Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Betahistine dihydrochloride 4mg
Russells Pharmaceuticals Ltd
Betahistine dihydrochloride 4 mg
4 mg
Tablet
Active: Betahistine dihydrochloride 4mg Excipient: Colloidal silicon dioxide Erythrosine Lactose monohydrate Magnesium stearate
Bottle, glass, 1x100, 100 tablets
Prescription
Prescription
Custom Pharmaceuticals (Canada)
Package - Contents - Shelf Life: Bottle, glass, 1x100 - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1969-12-31
Page 1 of 6 NEW ZEALAND DATA SHEET SERC ® 1. PRODUCT NAME SERC, 8 mg, 16 mg tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg tablet contains 8 mg betahistine dihydrochloride corresponding to 5.21mg betahistine, Each 16 mg tablet contains 16 mg betahistine dihydrochloride corresponding to 10.42 mg betahistine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 8 mg tablet: round, flat, white to almost white tablet with bevelled edges, one side inscribed with ‘256’. 16 mg: round, biconvex, scored, white to almost white tablet with bevelled edges, one side inscribed ‘267’ on either side of the score. SERC 16 mg tablets can be divided into equal doses. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Ménière’s Syndrome as defined by the following core symptoms: Vertigo (with nausea/vomiting) Hearing loss (hardness of hearing) Tinnitus _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE The recommended starting dose is 8 to 16 mg taken three times a day. The maximum recommended daily dose is 48 mg. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. _SPECIAL POPULATIONS_ PAEDIATRIC Due to lack of clinical experience, betahistine dihydrochloride should not be used in children less than 18 years (see section 4.3). Page 2 of 6 METHOD OF ADMINISTRATION The tablets may be taken with or without food. However, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals. _4.3_ _CONTRAINDICATIONS_ Serc (betahistine dihydrochloride) Tablets are contraindicated as follows: During pregnancy and lactation In children less than 18 years In patients suffering from phaeochromocytoma In patients with active peptic ulcer or a history of this condition In patients with hypersensitivity to any component to the product (see Section 6.1) _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ Patients with bronchial asthma need to be carefu Đọc toàn bộ tài liệu