SINTHROME TABLETS 1MG
Active substance: ACENOCOUMAROL
View full screen / Print PDF » Download PDF ⇩
Transcript
ALLIANCE
PATIENT INFORMATION LEAFLET
Sinthrome Tablets 1mg
acenocoumarol
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. The information in this leaflet has been divided into the following sections: 1. What Sinthrome is and what it is taken for 2. Check before you take Sinthrome 3. How to take Sinthrome 4. Possible side effects 5. How to store Sinthrome 6. Further information 1. What Sinthrome is and what it is used for Sinthrome belongs to a group of medicines called anticoagulants (blood thinning medicines). Sinthrome is used to treat and prevent blood clots blocking the blood vessels e.g. deep vein thrombosis (DVT). Sinthrome does not dissolve blood clots that have already formed but it may stop the clots from becoming larger and causing more serious problems. 2. Check before you take Sinthrome Do not take Sinthrome: if you are allergic (hypersensitive) to acenocoumarol, any other medicines that you have taken to thin your blood or to any of the ingredients in Sinthrome (see Section 6 Further information) if you are pregnant, planning to become pregnant or breast-feeding if you are an alcoholic if you have any mental illness for example, schizophrenia or dementia if you have recently had, or are about to have an operation on your spine, brain or eyes or any major surgery if you have had a stroke caused by bleeding into your brain if you suffer from very high blood pressure if you have a stomach ulcer or any intestinal bleeding if you pass blood in your water or cough up blood if you suffer from any bleeding disorders, bleeding problems or unexplained bruising if you have pericarditis or endocarditis inflammation or infection around the heart which causes pain in the chest if you regularly drink cranberry juice or take cranberry extracts. If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome. Take special care with Sinthrome Before you take Sinthrome tell your doctor: if you have cancer if you have an infection or inflammation (swelling) if you have heart failure (which causes swelling and shortness of breath) if you have liver or kidney problems if you have an overactive thyroid if you are elderly if you suffer from a blood disorder such as protein C or protein S deficiency this would cause you to bleed for longer than normal after a cut or injury. You should not receive any injections into your muscles whilst you are taking Sinthrome. If you need any injections into your spine or as part of a scan or X-ray test or if you need minor surgery, including dental surgery, make sure you discuss your treatment with your doctor first. If you are involved in an accident while on Sinthrome you are likely to bleed more than normal. The doctor or hospital staff must be informed that you are taking Sinthrome immediately. Always carry your personal anticoagulation card (an identification card from your pharmacist stating that you are using this medicine). If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome. Taking other medicines Tell your doctor or pharmacist if you are taking or have taken any of the following medicines as they may interfere with Sinthrome: paracetamol and non-steroidal anti-inflammatories statins and other lipid lowering drugs such as fenofibrate, (NSAIDs) such as aspirin, ibuprofen and celecoxib - used simvastatin or colestyramine - used to lower blood for pain relief or to treat rheumatic diseases cholesterol levels tramadol - a strong pain killer antibiotics such as rifampicin, amoxicillin and metronidazole - used to treat infections sulfonamides such as co-trimoxazole - used to treat infections sulphonylureas such as tolbutamide, chlorpropamide and glibenclamide - oral medicines for diabetes glucagon - used to treat low blood sugar levels thyroid hormones such as levothyroxine - used to treat an underactive thyroid allopurinol or sulfinpyrazone - for the treatment of gout and to lower uric acid levels anti-arrhythmic agents such as amiodarone and quinidine - medicines for an irregular heartbeat oral contraceptives such as Femodene, Logynon and Cilest - for birth control antiepileptics such as carbamazepine or phenytoin - used to treat epilepsy H2-agonists such as cimetidine or ranitidine - used to treat stomach or intestinal ulcers aminoglutethimide - used to treat cancer or Cushings syndrome barbiturates such as sodium amytal or phenobarbital - for epilepsy or to help you sleep etacrynic acid or thiazide diuretics (water tablets) such as bendroflumethiazide or metolazone - for water retention or high blood pressure Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking with food and drink Be careful when drinking alcohol as it may affect how Sinthrome thins your blood. Check with your doctor first. You should avoid drinking cranberry juice or taking other cranberry products, such as capsules or concentrates as this could mean you do not receive the correct amount of acenocoumarol. Pregnancy and breast-feeding Do not take Sinthrome if you are pregnant. Sinthrome, like other anticoagulants can cause serious harm to your baby. Tell your doctor if you are pregnant or trying to become pregnant. Your doctor will discuss with you the potential risk of taking Sinthrome during pregnancy. The decision to breast-feed while taking Sinthrome should be carefully considered with your doctor. You and your child may require blood tests if you are breast-feeding while you are taking Sinthrome. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from being thinned. If you are of child bearing age, a pregnancy test may be done by your doctor to rule out pregnancy before you are given Sinthrome. You may also be asked to use birth control while taking Sinthrome. Ask your doctor or pharmacist for advice before taking any medicine.
