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FLAVAMED HUSTENSAFT Oral solution (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Flavamed Hustensaft 15 mg/5 ml oral solution.

Qualitative and quantitative composition

1 ml of oral solution contains 3 mg ambroxol hydrochloride. One measuring spoon with 5 ml of oral solution contains 15 mg ambroxol hydrochloride. Excipients with known effect: Sorbitol 1.75 g/5 ml oral ...

Pharmaceutical form

Oral solution. Clear, colourless to slightly brownish liquid with a fruity odour of raspberry.

Therapeutic indications

Mucolytic therapy of productive cough associated with acute or chronic bronchopulmonary diseases. Flavamed Hustensaft is indicated in children from two years, adolescents and adults.

Posology and method of administration

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Flavamed Hustensaft must not be used in children under two years.

Special warnings and precautions for use

There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated ...

Interaction with other medicinal products and other forms of interaction

On combined use of Flavamed Hustensaft with antitussives (cough-suppressant medicines), a dangerous build-up of secretion may develop due to the impaired cough reflex, meaning that the indication for this ...

Fertility, pregnancy and lactation

Pregnancy There are no sufficient data for the use of ambroxol in pregnant women. This particularly concerns the period up to the 28th week of pregnancy. Ambroxol has shown no teratogenic effects in animal-experiment ...

Effects on ability to drive and use machines

There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.

Undesirable effects

The following frequencies are taken as a basis when evaluating undesirable effects: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cough and cold preparations, Mucolytics ATC code: R05CB06 Ambroxol, a substituted benzylamine, is a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl ...

Pharmacokinetic properties

Ambroxol is practically completely absorbed following oral administration. Tmax following oral administration is 1-3 hours. The absolute bioavailability of ambroxol on oral administration is reduced by ...

Preclinical safety data

Preclinical data based on conventional studies on the safety pharmacology, investigations on the toxicity following acute and repeated administration, genotoxicity and carcinogenicity show no particular ...

List of excipients

Sorbitol, liquid non-crystallising (E420) Benzoic acid Glycerol 85 per cent Hydroxyethylcellulose Raspberry flavouring Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years. After first opening of the bottle: 6 months.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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 ...

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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