Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenindione
Advanz Pharma
B01AA02
Phenindione
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200; GTIN: 5021691108498
PACKAGE LEAFLET: INFORMATION FOR THE USER PHENINDIONE 10 MG TABLETS, PHENINDIONE 25 MG TABLETS, PHENINDIONE 50 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 prescri bed f or 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, 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, Phenindione 50 mg Tablets. It will be referred to as ‘Phenindione Tablets’ for ease hereafter. W HAT 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, 25 or 50 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 three strengths: 10 mg (creamy white); 25 mg (green) and 50 mg (creamy white). 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-feed Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dindevan 50mg Tablets Phenindione 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg phenindione. Excipient with known effect: Each tablet contains - 52mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Creamy white, flat, bevel-edged uncoated tablets, scored on one side, engraved D50 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. Anticoagulant therapy in the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Adults: Initial loading dose of 200mg, followed on the second day by a dose of 100mg. Dosage must be adjusted from the third day, dependent on the results of the appropriate coagulation tests such as prothrombin time, reported as international normalised ratio (INR). Note: Concomitant heparin therapy affects the results of INR control tests, and heparin should be discontinued at least 6 hours before the first INR control test is undertaken. Control tests must be undertaken at regular intervals and the dosage adjusted according to the results of the INR tests. A maintenance dose of 50-150mg/day is satisfactory in most patients, but a "resistant" patient may need 200mg/day or more. A "sensitive" patient may need less than 50mg/day. Method of administration: Oral 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance Read the complete document