Warfarin 5 mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have 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.

1. What Warfarin Tablets are and what they are used for
2. What you need to know before you take Warfarin Tablets
3. How to take Warfarin Tablets
4. Possible side effects
5. How to store Warfarin Tablets
6. Contents of the pack and other information

• are allergic to warfarin sodium or any of the other ingredients of this medicine (listed in section 6)
• 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.

• plan to have any surgery or a dental procedure. Tell all of your healthcare professionals and dentists that you are taking Warfarin Tablets. They should talk to the healthcare professional who prescribed Warfarin Tablets for you. This should be done before you have any surgery or dental procedure. Your Warfarin Tablets may need to be stopped for a short time or you may need your dose adjusted. Warfarin Tablets can affect your anaesthetic or cause bleeding
• lose weight, have an acute illness, have kidney problems or increase your intake of Vitamin K while taking Warfarin Tablets, as your dose may need to be changed (see section 3).

Tell your doctor if you are taking, have recently taken or might take any other 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, ciprofloxacin, 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, dipyridamole (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.

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Warfarin Tablets 0.5 mg, 1 mg, 3 mg and 5 mg 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.

Warfarin Tablets 1 mg contain quinoline yellow (E104) which may cause allergic reactions.

Warfarin Tablets 1 and 3 mg contain indigotin (E132) which may cause allergic reactions.

Warfarin Tablets 1 and 5 mg contain allura red (E129) which may cause allergic reactions.

Warfarin Tablets 5 mg contain erythrosine (E127) which may cause allergic reactions.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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.

Adults and the elderly (over 65 years):

The recommended 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 recommended 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.

Swallow the tablets or half tablets whole with water.

The tablets can be divided into equal doses.

No dose has been established for children.

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 a dose at the right time, take it as soon as you remember unless it is nearly time for the next dose.

Do not take a double dose to make up for forgotten dose.

Do not stop taking the tablets unless told to do so by your doctor.

• if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding
• blurred vision, slurred speech, loss of movement, numbness, dizziness, headache, confusion, feeling or being sick, fits, loss of consciousness. These could be a sign of a bleed in the brain
• 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.

• 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.

• 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.

• Impairment of renal function occurring with excessive anticoagulation and presence of blood in urine (anticoagulant-related nephropathy).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is 0.5, 1, 3 or 5 mg warfarin sodium.
• The other ingredients are anhydrous lactose, pregelatinised 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).

Warfarin Tablets 0.5 mg are white, flat round tablets, plain on one side and scored on the other with ‘w’ and 0.5 on either side of the line.

Warfarin Tablets 1 mg are brown, flat round tablets, plain on one side and scored on the other with ‘w’ and 1 on either side of the line.

Warfarin Tablets 3 mg are blue, flat round tablets, plain on one side and scored on the other with ‘w’ and 3 on either side of the line.

Warfarin Tablets 5 mg are pink, flat round tablets, plain on one side and scored on the other with ‘w’ and 5 on either side of the line.

Packs contain 21, 28, 50, 100, 200 or 500 tablets.

Not all pack sizes may be marketed.