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Warfarin

3 mg Tablets

Oral Use

500 Tablets

■izuzn*

Leaflet outside (Prima)

I 34 mm

Page 7

Medicines which decrease the effect of Warfarin: Tell your doctor or pharmacist if you are taking:

•    barbiturates (sedatives)

•    primidone, phenytoin, carbamazepine (to treat epilepsy)

•    griseofulvin (forfungal infections)

•    oral contraceptives (the'Pill')

•    rifampicin (fortuberculosis)

•    azathioprine (for inflammatory bowel disease and rheumatoid arthritis and to prevent organ rejection)

•    sucralfate (for stomach ulcers)

•    colestyramine (for lowering cholesterol).

Medicines which have varying effects on Warfarin: Tell your doctor or pharmacist if you are taking:

•    corticosteroids (for inflammation and many other diseases)

•    nevirapine, ritonavir (for HIV infection).

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, may become pregnant or have had a baby within the last 48 hours.

Tj See your doctor straight away if you get pregnant whilst taking this medicine.

J Warfarin is unlikely to harm your baby during breast-feeding, if taken atthe correct dose.

Driving and using machines

Warfarin has no known effect on the ability to drive or operate machines.

Important information about some of the ingredients

•    If you have been told by your doctorthatyou have an intolerance to some sugars, contactyour doctor before taking this medicine.

^ HOW TO TAKE

Always take Warfarin exactly as your doctor hastold you. Ifyou are not sure, checkwith your doctor or pharmacist. Your dose will be decided by your doctor and will depend on the results of the blood tests carried outto measure the time ittakes your blood to clot.

Onceyou have been stabilised on this medicine the usual dose is between 3-9 mg.Tryto take the medicine atthe sametime each day.

If you take more Warfarin than you should

Talk to your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you. Symptoms of taking too much Warfarin include bleeding, black tarry stools, blood in urine, heavy bleeding or oozing from cuts and wounds or unusually heavy menstrual bleeding._

If you forget to take Warfarin

Ifyou usuallytake your Warfarin in the evening and you have forgotten to take it, if you remember before midnight on the same day, take the missed dose. If midnight has passed do nottake that dose. Make a note thatyou have missed a dose and take your normal dose the next day atthe usual time.

Ifyou usuallytake your Warfarin in the morning and have forgotten to take it the general advice is as follows:

•    if it is less than two hours late, take the dose as soon as you remember and then continue as normal.

• if it is more than two hours late, take the dose as soon as you remember and then continue as normal. However, if it is time to take your next dose leave out the missed dose. Nevertake a double dose to catch up. Make a note thatyou have missed a dose.

Ifyou are not sure what to do if you have missed a dose ask your GP or anticoagulant clinic for advice.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Warfarin can cause side effects. Do not be concerned about this list of side effects. You may not get any of them, but it is important to knowwhatto do if they occur.

Stop taking Warfarin and go to hospital at once if you have:

•    a rare allergic reaction such as swelling ofthe face, tongue, lips and throat, difficulty breathing, severe itching of your skin with raised lumps. You may need urgent medical attention.

Tell your doctor straight away if you have any of the following side effects:

•    any unexpected bleeding orsigns of bleeding (as this could mean thatyour clotting levels are too low and thatyour dose needs to be adjusted);

•    unexplained nose bleeds, bleeding gums

•    unexplained bruising or pinpoint red spots on your skin

•    heavy bleeding or oozing from cuts and wounds

•    pink, dark red or brown urine (this may be due to bleeding in the bladder or kidneys)

•    black tarry stools, vomiting blood or particles that look like coffee grounds (signs of bleeding in the stomach or intestines), bleeding from the back passage (rectum)

•    coughing up blood

•    (in women) unusually heavy periods or bleeding from the vagina

•    blurred vision, slurred speech, loss of movement, numbness, dizziness, headache,feeling or being sick,fits, loss of consciousness. These could be a sign of a bleed in the brain.

•    painful, blue-purple coloured toes

» yellowing of the skin and white of eyes (jaundice)_

•    severe pain in the upper abdomen (a sign of inflammation ofthe pancreas),

Tell your doctor or pharmacist if any of the following side effects persist, get worse or if you notice any other side effects not listed:

•    feeling sick or being sick, diarrhoea

•    hair loss

•    skin rash

•    fever

•    drop in number of red blood cells, blood haemoglobin (shown in blood tests).

Q HOWTO STORE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package. Do not use Warfarin after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Medicines should notbe disposed of via wastewateror household waste. Askyour pharmacist howto dispose of medicines no longer required.These measures will help to protectthe environment.

Q FURTHER INFORMATION

What Warfarin tablets contain:

•    The active ingredient is warfarin sodium.

•    The other ingredients are lactose 170 mesh, maize starch, pregelatinised maize starch, sodium starch glycolate, magnesium stearate, purified water, indigo carmine (E132).

What Warfarin tablets look like and contents of the pack:

• Warfa rin 3 mg Tablets are blue with WFN above and 3 below a breakline on one side and twin triangle on reverse.

• Warfarin Tablets are available in packs of 7, 14, 21,28, 30, 50,56, 60,84, 90, 100, 1 12, 120 and 500 tablets, and in hospital packs of 10,000 and 100,000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: August 2011

PL 00289/1628_00017-D

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WARFARIN 3 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start using this medicine.

Keepthis leaflet. You may need to read itagain. Ifyou have any questions, askyour doctor or pharmacist.

