FLUIBRON Syrup Ref.[44646] Active ingredients: Ambroxol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

4.1. Therapeutic indications

Fluibron is indicated in the treatment of secretion impairments in acute and chronic broncho-pulmonary affections.

4.2. Posology and method of administration

Adults: at the start of treatment 10 ml 3 times daily, then 5 ml 3 times daily.

Children: up to 2 years of age: 2.5 ml twice daily; 2 to 5 years: 2.5 ml 3 times daily; over 5 years: 5 ml 3 times daily.

At the start of treatment, dosage can be increased or even doubled, according to the medical judgement. 10 ml = 30 mg. A 10 ml, 5 ml and 2.5 ml graduated measure is enclosed.

4.9. Overdose

No overdosage with Fluibron® is known so far.

Should it occur, it is advisable to induce vomit and/or apply gastric lavage.

Make sure that the patient has not concomitantly taken other drugs.

6.3. Shelf life

3 years.

The period of validity is for the unopened, correctly stored product.

6.4. Special precautions for storage

No special precaution for storage.

6.5. Nature and contents of container

Internal packaging: type III glass, amber-coloured bottle with childproof cap and measuring cap.

Outer packaging: printed thin cardboard box.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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

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