Dabigatran etexilate STADA
Dabigatran etexilate Stada contains a substance that helps prevent blood clots from forming in your body.
Form
kapseli, kova
Strength
75 mg
Active Ingredient
Dabigatran etexilate mesilate
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For adults, the typical dose is 220 mg once daily (two 110 mg capsules); if you have reduced kidney function, are over 75 years old, or take certain other medicines, the dose may be 150 mg once daily (two 75 mg capsules). For children, the dose depends on their weight and age.
Method
Take Dabigatran etexilate Stada with or without food. Swallow the capsule whole with a glass of water. Do not break, chew, or open the capsule, as this may increase the risk of bleeding. If preventing blood clots after knee/hip surgery, start 1-4 hours after surgery (1 capsule) then take 2 capsules once a day for 10 days (knee) or 28-35 days (hip). For children treating/preventing clots, take two times a day, morning and evening, about 12 hours apart.
Important
The maximum daily dose can be up to 600 mg for children (depending on weight and age) and 220 mg for adults.
Possible Side Effects
COMMON
- •Decreased red blood cell count (including hemoglobin)
- •Abnormal liver function test results or increased liver enzyme levels
- •Allergic rash, appearing as dark red, raised, itchy bumps
- •Sudden skin changes affecting skin color and appearance
- •Formation of hematomas or bruising
- •Nosebleed
- •Stomach acid rising into the esophagus (acid reflux)
- •Vomiting
- •Nausea
- •Loose stools or diarrhea
- •Indigestion
- •Hair loss
- •Decreased platelet count in the blood
RARE
- •Bleeding from various sites including stomach, intestines, penis/vagina, urinary tract (including blood in urine), hemorrhoids, rectum, under the skin, in a joint, from/after injury or procedure, in the brain, from surgical incisions, injection sites, or catheter sites
- •Blood detected in stool during laboratory tests
- •Decreased proportion of blood cells
- •General allergic reaction
- •Wound exudate or leakage (fluid from surgical wound)
- •Yellowing of skin or whites of eyes (jaundice) due to liver problems or changes in blood values
- •Bloody discharge at the site where a catheter connects to a vein
- •Coughing up blood or bloody saliva
- •Severe allergic reaction causing breathing difficulties or dizziness
- •Severe allergic reaction causing swelling of the face or throat
- •Itching
- •Stomach or intestinal ulcer (including esophageal ulcer)
- •Esophagitis or gastritis (inflammation of the esophagus or stomach)
- •Stomach or abdominal pain
- •Difficulty swallowing
- •Decreased white blood cell count (which helps fight infections)
- •Breathing difficulties and wheezing
Important Warnings
- Do not take this medicine if you are allergic to dabigatran etexilate or any other ingredient.
- Do not take this medicine if you have severe kidney problems.
- Do not take this medicine if you are currently bleeding.
- Do not take this medicine if you have an organ injury that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury, or recent brain/eye surgery).
- Do not take this medicine if you have an increased tendency to bleed, which can be inherited, from an unknown cause, or caused by other medicines.
Show 16 more warnings
- Do not take this medicine if you are taking other blood-thinning medicines (e.g., warfarin, rivaroxaban, apixaban, or heparin), unless your doctor has specifically instructed you to do so for switching treatment or for certain medical procedures.
- Do not take this medicine if you have severe liver problems or a liver disease that could be life-threatening.
- Do not take this medicine if you are taking oral medicines for fungal infections like ketoconazole or itraconazole.
- Do not take this medicine if you are taking ciclosporin, a medicine used after organ transplantation to prevent rejection.
- Do not take this medicine if you are taking dronedarone, a medicine used to treat irregular heart rhythm.
- Do not take this medicine if you are taking a combination medicine containing glecaprevir and pibrentasvir for hepatitis C.
- Do not take this medicine if you have an artificial heart valve that requires permanent blood-thinning treatment.
- Tell your doctor if you have a higher risk of bleeding, for example, if you've recently bled, had a biopsy or severe injury, have stomach/esophagus inflammation, heartburn, or take medicines that increase bleeding risk (like NSAIDs), or have a heart infection.
- Tell your doctor if you have reduced kidney function or symptoms of dehydration (e.g., thirst, less, dark, or foamy urine), or if you are over 75 years old or an adult weighing 50 kg or less.
- For children, tell your doctor if the child has an infection around or in the brain.
- Tell your doctor if you have had a heart attack or have a condition that increases the risk of a heart attack.
- Tell your doctor if you have a liver disease with abnormal blood test results (this medicine is not recommended in such cases).
- If you need surgery, Dabigatran etexilate Stada treatment must be stopped temporarily due to increased bleeding risk. Follow your doctor's instructions carefully for when to stop and restart the medicine.
- If you have a catheter inserted or medicine injected into your spine (e.g., for anesthesia), it's very important to follow your doctor's instructions for when to take this medicine. Tell your doctor immediately if you feel numbness or weakness in your legs, or have bowel/bladder problems after anesthesia, as urgent care is needed.
- If you fall or injure yourself during treatment, especially your head, contact your doctor immediately. You may have a higher risk of bleeding and need to be examined.
- Tell your doctor if you have antiphospholipid syndrome (an immune disorder that increases the risk of blood clots), as your treatment may need to be changed.