FLAVAMED HUSTENSAFT Oral solution Ref.[6243] Active ingredients: Ambroxol

Posology

The following dosages are recommended for Flavamed Hustensaft:

Children from 2 to 5 years: ½ a measuring spoon each with 2.5 ml oral solution is taken 3 times daily (equivalent to 22.5 mg ambroxol hydrochloride/day).

Children from 6 to 12 years: 1 measuring spoon each with 5 ml oral solution is taken 2-3 times daily (equivalent to 30 – 45 mg ambroxol
hydrochloride/day).

Adults and adolescents from 12 years: As a rule, 2 measuring spoons each with 5 ml oral solution are taken 3 times daily (equivalent to 90 mg ambroxol hydrochloride/day) during the first 2 to 3 days, then 2 measuring spoons each with 5 ml oral solution are taken 2 times daily (equivalent to 60 mg ambroxol hydrochloride/day).

Note: The dose in adults can be increased up to 60 mg 2 times daily (equivalent to 120 mg ambroxol hydrochloride/day), where appropriate.

See Section 4.4 for dosage in renal and hepatic diseases.

Paediatric population

See Section 4.3 for use in children under 2 years.

See Section 4.4 for use in children from 2-4 years.

Method and duration of administration

Flavamed Hustensaft is for oral use.

Flavamed Hustensaft is taken after meals with the aid of the measuring spoon.

Flavamed Hustensaft should not be taken for longer than 4-5 days without the advice of a doctor.

Symptoms of an overdose

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

Therapeutic measures in overdose

Acute measures such as instituting vomiting and gastric lavage are not generally indicated and are to be considered only in extreme overdose. A symptomatic therapy is recommended.

Shelf life: 3 years.

After first opening of the bottle: 6 months.

This medicinal product does not require any special storage conditions.

Amber glass bottle (glass type III) with a screw cap, a tamper evident closure and a measuring spoon

The screw cap is made from polypropylene. Colour concentrate white serves as colouring agent.

A 5 ml measuring spoon with ¼ and ½ graduation is part of the product. The measuring spoon is made from polypropylene.

Pack sizes:

• 1 × 60 ml of oral solution
• 1 × 100 ml of oral solution

Not all pack sizes may be marketed.

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