FLUIBRON Syrup (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

FLUIBRON 15 mg/5 ml syrup (0.3% w/v).

2. Qualitative and quantitative composition

FLUIBRON 15 mg/5 ml syrup. 100 ml of syrup contain: ambroxol hydrochloride 0.300 g. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Syrup.

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 ...

4.3. Contraindications

Fluibron should not be used in subjects with hypersensitivity to the drug and in those with serious hepatic and/or renal impairments.

4.4. Special warnings and precautions for use

Fluibron should be administered with caution in patients with peptic ulcer. Keep out of the reach and sight of children. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson ...

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

Usually it does not interfere with other drugs.

4.6. Fertility, pregnancy and lactation

Teratogenesis and foetal toxicity studies pointed out no noxious effect of Fluibron even when given at high doses. However, the use of the product is not advisable, as for all drugs recently instituted, ...

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

At the recommended doses, the drug is generally well tolerated. Seldom, nausea, headache and gastrointestinal disturbances were reported. Immune system disorders Rare: hypersensitivity reactions ...

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.

5.1. Pharmacodynamic properties

Pharmaceutical group: Mucolytic ATC code: R05CB06 Ambroxol acts by regularizing mucus secretion transportation throughout the respiratory tree. Moreover, it owns a marked mucolytic and mucoregulating ...

5.2. Pharmacokinetic properties

Ambroxol bioavailability was assessed in humans after oral administration of the drug in healthy volunteers. Ambroxol was deduced to be rapidly absorbed through the intestinal tract. Its half life is 10 ...

5.3. Preclinical safety data

Acute toxicity: Fluibron acute toxicity, evaluated on small animals, showed to be very low (LD50/os in mice = 2842 mg/kg; LD50/os in rats >4000 mg/kg). Chronic toxicity: the ...

6.1. List of excipients

Liquid non-crystallizing sorbitol, glycerol, citric acid monohydrate, benzoic acid, sucralose, raspberry natural flavour, purified water.

6.2. Incompatibilities

See paragraph 4.5, Interaction with other medicaments and other forms of interaction.

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.

7. Marketing authorization holder

Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

8. Marketing authorization number(s)

12668

9. Date of first authorization / renewal of the authorization

22-02-1990 / 29-04-2011

10. Date of revision of the text

13/01/2021

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