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Keep tablets in original blister pack until used.

The 150 mg capsule for oral administration contains 172.95 mg dabigatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, and the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2 (150 mg only), FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink. The 75 mg capsule contains 86.48 mg dabigatran etexilate mesylate, equivalent to 75 mg dabigatran etexilate, and is otherwise similar to the 150 mg capsule.

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SIDE EFFECTS: Dizziness, drowsiness, trouble sleeping, lack of coordination, loss of appetite, diarrhea, and double vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any unlikely but serious side effects, including: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), mental/mood problems (such as confusion, difficulty concentrating, memory problems, agitation, irritability), speech problems, decreased sweating, sudden back/side/abdominal pain, painful urination, pink/bloody urine. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. This medication may cause a serious metabolic problem (metabolic acidosis). Get medical help right away if you have any of the following symptoms: bone pain/breakage, rapid breathing, fast/irregular heartbeat, sudden/unexplained tiredness, severe drowsiness/difficulty staying awake. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. National Headache Foundation

8. "Product Information. Sustiva (efavirenz)." DuPont Pharmaceuticals, Wilmington, DE.

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