Prada capsules 150 milligrams (Dabigatran etexilate mesylate)

Adult dosage

This medicine should be taken with water, with or without food. 1. Adults (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Take 150 mg orally twice daily. (2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism After at least 5 days of treatment with a parenteral anticoagulant, take 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding for any of the three indications above (see “3. Patients requiring careful administration” under Precautions for Use), administration of 110 mg orally twice daily may be considered. These patients should be carefully monitored clinically for signs of bleeding or anemia, and coagulation tests such as aPTT should be used to assess whether excessive exposure to this medicine may increase the risk. 2. Switching therapy (1) Switching from this medicine to a parenteral anticoagulant Start the parenteral anticoagulant 12 hours after the last dose of this medicine. (2) Switching from a parenteral anticoagulant to this medicine For patients currently receiving a parenteral anticoagulant, administer this medicine 0~2 hours before the next scheduled dose of the parenteral anticoagulant, or when continuous administration (e.g., intravenous administration of unfractionated heparin) is discontinued. (3) Switching from this medicine to a vitamin K antagonist Adjust the time to start the vitamin K antagonist according to creatinine clearance (Creatinine Clearance, CrCl), as follows. • CrCl 50 mL/min or greater: Start the vitamin K antagonist 3 days before discontinuing this medicine. • CrCl ≥ 30~<50 mL/min: Start the vitamin K antagonist 2 days before discontinuing this medicine. Because this medicine may increase INR, INR testing at least 2 days after discontinuing this medicine better reflects the effect of the vitamin K antagonist; until then, INR values should be interpreted with caution. (4) Switching from a vitamin K antagonist to this medicine Discontinue the vitamin K antagonist and administer this medicine immediately when the INR is less than 2.0. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment (50 ≤ CrCL ≤ 80 mL/min). In patients with moderate renal impairment (30 ≤ CrCL < 50 mL/min), administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. This medicine is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). 4. Patients aged 75 years or older Administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. 5. If you forget to take this medicine If you forget to take this medicine, take it as soon as possible on the same day, but no later than 6 hours before the next scheduled dose. Do not take twice the recommended daily dose to make up for a missed dose.

This medication can cause bleeding, so caution is needed when using it. It should not be administered to patients at high risk of bleeding or those with severely reduced renal function. If bleeding is suspected, the use of this medication should be discontinued immediately and the cause should be investigated. Signs of bleeding or anemia should be closely monitored while using this medication. It should be temporarily discontinued before surgeries or invasive procedures and resumed only after complete hemostasis post-surgery. The risk of bleeding may increase when used with other anticoagulants or antiplatelet agents, so caution is required. Dose adjustment and renal function tests are important for patients with impaired renal function or the elderly. Women who are pregnant or may become pregnant should not use this medication, and breastfeeding mothers should also avoid it. Capsules should never be opened or crushed and should be taken only in the prescribed manner. If symptoms of bleeding such as nosebleeds, gum bleeding, hematuria, black stools, severe bruising appear, immediate consultation with healthcare personnel is required. This medication does not have a significant impact on driving or operating machinery, but caution is advised due to the risk of bleeding. In case of overdose, the risk of bleeding is increased, so the prescribed dosage must be strictly followed, and if overdose is suspected, immediate medical attention should be sought. There are many medications that can interact with this drug, so if you are taking other medications, be sure to consult with healthcare professionals.

• Hemorrhage
• decrease in hemoglobin
• decrease in hematocrit
• anemia
• thrombocytopenia
• drug hypersensitivity reaction
• rash
• pruritus
• anaphylactic reaction
• angioedema

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius. To maintain the effectiveness of the drug, it should be stored away from humid areas.

Appearance

A hard capsule with a white upper part and white lower part containing white pellets and yellow granules

Package unit

50 capsules (10 capsules/PTP x 5)