Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
MECLOZINE HYDROCHLORIDE
GR Lane Health Products Ltd
R06AE05
MECLOZINE HYDROCHLORIDE
12.5 Milligram
Tablets
Product not subject to medical prescription
meclozine
Not Marketed
2000-07-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sea-Legs Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 12.50mg Meclozine Hydrochloride. Also contains 132.6 mg lactose monohydrate. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. White, round biconvex tablet with a scoreline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prevention and treatment of motion sickness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Adults and Children over 12 years Two tablets (25mg) per 24 hours. The tablets may be taken one hour prior to commencement of journey or, as Sea- Legs can remain active for 24 hours after one dose, the previous night. Children 6-12 years of age One tablet (12.5mg) per 24 hours. Children 2-6 years of age Half of one tablet (6.25mg) per 24 hours. 4.3 CONTRAINDICATIONS Contraindicated in pregnancy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE May cause drowsiness, if affected do not drive or operate machinery. Avoid alcoholic drink. Sea legs tablets contain Lactose and therefore should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _9_ _6_ _9_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS Đọc toàn bộ tài liệu