WARFARIN TABLETS 1MG
Active substance: WARFARIN SODIUM
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PATIENT INFORMATION LEAFLET
Warfarin 1mg, 3mg, 5mg Tablets
Read all of this leaflet carefully before you start using this medicine. Keep this 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. 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 asprin, ibuprofen and other NSAIDs (non steroidal anti-infammatory 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 Tablets are and what they are used for 2. Before you take Warfarin Tablets 3. How to take Warfarin Tablets 4. Possible side effects 5. How to store Warfarin Tablets 1 6. Further information
1. WHAT WARFARIN TABLETS ARE AND WHAT ARE THEY 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 TABLETS Do not take Warfarin Tablets 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 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 (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 if you are over 65 years of age or 2 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. Increases effect of Reduces effect of What to do Warfarin Warfarin Weight loss Weight gain Do not go on a weight reducing diet or change your eating habits without discussing it first 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 Dont make any major changes to your diet liver, broccoli, whilst taking warfarin. brussel sprouts and green leafy vegetables contain large amounts of vitamin K. Cranberry juice and cranberry products (and possibly grapefruit juice) Large amounts of alcohol Sudden illness such Stomach upset, as the flu or feeling diarrhoea, being run down sick (vomiting) Stopping smoking Dont drink either cranberry juice or grapefruit juice or products containing these whilst taking warfarin. Only drink small amounts whilst taking warfarin. If any of these happen, tell your doctor or nurse, as your dose may need to be changed. 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. 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 Johns 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)
3
4
Date of Approval: To be implemented by:
PROOF
29/10/2012
Product Description: Originated by Date: Tech Approved Date:
4
Warfarin 1mg, 3mg & 5mg Tablets
Component: Revised by
19/06/2009
N/A
N/A 100221/LF/2
Version: 100219/LF/2, 100220/LF/2,
Leaflet
Manufacturer: File Name: CRF No.:
Bristol
Market:
10960-62LF WarfarinTabs Bristol V2_4 QA.CRF.066.2012
Software Package: Barcode:
UK
Minimum Font Size & Typeface:
Quark Xpress 9
Dimensions:
N/A
Pharma Code:
8pt Swiss 721 CN BT
128 x 420mm
Colours:
Black
N/A
Key Line:
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 breast feeding: 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 Tablets has no known effect on the ability to drive or operate machines. Important Information about some of the ingredients of Warfarin Tablets: This medicine contains lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 5 before taking this product.
3. HOW TO TAKE WARFARIN TABLETS Always take Warfarin Tablets 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 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 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. If you stop taking Warfarin Tablets: DO NOT STOP taking your tablets except on your doctors advice as your condition may worsen. If you have any further questions about these tablets, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Warfarin Tablets 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 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 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). 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). 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 25C. Do not use this medicine after the expiry date printed on the container. The expiry date refers to the last day of that month. Return any unused tablets to your pharmacist who can dispose of them safely for you. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION The active substance is Warfarin sodium clathrate and each tablet contains respectively 1mg, 3mg or 5mg Warfarin sodium. The other ingredients are lactose, maize starch, sodium starch glycolate, magnesium stearate and purified water. The 1mg tablet also contains colourant Ansteads dispersed Brown 15026; 3mg tablet also contains colourant Ansteads dispersed Indigo Carmine Lake 15009, and 5mg tablet also contains colourant Ansteads Dispersed Red (Erythrosine Lake) 15058. What Warfarin Tablets look like and contents of pack: The 1mg tablets are light brown tablets, flat with bevelled edges scored embossed 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 pink tablets, flat with bevelled edges, scored and embossed W5 on one side with company logo on reverse. The tablets are packaged in polypropylene containers of 28, 56, 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 October 2012. Also you can help to make sure that medicines remain safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form avaible from your local pharmacy. 100219/LF/2, 100220/LF/2, 100221/LF/2
6
7
8
Date of Approval: To be implemented by:
PROOF
29/10/2012
Product Description: Originated by Date: Tech Approved Date:
4
Warfarin 1mg, 3mg & 5mg Tablets
Component: Revised by
19/06/2009
N/A
N/A 100221/LF/2
Version: 100219/LF/2, 100220/LF/2,
Leaflet
Manufacturer: File Name: CRF No.:
Bristol
Market:
10960-62LF WarfarinTabs Bristol V2_4 QA.CRF.066.2012
Software Package: Barcode:
UK
Minimum Font Size & Typeface:
Quark Xpress 9
Dimensions:
N/A
Pharma Code:
8pt Swiss 721 CN BT
