البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Thiamine hydrochloride
Mawdsley-Brooks & Company Ltd
A11DA01
Thiamine hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060206
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 YOU NEED MORE INFORMATION OR ADVICE. • YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE. • IF YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR PHARMACIST. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4 1. WHAT THIAMINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR Thiamine Hydrochloride Tablets are vitamin tablets which contain thiamine (vitamin B 1 ). They are used to treat thiamine deficiency (when your body does not have enough of the vitamin). Even though thiamine is found naturally in many foods (especially in yeast, wholegrain cereals, meats and beans), sometimes your body requires a supplement. This may be because your diet does not contain enough thiamine or you may not be absorbing it from your diet effectively. You may also have a special need for extra thiamine, especially if you are excreting it quickly from your body (e.g. in your urine). By taking Thiamine Hydrochloride Tablets, you can make sure you have sufficient thiamine in your diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIAMINE HYDROCHLORIDE TABLETS DO NOT TAKE THIAMINE HYDROCHLORIDE TABLETS IF YOU ARE: • Allergic (hypersensitive) to thiamine or any of the other ingredients in this medicine (see section 6, Contents of the pack and other information) • Under 12 years of age OTHER MEDICINES AND THIAMINE HYDROCHLORIDE TABLETS: Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself. Certain medicines can reduce the effect of your thiamine tablets. Tell your doctor i اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Thiamine Hydrochloride 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Thiamine Hydrochloride 100mg Tablets are a thiamine (vitamin B1)- containing monovitamin product. Each tablet contains thiamine hydrochloride, 100mg. Excipient(s) with known effect: This product contains lactose monohydrate, see section 4.4. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white or almost white, biconvex tablets embossed with “T100” 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 اقرأ الوثيقة كاملة