Document: leaflet MAH GENERIC_PL 02848-0186 change

• leaflet MAH GENERIC_PL 02848-0186
• leaflet MAH GENERIC_PL 20416-0169

---

5 mm

MercuryPharma

Package leaflet: Information for the patient

Warfarin 1 mg, 3mg, 5mg Tablets

_Warfarin sodium_

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    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, pharmacist or nurse. This includes

any possible side effects not listed in this leaflet. See section 4._

What is in this leaflet

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

1. WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Warfarin 1 mg, 3mg, 5mg Tablets and the active ingredient is warfarin sodium.

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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN TABLETS

Do not take Warfarin Tablets:

• if you are allergic to Warfarin or any of the other ingredients of this medicine (listed in section 6).

•    if you are pregnant or may become pregnant or have had a baby in the last 48 hours

•    if you have or have ever had any bleeding problems

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

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

•    if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or anti-clotting medicines as this may increase the risk of bleeding. (See Section 2 ‘Other medicines and Warfarin Tablets’).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Warfarin Tablets:

•    if you have very high blood pressure which is not controlled by medicines

•    if you have a stomach or duodenal ulcer or have ever had one

•    if you have previously had gastrointestinal bleeding

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

•    if you have an infection of the heart lining (bacterial endocarditis)

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

•    if you have thyroid problems

•    if you have severe heart disease, liver or kidney problems

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

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

•    if you have a tumour or cancer

•    if you have had a recent wound or injury

•    if you have a higher risk of bleeding for example if 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

5 mm

treatment. To make sure your warfarin works properly and safely, it is important to follow the advice below.

Increases effect of Warfarin	Reduces effect of Warfarin	What to do
Weight loss	Weight gain	Do not go on a weight reducing diet or change your eating nabits without discussing it first with your doctor or nurse. Keep your level of activity as dose to normal as possible.
	Vitamin K	Do not take vitamin K supplements.
	Foods such as liver, broccoli, brussel sprouts and green leafy vegetables contain large amounts of vitamin K.	Don’t make any major changes to your diet whilst taking warfarin.
Cranberry juice and cranberry products (and possibly grapefruit juice)		Don’t drink either cranberry juice or grapefruit juice or products containing these whilst taking warfarin.
Large amounts of alcohol		Only drink small amounts whilst taking warfarin.
Sudden illness such as the flu or feeling run down	Stomach upset, diarrhoea, peing sick (vomiting)	If any of these happen, tell your doctor or nprse, as your dose may need to be changed.
Stopping smoking		Seek medical advice before you give up smoking.

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.

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.

Other medicines and Warfarin Tablets

Many medicines affect the way warfarin works. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over the counter medicines, herbal remedies and vitamin supplements.

Do not take Warfarin and tell your doctor it 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 anti depressants 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)

•    zafiriukast (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)

•    oriistat (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).

Warfarin Tablets with food, drink and alcohol

Patients should seek medical advice before undertaking any major changes in diet while taking warfarin tablets. Patients should be advised to avoid cranberry products. Acute ingestion of a large amount of alcohol may inhibit the metabolism of Warfarin and increase INR. Conversely chronic heavy alcohol intake may induce metabolism of Warfarin.

Pregnancy, breast-feeding and fertility

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 narm your baby dunng breastfeeding, if taken at the correct dose.

3. HOW TO TAKE WARFARIN TABLETS

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

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.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Warfarin Tablets 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 Tablets 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 Tablets:

If you usually take your warfarin tablets 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. Do not take a double dose to make up for a forgotten dose. 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.

If you stop taking Warfarin Tablets:

DO NOT STOP taking your tablets except on your doctor's advice as your condition may worsen.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be concerned about this list of side effects. You may not get any of them, but it is important to know what to do if they occur.

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 or go to a hospital straight away if you get any of the following side effects.

The following side effects have been reported but their frequency is not known:

•    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 Drain.

•    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.

e

5. HOW TO STORE WARFARIN TABLETS

Keep this medicine out of the sight and reach of children.

Store in original package/container in order to protect from light.

Do not store above 25 °C.

Do not use this medicine after the expiry date printed on the container. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Warfarin tablets contain

The active substance is Warfarin sodium. Each tablet contains warfarin sodium clathrate equivalent to 1 mg, 3mg and 5mg of warfarin sodium.

The other ingredients are lactose, maize starch, sodium starch glycollate, magnesium stearate and alumina.

The 1mg tablets also contain Tartrazine Lake (E102), Amaranth Lake (E123), Indigo Carmine Lake (E132).

The 3mg tablets also contain Indigo Carmine Lake (E132).

The 5mg tablets also contain Erythrosine Lake (E127).

What Warfarin Tablets look like and contents of the pack

The 1mg tablets are round, brown uncoated tablets, scored and marked 'W1' on one

side with company logo on reverse.

Warfarin 3mg tablets are round blue, uncoated tablets, scored and marked ‘W3’ on one side with company logo on reverse.

The 5mg tablets are round, pink uncoated tablets, scored and marked 'W5' on one side with company logo on reverse.

The tablets are packaged in polypropylene containers of 100 or 500 tablets or in aluminium blister packs of 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder Mercury Pharma International Ltd,

4045, Kingswood Road, City West Business Park, Co Dublin, Ireland Manufacturer:

Bristol Laboratories Limited,

Laporte Way, Luton, Bedfordshire, LU4 8WL, UK This leaflet was last revised in July 2016.

XXXXXX/LF/027/03, XXXXXX/LF/027/03, XXXXXX/LF/027/03    W