Country: Afrika Selatan
Bahasa: Inggeris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
BRONKESE® 4 TABLETS BRONKESE® 8 TABLETS BRONKESE® SOLUTION SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form) : BRONKESE ® 4 TABLETS BRONKESE ® 8 TABLETS BRONKESE ® SOLUTION COMPOSITION: Tablets containing: Bromhexine Hydrochloride 4,00 mg Bromhexine Hydrochloride 8,00 mg Solution containing: Each 5 mL contains: Bromhexine Hydrochloride 10,00 mg Preservative: Methyl Hydroxybenzoate 0,10 %m/v. PHARMACOLOGICAL CLASSIFICATION: A 10.1 Antitussives and Expectorants. PHARMACOLOGICAL ACTION: BRONKESE® is a mucolytic which changes the structure of uninfected bronchial secretions and reduces the viscosity of sputum. INDICATIONS: BRONKESE® reduces the viscosity of uninfected bronchial secretions in bronchial asthma, chronic bronchitis, cystic fibrosis and pulmonary emphysema. CONTRA-INDICATIONS: None. WARNING: KEEP OUT OF REACH OF CHILDREN. DOSAGE AND DIRECTIONS FOR USE: Tablets 4 mg: Children 5 - 10 years: Take 1 tablet three or four times a day. Tablets 8 mg: Adults: Take 1 - 2 tablets three or four times a day. Solution 10 mg/5 mL: Adults and children over 10 years: Take 5 - 10 mL three times a day. Children under 10 years: Take 2,5 - 5 mL three times a day. SIDE EFFECTS AND SPECIAL PRECAUTIONS: SIDE EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal side-effects may occur occasionally and a transient rise in serum transaminase has been reported. Special Precautions: Since Bromhexine may disrupt the gastric mucosal barrier it should be given cautiously to patients with gastric and duodenal ulceration. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: None. IDENTIFICATION: 4 mg tablets: Flat, white tablets with bevelled edges, bisected on one side. 8 mg tablets: Flat, yellow tablets with b Baca dokumen lengkap