País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
6-mercaptopurine
Primecrown 2010 Limited
L01BB; L01BB02
6-mercaptopurine
50 milligram(s)
Tablet
Purine analogues; mercaptopurine
2020-07-31
PACKAGE LEAFLET: INFORMATION FOR THE USER HANIXOL 50 MG TABLETS 6-mercaptopurine WHAT IS IN THIS LEAFLET 1. What Hanixol 50 mg Tablets are and what they are used for 2. What you need to know before you take Hanixol 50 mg Tablets 3. How to take Hanixol 50 mg Tablets 4. Possible side effects 5. How to store Hanixol 50 mg Tablets 6. Contents of the pack and other information 1. WHAT HANIXOL 50 MG TABLETS ARE AND WHAT THEY ARE USED FOR Hanixol 50 mg Tablets contain a medicine called 6-mercaptopurine. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Hanixol 50 mg Tablets are used to treat cancer of the blood (leukaemia) in adults, adolescents and children. It works by reducing the number of new blood cells your body makes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HANIXOL 50 MG TABLETS DO NOT TAKE HANIXOL 50 MG TABLETS: If you are allergic to 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor before using Hanixol 50 mg Tablets: - If you have recently received, or are due to receive, a vaccination (vaccine). If you take Hanixol, you should not have a live organism vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you receive them while you are taking Hanixol - If you have a genetic disease called TPMT (thiopurine methyltransferase) deficiency. - If you are allergic to a medicine called azathioprine (also used to treat cancer). - If you have reduced liver function or liver damage. - If you have a genetic disease called Lesch-Nyhan syndrome. - If you have a kidney problem. - Tell your doctor whether you have, or have not, had chicken pox, shingles or hepatitis B (a liver disease caused by a virus). - If you are pregnant or breast-feeding. If you are male, please note the risk of teratogenic effect. - If you are taking at the same time allopurinol. - If you are taking at the sa Leer el documento completo
Health Products Regulatory Authority 31 July 2020 CRN009SCS Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hanixol 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of 6-mercaptopurine. Excipient with known effect - Lactose anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets _Product imported from the UK_ Round 6 mm yellowish tablets, scored on one side and plain on the other. 4 CLINICAL PARTICULARS As per PA22756/001/001 5 PHARMACOLOGICAL PROPERTIES As per PA22756/001/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose anhydrous Maize starch Starch, pregelatinized Stearic acid Magnesium stearate 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. After first opening the bottle: 7 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from light. Health Products Regulatory Authority 31 July 2020 CRN009SCS Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Type III 20 ml amber glass bottle containing 25 tablets with a polypropylene child-proof cap and silica gel desiccant. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Safe handling: It is recommended that 6-mercaptopurine Tablets should be handled following the prevailing local recommendations and/or regulations for the handling and disposal of cytotoxic agents. Disposal Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Primecrown 2010 Limited 4/5 Northolt Trading Estate Belvue Road Northolt Middlesex UB5 5QS United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1633/072/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 st July 2020 10 DATE OF REVISION OF THE TEXT Leer el documento completo