Innoklod 2,5 mg/5 mg Film-Coated Tablets

INNOKLOD contains the active substance apixaban and 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.

INNOKLOD 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 [PE]) can be life-threatening and requires immediate medical attention.
• to prevent a blood clot from forming in the heart in patients with an irregular heartbeat (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 travel 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 (DVT) and in the blood vessels of your lungs (PE), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Do not take INNOKLOD:

• if you are hypersensitive (allergic) to apixaban or to any of the other ingredients of INNOKLOD (listed in section 6)
• if you are bleeding excessively
• if you have a severe kidney disease or if you are on dialysis
• if you have a liver disease which leads to increased risk of bleeding (hepatic coagulopathy)
• if you are taking antiplatelet medicines (e.g., clopidogrel or ticagrelor) other than aspirin
• if you suffer from a condition called antiphospholipid syndrome (APS) with persistent positivity for all three antiphospholipid antibodies.
• If you have a disease patch of skin or condition is considered a high risk for excessive bleeding. This may include present or recent stomach ulcers, presence of an abnormal growth of tissue that can be malignant (cancerous) which has high risk of bleeding, recent brain or back injury, recent brain, back or eye surgery, recent bleeding within the cranium, which is the bony dome that houses and protects the brain, known or suspected enlarged veins in the oesophagus, a tangle of blood vessels that irregularly connects arteries and veins, a bulge in the wall of an artery, major within the spine or inner brain arteries and veins abnormal features.

Warnings and precautions

Take special care with INNOKLOD: Tell your doctor before you take this medicine if you have any of the following:

• an increased risk of bleeding, such as:
• bleeding disorders, including conditions resulting in reduced platelet activity
• an active or a recent ulcer of your stomach or bowel
• infection of the heart (bacterial endocarditis)
• recent bleeding in your brain (haemorrhagic stroke)
• very high blood pressure, not controlled by medical treatment
• a recent operation on your brain, spinal column or eye
• have had a prosthetic heart valve inserted
• know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots)
• had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take INNOKLOD 6 hours or more after catheter removal
• a liver problem or a history of liver problems. Your doctor will perform a test on your liver function before you take INNOKLOD and it will be used with caution in patients with signs of altered liver function
• a severe kidney disease or if you are on dialysis
• If you need to undergo surgery your doctor might ask you to temporarily stop taking INNOKLOD.

Children and adolescents

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

Other medicines and INNOKLOD

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 INNOKLOD, and some may decrease its effects. Your doctor will decide if you should be treated with INNOKLOD when taking these medicines and how closely you should be monitored.

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

INNOKLOD can be taken with or without food.

Swallow the tablet with a drink of water. Take one tablet twice a day, every day, for as long as your doctor tells you to take INNOKLOD.

Dose

To prevent blood clots (deep vein thrombosis (DVT)) from forming after hip or knee replacement operations or to prevent a blood clot from forming in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening. Take the tablets at the same time every day.

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 5 mg tablets 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 5 mg tablet twice a day.

For preventing blood clots from re-occurring following completion of 6 months of treatment The recommended dose is one 2,5 mg tablet twice a day for example, one in the morning and one in the evening. Your doctor will decide how long you must continue your treatment.

If you are undergoing cardioversion If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take INNOKLOD at the times your doctor tells you, to prevent blood clots in blood vessels in your brain and other blood vessels in your body. If you are unable to swallow whole tablets, you may crush the tablets and add it to water, apple juice or mix it with applesauce. This should be taken immediately.

If you have the impression that the effect of INNOKLOD is too strong or too weak, tell your doctor or pharmacist.

If you take more INNOKLOD than you should Tell your doctor immediately if you have taken more than the prescribed dose of INNOKLOD. Take the medicine pack with you, even if there are no tablets left. If you take more INNOKLOD than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery or blood transfusions may be required.

Your doctor may administer activated charcoal to you which may be useful if you have taken INNOKLOD accidently or taken more than you should have. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take INNOKLOD Take the tablet as soon as you remember. Take the next tablet of INNOKLOD at the usual time and then continue as normal. Do not take a double dose to make up for forgotten individual doses. If you are not sure what to do or have missed more than one dose, ask your doctor, pharmacist or other health care provider.

If you stop taking INNOKLOD Do not stop taking INNOKLOD without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. If you have any further questions on the use of INNOKLOD, ask your doctor, pharmacist or other health care provider.

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

INNOKLOD can be given for different medical conditions. The known possible side effects and how frequently they occur for each of these medical conditions may differ and are listed separately below. The most common general possible side effect of INNOKLOD is bleeding which may be potentially life-threatening and require immediate medical attention.

The following side effects are known if you take INNOKLOD to prevent blood clots (deep vein thrombosis (DVT)) from forming after hip or knee replacement operations. Tell your doctor if you notice any of the following:

Frequent side effects:

• Anaemia 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)
• Itching
• Low blood pressure which may make you feel faint or have a quickened heartbeat.
• Bleeding including:
• bleeding from your nose
• bleeding in your stomach, bowel or blood in the stools
• blood found in the urine (that stains the urine pink or red)
• bleeding from your vagina
• bleeding occurring after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision (wound secretion)
• in your eyes
• from your gums and blood in your spit when coughing
• from your rectum
• into a muscle
• 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
• 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
• Hair loss

Other side effects

• Angioedema (swelling of areas of tissue under your skin)
• 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 haemorrhoid
• tests showing blood in the stools or in the urine
• Skin rash

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

Store all medicines out of reach of children

Store at or below 30 °C. Do not remove blister from carton until required for use. Do not use this medicine after the expiry date which is stated on the carton and on the blister. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).