Paradexa 150 mg 60 Capsules
Dabigatran 150 mg capsules
What is dabigatran used for?
The active ingredient, dabigatran, belongs to a group of medications called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.
Do not use dabigatran
Do not use dabigatran
• If you are allergic to dabigatran or any of the other ingredients of this medicine
• If you suffer from severe kidney failure
• If you are currently bleeding
• If you have a disease in a body organ that increases the risk of serious bleeding (such as a stomach ulcer, injury or bleeding in the brain, or recent brain or eye surgery)
• If you have an increased tendency to bleed. This may be due to congenital bleeding, an unknown cause, or other medications.
• If you are taking medications to prevent blood clots (such as warfarin, rivaroxaban, apixaban, or heparin), except when changing anticoagulant therapy, while you have an intravenous or arterial line and are receiving heparin through that line to keep it open, or while your heartbeat is being restored to normal through a procedure called catheter ablation for atrial fibrillation
• If you suffer from severe liver failure or liver disease that can cause death
• If you are taking ketoconazole or itraconazole by mouth, medicines to treat fungal infections
• If you are taking oral cyclosporine, a medication to prevent organ rejection after a transplant
• If you are taking Dronedarone, a medicine used to treat abnormal heart rhythms
• 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 that requires permanent blood thinning.
Warnings and precautions
Tell your doctor if you have any medical conditions or diseases, especially any of the following:
Those listed below:
• If you have an increased risk of bleeding, such as:
o If you have recently had bleeding
o If you have had surgical tissue removal (biopsy) in the last month
o If you have a serious injury
o If you suffer from esophagitis or gastritis
o If you have problems with gastric reflux into the esophagus
o If you are receiving medications that can increase the risk of bleeding
o If you are taking anti-inflammatory medications such as diclofenac, ibuprofen, piroxicam.
o If you have heart infection (bacterial endocarditis)
o If you know you have kidney dysfunction, or you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored (concentrated) urine)
o If you are over 75 years old
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 your risk of:
Risk of heart attack.
• If you have liver disease associated with changes in blood tests. Dabigatran is not recommended in this case.
Possible side effects
Stop using the product and seek immediate medical attention if you experience throat tightness, swelling of the eyes, face, lips, or tongue, feel faint, or have difficulty breathing. Stop using the product if you experience hives or itching of the face or body.
Other medications Dabigatran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Medications. In particular, you should tell your doctor before taking dabigatran if you are taking it.
From the medications mentioned below:
• Medicines to reduce blood clotting (such as warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole), unless applied only to the skin
• Medications used to treat abnormal heartbeats (such as amiodarone, dronedarone, quinidine, verapamil). If you are taking medications containing verapamil, your doctor will tell you to use a lower dose of dabigatran.
• Medications that prevent organ rejection after transplantation (such as tacrolimus and cyclosporine)
• A combination product of glecaprevir and pibrentasvir (an antiviral drug used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medications (such as acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's wort, an herbal medicine for treating depression
• Antidepressant medications called selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
• Rifampicin or clarithromycin (antibiotics)
• Antiviral medications to combat AIDS (such as ritonavir)
• Certain medications to treat epilepsy (such as carbamazepine, phenytoin)
How to use dabigatran
• Prevention of blood clots after knee or hip replacement surgery: The recommended dose is 220 mg once a day (taken as two 110 mg capsules).
• Prevention of blockage of the brain or blood vessels due to the formation of blood clots that develop after abnormal heart rhythms and treatment of blood clots in the veins of the legs and lungs, including preventing the recurrence of blood clots in the veins of the legs and lungs: Recommended dosage: 300 mg, one 150 mg capsule taken twice a day.
How to store dabigatran
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the carton, blister, or bottle after 'EXP'. The expiry date refers to the last day of that month.
*The dosage form and route of administration of Dabigatran 110 mg should be determined according to the therapeutic indication and severity of the disease for each individual patient.