PIL UK 006 v5a
imidazoles such as econazole and ketoconazole or griseofulvin - used to treat fungal infections antineoplastics such as mercaptopurine and 5-fluorouracil - for breast, gastrointestinal and skin cancer tamoxifen - for breast cancer and fertility anti-platelet medicines such as dipyridamole, clopidogrel to prevent blood clots forming selective serotonin re-uptake inhibitors such as fluoxetine and paroxetine - used to treat anxiety and depression St Johns Wort - for depression protease inhibitors such as ritonavir or indinavir - used to treat HIV anabolic steroids - used as replacement therapy androgens such as testosterone and mesterolone - used as replacement therapy corticosteroids such as prednisolone and methylprednisolone - steroids used to treat inflammatory bowel disease, arthritis and certain skin conditions azathioprine - for organ transplantation, chronic inflammatory and autoimmune diseases disulfiram - for alcohol dependence heparin - to thin the blood in the treatment of deep vein thrombosis, blood clots or after surgery.
Driving and using machines You can drive and use machines as normal while taking Sinthrome. Important information about some of the ingredients of Sinthrome Sinthrome tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Sinthrome Always take Sinthrome exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Sinthrome should be taken as a single dose at the same time every day. Swallow your tablets whole with a drink of water. Your doctor will arrange regular blood tests during treatment with Sinthrome to check on how fast your blood is clotting. This will help the doctor decide on your dose. The dose of Sinthrome will vary from patient to patient and from day to day. The following can be used as a guide: Adults and elderly: Most patients will receive doses of between 1 to 8 mg (milligrams) a day. A dose of 4 mg is usual on the first day of treatment. Elderly patients, patients with liver disease or severe heart failure or malnourished patients may need lower doses. Children: Sinthrome is not recommended for children. What to do if you take more Sinthrome than you should If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor immediately or contact the nearest accident and emergency department. You may require blood tests to monitor your condition and treatment may be required. Show any left-over medicines or the empty packet to the doctor. If you forget to take Sinthrome Do not worry. 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. 4. Possible side effects Like all medicines, Sinthrome can cause side effects, although not everyone gets them. If you get any of the following, tell your doctor: unusual bleeding such as bleeding from the gums unexplained bruising or nosebleeds heavy periods heavy bleeding from cuts or wounds
signs of bleeding inside the body such as stomach or abdominal pain backache blood in the urine bloody or black tarry stools coughing up blood dizziness severe headache joint pain or stiffness blurred sight.
Tell your doctor or pharmacist if you think you have any of these or other problems with Sinthrome: Other rare side effects (that affect less than 1 person in 1000): loss of appetite feeling or being sick skin rashes itching unexplained fever hair loss. Very rare side effects (that affect less than 1 person in 10,000): red patches on the skin or bruising vasculitis (inflammation of the blood vessels) liver damage which can cause yellow eyes or skin. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store Sinthrome Keep out of the reach and sight of children. Do not take Sinthrome after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment. 6. Further information What Sinthrome contains The active ingredient in this medicine is acenocoumarol. This is the new name for nicoumalone. The ingredient itself has not changed. The other ingredients are lactose, hypromellose, magnesium stearate, maize starch, talc and silicon dioxide. What Sinthrome looks like and contents of the pack Sinthrome tablets are white, round, flat tablets, with CG imprinted on one side and AA on the other. They come in cartons of 100 tablets. Marketing Authorisation Holder and Manufacturer The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK. Sinthrome is manufactured by: Novartis Farmaceutica S.A., Barber del Valls, Barcelona, Spain. The information in this leaflet applies only to Sinthrome. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist. This leaflet was last approved in July 2007. Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited and is used under licence by Alliance Pharmaceuticals Limited. Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks Alliance Pharmaceuticals Ltd 2007.
