Warfarin 5mg Tablets
Package leaflet: Information for the user Warfarin 1mg, 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 1mg, 3mg or 5mg Tablets.
Warfarin belongs to a group of medicines called anticoagulants. These medicines increase the time it takes for your blood to clot. Warfarin is used to prevent and treat blood clots in the veins and arteries, for example clots in the legs, lungs, brain or heart.
2. What you need to know before you take Warfarin Tablets Do not take Warfarin Tablets if:
• you are allergic to Warfarin or to any of the other ingredients of this medicine (listed in section 6 )
• you have had a stroke as a result of bleeding from a blood vessel in the brain
• you are pregnant, planning to become pregnant or have just had a baby in the last 48 hours (please see the Section on “Pregnancy and breastfeeding”)
• you have had surgery in the last 72 hours
• you are taking medicines that may increase your risk of bleeding or other medicines that stop the blood from clotting (please see the Section ' Warnings and precautions).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking warfarin tablets if:
• you are elderly (over 65 years)
• you have recently lost or gained a lot of weight
• you have any short term illness
• you are suffering from vomiting or have diarrhoea
• you are changing your diet (vitamin K content may be different in different types of food. Vitamin K supplements should be taken only if prescribed by doctors as sudden increase in Vitamin K intake may decrease the effect of Warfarin. On the other hand, lowering your Vitamin K intake suddenly could increase the effect of Warfarin).
• you have raised blood pressure that is not controlled by medicines
• you have liver or kidney problems
• you have an infection of the lining of your heart (bacterial endocarditis)
• you have low levels of iron in the blood (which may lead to pale appearance of the eyes and skin)
• you have heart disease
• you have problems with circulation of blood to the brain (cerebrovascular disease)
• you have a tumour or cancer
• you have thyroid problems
• you have ever had a stomach ulcer or bleeding in the stomach or intestines
• you have had a stroke
• You have low levels of a substance called “Protein C” or “Protein S”. These stop blood clotting
• you have a high risk of injury or falling
• you are taking any medicines that may increase your risk of bleeding such as non-steroidal antiinflammatories (NSAIDs) e.g. aspirin, ibuprofen or other medicines that stop the blood from clotting
• you are going to have surgery. The doctor may have to change your dose or stop your warfarin treatment.
Tell your doctor if any of the above apply to you as they may alter the effect of Warfarin and require an adjustment to the dose. You should be given a „warfarin cardD (patient-held information booklet) at the start of treatment.
Other medicines and Warfarin Tablets:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because warfarin can affect the way some other medicines work. Also some other medicines can affect the way warfarin works. Other medicines can make you more likely to bleed or you may need to take more warfarin because of what you are already taking.
Do not take warfarin and tell your doctor if you are taking any of the following medicines:
• other medicines used to thin your blood (anticoagulants) or stop clotting such as clopidogrel, dipyridamole, dabigatran, bivalirudin, heparins, fondaparinux, rivaroxaban, eptifibatide, tirofiban, abciximab, danaparoid and prostacyclin
• clot dissolving medications e.g. streptokinase, alteplase
• medicines for gout, pain and inflammation called non-steroidal anti inflammatory drugs (NSAIDs) such as aspirin, indometacin, celecoxib
• medicines to treat depressions such as SSRIs (selective serotonin reuptake inhibitors), for example, fluoxetine and citalopram or SNRIs (selective noradrenaline reuptake inhibitors) such as venlafaxine
• sulfinpyrazone - used for gout
• St. JohnDs Wort - a herbal remedy used for depression.
Do not take warfarin and tell your doctor if you are taking any of the above medicines. If you are not sure, talk to your doctor or pharmacist.
The following medicines may increase the effect of your warfarin. Tell your doctor or pharmacist if you are taking:
• medicines for heart problems such as amiodarone, propafenone
• medicines that reduce high levels of fats (lipids) in your blood such as bezafibrate or gemfibrozil or lower your cholesterol levels such as fluvastatin
• steroids such as zafirlukast
• medicines for pain and fever such as paracetamol
• allopurinol used to treat gout
• medicines for infection such as erythromycin, metronidazole, sulfamethoxazole
• medicines for fungal infections such as fluconazole, ketoconazole and azole anti-fungals
• omeprazole used for stomach ulcers or too much stomach acid
• tamoxifen, capecitabine, erlotinib - used to treat cancer
• methylphenidate - used for hyperactivity disorder
• disulfiram - used for alcohol addiction
The following medicines may decrease the effect of your warfarin. Tell your doctor or pharmacist if you are taking:
• medicines for epilepsy such as phenobarbital, phenytoin, primidone or carbamazepine
• medicines for arthritis such as azathioprin
• rifampicin - used for infections like TB (tuberculosis)
• griseofulvin - used for fungal infections
• oral contraceptives (the “pill”).
If you are taking the following drugs, tell your doctor:
• corticosteroids such as prednisolone used to treat various allergic disorders and arthritis
• nevirapine, ritonavir used to treat HIV infection
• medicines for infection such as cefamanadole, chloramphenicol, ciprofloxacin, co-trimoxazole
• orlistat - used to help weight loss
• cholestyramine used to treat itching and high levels of lipids (fats) in the blood
• sucralfate used to treat ulcers
• glucosamine used to treat arthritis
• vitamin K which can be found in vitamin supplements and enteral feeds.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking warfarin.
