Pradaxa 150 mg Tab 60 s

The active substance dabigatran etexilate belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation.

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine

• if you have severely reduced kidney function

• if you are currently bleeding

• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)

• if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines

• if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban 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 while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation

• if you have a severely reduced liver function or liver disease which could possibly cause death

• if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections

• if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation

• if you are taking dronedarone, a medicine used to treat abnormal heart beat

• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C

• if you have received an artificial heart valve which requires permanent blood thinning

Talk to your doctor before taking dabigatran. You may also need to talk to your doctor during treatment

with Dabigatran if you experience symptoms or if you have to undergo surgery.

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of

those included in the following list:

• if you have an increased bleeding risk, such as:

o if you have been recently bleeding

o if you have had a surgical tissue removal (biopsy) in the past month

o if you have had a serious injury

o if you are suffering from an inflammation of the gullet or stomach

o if you have problems with reflux of gastric juice into the gullet

o if you are receiving medicines which could increase the risk of bleeding

o if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam

o if you are suffering from an infection of the heart (bacterial endocarditis)

o if you know you have impaired kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) urine)

o if you are older than 75 years

o if you weigh 50 kg or less

• if you have had a heart attack or if you have been diagnosed with conditions that increase the

risk to develop a heart attack.

• if you have a liver disease that is associated with changes in the blood tests. The use of Dabigatran is not recommended in this case.

Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. In particular you should tell your doctor before taking Dabigatran, if you are taking one

of the medicines listed below:

• Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)

• Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin

• Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking verapamil containing medicines, your doctor will tell you to use a reduced dose of Dabigatran

• Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)

• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)

• Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)

• St. John’s wort, a herbal medicine for depression

• Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors

• Rifampicin or clarithromycin (two antibiotics)

• Anti-viral medicines for AIDS (e.g. ritonavir)

• Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

• Prevention of blood clot formation after knee or hip replacement surgery: The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).

• Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs: The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

* Dosage form and route of administration of dabigatran 110mg should be prescribed according to therapeutic indication and disease severity of each individual patient.