País: Jordania
Idioma: inglés
Fuente: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Bromhexine Hcl 8 mg
شركة مستودع الادوية العربي - THE ARAB DRUG STORE P.S.C
R05CB02
Bromhexine Hcl 8 mg
8 mg
20
Delpharm Remis S.A.S (فرنسا)
1.97 :سعر الجمهور + الضريبة
Status: FRE_v12_12.03.2012 Bisolvon tablets 8 mg Record no.: 5407952011 Product information Page 1 of 7 PRODUCT INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Bisolvon ® tablets 8 mg/tablet Active substance: Bromhexine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 8 mg bromhexine hydrochloride. Excipient: Lactose (see section 4.4) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral use 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secretolytic therapy of acute and chronic bronchopulmonary diseases associated with impaired mucus formation and transport 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise prescribed, the following dosages are recommended for Bisolvon tablets: Adults and adolescents over 14 years: 1 - 2 tablets 3 times a day (equivalent to 24 - 48 mg bromhexine hydrochloride a day) Children and adolescents between 6 and 14 years and patients under 50 kg bodyweight: 1 tablet 3 times a day (equivalent to 24 mg bromhexine hydrochloride a day) More appropriate pharmaceutical forms of lower strength are available for children under 6 years of age. Method of administration and duration of treatment The duration of treatment should be determined on an individual basis depending on the indication and the course of the disease. Bisolvon tablets should not be taken for more than 4 - 5 days without medical advice. The tablets should be taken with plenty of liquid after meals. L13514 Status: FRE_v12_12.03.2012 Bisolvon tablets 8 mg Record no.: 5407952011 Product information Page 2 of 7 4.3 CONTRAINDICATIONS Bisolvon tablets are contraindicated in patients with known hypersensitivity to any of the components. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In a very small number of cases, there have been reports of severe skin reactions such as Stevens-Jo- hnson syndrome and toxic epidermal necrolysis (TEN) occurring in temporal association with the use of expectorants such as bromhexine. Most of these cases were attributable to the unde Leer el documento completo