PIL UK 006 v5a
PATIENT INFORMATION LEAFLET
Sinthrome Tablets 1mg
acenocoumarol
Read all of this leaflet carefully before you start taking this medicine 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. The information in this leaflet has been divided into the following sections: 1. What Sinthrome is and what it is taken for 2. Check before you take Sinthrome 3. How to take Sinthrome 4. Possible side effects 5. How to store Sinthrome 6. Further information 1. What Sinthrome is and what it is used for Sinthrome belongs to a group of medicines called anticoagulants (blood thinning medicines). Sinthrome is used to treat and prevent blood clots blocking the blood vessels e.g. deep vein thrombosis (DVT). Sinthrome does not dissolve blood clots that have already formed but it may stop the clots from becoming larger and causing more serious problems. 2. Check before you take Sinthrome Do not take Sinthrome: if you are allergic (hypersensitive) to acenocoumarol, any other medicines that you have taken to thin your blood or to any of the ingredients in Sinthrome (see Section 6 Further information) if you are pregnant, planning to become pregnant or breast-feeding if you are an alcoholic if you have any mental illness for example, schizophrenia or dementia if you have recently had, or are about to have an operation on your spine, brain or eyes or any major surgery if you have had a stroke caused by bleeding into your brain if you suffer from very high blood pressure if you have a stomach ulcer or any intestinal bleeding if you pass blood in your water or cough up blood if you suffer from any bleeding disorders, bleeding problems or unexplained bruising if you have pericarditis or endocarditis inflammation or infection around the heart which causes pain in the chest if you regularly drink cranberry juice or take cranberry extracts. If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome. Take special care with Sinthrome Before you take Sinthrome tell your doctor: if you have cancer if you have an infection or inflammation (swelling) if you have heart failure (which causes swelling and shortness of breath) if you have liver or kidney problems if you have an overactive thyroid if you are elderly if you suffer from a blood disorder such as protein C or protein S deficiency this would cause you to bleed for longer than normal after a cut or injury. You should not receive any injections into your muscles whilst you are taking Sinthrome. If you need any injections into your spine or as part of a scan or X-ray test or if you need minor surgery, including dental surgery, make sure you discuss your treatment with your doctor first. If you are involved in an accident while on Sinthrome you are likely to bleed more than normal. The doctor or hospital staff must be informed that you are taking Sinthrome immediately. Always carry your personal anticoagulation card (an identification card from your pharmacist stating that you are using this medicine). If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome. Taking other medicines Tell your doctor or pharmacist if you are taking or have taken any of the following medicines as they may interfere with Sinthrome: paracetamol and non-steroidal anti-inflammatories statins and other lipid lowering drugs such as fenofibrate, (NSAIDs) such as aspirin, ibuprofen and celecoxib - used simvastatin or colestyramine - used to lower blood for pain relief or to treat rheumatic diseases cholesterol levels tramadol - a strong pain killer antibiotics such as rifampicin, amoxicillin and metronidazole - used to treat infections sulfonamides such as co-trimoxazole - used to treat infections sulphonylureas such as tolbutamide, chlorpropamide and glibenclamide - oral medicines for diabetes glucagon - used to treat low blood sugar levels thyroid hormones such as levothyroxine - used to treat an underactive thyroid allopurinol or sulfinpyrazone - for the treatment of gout and to lower uric acid levels anti-arrhythmic agents such as amiodarone and quinidine - medicines for an irregular heartbeat oral contraceptives such as Femodene, Logynon and Cilest - for birth control antiepileptics such as carbamazepine or phenytoin - used to treat epilepsy H2-agonists such as cimetidine or ranitidine - used to treat stomach or intestinal ulcers aminoglutethimide - used to treat cancer or Cushings syndrome barbiturates such as sodium amytal or phenobarbital - for epilepsy or to help you sleep etacrynic acid or thiazide diuretics (water tablets) such as bendroflumethiazide or metolazone - for water retention or high blood pressure Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking with food and drink Be careful when drinking alcohol as it may affect how Sinthrome thins your blood. Check with your doctor first. You should avoid drinking cranberry juice or taking other cranberry products, such as capsules or concentrates as this could mean you do not receive the correct amount of acenocoumarol. Pregnancy and breast-feeding Do not take Sinthrome if you are pregnant. Sinthrome, like other anticoagulants can cause serious harm to your baby. Tell your doctor if you are pregnant or trying to become pregnant. Your doctor will discuss with you the potential risk of taking Sinthrome during pregnancy. The decision to breast-feed while taking Sinthrome should be carefully considered with your doctor. You and your child may require blood tests if you are breast-feeding while you are taking Sinthrome. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from being thinned. If you are of child bearing age, a pregnancy test may be done by your doctor to rule out pregnancy before you are given Sinthrome. You may also be asked to use birth control while taking Sinthrome. Ask your doctor or pharmacist for advice before taking any medicine.
