FLUIBRON Syrup Ref.[44646] Active ingredients: Ambroxol

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 syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.

Warnings regarding certain excipients of Fluibron

FLUIBRON syrup contains:

Sorbitol: This medicine contains 300mg of sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Benzoic acid: This medicine contains 1.3mg of benzoic acid in each ml. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Usually it does not interfere with other drugs.

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, during the first three months of pregnancy and, in the following period, the product should be administered only in case of real need and under direct medical control.

None.

At the recommended doses, the drug is generally well tolerated. Seldom, nausea, headache and gastrointestinal disturbances were reported.

Immune system disorders

Rare: hypersensitivity reactions

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

Skin and subcutaneous tissue disorders

Rare: rash, urticaria

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

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