Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Thiamine hydrochloride
Teva UK Ltd
A11DA01
Thiamine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060206
PARTICULARS TO APPEAR ONПрочитайте повний документ {POT – OUTER } 1. NAME OF THE MEDICINAL PRODUCT Thiamine Hydrochloride 50mg Tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50mg of the active substance thiamine hydrochloride (vitamin B 1 ) 3. LIST OF EXCIPIENTS Also contains lactose monohydrate 4. PHARMACEUTICAL FORM AND CONTENTS 100 Tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use DOSAGE: (Adults and children over 12 years of age) Mild thiamine deficiency: 1-2 tablets once a day. Severe thiamine deficiency: 2 tablets 2-3 times a day. The tablets should be swallowed with water. Do not chew the tablets. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN K EEP OUT OF THE SIGHT AND REACH OF CHILDREN . 7. OTHER SPECIAL WARNING(S), IF NECESSARY If your condition does not improve, tell your doctor. 8. EXPIRY DATE EXP: 9. SPECIAL STORAGE CONDITIONS Store below 25ºC. Store in the original pack. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER PL HOLDER: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. 12. MARKETING AUTHORISATION NUMBER(S) PL 30464/0136 13. BATCH NUMBER<, DONATION AND PRODUCT CODES> _ _ BN: 14. GENERAL CLASSIFICATION FOR SUPPLY _ _ P 15. INSTRUCTIONS ON USE READ THE PACKAGE LEAFLET CAREFULLY BEFORE USING THIS PRODUCT. AFTER OPENING PLEASE USE IN 100 DAYS USE BY DATE………………….. 16. INFORMATION IN BRAILLE Thiamine Hydrochloride #50mg Tablets PATIENT INFORMATION LEAFLET THIAMINE HYDROCHLORIDE 50MG & 100MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAS TOLD YOU. • KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. • ASK YOUR PHARMACIST IF
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Thiamine Hydrochloride 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Thiamine Hydrochloride 50mg Tablets are a thiamine (vitamin B1)-containing monovitamin product. Each tablet contains thiamine hydrochloride, 50mg. Excipient(s) with known effect: This product contains lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white or almost white, biconvex tablets embossed with “T50” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of thiamine deficiencies due to increased dietary requirements, reduced intakes, reduced absorption or increased excretion. Also for treatment of Wernicke-Korsakoff syndrome, beriberi and thiamine deficiency related to chronic alcoholism. Situations often accompanied by marginal thiamine deficiency and requiring supplementation include but are not limited to: • Regular heavy drinking / chronic alcohol consumption • High carbohydrate intakes • Heavy physical exertion • Compromised nutritional status • High dose diuretics • Type I and Type II diabetes mellitus 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Treatment: _ Adults and adolescents from 12 years of age: Mild deficiency: 50-100mg per day Severe deficiency: 200-300mg per day in divided doses Not recommended for children under 12 years. Route of Administration Oral 4.3 CONTRAINDICATIONS Known allergy or hypersensitivity to thiamine or to any of the excipients in Thiamine Hydrochloride 50mg Tablets (see section 6.1). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The thiamine antagonists thiosemicarbazone and 5-fluorouracil can neutralise the effect of thiamine. Patients us Прочитайте повний документ