Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acenocoumarol
Lexon (UK) Ltd
B01AA07
Acenocoumarol
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200
SINTROM UNO 1MG TABLETS (acenocoumarol) PATIENT INFORMATION LEAFLET 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 have told 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. Your medicine is called Sintrom Uno 1mg tablets but will be reffered to as Sintrom Uno throughout the leaflet. WHAT IS IN THIS LEAFLET What Sintrom Uno is and what it is used for What you need to know before you take Sintrom Uno How to take Sintrom Uno Possible side effects How to store Sintrom Uno Contents of the pack and other information WHAT SINTROM UNO IS AND WHAT IT IS USED FOR Sintrom Uno 1 mg Tablets (acenocoumarol) belongs to a group of medicines called anticoagulants (blood thinning medicines). Sintrom Uno is used to treat and prevent blood clots blocking the blood vessels e.g. deep vein thrombosis (DVT). Sintrom Uno does not dissolve blood clots that have already formed but it may stop the clots from becoming larger and causing more serious problems. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SINTROM UNO Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. • DO NOT TAKE SINTROM UNO IF YOU: are allergic (hypersensitive) to acenocoumarol, or similar medicines to thin the blood called coumarin derivatives (e.g. warfarin, phenprocoumon), or to any of the ingredients in Sintrom Uno (see Section 6, Contents of the pack and other information) • are pregnant, planning to become pregnant or breast-feeding (see Pregnancy, breast-feeding a Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sinthrome 1mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Acenocoumarol BP 1mg. Excipient(s) with known effect: Lactose (20mg). For the full list of excipients see, section 6.1. 3 PHARMACEUTICAL FORM Tablets for oral administration. White, round, flat tablets with slightly bevelled edges, with one side bearing the imprint “CG”, and the other the imprint “AA”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of thromboembolic diseases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology GENERAL TARGET POPULATION Sensitivity to anticoagulants varies from patient to patient and may also fluctuate during the course of treatment. Therefore, it is essential to perform regular testing of prothrombin time (PT)/International Normalised Ratio (INR) and to adjust the patient’s dosage accordingly. If this is not possible, Sinthrome should not be used. Sinthrome should be given in a single oral dose. INITIAL DOSAGE: The dosing of Sinthrome must be individualised. If the PT/INR value is within the normal range before starting treatment, the following dosage schedule is recommended: The usual starting dose is between 2 mg/day to 4 mg/day without administration of a loading dose. Treatment may also be initiated with a loading dose regimen, usually 6 mg on the first day followed by 4 mg on the second day. If the initial thromboplastin time is abnormal, treatment should be instituted with caution. Elderly patients ( ≥ 65), patients with liver disease or severe heart failure with hepatic congestion or malnourished patients may require lower doses during treatment initiation and maintenance (see section 4.4). Measurement of the thromboplastin time should be carried out daily in hospital starting from second or third dose of Sinthrome and up to the time when the coagulation status is stabilized within the target range. The interval between tests can later be extended, depending on the stability of PT/INR results. Blood sam Read the complete document