BISOLVON Oral solution Ref.[9892] Active ingredients: Bromhexine

Bromhexine should be used with caution in patients with a history of, or existing, peptic ulceration.

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 bromhexine hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, bromhexine hydrochloride treatment should be discontinued immediately and medical advice should be sought.

As the product contains maltitol liquid, patients with rare hereditary problems of fructose intolerance should not take this medicine.

This product may have a mild laxative effect.

Each 5 ml dose supplies up to 2.5 g of maltitol liquid which has a calorific value of 5.75 Kcal.

No clinically relevant unfavourable interactions with other medications, such as ampicillin, amoxicillin, oxytetracycline or erythromycin, have been reported (see section 5.1).

Pregnancy

There are limited data from the use of bromhexine in pregnant women. Pre-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of BISOLVONduring pregnancy.

Lactation

It is unknown whether bromhexine/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in pre-clinical studies have shown excretion of bromhexine in breast milk. A risk to the breastfed infant cannot be excluded. BISOLVON should not be used during breast-feeding.

Fertility

No studies on the effect on human fertility have been conducted with BISOLVON. Based on available pre-clinical experience there are no indications for possible effects of the use of bromhexine on fertility.

No studies on the effect on the ability to drive and use machines have been performed with BISOLVON.

The following side effects have been reported based on clinical trials involving 3,992 patients.

Frequencies:

Very common ≥1/10
Common ≥1/100 <1/10
Uncommon ≥1/1,000 <1/100
Rare ≥1/10,000 <1/1,000
Very rare <1/10,000
Not known cannot be estimated from the available data

Immune system disorders

Rare: Hypersensitivity reactions

Not known: Anaphylactic reactions including anaphylactic shock*

Respiratory, thoracic and mediastinal disorders

Not known: Bronchospasm*

Gastro-intestinal disorders

Uncommon: Abdominal pain upper, Nausea, Vomiting, Diarrhoea

Skin and subcutaneous tissue disorders

Rare: Rash, Urticaria*

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

* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than rare (3/3,992), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 3,992 patients.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.