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

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 (NSAIDs) such as aspirin, ibuprofen and celecoxib - used for pain relief or to treat rheumatic diseases
• 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 Cushing’s 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
• statins and other lipid lowering drugs such as fenofibrate, simvastatin or colestyramine - used to lower blood cholesterol levels
• 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 John’s 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.

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.

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.

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.

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:

Sinthrome is manufactured by: