iMedi.co.uk

Warfarin 5 Mg Tablets

Informations for option: Warfarin 5 Mg Tablets, show other option
Document: label-leaflet MAH GENERIC_PL 00289-1629 change

For proofreading of Braille


• •

• • •

• •

• • •

• •

A

R F

A

R

N

• •

• •

• •

• •

• •

5

■■

• •

• •

B L

E

T

S


Base label (Selfadhesive)


20 mm


I I mm Tab/Glue


I 24 mm


10 mm Glue


30 mm


Braille placement only 20 mm


I I mm Tab/Glue


cb 3

u_

CD

Q- O S- J=

O 00

00 m

CD 3

-C- CD O

CD CD

> CD

a <

M= 00

CD O


■a

CD


^ LD I CVJ O CD

< >

iTi O

cc -e

UJ ro

= Sf

I- 2

U- GO


’a


2 2 0 _I LL.

E <° ro A E

<o “t X

0J SJ ta 2 ^ oo


Store in the original container.


124 mm

10 mm .

30 mm


Leaflet outside (Prima)

I I mm

I 34 mm

10 mm

124 mm

134 mm

Tab

Front page outside

Glue |

Page 5

Page 6


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 ifyou 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 unlikelyto 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.

0 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.

f you forget to take Warfarin

f you 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, f 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.

f you 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.

f you are not sure what to do if you have missed a dose askyour GP or anticoagulant clinic for advice.

0 POSSIBLE SIDE EFFECTS

-ike 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 importantto cnowwhatto 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.

Pell your doctor straight away ifyou 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 of the pancreas).

Pell 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).

0 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.

0 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, erythrosine (E127).

What Warfarin tablets look like and contents of the pack:

Warfarin 5 mg Tablets are pink with WFN above and 5 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 00289/1629 00018-D


Leaflet inside (Sekunda)


I 34 mm

Page I


I 34 mm

Page 2


134 mm

Page 3


I 34 mm

Page 4 (Front page inside)


I I mm Tab/Glue


WARFARIN 5 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,'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 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 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-steroidai 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 not take 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 it takes 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._


riiings 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 importantto 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 habits without discussing itfirst with your doctor or nurse.

Keep your level of activity as close 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 yourdietwhilsttaking Warfarin.

Cranberry juice and cranberry products (and possibly grapefruit juice)

Don't drink either cranberry juice or grapefruit juice or products containing these whilsttaking Warfarin.

Large amounts of alcohol

Only drinksmall amounts whilsttaking Warfarin.

Sudden illness such as the flu orfeeling run down

Stomach upset, diarrhoea, being sick (vomiting).

If any of these happen, tell your doctor or nurse, asyour dose may need to be changed.

Stopping smoking

Seek medical advice before you give up smoking.

Keep healthcare professionals informed

Carryyour anticoagulation record card with you at ALLtimes. Always tell any doctors, surgeons, nurses, dentists or pharmacists thatyou goto thatyou are taking Warfarin. You should also have received a bookletwhich 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 loweryour dose before an operation or removal of teeth. You should stop taking Warfarin 72 hours before and aftersurgery where there is a risk of severe bleeding. Make sure you tell your doctor or dentistyou are taking Warfarin.


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).