PIL UK 006 v5a
imidazoles such as econazole and ketoconazole or griseofulvin - used to treat fungal infections antineoplastics such as mercaptopurine and 5-fluorouracil - for breast, gastrointestinal and skin cancer tamoxifen - for breast cancer and fertility anti-platelet medicines such as dipyridamole, clopidogrel to prevent blood clots forming selective serotonin re-uptake inhibitors such as fluoxetine and paroxetine - used to treat anxiety and depression St Johns Wort - for depression protease inhibitors such as ritonavir or indinavir - used to treat HIV anabolic steroids - used as replacement therapy androgens such as testosterone and mesterolone - used as replacement therapy corticosteroids such as prednisolone and methylprednisolone - steroids used to treat inflammatory bowel disease, arthritis and certain skin conditions azathioprine - for organ transplantation, chronic inflammatory and autoimmune diseases disulfiram - for alcohol dependence heparin - to thin the blood in the treatment of deep vein thrombosis, blood clots or after surgery.
Driving and using machines You can drive and use machines as normal while taking Sinthrome. Important information about some of the ingredients of Sinthrome Sinthrome tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Sinthrome Always take Sinthrome exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Sinthrome should be taken as a single dose at the same time every day. Swallow your tablets whole with a drink of water. Your doctor will arrange regular blood tests during treatment with Sinthrome to check on how fast your blood is clotting. This will help the doctor decide on your dose. The dose of Sinthrome will vary from patient to patient and from day to day. The following can be used as a guide: Adults and elderly: Most patients will receive doses of between 1 to 8 mg (milligrams) a day. A dose of 4 mg is usual on the first day of treatment. Elderly patients, patients with liver disease or severe heart failure or malnourished patients may need lower doses. Children: Sinthrome is not recommended for children. What to do if you take more Sinthrome than you should If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor immediately or contact the nearest accident and emergency department. You may require blood tests to monitor your condition and treatment may be required. Show any left-over medicines or the empty packet to the doctor. If you forget to take Sinthrome Do not worry. 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. 4. Possible side effects Like all medicines, Sinthrome can cause side effects, although not everyone gets them. If you get any of the following, tell your doctor: unusual bleeding such as bleeding from the gums unexplained bruising or nosebleeds heavy periods heavy bleeding from cuts or wounds
signs of bleeding inside the body such as stomach or abdominal pain backache blood in the urine bloody or black tarry stools coughing up blood dizziness severe headache joint pain or stiffness blurred sight.
Tell your doctor or pharmacist if you think you have any of these or other problems with Sinthrome: Other rare side effects (that affect less than 1 person in 1000): loss of appetite feeling or being sick skin rashes itching unexplained fever hair loss. Very rare side effects (that affect less than 1 person in 10,000): red patches on the skin or bruising vasculitis (inflammation of the blood vessels) liver damage which can cause yellow eyes or skin. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store Sinthrome Keep out of the reach and sight of children. Do not take Sinthrome after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment. 6. Further information What Sinthrome contains The active ingredient in this medicine is acenocoumarol. This is the new name for nicoumalone. The ingredient itself has not changed. The other ingredients are lactose, hypromellose, magnesium stearate, maize starch, talc and silicon dioxide. What Sinthrome looks like and contents of the pack Sinthrome tablets are white, round, flat tablets, with CG imprinted on one side and AA on the other. They come in cartons of 100 tablets. Marketing Authorisation Holder and Manufacturer The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK. Sinthrome is manufactured by: Novartis Farmaceutica S.A., Barber del Valls, Barcelona, Spain. The information in this leaflet applies only to Sinthrome. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist. This leaflet was last approved in July 2007. Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited and is used under licence by Alliance Pharmaceuticals Limited. Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks Alliance Pharmaceuticals Ltd 2007.
PIL UK 006 v5a
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
