Pradaxa 150 Mg Hard Capsules 60 Pieces ingredient Dabigatran

Consult your doctor or pharmacist before using the medicine.

The effect of PRADAXA on pregnancy and the unborn child is unknown. Do not use this medicine during pregnancy unless your doctor specifically recommends it. If you are a woman of childbearing age, you should not get pregnant while taking PRADAXA. In this case, use an appropriate, reliable method of contraception.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

takingany

consult your doctor or pharmacist before medicine.

Do not breastfeed while using this medicine.

Use of tools and machinery PRADAXA has no known influence on the ability to drive and use machines.

Important information about some of the ingredients in the PRADAXA contains the

sunset yellow (E110) as a dyestuff in the PRADAXA capsule sheath. May cause allergic reactions.

Use with

other medicines If you have used any other medicines, including the drugs listed below, or if you have used it recently, inform your doctor:

- Drugs that reduce blood clotting (Ex: Warfarin, fenprokumon, heparin, klopidogrel, prasugrel , ticagrelor, rivaroxaban)

- Anti-inflammatory (anti-inflammatory) and analgesic drugs (eg aspirin)

- is a herbal product for depression St. John's Wort (worty wort)

- Selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors called depression drugs

- Rifampicin or clarithromycin (two antibiotics)

- Drugs used to treat your irregular heartbeats (eg, Amiodarone, dronedaron, quinidine, verapamil)

If you are taking medication containing verapamil, you should be treated with a reduced dose of PRADAXA to 220 mg, which is used as a capsule of 110 mg twice a day, because the risk of bleeding will increase. Medications containing PRADAXA and verapamil should also be taken.

- Only medications used for fungal infections (eg ketoconazole, itraconazole, posaconazole) can only be applied to the skin. Other forms should not be used.

- transplant drugs used to prevent organ rejection after (eg tacrolimus, cyclosporine)

- used for AIDS anti-viral drugs (eg ritonavir)

- Epilepsy (epilepsy) of drugs used for the treatment (eg, carbamazepine, phenytoin)

If the prescription or please inform your doctor or pharmacist if you are currently using any non-prescription medication or if you have recently used it.

3. PRADAX used?

Instructions for appropriate use and dose / frequency of administration:instructed by

Always take your medicine exactly asyour doctor. If in doubt, check with your doctor.

The recommended dose is 300 mg taken twice daily as a capsule of 150 mg.

If you are 80 years old or older, the recommended daily dose of PRADAXA is 220 mg taken as a capsule of 110 mg twice a day.

If you're using with drug containing verapamil, for you will increase the risk of bleeding, PRADAX to your dose, taken twice daily as a 110 mg capsule dose should be reduced to 220 mg.

If there is a greater risk of bleeding, your doctor may decide to take a total of 220 mg daily, twice a day with a capsule of 110 mg.

Method and method of:

administrationPRADAXA should be taken with or without food, with a glass of water to make it easier to reach the stomach. Do not break, chew or dispose of the contents. Otherwise, your risk of bleeding may increase.

When receiving the PRADAXA capsule from a blister, please proceed as follows:

The following illustrations show how to remove the PRADAXA capsule from the blister.

Separate a blister from the blister strip along the line marked with a perforated line

. Remove the foil from the single blister you are removing and remove the capsule.

• Do not push the capsule out of its housing.

• Do not open the blister film until the time you use the capsule.

Different age groups:

Use in children and adolescents:

PRADAXA should not be used in adolescents and children under 18 years of age.

Use in the elderly:

75-80 years old patients should be treated with a daily dose of 300 mg taken as a 150 mg capsule twice a day. If the risk of thromboembolism (clotting with any vein clogs) is low and the risk of bleeding is high, a daily dose of 220 mg in the form of a capsule of 110 mg per day may be administered, depending on the individual evaluation of the physician.

Patients aged 80 years or older should be treated with a daily dose of 220 mg taken in the form of a capsule of 110 mg twice a day, as the risk of bleeding is increased in this age group.

Special Use:

Kidney Failure:

ConditionsIf you have severe renal insufficiency, you should not use PRADAXA.

If you have moderate renal impairment, dose adjustment is required for any. If you have moderate renal impairment, your dose is 300 mg taken as a 150 mg capsule twice a day. However, if your risk of bleeding is high, it should be considered to reduce your dose to 220 mg twice a day in the form of a capsule of 110 mg each. Your doctor will monitor you closely if you have kidney dysfunction.

Hepatic impairment: If your

liver enzymes increase more than twice the upper limit of normal, the use of PRADAXA is not recommended.

Modification of anticoagulant therapy:

Transition from PRADAXA treatment to anticoagulant drugs used by injection:

Wait for 12 hours after the last dose of PRADAXA before switching to a anticoagulant drug (Ex. Heparin) used by injection from PRADAXA treatment.

The transition from anticoagulants used in injection to PRADAXA therapy:

PRADAXA treatment should be started 0-2 hours before the next injection dose time.

Transition from PRADAXA to vitamin K anti-blood thinners (eg Fenprokumon):

After your blood measurements, your doctor will decide on the time you need to start anti-vitamin C treatment.

The transition fromDinflammatory drugs (Ex: Fenprokumon) to PRADAXA:

anti-vitaminanti-Vitamin K anti-drug should be discontinued. Your doctor will decide on the time to start PRADAXA treatment after performing your blood measurements.

If you have an impression that the effect of PRADAXA is too strong or too weak, talk to your doctor or pharmacist.

If you use more PRADAXA than you should use, the

doses of PRADAXA will increase your risk of bleeding. Your doctor may perform a blood test to determine the risk of bleeding.

If you have used PRADAXA more than the recommended dose, contact your doctor immediately. If you bleed, you may need to be treated by surgery or blood transfusion.

If you have used more than you should use from PRADAXA, talk to a doctor or pharmacist.

If you forget to use PRADAXA

A forgotten dose of PRADAXA can be taken up to 6 hours before the next dose. If less than 6 hours remain for the next dose, the missed dose should be skipped.

Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment with PRADAXA is discontinued

Take your medicine exactly as prescribed. Do not stop using PRADAXA without consulting your doctor in advance. Discontinuation of PRADAXA treatment may increase the risk of obstruction in brain or body blood vessels in people with abnormal heartbeats.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medications, people using PRADAXA may have side effects. However, these effects do not occur in every patient.

Because this drug affects blood clotting, most of the side effects are associated with bruising and bleeding. Major and severe bleeding may occur, these are the most serious side effects and may cause injury, life-threatening and even death, no matter where they occur. These bleeding may not be obvious in some cases.