Warfarin Tablets with food, drink and alcohol:
• Drinking grapefruit juice, cranberry juice or taking other cranberry products (for example, capsules or concentrates) might increase the effect of warfarin in „thinningD the blood. You should therefore avoid drinking / taking these products whilst taking warfarin. If you have been advised to take cranberry for medical reasons (e.g. bladder infections), or are regularly drinking or taking cranberry products, you should contact your anticoagulant clinic or health advisor before making any changes to the amount you drink / take. Your doctor or clinic may wish to monitor you more frequently while you are taking any cranberry product
• Do not drink large amounts of alcohol when taking warfarin
• It is important to keep your diet as close to normal as possible while taking warfarin. This is because making changes in your diet may affect how your body responds to warfarin. This is particularly likely to happen with foods which contain vitamin K such as liver and leafy green vegetables.
Pregnancy and breast-feeding:
Warfarin Tablets should not be taken if you are pregnant, think you are pregnant, planning to become pregnant or have just had a baby in the last 48 hours.
You should use a barrier method of contraception such as a condom.
If you are female and think that you may have become pregnant, contact your doctor as soon as possible. Warfarin can have an adverse effect on the unborn child, and alternative medicines are available if considered necessary by your doctor.
It may be possible to take warfarin whilst breast feeding. Speak to your doctor about this if it applies to you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
Warfarin Tablets should not affect your ability to drive or use 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 before taking this medicinal product.
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.
Adults:
• Usual starting dose of 10mg daily for 2 days.
• After 2 days the dose is usually reduced to between 3 mg and 9 mg once a day.
The doctor may vary your dose up or down depending on the results of a blood test which will be performed at the start and at regular intervals during your treatment. The dosage is likely to be less for the elderly.
• Swallow the tablets whole with a drink of water
• Try to take the tablets at the same time each day
• Do not take more tablets than the doctor tells you to
• Do not stop taking your tablets except on your doctor’s advice as your condition may worsen.
This product is not suitable for use in children.
If you have to go to another doctor, to hospital, or to a dentist, tell them that you are being treated with warfarin and ask them to contact your own doctor.
If you take more Warfarin Tablets than you should:
If you take too many Warfarin Tablets, tell your doctor immediately or go to your nearest Hospital Casualty/Accident & Emergency Department. Take any remaining tablets and this leaflet with you so that the medical staff will know what you have taken.
If you forget to take your Warfarin Tablets:
• If you miss a dose and remember within two or three hours, you can still take that dose
• If you forget for a longer time, do not take that dose to catch up, but take your next dose when it is due. Remember to tell your doctor when you see him/her next and have your blood test
• DO NOT TAKE DOUBLE THE AMOUNT OF TABLETS IF YOU MISS A DOSE.
If you have any further questions about these tablets, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking warfarin and see a doctor or go to a hospital straight away if you notice the following serious side effect - you may need urgent medical treatment:
Allergic reaction - the signs may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps.
If you get any of the above, stop taking warfarin and see a doctor or go to a hospital straight away.
Tell your doctor or go to a hospital straight away if you get any of the following side effects.
The following side effects have also been reported but their frequency is not known:
Your doctor may decide to stop your warfarin treatment:
• Any bleeding at all as this is a sign that your clotting levels are low:
Examples of bleeding that have been noted with the use of warfarin are:
- nose bleeds without any obvious reason
- loss of consciousness, fits, numbness, headache, dizziness, feeling or being sick, slurred speech, blurred vision. These could be signs that there is a bleed in your brain
- change in the colour of your urine - a dark red or brown urine might be due to bleeding in your kidneys or bladder
- black or red stools due to bleeding from the stomach, intestine or rectum
- red or purple swollen patches on your skin that look like bruises
- painful red patches of skin that have blood filled blisters that turn black
• Fever
• Vomiting of blood
• Swelling or tenderness in your stomach or back
• Difficulty in breathing and chest pain due to collection of blood in the chest
• Yellowing of the skin and whites of the eyes (jaundice), problems with your liver
• Purple painful toes
• Unusual bleeding or bruising more easily, getting more infections, feeling weak or tired more than usual. This is due to decreased blood cell count (your doctor will do tests to check this) • 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.
If you get any of the above, please tell your doctor or go to hospital straight away.
Tell your doctor if you get any of these side effects:
• Hair loss
• Loose stools
• Feeling sick (nausea) or being sick (vomiting)
• Skin rash.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 out of the sight and reach of children.
• Store in the original packaging/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.
Return any unused tablets to your pharmacist who can dispose of them safely for you. 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._
Remember:
This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else; it could harm them, even if their symptoms seem the same as yours.
6. Contents of the pack and other information What Warfarin Tablets Contain:
The active substance is Warfarin sodium. Each tablet contains 1mg, 3mg or 5 mg of warfarin sodium. The other ingredients are lactose, maize starch, maize starch pregelatinised, sodium starch glycollate and magnesium stearate.
The 1 mg tablets also contain dispersed blue 17488 Ansteads (E132), yellow iron oxide (E172), and red iron oxide (E172).
The 3 mg tablets also contain dispersed blue 17488 Ansteads (E132).
The 5 mg tablets also contain dispersed pink 11150 Ansteads (E127).
What Warfarin Tablets look like and contents of the pack:
The 1 mg tablet is brown, flat, uncoated and is engraved FW on one side of the breakline and 51 on the other.
The 3 mg tablet is blue, flat, uncoated and is engraved FW on one side of the breakline and 61 on the other.
The 5 mg tablet is pink, flat, uncoated and is engraved FW on one side of the breakline and 71 on the other.
The tablets are packaged in either plastic pots (polypropylene containers) containing 28, 56, 100, 112 or 500 tablets, or in aluminium foil blister packs of 28, 56 or 112 tablets. Not all pack sizes are marketed.
Marketing authorisation holder:
Mercury Pharma (Generics) Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL,
UK
Manufacturer:
Recipharm Limited,
Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR, United Kingdom.
This leaflet was last revised in July 2016.