Dabigatran etexilate Sandoz

This medicine helps prevent and treat blood clots in adults and children.

Form
kapseli, kova
Strength
150 mg
Active Ingredient
Dabigatran etexilate mesilate
Manufacturer
Sandoz A/S

How to Use

Dosage

Adults typically take one 150 mg capsule twice a day. For those 80 or older, or taking verapamil, or at higher bleeding risk, the dose may be one 110 mg capsule twice a day. For children, the dose depends on weight and age and is decided by the doctor.

Method

Swallow the capsule whole with a glass of water, with or without food. Do not break, chew, or open the capsule, as this may increase the risk of bleeding.

Important

The typical maximum daily dose for adults is 300 mg. Always follow your doctor's instructions for your specific maximum daily dose.

Possible Side Effects

COMMON
  • Bleeding from the nose, stomach, intestines, penis/vagina, or urinary tract (including blood in urine making it pink or red), or under the skin.
  • Decrease in red blood cells.
  • Stomach or abdominal pain.
  • Indigestion.
  • Loose stools, diarrhea.
  • Nausea.
  • Decrease in blood platelets.
  • Allergic rash with dark red, raised, itchy bumps.
  • Sudden skin change affecting color and appearance.
  • Bruising.
  • Nosebleed.
  • Stomach acid rising into the esophagus (heartburn).
  • Vomiting.
  • Hair loss.
  • Increased liver enzyme levels.
RARE
  • Bleeding into a joint, from a surgical incision, injury, injection site, where a catheter connects to a vein, or in the brain.
  • Severe allergic reaction causing breathing difficulties or dizziness.
  • Severe allergic reaction causing swelling of the face or throat.
  • Decrease in blood cell count.
  • Yellowing of skin or whites of eyes due to liver problems or changes in blood values.
  • Difficulty swallowing.
  • Lack of white blood cells (which help fight infections).
  • Decreased hemoglobin in the blood (a substance in red blood cells).
  • Coughing up blood or bloody mucus.
  • Inflammation of the esophagus and stomach.

Important Warnings

  • Do not take if you are allergic to dabigatran etexilate or any other ingredient in this medicine.
  • Do not take if you have severe kidney problems or are currently bleeding.
  • Do not take if you have an organ injury that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury, or recent brain or eye surgery).
  • Do not take if you have an increased tendency to bleed, whether it's genetic, unexplained, or caused by other medicines.
  • Do not take if you are already taking other blood thinners (like warfarin, rivaroxaban, apixaban, or heparin), unless you are switching treatments, or if you are receiving heparin for a catheter, or for a specific heart rhythm procedure.
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  • Do not take if you have severe liver problems or a liver disease that could be life-threatening.
  • Do not take if you are taking oral ketoconazole or itraconazole for fungal infections, or oral cyclosporine (an anti-rejection medicine), or dronedarone (for irregular heart rhythm), or a combination medicine containing glecaprevir and pibrentasvir (for Hepatitis C), or if you have an artificial heart valve that requires permanent blood-thinning treatment.
  • Talk to your doctor before taking this medicine, especially if you have symptoms or need surgery.
  • Tell your doctor if you have a higher risk of bleeding due to any medical condition or other medicines you are taking.
  • Tell your doctor if you have had a heart attack or have a condition that increases your risk of a heart attack.
  • Tell your doctor if you have liver disease with abnormal blood tests; this medicine is not recommended in such cases.
  • If you need surgery, you may need to stop taking this medicine temporarily due to increased bleeding risk. Follow your doctor's exact instructions on when to stop and restart.
  • If you fall or get injured, especially hitting your head, contact your doctor immediately as there's an increased risk of bleeding.
  • Do not take this medicine if you are pregnant, planning to become pregnant, or breastfeeding, unless your doctor says it is safe.

Use in Elderly Patients

Category C

Suitable for older adults, with specific precautions. Consider renal impairment, age and body weight when determining the dosage. Consider potential interactions especially with other drugs that increase the risk of bleeding. (updated 19.9.2025)