Heamawarin 5 mg Tablets

Heamawarin contains the active ingredient warfarin which belongs to a group of medicines called anticoagulants. It is used to decrease the clotting ability of the blood and therefore helps to prevent harmful clots from forming in the blood vessels.

Heamawarin is used to prevent and treat blood clots forming in the legs, lungs, brain or heart.

Do not take Heamawarin

• if you are hypersensitive (allergic) to warfarin sodium or any of the other ingredients of Heamawarin listed in section 6.1
• if you recently had a stroke caused by bleeding in the brain
• if you have a bleeding situation
• 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 a peptic ulcer or other stomach disease that causes you to bleed internally
• if you have a severe wound
• if you have a prosthetic heart valve
• 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 have the possibility of losing your baby (threatened abortion)
• if you are younger than 18 years of age, because safety has not been established
• if you are taking other medicines that increase your risk of bleeding
• if you are taking other medicines to treat and prevent blocking of a blood vessel by a blood clot
• if you are pregnant or may become pregnant or breastfeeding, you baby.

Warnings and precautions

Take special care with Heamawarin

• if you have a genetic disorder called protein C deficiency making you prone to blood clots (thrombophilia);
• you should not stop your treatment with Heamawarin abruptly. Your doctor will decrease your dose gradually over three to four weeks;
• if you have a Vitamin K deficiency;
• medicines like Heamawarin, which work against vitamin K, might put you at risk for weaker bones (increased risk in fractures). You need extra attention to avoid this problem;
• if you suffer from dietary deficiency, are on antibiotic treatment, suffer from vascular disease, diabetes or have allergic disorders;
• if you had recent ischaemic stroke (caused by blockage of blood vessels in the brain);
• if you had an infection of the heart lining (bacterial endocarditis);
• if you previously had gastrointestinal bleeding;
• 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;
• very high blood pressure which is not controlled by medicines;
• problems with circulation of blood to the brain (cerebrovascular disease);
• if you have severe heart disease, liver or kidney problems;
• if you have anaemia (low haemoglobin causing extreme tiredness, breathlessness, poor resistance to infection);
• if you have a tumour or cancer;
• if you had trauma, had a recent wound or injury;
• if you use any anti-platelet medicines (such as clopidrogel, aspirin), because that can increase the risk of bleeding;
• if you have the condition calciphylaxis, where calcium builds up inside the blood vessels of the fat and skin;
• if you have an overactive thyroid gland;
• if you experience a painful and prolonged erection called priapism. This problem seems to be linked to a lack of protein C, and it often happens alongside another issue called warfarin-induced skin necrosis;
• if you experience a painful spot on the skin, which may look red or bleed at first. Later, it can form blisters and turn black from tissue death. People with lack of protein C levels seem to be at the highest risk;
• Be cautious if you have "wet" age-related eye disease that can blur your central vision and are taking Heamawarin because it could make you bleed inside your eye and lead to vision loss.

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.

Do not share medicines prescribed for you with any other person. Always take Heamawarin exactly as you doctor, or pharmacist 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 health care provider should check your progress with Heamawarin 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.

Adults: The usual starting dose of Heamawarin is 5 mg once a day. Then, your dose may be adjusted, depending on your condition and results of your blood tests. Try to take the Heamawarin at the same time each day. Your doctor will tell you how long your treatment with Heamawarin will last. Do not stop treatment early. If you have the impression that the effect of Heamawarin is too strong or too weak, tell your doctor or pharmacist.

If you take more Heamawarin than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of taking too much Heamawarin include bleeding, black tarry stools, blood in urine, heavy bleeding or oozing from cuts and wounds or unusually heavy menstrual bleeding. Activated charcoal should be used if you have symptoms 1 hour after taking too much (50 g for adults and 1g/kg for children) Heamawarin.

If you forget to take Heamawarin

Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking Heamawarin and tell your doctor immediately or go the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, 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 Heamawarin. 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:

• an artery in the brain bursting and causing bleeding in the brain (cerebral haemorrhage)
• bleeding that occurs within the skull of head but outside the actual brain tissue (cerebral subdural haematoma)
• escape of blood from a ruptured blood vessel (haemorrhage)
• haemothorax (blood collects between your chest wall and your lungs)
• bleeding in the gastrointestinal tract, from the mouth to the rectum. When there is a lot of blood loss over a short time, symptoms may include vomiting red blood, vomiting black blood, bloody stool, or black stool (Gastrointestinal haemorrhage, rectal haemorrhage, haematemesis).
• severe pain in the upper abdomen (a sign of inflammation of the pancreas) (pancreatitis)
• the production of dark sticky faeces containing partly digested blood, as a result of internal bleeding or the swallowing of blood (melaena).
• damage to your liver that results in dark urine (hepatic dysfunction)
• 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 have a bone disease that occurs when the body loses too much bone, makes too little bone, or both. As a result, bones become weak and may break from a fall or, in serious cases, from sneezing or minor bump (osteoporosis)
• if you have blood in your urine (haematuria)
• drop in number of red blood cells, blood haemoglobin (shown in blood tests).

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:

• lower-than-normal number of leukocytes (white blood cells) in the blood
• too many granulocytes (certain type of white blood cells) in the blood
• reduced blood clotting (by inhibiting vitamin K synthesis), may also increase the risk of bleeding
• diarrhoea
• nausea
• vomiting
• feeling bloated
• loss of appetite
• stomach pain
• kidney damage (leading to swelling in different parts of the body, abnormal amount of protein in the urine or difficulty passing urine).

Side effects with unknown frequency

• fever
• low number of red blood cells (anaemia)
• bleeding from the nose (epistaxis)
• yellowing of the skin and white of eyes (jaundice)
• skin rash
• hair loss
• a rash of purple spots on the skin caused by internal bleeding from small blood vessels (purpura)
• painful skin lesion seen in patients with moderate to severe kidney problems
• skin redness
• skin necrosis (also called warfarin-induced skin necrosis-condition in which skin and tissue death occurs)
• arm or leg become severely damaged and may die to problems with the veins in that limb
• sores or white spots in your mouth or throat.

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

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Heamawarin.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).