This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours,

•    It is importantto take the correct dose. If you have difficulty, ask someone to help you. Ifyou take the wrong dose ortake too much, contactyour doctor or pharmacist (See Section 3).

•    Carry your Warfarin record card with you at ALL times. Always tell any doctors, surgeons, nurses, dentists or pharmacists that you are taking Warfarin,

•    Warfarin can be affected by many other medicines including non prescription medicines, herbal remedies, vitamin and food supplements. (See Section 2.'Ta king other medicines'). Do not start taking any new medicine without checking it is safe to take it with Warfarin; especially aspirin, ibuprofen and other NSAIDs (non-steroidal anti-inflammatory medicines), as these can make you more likely to bleed.

•    Some foods and illnesses can affect Warfarin treatment. Follow the advice in Section 2 Things which affect Warfarin',

•    If you have any signs or symptoms of bleeding, contact a doctor straight away (See Section 4).

•    Seek medical help at once if you unable to stop any bleeding, you fall, get hurt or hit your head.

IN THIS LEAFLET:

1.    What Warfarin is and what it is used for

2.    Before you take Warfarin

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

Q WHAT WARFARIN IS AND WHAT IT IS USED FOR

Warfarin belongs to a group of medicines called anticoagulants. It is used to reduce the clotting ability of the blood. (It is sometimes called a 'blood thinner', but it does not actually thin the blood.)

Warfarin is used to prevent and treat blood clots forming in the legs, lungs, brain and heart.

The tablets come in three stengths and colours: 1 mg (brown); 3 mg (blue); 5 mg (pink)._

Q BEFORE YOU TAKE WARFARIN

DO NOT take Warfarin if you:

•    are allergic to Warfarin or any ofthe other ingredients (see Section 6)

•    are pregnant or may become pregnant or have had a baby in the last 48 hours » have or have ever had any bleeding problems

•    have recently had a stroke caused by bleeding in the brain

•    have had surgery within the last 72 hours or are going to have surgery in the next 72 hours

•    are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or anti-clotting medicines as this may increase the risk of bleeding,

(See S ection 2 'Taking other medicines').

If any of these apply to you, do nottake this medicine and go back to your doctorto discuss your treatment.

Check with your doctor or pharmacist before taking these tablets if you have:

•    very igh blood pressure which is not controlled by medicines

•    a stomach or duodenal ulcer or have ever had one

•    previously had gastrointestinal bleeding

•    had recent ischaemic stroke (caused by blockage of blood vessels in the brain)

•    an infection of the heart lining (bacterial endocarditis)

•    problems with circulation of blood to the brain (cerebrovascular disease)

•    thyroid problems

•    severe heart disease, liver or kidney problems

•    have a condition making you prone to blood clots (thrombophylia)

•    anaemia (low haemoglobin causing extreme tiredness, breathlessness, poor resistance to infection)

•    a tumour or cancer

•    had a recent wound or injury

•    a higher risk of bleeding, for example because you are over 65 years of age or are unsteady on yourfeet and more likelyto fall and injure yourself.

If any of these apply to you, tell your doctor or pharmacist before taking Warfarin, as you may need to be checked more often during treatment.

Regular blood tests

You will have regular blood tests to see how long ittakes your blood to clot. These blood tests are very importantto make sure you are taking the right dose. Blood tests will be more frequent if have had your dose of Warfarin changed, ifyou have started or stopped taking other medicines, or have liver or kidney problems._

raking other medicines

Many medicines affectthe way Warfarin works. You musttell your doctor before you start taking any other medicines including over the counter medicines, herbal remedies and vitamin supplements.

Do not take Warfarin and tell your doctor if you are taking:

*    alteplase, reteplase, streptokinase, tenecteplase, urokinase (fibrinolytic drugs to treat or prevent blood clots)

*    St John's wort [Hypericum perforatum) a herbal remedy for depression.

Check with your doctor first before taking these medicines:

*    non-steroidal anti-inflammatory drugs (NSAIDs)for pain and inflammation including aspirin, ibuprofen, celecoxib, diclofenac, indometacin, meloxicam

*    clopidogrel, abciximab, dipyridamole, eptifibatide, tirofiban (antiplatelet drugs to prevent or break down blood clots)

*    heparin or medicines containing heparin, bivalirudin, fondaparinux, dabigatran, rivaroxaban, danaparoid, prostacyclin (other anticoagulants)

*    sulfinpyrazone (for gout)

*    glucosamine (for osteoarthritis)

*    SSRI and SNRI antidepressants such as citalopram,fluoxetine, paroxetine, venlafaxine.

Medicines which increase the effect of Warfarin: Tell your doctor if you are taking:

*    prolonged, regular use of paracetamol (for pain or inflammation)

*    antibiotics such as amoxicillin, levofloxacin and tetracycline

*    vitamin K (in vitamin supplements or in cod liver oil)

*    allopurinol (for gout)

*    capecitabine, erlotinib, tamoxifen (for types of cancer)

*    disulfiram (for alcohol dependence)

*    ketoconazole, fluconazole, itraconazole (forfungal infections)

*    omeprazole (for stomach ulcers)

*    propafenone, amiodarone, quinidine (for heart disorders)

*    methylphenidate (for attention deficit disorder)

*    zafirlukast (for asthma)

*    bezafibrate, ciprofibrate, fenofibrate, gemfibrozil (to reduce high blood fats)

*    statins such as fluvastatin to lower cholesterol (butthis does not include pravastatin)

*    erythromycin, sulfamethoxazole, metronidazole (for bacterial infections)

*    orlistat (for obesity).