BISOLVON Oral solution Ref.[9892] Active ingredients: Bromhexine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

4.1. Therapeutic indications

As a mucolytic in the management of viscid mucoid secretions associated with bronchitis, bronchiectasis, sinusitis.

4.2. Posology and method of administration

Oral.

Adults and children over 12 years:

Recommended total daily dose: 10 ml (8 mg) three times daily.

Recommended maximum daily dose: 15 ml (12 mg) four times daily.

The recommended maximum daily dose which may be needed at the commencement of treatment should not be exceeded.

Children over 5 to ≤12 years: Recommended total daily dose 5 ml (4 mg) four times daily.

Children 2 to ≤5 years: Recommended total daily dose 5 ml (4 mg) twice daily. The measuring cup provided should be used for dosing. BISOLVON can be taken with or without food (see section 5.2).

Additional information on specific populations

BISOLVON Oral Solution is sugar free and therefore suitable for diabetes patients.

4.9. Overdose

No specific overdose symptoms have been reported in man. Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Bisolvon at recommended doses and may need symptomatic treatment.

6.3. Shelf life

Shelf life

Unopened: 3 years.

In use: Use within 12 months of opening bottle.

6.4. Special precautions for storage

Store in the original container.

6.5. Nature and contents of container

Bisolvon Oral Solution is available in amber type III glass bottles with tamper-evident polyethylene caps with low density polyethylene liners. The registered pack sizes are 100 ml, 200 ml, and 250 ml.

Not all pack sizes may be marketed.

A polypropylene measuring dish is provided.

6.6. Special precautions for disposal and other handling

No special requirements.

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