PATIENT INFORMATION LEAFLET

WARFARIN Tablets I mg, 3 mg & 5mg

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

Keep the leaflet. You may need to read it again. If you have any 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

■    It is important to take the correct dose. If you have difficulty, ask someone to help you. If you take the wrong dose or take too much, contact your 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 ‘Taking 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 are 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

1.    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 strengths and colours: 1mg (brown);

3mg (blue); 5mg (pink).

2.    Before you take Warfarin

Do not take Warfarin if you

■    are allergic to Warfarin or to any of the 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 Section 2 ‘Taking other medicines’).

If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment.

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

very high 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 (thrombophilia) 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 examples because you are over 65 years of age or are unsteady on your feet and more likely to 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 it takes your blood to clot. These blood tests are very important to make sure you are taking the right dose. Blood tests will be more frequent if you have had your dose of warfarin changed, if you have started or stopped taking other medicines, or have liver or kidney problems.

Things which affect warfarin

A number of things affect blood clotting and can therefore affect your warfarin treatment. To make sure your warfarin works properly and safely, it is important to follow the advice below.

Keep healthcare professionals informed

Carry your anticoagulation record card with you at ALL times. Always tell any doctors, surgeons, nurses, dentists or pharmacists that you go to that you are taking Warfarin. You should also have received a booklet which includes more information about warfarin along with a list of symptoms which need to be checked by your doctor immediately. Operations

Due to the risk of bleeding, you may need to lower your dose before an operation or removal of teeth. You should stop taking warfarin 72 hours before and after surgery where there is a risk of severe bleeding. Make sure you tell your doctor or dentist you are taking warfarin.

Taking other medicines

Many medicines affect the way warfarin works. You must tell 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)

Measure bar should be 150mm at 100% scale

■    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

■    allopurinol (for gout)

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

•    disulfiram (for alcohol dependence)

•    ketoconazole, fluconazole, itraconazole (for fungal 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 (but this does not include pravastatin)

■    erythromycin, sulfamethoxazole, metronidazole (for bacterial infections)

•    orlistat (for obesity).

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 (for fungal infections)

•    oral contraceptives (the ‘Pill’)

■    rifampicin (for tuberculosis)

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

•    sucralfate (for stomach ulcers)

■    cholestyramine (for lowering cholesterol)

•    vitamin K (in vitamin supplements or in cod liver oil).

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 breastfeeding

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

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

Warfarin is unlikely to harm your baby during breastfeeding, if taken at the 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

This medicine contains both sucrose and lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The 1mg strength tablet contains amaranth (E123). This may cause allergic reactions.

3. How to take

Always take Warfarin exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Your dose will be decided by your doctor and will depend on the results of the blood tests carried out to measure the time it takes your blood to clot.

Once you have been stabilised on this medicine the usual dose is between 3-9 mg. Try to take the medicine at the same time 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

If you usually take 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 not take that dose. Make a note that you have missed a dose and take your normal dose the next day at the usual time.

If you usually take 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. Never take a double dose to catch up. Make a note that you have missed a dose.

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

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking warfarin and go to hospital at once if you have

*    a rare allergic reaction such as swelling of the 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 or signs of bleeding (as this could mean that your clotting levels are too low and that your 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 of the pancreas)

*    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.

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).

Reporting of side effects

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Warfarin Tablets

Keep this medicine in the pack provided. Do not store above 25°C. Keep out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help protect the environment.

6.    Further information

Ingredients:

Warfarin tablets are available in 3 strengths: as 1 mg (brown),

3 mg (blue) and 5 mg (pink) and contain either 1 mg, 3 mg or 5 mg of warfarin sodium as the active ingredient. They also contain the following other ingredients: lactose, sucrose, maize starch, magnesium stearate and pregelatinised starch. The following colours are also present in the tablets: Warfarin Tablets 1 mg: Eurolake Brown Lake containing quinoline yellow (E104), amaranth (E123), indigo carmine (E132). Warfarin Tablets 3 mg: Dispersed Indigo Carmine Lake (E132).

Warfarin Tablets 5 mg: Dispersed Erythrosine Lake (E127).

What the medicine looks like and contents of pack: Warfarin Tablets 1mg are flat bevelled edged, brown tablets engraved with the company logo on one side and with a breakline and A338 on the other side. Warfarin Tablets 3mg are flat bevelled edged, blue tablets engraved with the company logo on one side and with a breakline and A324 on the other side. Warfarin Tablets 5mg are flat bevelled edged, pink tablets engraved with the company logo on one side and with a breakline and A325 on the other side.

This medicine is available in pack sizes of 28, 50,100, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Text revised August 2016

If you would like this leaflet in a different format please contact the licence holder at the above address.

- Measure bar should be 150mm at 100% scale -