Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pyridoxine hydrochloride
A A H Pharmaceuticals Ltd
A11HA02
Pyridoxine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060204; GTIN: 5025903084853
Peel here but do not remove TOR GENERICS Tor Generics Ltd; Northwood HA6 2TH, UK READ THE PACKAGE LEAFLET BEFORE USE. DOSAGE: For oral use. Swallow whole, do not chew. Use as directed by your doctor. Do not store above 25°C . This container is fitted with a tamper evident cap, if damaged or missing do not use. Replace cap firmly after use. Please store the tablets in the original container. DO NOT EXCEED THE STATED DAILY DOSE Keep out of sight and reach of children. PL20491/0003 PRODUCT INFORMATION 28 Tablets 10 MG TABLETS PYRIDOXINE EXCIPIENTS: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate. Each tablet contains 10 mg pyridoxine hydrochloride equivalent to 8.2mg pyridoxine. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PYRIDOXINE 10MG TABLETS Pyridoxine Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET 1. WHAT PYRIDOXINE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRIDOXINE 3. HOW TO TAKE PYRIDOXINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PYRIDOXINE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PYRIDOXINE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Pyridoxine Tablets is pyridoxine hydrochloride, which is Vitamin B6. Pyridoxine Tablets are used to treat damage to the nerves (peripheral neuritis) caused by isoniazid, a drug used to treat tuberculosis. Pyridoxine Tablets are also used to treat low levels of Vitamin B6 in the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRIDOXINE TABLETS DO NOT TAKE P Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pyridoxine 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pyridoxine hydrochloride 10 mg equivalent to 8.2 mg pyridoxine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pyridoxine 10mg tablets are plain white uncoated biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pyridoxine is indicated for adults and children over 12 years old in the treatment of isoniazid-induced peripheral neuritis and pyridoxine deficiency states. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years old Isoniazid neuropathy: Prophylaxis 10mg daily Treatment 50mg three times daily (Adults) Treatment 30-50mg two to three times a day (children over 12 years) Deficiency states: 20-50mg up to three times daily Elderly As for adults. Paediatric population Little information is available on the use of pyridoxine in children under 12 years. Doses of 4mg/Kg have been used to treat children with familial pyridoxine resistance. Method of administration Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to the pyridoxine or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Pyridoxine antagonises the therapeutic effect of levodopa when it is used without a dopa-decarboxylase inhibitor. Larger doses of pyridoxine can cause a reduction in serum phenytoin and phenobarbitone levels in some patients. Pyridoxine requirements have been reported to be increased by oral contraceptives, hydralazine, isoniazid, cycloserine and penicillamine. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy There are no or limited amount of data from the use of pyridoxine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3) Pyridoxine is not recommended during the first trimester of pregnancy. B Læs hele dokumentet