Warfarin 0.5mg Tablets
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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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally and you should 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Warfarin Tablets are and what they are used for
2. Before you take Warfarin Tablets
3. How to take Warfarin Tablets
4. Possible side effects
5. How to store Warfarin Tablets
6. Further information
1. WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR
Warfarin Tablets belong to a group of drugs called anti-coagulants. You take Warfarin Tablets to help thin your blood if you have had a heart problem, problems with blood clots or your blood flow. You may also be given Warfarin Tablets if you have been fitted with a replacement heart valve.
2. BEFORE YOU TAKE WARFARIN TABLETS
Do not take Warfarin Tablets if you:
- are allergic (hypersensitive) to warfarin sodium or any of the other ingredients of Warfarin Tablets (See section 6 for a full list of ingredients)
- are pregnant, breast-feeding or planning to become pregnant
- have problems with your liver or kidneys
- have had an infection of the lining of your heart
- have a condition which causes bleeding (such as a peptic ulcer) or makes you bruise easily
- have high blood pressure
- are taking the herbal remedy, St John’s Wort (Hypericum perforatum) for depression Do not take Warfarin Tablets within 24 hours of surgery or giving birth to a child.
Tell your doctor if you:
- require surgery or dental treatment as Warfarin Tablets can affect your anaesthetic or cause bleeding
- lose weight, have an acute illness, have kidney problems or increase your intake ofVitamin K while taking Warfarin Tablets, as your dose may need to be changed.
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Taking other medicines
Always tell your doctor if you are taking other medicines including herbal remedies and non-prescription medicines. Many drugs may increase or decrease the effects of Warfarin Tablets. It is particularly important to tell your doctor if you are taking, or have recently taken any of the medicines listed below:
- drugs for heart problems (amiodarone, quinidine, propafenone)
- drugs for depression (amitriptyline, nortriptyline)
- Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, aspirin, oxyphenbutazone, phenylbutazone and feprazone
- drugs to lower cholesterol in your blood (bezafibrate, gemfibrozil,clofibrate, cholestyramine)
- drugs to treat bacterial infections (aztreonam, cephamandole, co-trimoxazole, chloramphenicol, ciprofloxa cin, erythromycin, metronidazole, nalidixic acid, neomycin, norfloxacin, rifampicin, sulphonamides, latamoxef, griseofulvin, tetracyclines and other broad spectrum antibiotics)
- drugs to treat fungal infections (miconazole, fluconazole, ketoconazole)
- drugs for pain and/or inflammation (paracetamol, azapropazone, diflunisal, dextropropoxyphene, phenyramidol)
- cimetidine or sucralfate (stomach ulcers or acid) or omeprazole to reduce stomach acid
- danazol for menstrual problems
- drugs for diabetes (tolbutamide, glucagon, phenformin)
- salicylates used to treat ulcers
- allopurinol for gout
- tamoxifen for breast cancer or aminoglutethimide for breast or prostate cancer
- chloral hydrate or triclofos if you are having problems sleeping
- disilfram for alcoholism, oral contraceptives, anabolic steroids, corticosteroids, methylphenidate for hyperactivity, dipyrida mole (to stop blood cells sticking together)
- drugs to treat thyroid problems
- carbamazepine, primidone or phenytoin for control of epilepsy
- vitamin K supplements
- sedatives such as barbiturates, ethchlorvynol or glutethimide
- the hormone ACTH, to treat a hormone deficiency or as part of a test requested by your doctor.
Do not take any other drug without speaking to your doctor first.
Taking Warfarin Tablets with food and drink
Do not drink large amounts of alcohol while taking Warfarin Tablets.
Drinking cranberry juice or taking other cranberry products (for example capsules or concentrates), might increase the effect of Warfarin Tablets in “thinning” the blood. You should therefore avoid drinking/taking these products whilst taking Warfarin Tablets. If you have been advised to take cranberry juice or other products for medical reasons (e.g. bladder infections), or are regularly drinking or taking cranberry products, you should contact your anticoagulant clinic or health advisor before making any changes to the amount you drink/take. Your doctor or clinic may wish to monitor you more frequently while you are taking any cranberry product.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, thinking you might be pregnant or are breast-feeding, you should not take Warfarin Tablets.
Important information about some of the ingredients of Warfarin Tablets.
Warfarin Tablets contain lactose. If you are lactose intolerant, speak with your doctor before taking this medicine.
3. HOW TO TAKE WARFARIN TABLETS
Dosage
Take Warfarin Tablets exactly as prescribed by your doctor. Your doctor will prescribe the dose of Warfarin Tablets that is right for you. Do not change your dose of Warfarin Tablets without talking to your doctor. Your doctor may test your blood while you are taking Warfarin Tablets.
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Adults and the elderly (over 65 years):
The usual starting dose is 10 mg daily for 2 days. Your doctor will do a blood test to decide the exact dose you should take. After the second day the usual dose of Warfarin Tablets is between 3 and 9 mg once a day. Your doctor will tell you exactly how many Warfarin Tablets you should take. Try to take your tablets at the same time each day.
No dose has been established for children.
Swallow the tablets whole with water.
If you take more Warfarin Tablets than you should
If you take too many tablets, or if you have unexplained bleeding, call your doctor or contact your nearest hospital immediately. Do not take more tablets than your doctor tells you to.
If you forget to take your Warfarin Tablets
If you forget to take a dose at the right time, take it as soon as you remember unless it is nearly time for the next dose.
Never double-up on the next dose to make up for the one you missed.
If you stop taking your Warfarin Tablets
Do not stop taking the tablets unless told to do so by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Warfarin Tablets can have side effects, but not everybody gets them.
If any of the following occur, stop taking the tablets and tell your doctor immediately:
- unexplained nose bleeds
- black or red faeces which may be caused by internal bleeding
- dark red or brown urine which may be caused by problems with your kidneys or bladder
- fever
- nausea and vomiting
Tell your doctor straight away if you have any of the following side effects:
- A painful skin rash. On rare occasions warfarin can cause serious skin conditions, including one called calciphylaxis that can start with a painful skin rash but can lead to other serious complications. This adverse reaction occurs more frequently in patients with chronic kidney disease.
If any of the following occur, call your doctor as soon as possible:
- allergic reaction
- skin rashes
- hair loss
- diarrhoea
- purple discolouration or ‘bruising’ to your skin
- a yellowing of your skin or whites of your eyes
- changes in the amount or colour of your urine
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORING WARFARIN TABLETS
Keep out of the reach and sight of children
Do not store above 25°C. Store in original container.
Do not use after the expiry date printed on the carton. Return any unused tablets to your pharmacist who can dispose of them safely for you.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Warfarin Tablets contain
Each tablet contains 0.5, 1, 3 or 5 mg of active ingredient warfarin sodium. The inactive ingredients in the tablets are lactose, pre-gelatinised maize starch and magnesium stearate, E104 (1 mg only), E127 (5 mg only), E129 (1 mg and 5 mg) and E132 (1 mg and 3 mg).
What Warfarin Tablets look like and contents of the pack
Warfarin Tablets 0.5 mg are white, scored on one side with ‘w’ and 0.5 either side of the line.
Warfarin Tablets 1 mg are brown, scored on one side with ‘w’ and 1 either side of the line.
Warfarin Tablets 3 mg are blue, scored on one side with ‘w’ and 3 either side of the line.
Warfarin Tablets 5 mg are pink, scored on one side with ‘w’ and 5 either side of the line.
Packs contain 21, 28, 50, 100, 200 or 500 tablets.
The Marketing Authorisation holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
This leaflet was prepared in 08/2016.
PL 31750/0092-95
