be taken orally.

The enclosed measuring cup should be used for proper dosing. The measuring cup should be washed and dried after each use.

4.9. Overdose

Symptoms

Butamirate overdose may lead to the following symptoms: drowsiness, dizziness, nausea, vomiting, diarrhoea, hypotension.

Management

Gastric lavage and administration of activated charcoal in order to eliminate the medicine and reduce the degree of absorption in the gastrointestinal tract are the first therapeutic measures in suspected or established overdose with this product. Measures to maintain the function of cardiovascular and respiratory systems and administration of appropriate symptomatic agents should be considered, if needed. No specific antidote is known.

6.3. Shelf life

Shelf life: 2 years.

After first opening: 6 months.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5. Nature and contents of container

Amber glass bottle or polyethylene terephthalate bottle with child-proof HDPE screw cap with outer PP cap, PP measuring cup, carton box.

Pack size: 100 ml or 200ml.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

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

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