Aspen Warfarin 5 mg Tablets

ASPEN WARFARIN 5 mg belongs to a group of medicines called anticoagulants. This medicine decreases the clotting ability of the blood and therefore helps to prevent harmful clots from forming in the blood vessels. ASPEN WARFARIN 5 mg is used in adults to treat and prevent blocking of a blood vessel by a blood clot, which has been transported from a distant area by the blood stream.

Do not take ASPEN WARFARIN 5 mg:

• if you are hypersensitive (allergic) to warfarin or any of the other ingredients of ASPEN WARFARIN 5 mg (listed in section 6).
• if you recently had a stroke caused by bleeding in the brain.
• if you have any bleeding disorder or disease.
• if you had surgery within the last 72 hours or are going to have surgery in the next 72 hours.
• if you have loss of feeling in a large part of the body for a medical procedure (major regional block anaesthesia).
• if you have a peptic ulcer or other stomach disease that causes you to bleed internally.
• If you have a condition that involves bleeding from the airways or bladder or sex organs.
• if you have a severe wound.
• if you have an infection of the heart valves.
• if your kidney or liver function is impaired.
• if you have high blood pressure.
• if you had an aneurysm (blood vein or artery that formed a sac or burst).
• if you have inflammation (swelling) of the pericardium, which is the fluid-filled sac that surrounds your heart (pericarditis).
• if you have an abnormal amount of fluid between the heart and pericardium (pericardial perfusion).
• if you had or are going to have surgery that involves your eyes, brain, back or nerves or any other major surgeries.
• if you had a baby in the last 48 hours.
• if you have severe arthritis (inflammation of the joints) affecting five or more joints at the same time.
• if you have a vitamin C deficiency.
• if you live in an area where you do not have access to laboratory facilities or you are not willing to do regular blood tests to see how fast your blood is clotting.
• if you have the possibility of losing your baby (threatened abortion).
• if you are younger than 18 years of age.
• if you are taking other medicines that increase your risk of bleeding (see Other medicines and ASPEN WARFARIN 5 mg).
• if you are taking other medicines to treat and prevent blocking of a blood vessel by a blood clot (see Other medicines at ASPEN WARFARIN 5 mg).
• if you are using over-the-counter miconazole oral gel (see Other medicines at ASPEN WARFARIN 5 mg).
• if you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility).

Do not share medicines prescribed for you with any other person. Always take ASPEN WARFARIN 5 mg exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Never take more or less tablets than your recommended dose. Your doctor or healthcare provider should check your progress with ASPEN WARFARIN 5 mg at regular visits. A blood test must be taken regularly to see how fast your blood is clotting. This test is called INR (international normalised ratio) test.

The usual dose of ASPEN WARFARIN 5 mg is:

Adults: The usual starting dose is 5 mg once a day. Then, your dose may be adjusted, depending on your condition and results of your blood tests. Take your ASPEN WARFARIN 5 mg dose at the same time each day. Your doctor will tell you how long your treatment with ASPEN WARFARIN 5 mg will last. Do not stop treatment early without instructions from your doctor. If you have the impression that the effect of ASPEN WARFARIN 5 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more ASPEN WARFARIN 5 mg than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ASPEN WARFARIN 5 mg

If you miss a dose of this medicine, take it as soon as possible. Then continue with your regular dosing schedule. If you do not remember until the next day, do not take the missed dose at all. Do not take a double dose to make up for any forgotten individual doses. Continue to take the next tablet at the usual time. Double dosing may cause bleeding. It is recommended that you keep a record of each dose as you take it, to avoid mistakes.

ASPEN WARFARIN 5 mg can have side effects. Not all side effects reported for ASPEN WARFARIN 5 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ASPEN WARFARIN 5 mg, please consult your healthcare provider for advice.

If any of the following happens, stop taking ASPEN WARFARIN 5 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ASPEN WARFARIN 5 mg. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Bleeding from almost any organ of your body,
• Bleeding in the brain (cerebral haemorrhage), bleeding within the skull (intracranial haemorrhage), including a blood clot that occurs between the brain and the skull (cerebral subdural haematoma), bleeding in the digestive tract (gastrointestinal haemorrhage),
• Unusual heavy bleeding from cuts or wounds,
• Unusual heavy or unexpected menstrual bleeding,
• Black tarry stools,
• Bleeding in your eye,
• Blood in your stools,
• Blood in vomit or vomit that looks like coffee grounds,
• Bleeding in the space in between the layers that line the lungs (haemothorax),
• Liver damage (hepatotoxicity), usually asymptomatic and seen on laboratory results,
• Skin tissue death (skin necrosis, also called warfarin-induced skin necrosis - condition in which skin and tissue death occurs),
• Fatigue, pale skin, fever, chills. (Red or white blood cell conditions such as anaemia, leukopenia, granulocytosis),
• Fat clots in the blood (lipid emboli, including systemic athero-emboli and cholesterol emboli),
• Pain in the upper abdomen (inflammation of the pancreas),
• A rare, serious disease that involves build-up of calcium in small blood vessels of fat tissues and skin (calciphylaxis). This can lead to gangrene of the limbs, sores, ulcers or white spots in the mouth or throat,
• Anticoagulant-related kidney damage (see Warnings and precautions),
• Kidney damage with resultant fluid retention and protein in urine, with difficult urination,
• Prolonged erection of the penis (priapism).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• Fever,
• Diarrhoea, nausea, vomiting, bloated stomach or gas, loss of appetite, stomach cramps or pain,
• Skin rash, loss of hair, purple, red or brown patches on the skin (purpura), purple or blue toes, red swollen skin patches leading to bruises (ecchymosis), painful skin lesions (infarction), skin tissue death (necrosis), skin reactions,
• Weak bones (osteoporosis), increased risk of osteoporotic fracture due to vitamin K deficiency, patients on long-term ASPEN WARFARIN 5 mg treatment may be at increased risk,
• Blood in urine,
• Unexplained drop in red blood cells, decreased haemoglobin.

Side effects with an unknown frequency:

• Dark urine.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C in airtight containers. Protect from light. Keep in original packaging until required for use. Do not store in bathroom. Do not use after the expiry date printed on the label or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.