Sintrom

Product Information Change Font Size The following information is a summary about Sintrom. It is not intended to replace a doctor's instructions. What you need to know about Sinthrome Tablets Please read this leaflet carefully before you start to take your medicine. It contains important information. What’s in your medicine? The active ingredient in this medicine is acenocoumarol. This is the new name for nicoumalone. The ingredient itself has not changed. Each Sinthrome Tablet contains 1mg acenocoumarol BP. They contain the following inactive ingredients: Lactose, hydroxypropylmethylcellulose, magnesium stearate, maize starch, talc and silicon dioxide. Sinthrome comes in packs of 100 tablets. Acenocoumarol is one of a group of medicines called anticoagulants (blood thinning medicines). Who makes your medicine? Name of Product Licence holder: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, England Made by: Novartis Farmaceutica S.A., Barberà del Vallés, Barcelona, Spain What’s this medicine used for? Sinthrome is used to treat and prevent certain blood vessel, heart and lung diseases. Sinthrome decreases the clotting ability of the blood and therefore helps to prevent harmful clots from forming in the blood vessels. Sinthrome does not dissolve clots that have already formed but it may stop the clots from becoming larger and causing more serious problems. Before starting treatment If the answer to any of these questions is YES, tell your doctor. Have you had an allergic reaction to acenocoumarol, any other anticoagulant or to any of the ingredients in Sinthrome (listed in “What’s in your medicine”)? Many different medicines can affect the way Sinthrome works. You should tell your doctor or pharmacist if you are taking any of the following: Aspirin or other non-steroidal anti-inflammatories (NSAIDs) (for painful conditions or rheumatic diseases); Anabolic steroids (as replacement therapy); Antibiotics (for infections); Rifampicin (for bacterial infections or tuberculosis, TB); Medicines for diabetes by mouth; Glucagon (for low blood sugar); Thyroid hormones (e.g. thyroxine); Allopurinol or sulfinpyrazone (for gout); Medicines for heart disease (e.g. amiodarone); Oral contraceptives; Medicines for epilepsy (e.g. carbamazepine or phenytoin); Medicines to treat stomach disorders (e.g. cimetidine or ranitidine); Aminoglutethimide (for cancer or Cushing’s syndrome); Barbiturates (for epilepsy or to help you sleep); Etacrynic acid or diuretics (“water tablets”, for fluid retention); Clofibrate, simvastatin or colestyramine (to lower blood lipid levels); Disulfiram (for alcohol dependence); Heparin (treatment of deep vein thrombosis or after surgery); Imidazoles or griseofulvin (for fungal infections); Salicylic acid (for skin disorders); Tamoxifen (for breast cancer or infertility) Platelet aggregation inhibitors such as dipyridamole and clopidogrel; Medicines for mental depression (e.g. fluoxetine, paroxetine also known as selective serotonin re-uptake inhibitors); 5-fluorouracil (for breast, gastrointestinal and skin cancer) Azathioprine (for organ transplantation, chronic inflammatory and autoimmune diseases); St. John’s Wort (for mental depression) Protease inhibitors (such as ritonavir or indinavir, for HIV). Are you pregnant, planning to become pregnant or breast feeding? Have you recently had or are you due to have any medical or dental surgery? Do you have any heart, liver, thyroid or kidney problems? Do you have a stomach ulcer or intestinal bleeding disorder? Have you had a stroke? Do you suffer from any blood disorder? Do you suffer from very high blood pressure? Have you had any infection recently? Do you have any tumours? Do you suffer from swellings (inflammation)? Do you regularly drink cranberry juice or take other cranberry products, such as capsules or concentrates? Other special warnings Be careful when drinking alcohol. It may affect how Sinthrome thins your blood. Check with your doctor first. Your doctor will want to do regular blood tests during treatment with Sinthrome to check on how fast your blood is clotting. Sinthrome should not be used in children. You should not receive any injections into your muscles (intramuscular) whilst you are taking Sinthrome. How to take your medicine It is important to take your medicine as instructed by your doctor. Sinthrome should be taken as a single dose at the SAME time every day. Swallow your tablets whole with a drink of water. The dose of Sinthrome will vary from patient to patient. Blood tests will help your doctor decide on the correct amount of Sinthrome you should take. Most patients will receive doses of between 1 to 8mg a day. Up to 12mg may be used on the first day of treatment. Elderly patients may need lower doses. If you are not sure how many tablets to take, ask your doctor or pharmacist. What to do if an overdose is taken If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor at once or contact your nearest casualty department. Show any left-over medicines or the empty packet to the doctor. What to do if you miss a dose If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. DO NOT take a double dose. Then go on as before. After taking your medicine These tablets sometimes cause unwanted effects in some people. Effects which may occur include: Loss of appetite and hair loss. If these are severe or last for more than a few days, tell your doctor. If you get any of the following, tell your doctor: Unusual bleeding - (bleeding from the gums; unexplained bruising or nosebleeds; heavy periods; heavy bleeding from cuts or wounds).