Saturday, August 1, 2009

Bisolvon

Bisolvon®
Bromhexine HCl

Composition
Each tablet contains Bromhexine HCl 8 mg
5 ml elixir contains Bromhexine HCl 4 mg
(containing ethyl alcohol 3.72% v/v)

Properties
Bromhexine is a synthetic derivative of the herbal active ingredient vasicine.
Preclinically, it has been shown to increase the proportion of serous bronchial secretion. Bromhexine enhances mucus transport by reducing mucus viscosity and by activating the ciliated epithelium (mucociliary clearance).

In clinical studies. Bromhexine showed a secretolytic and secretomotor effect in the bronchial tract area, which facilitates expectoration and eases cough.

Indication
BISOLVON acts as a mucolytic to facilitate productive cough.

Dosage
Tablet
Adults and children › 10 years : 3 x 1 tablet dally
Children 5 - 10 years : 3 x 1/2 tablet daily
Children 2-5 years : 2 x 1/2 tablet daily

Elixir
Adults and children ›10years : 3 x 10 ml daily
Children 5-10 years : 3 x 5 ml daily
Children 2-5 years : 2 x 5 ml daily
Or according to doctor’s prescription.

Special Precautions
As with other drugs, it is advisable to avoid using it during the first trimester of pregnancy and lactation. BISOLVON should be used with caution in patients with gastric ulcers.

Pregnancy and Lactation
Available preclinical studies as well as clinical experience to date have shown no evidence of ill-effects during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the first trimester, should be observed.
The drug is expected to enter breast milk and thus should be avoided during lactation.

Side Effects
BISOLVON is generally well tolerated. Diarrhoea, nausea, vomiting and other mild gastro-intestinal side effects have been reported. Allergic reactions including skin rashes, urticaria, bronchospasm, angio-oedema, and anaphylaxis have also been reported.

Contra-indications
BISOLVON should not be used in patients known to be hypersensitive to Bromhexine or other components of the formulations.

Interactions
Administration of Bromhexine together with antibiotics (Amoxicilline, Cefuroxime, Doxycycline) leads to higher antibiotic concentration in the lung tissue.

Overdose
No symptoms of overdose have been reported in man to date. If they occur, symptomatic treatment should be provided.

Availability
Tablet 8 mg
Box contains 10 strips of 10 tablets Reg. No. DTL0133700410A1
Box contains 10 catch cover of 4 tablets Reg. No. DTL0133700410A1

Elixir 4 mg/5 ml
Bottle of 60 ml Reg. No. DTL0133700534A1
Bottle of 125 ml Reg. No. DTL0133700534A1

Manufactured by:
PT. Boehringer Ingelheim Indonesia
Bogor, Indonesia

Under license from:
Boehringer Ingelheim International GmbH
Ingelheim am Rhein
Germany

Store in temperature 25-30°C, in a well-closed container.
Store in a safe place, out of the reach of children.

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