Euradac Capsule 150 mg (Dabigatran Etexilate)

Adult dose

Administer this medicine with water, regardless of meals. 1. Adults (1) Reduction of the risk of stroke and systemic embolism in patients with non-valvular 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 parenteral anticoagulant use, take 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding with the three indications above (see “3. Patients Requiring Caution” 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 the aPTT test should be used to assess whether excessive exposure to this medicine has increased the risk. 2. Switching medications (1) Switching from this medicine to a parenteral anticoagulant Start administering a 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 at which the vitamin K antagonist is started according to creatinine clearance (Creatinine Clearance, CrCl), as follows. • CrCl 50 mL/min or higher: Start administering a vitamin K antagonist 3 days before discontinuing this medicine. • CrCl ≥ 30~<50 mL/min: Start administering a vitamin K antagonist 2 days before discontinuing this medicine. Because this medicine may increase the INR, checking the INR 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 This medicine may be administered immediately after discontinuing the vitamin K antagonist if the INR is below 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 miss a dose If you miss a dose, 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 prevents blood clots by inhibiting coagulation. However, it may increase the risk of bleeding, thus it must be used with caution in conditions where bleeding is a concern. If bleeding occurs, discontinue the medication immediately and assess the bleeding site. Patients with severely impaired renal function must stop using this medication and have their renal function checked regularly. This medication should not be used in individuals with allergies to the active ingredient or the excipients, severe kidney dysfunction, or clinically significant bleeding. Patients with a recent history of gastrointestinal ulcers, brain injury, surgical history, high-risk bleeding cancers, or esophageal varices should also refrain from its use. When combined with other anticoagulants or antiplatelet agents, there is a significantly increased risk of bleeding, hence it must be used under medical supervision. Elderly patients, underweight individuals, patients with moderate renal impairment, and those taking certain drugs must be cautious as the blood concentration of this medication may increase, raising the risk of bleeding. When combined with gastrointestinal diseases or anti-inflammatory medications, the risk of bleeding may also increase. Women who are pregnant or breastfeeding are advised against using this medication, and women of childbearing age should avoid pregnancy while taking it. Safety and efficacy in children have not been established for this medication, hence it is not recommended for use in this population. Before and after surgery or invasive procedures, this medication may need to be temporarily discontinued or its resumption timed carefully due to bleeding risks. When taking this medication, symptoms of bleeding or anemia should be monitored closely, and any unusual symptoms should be discussed immediately with healthcare professionals. In cases of overdose, the risk of bleeding increases further, so it is crucial to adhere to the prescribed dose and, if necessary, reversal agents can be used to mitigate anticoagulant effects. This medication should never be opened or broken; keep it out of reach of children. Due to potential drug interactions, inform healthcare professionals about any other medications being taken.

• Hemorrhage
• decreased hemoglobin
• hypotension
• anemia
• thrombocytopenia
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction
• angioedema

This medication should be stored at room temperature between 1 and 30 degrees Celsius in a tightly closed container. It is important to avoid storing it in damp areas. Proper storage helps maintain the medication's effectiveness.

Appearance

A hard capsule with a light blue upper part and a white lower part filled with pale yellow pellets.

Package unit

60 capsules (10 capsules/PTP x 6)