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

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 with the administration of ambroxol. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol treatment should be discontinued immediately and medical advice should be sought.Because of a possible build-up of secretion, Flavamed Hustensaft should only be used with caution in disturbed bronchomotor function and large quantities of secretion (e.g. in the rare primary ciliary dyskinesia).

Flavamed Hustensaft must only be used with particular caution (i.e. at longer intervals or at a reduced dose) in impaired renal function or a severe hepatic disease.

In severe renal insufficiency, an accumulation of the metabolites of ambroxol formed in the liver must be expected.

This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take Flavamed Hustensaft.

Each measuring spoon with 5 ml of oral solution contains sorbitol 1.75 g (= 0.15 bread units). Sorbitol may have a mild laxative effect. The calorific value is 2.6 kcal/g sorbitol.

Caution should be exercised in patients with histamine intolerance. Long-term therapy should be avoided in these patients, as ambroxol influences the histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).

Since mucolytics may disrupt the gastric mucosal barrier ambroxol should be used with care in patients with a history of peptic ulcer disease.

Paediatric population

Persistent or recurrent cough in children beween 2-4 years requires medical diagnosis before treatment.

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 combination treatment should be examined particularly carefully.

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 studies (see Section 5.3). Flavamed Hustensaft should only be used in pregnancy after careful benefit/risk evaluation, particularly during the first trimester.

Breast-feeding

Ambroxol crosses into the breast milk in animals. As there is no adequate experience in humans to date, Flavamed Hustensaft should only be used in lactation after careful benefit/risk assessment.

Fertility

There are no sufficient data about the influence of ambroxol on fertility in humans. In animalexperiment studies, ambroxol showed no influence on fertility (see Section 5.3).

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.

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
Not known: Cannot be estimated from the available data

Immune system disorders

Uncommon: Fever

Rare: Hypersensitivity reactions

Not known: Anaphylactic reactions including anaphylactic shock, angioedema and pruritus

Nervous system disorders

Common: Dysgeusia (e.g. changed taste)

Respiratory, thoracic and mediastinal disorders

Common: Oral and pharyngeal hypaesthesia

Not known: Dry throat

Gastrointestinal disorders

Common: Nausea

Uncommon: Vomiting, dry mouth, diarrhoea, dyspepsia and abdominal pain Skin and subcutaneous tissue disorders

Rare: Rash, urticaria

Not known: Severe cutaneous adverse reactions (including erythema multiforme, StevensJohnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.