Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenindione
Advanz Pharma
B01AA02
Phenindione
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200; GTIN: 5021691108474
PACKAGE LEAFLET: INFORMATION FOR THE USER PHENINDIONE 10 MG TABLETS, PHENINDIONE 25 MG TABLETS 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pas s 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Phenindione 10 mg Tablets, Phenindione 25 mg Tablets. It will be referred to as ‘Phenindione Tablets’ for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Phenindione Tablets are and what they are used for 2. What you need to know before you take Phenindione Tablets 3. How to take Phenindione Tablets 4. Possible side effects 5. How to store Phenindione Tablets 6. Contents of the pack and other information 1. WHAT PHENINDIONE TABLETS ARE AND WHAT THEY ARE USED FOR Phenindione Tablets (either 10 or 25 mg) belong to a group of medicines called anticoagulants. These medicines increase the time it takes for your blood to clot. Phenindione is used to prevent and treat blood clots in the veins and arteries, for example clots in the legs, lungs, brain or heart. The tablets come in two strengths: 10 mg (creamy white) and 25 mg (green). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENINDIONE TABLETS DO NOT TAKE PHENINDIONE TABLETS • if you are allergic to Phenindione or any of the other ingredients of this medicine (listed in section 6) • if you have severe liver or kidney problems • if you are pregnant or trying for a baby • if you within the last 72 hours have had an operation or you have given birth within the last 48 hours • if you are currently breast-feeding • if you suffer from any unusual bruising or bleeding • if you suffer from u Lees het volledige document
OBJECT 1 PHENINDIONE 25MG TABLETS Summary of Product Characteristics Updated 15-Dec-2017 | ADVANZ Pharma • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Dindevan 25mg Tablets Phenindione 25mg Tablets 2. Qualitative and quantitative composition Each tablet contains 25mg phenindione Excipient with known effect: Each tablet contains 72mg lactose For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet Green flat, bevel-edged uncoated tablets, scored on one side, engraved D25 on the scored side. The score line is not intended for breaking the tablet. 4. Clinical particulars 4.1 Therapeutic indications Dindevan (Phenindione BP) is a synthetic anticoagulant which acts by interfering with the formation of clotting factors II, VII, IX and X. It produces its effect in 36-48 hours after the initial dose; the effect wanes over a period of 48-72 hours after Dindevan is stopped. Anticoagulant therapy can be initiated with Heparin and Dindevan together. Anticoag Lees het volledige document