Apixaban Accord Film-Coated Tablets

• APIXABAN ACCORD contains the active substance apixaban.

• It belongs to a group of medicines called anticoagulants.

• This medicine helps to prevent blood clots from forming by blocking Factor Xa, which is an important component of blood clotting.

• APIXABAN 2, 5 ACCORD is used in adults:

• to prevent blood clots (deep vein thrombosis [DVT]) from forming after hip or knee replacement operations. After an operation to the hip or knee you may be at a higher risk of developing blood clots in your leg veins. This can cause the legs to swell, with or without pain. If a blood clot travels from your leg to your lungs, it can block blood flow causing breathlessness, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• Apixaban 2,5 Accord and APIXABAN 5 ACCORD is used in adults:
• to prevent a blood clot from forming in the heart in patients with an irregular heart beat (atrial fibrillation) and at least one additional risk factor. Blood clots may break off and travel to the brain and lead to a stroke or to other organs and prevent normal blood flow to that organ (also known as a systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Do not take APIXABAN ACCORD:

• if you are hypersensitive (allergic) to apixaban or any of the other ingredients of APIXABAN ACCORD (listed in section 6).
• If you are bleeding excessively
• If you have a disease in an organ of the body that increases the risk of serious bleeding (such as an active or a recent ulcer of your stomach or bowel, recent bleeding in your brain)
• If you have a liver disease which leads to increased risk of bleeding (hepatic coagulopathy)
• If you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open, or if a tube is inserted into your blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Special care should be taken with APIXABAN ACCORD if you have any of the following:

• an increased risk of bleeding, such as:
• bleeding disorders, including conditions resulting in reduced platelet activity
• very high blood pressure, not controlled by medical treatment
• you are older than 65 years
• you weigh 60 kg or less
• a severe kidney disease or if you are on dialysis
• a liver problem or a history of liver problems APIXABAN ACCORD will be used with caution in patients with signs of altered liver function.
• had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take APIXABAN ACCORD 5 hours or more after catheter removal
• if you have a prosthetic heart valve
• if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned

Take special care with APIXABAN ACCORD - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. If you need to have surgery or a procedure which may cause bleeding, your doctor might ask you to temporarily stop taking this medicine for a short while. If you are not sure whether a procedure may cause bleeding ask your doctor.

Children and adolescents

APIXABAN ACCORD is not recommended in children and adolescents under 18 years of age.

Other medicines and APIXABAN ACCORD

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Some medicines may increase the effects of APIXABAN ACCORD and some may decrease its effects. Your doctor will decide, if you should be treated with APIXABAN ACCORD when taking these medicines and how closely you should be monitored.

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

Dose

Swallow the tablet with a drink of water. APIXABAN ACCORD can be taken with or without food. Try to take the tablets at the same times every day to have the best treatment effect. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take APIXABAN ACCORD. The tablet may be crushed and mixed with water, or 5% dextrose in water, or apple juice or apple puree, immediately before you take it.

Instructions for crushing:

• Crush the tablets with a pestle and mortar.
• Transfer all the powder carefully into a suitable container then mix the powder with a little e.g., 30 mL (2 tablespoons), water or one of the other liquids mentioned above to make a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar you used for crushing the tablet and the container, with a little water or one of the other liquids (e.g., 30 mL), and swallow the rinse.
• If necessary, your doctor may also give you the crushed APIXABAN ACCORD tablet mixed in 60 mL of water or 5% dextrose in water, through a nasogastric tube.

Your doctor will tell you how long your treatment with APIXABAN ACCORD will last. If you have the impression that the effect of APIXABAN ACCORD is too strong or too weak, tell your doctor or pharmacist.

Take APIXABAN ACCORD as recommended for the following:

To prevent blood clots from forming after hip or knee replacement operations. The recommended dose is one tablet of APIXABAN ACCORD 2.5 mg twice a day. For example, one in the morning and one in the evening. You should take the first tablet 12 to 24 hours after your operation. If you have had a major hip operation you will usually take the tablets for 32 to 38 days. If you have had a major knee operation you will usually take the tablets for 10 to 14 days.

To prevent a blood clot from forming in the heart in patients with an irregular heartbeat and at least one additional risk factor. The recommended dose is one tablet of APIXABAN ACCORD 5 mg twice a day. The recommended dose is one tablet of APIXABAN ACCORD 2.5 mg twice a day if:

• you have severely reduced kidney function
• two or more of the following apply to you:
• your blood test results suggest poor kidney function (value of serum creatinine is 1.5 mg/dL (133 micromole/L) or greater)
• you are 80 years old or older
• your weight is 60 kg or lower.

The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening. Your doctor will decide how long you must continue treatment for.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs. The recommended dose is two tablets of APIXABAN ACCORD 5 mg twice a day for the first 7 days, for example, two in the morning and two in the evening. After 7 days the recommended dose is one tablet of APIXABAN ACCORD 5 mg twice a day, for example, one in the morning and one in the evening. For preventing blood clots from re-occurring following completion of 6 months of treatment the recommended dose is one tablet of APIXABAN ACCORD 2.5 mg twice a day for example, one in the morning and one in the evening. Your doctor will decide how long you must continue treatment for.

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

The following side effects are known if you take APIXABAN ACCORD to prevent blood clots from forming after hip or knee replacement operations.

Frequent side effects

• Anemia which may cause tiredness or paleness
• Bleeding including:
• bruising and swelling
• Nausea (feeling sick)

Less frequent side effects

• Reduced number of platelets in your blood (which can affect clotting)
• Bleeding:
• occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion) or injection site
• in your stomach, bowel or bright/red blood in the stools
• blood in the urine
• from your nose
• from the vagina
• Low blood pressure which may make you feel faint or have a quickened heartbeat
• Blood tests may show:
• abnormal liver function
• an increase in some liver enzymes
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.
• Itching

Less frequent side effects

• Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
• Bleeding:
• into a muscle
• in your eyes
• from your gums and blood in your spit when coughing
• from your rectum
• Hair loss

Frequency unknown

• Bleeding:
• in your brain or in your spinal column,
• in your lungs or your throat
• in your mouth
• into your abdomen or space behind your abdominal cavity
• from a hemorrhoid
• tests showing blood in the stools or in the urine
• Skin rash

• Store all medicines out of reach of children.

• Store at or below 30 °C.

• There are no special storage instructions for APIXABAN ACCORD.

• Store in original package until use.

• Do not use after the expiry date stated on the label / carton / bottle.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).