128 x 420mm
Colours:
Black
N/A
Key Line:
Warfarin 1mg, 3mg, 5mg Tablets
Read all of this leaflet carefully before you start using this medicine. Keep this 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. 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 asprin, ibuprofen and other NSAIDs (non steroidal anti-infammatory 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 Tablets are and what they are used for 2. Before you take Warfarin Tablets 3. How to take Warfarin Tablets 4. Possible side effects 5. How to store Warfarin Tablets 1 6. Further information
1. WHAT WARFARIN TABLETS ARE AND WHAT ARE THEY 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 TABLETS Do not take Warfarin Tablets 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 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 (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 if you are over 65 years of age or 2 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. Increases effect of Reduces effect of What to do Warfarin Warfarin Weight loss Weight gain Do not go on a weight reducing diet or change your eating habits without discussing it first 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 Dont make any major changes to your diet liver, broccoli, whilst taking warfarin. brussel sprouts and green leafy vegetables contain large amounts of vitamin K. Cranberry juice and cranberry products (and possibly grapefruit juice) Large amounts of alcohol Sudden illness such Stomach upset, as the flu or feeling diarrhoea, being run down sick (vomiting) Stopping smoking Dont drink either cranberry juice or grapefruit juice or products containing these whilst taking warfarin. Only drink small amounts whilst taking warfarin. If any of these happen, tell your doctor or nurse, as your dose may need to be changed. 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. 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 Johns 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)
3
4
Date of Approval: To be implemented by:
PROOF
29/10/2012
Product Description: Originated by Date: Tech Approved Date:
4
Warfarin 1mg, 3mg & 5mg Tablets
Component: Revised by
19/06/2009
N/A
N/A 100221/LF/2
Version: 100219/LF/2, 100220/LF/2,
Leaflet
Manufacturer: File Name: CRF No.:
Bristol
Market:
10960-62LF WarfarinTabs Bristol V2_4 QA.CRF.066.2012
Software Package: Barcode:
UK
Minimum Font Size & Typeface:
Quark Xpress 9
Dimensions:
N/A
Pharma Code:
8pt Swiss 721 CN BT
128 x 420mm
Colours:
Black
N/A
Key Line:
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 breast feeding: 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 Tablets has no known effect on the ability to drive or operate machines. Important Information about some of the ingredients of Warfarin Tablets: This medicine contains lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 5 before taking this product.
3. HOW TO TAKE WARFARIN TABLETS Always take Warfarin Tablets 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 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 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. If you stop taking Warfarin Tablets: DO NOT STOP taking your tablets except on your doctors advice as your condition may worsen. If you have any further questions about these tablets, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Warfarin Tablets 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 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 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). 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). 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 25C. Do not use this medicine after the expiry date printed on the container. The expiry date refers to the last day of that month. Return any unused tablets to your pharmacist who can dispose of them safely for you. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION The active substance is Warfarin sodium clathrate and each tablet contains respectively 1mg, 3mg or 5mg Warfarin sodium. The other ingredients are lactose, maize starch, sodium starch glycolate, magnesium stearate and purified water. The 1mg tablet also contains colourant Ansteads dispersed Brown 15026; 3mg tablet also contains colourant Ansteads dispersed Indigo Carmine Lake 15009, and 5mg tablet also contains colourant Ansteads Dispersed Red (Erythrosine Lake) 15058. What Warfarin Tablets look like and contents of pack: The 1mg tablets are light brown tablets, flat with bevelled edges scored embossed 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 pink tablets, flat with bevelled edges, scored and embossed W5 on one side with company logo on reverse. The tablets are packaged in polypropylene containers of 28, 56, 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 October 2012. Also you can help to make sure that medicines remain safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form avaible from your local pharmacy. 100219/LF/2, 100220/LF/2, 100221/LF/2
6
7
8
Date of Approval: To be implemented by:
PROOF
29/10/2012
Product Description: Originated by Date: Tech Approved Date:
4
Warfarin 1mg, 3mg & 5mg Tablets
Component: Revised by
19/06/2009
N/A
N/A 100221/LF/2
Version: 100219/LF/2, 100220/LF/2,
Leaflet
Manufacturer: File Name: CRF No.:
Bristol
Market:
10960-62LF WarfarinTabs Bristol V2_4 QA.CRF.066.2012
Software Package: Barcode:
UK
Minimum Font Size & Typeface:
Quark Xpress 9
Dimensions:
N/A
Pharma Code:
8pt Swiss 721 CN BT
128 x 420mm
Colours:
Black
N/A
Key Line:
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
