Pradaxa (dabigatran etesilate)

Please read the instructions before using Pradaxa (dabigatran etexilate mesylate) capsules.

Follow your doctor's prescription exactly. Take Pradaxa twice daily, about 12 hours apart. Swallow the capsules whole with a full glass of water. Do not break, chew, or open them. You can take Pradaxa with or without food.

If you miss a dose, take it as soon as you remember. If your next dose is in less than 6 hours, skip the missed dose. Do not take two doses at the same time.

Do not stop taking Pradaxa without talking to your doctor. Stopping suddenly may increase your risk of stroke or blood clots.

Refill your prescription before you run out. If you are having surgery or a medical or dental procedure, inform your doctor or dentist. You may need to stop taking Pradaxa temporarily.

If you take too much Pradaxa, seek emergency medical help immediately. If you fall or injure yourself, especially if you hit your head, contact your doctor right away.

Pradaxa comes in bottles or blister packs. Open only one bottle at a time and finish it before opening a new one. Use the medication within 4 months of opening a bottle. Keep the bottle tightly closed after each use.

Common Side Effects:

• Stomach pain or discomfort
• Upset stomach, burning
• Bleeding
• Heavy menstrual bleeding
• Nausea, vomiting, diarrhea

Serious Side Effects:

• Bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual or vaginal bleeding)
• Headache, weakness, dizziness, or feeling like you might pass out
• Bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
• Urine that looks red, pink, or brown
• Unexpected pain, joint pain, or swelling

Other Potential Side Effects:

• Redness of the skin
• Skin rash, hives, welts, or itching skin
• Sweating
• Trouble breathing
• Unusual tiredness or weakness

This is not a complete list of side effects, and others may occur. If you experience any concerning symptoms, seek medical advice promptly.

Consult with a healthcare professional before taking Pradaxa if you are pregnant or planning to become pregnant. Additionally, if you are breastfeeding, discuss your treatment options and the best way to feed your child with your healthcare provider.

For pediatric patients, specific precautions and considerations are outlined, including recommendations for discontinuation before elective surgery and the avoidance of use in patients with certain levels of kidney function.

Pradaxa capsules should only be dispensed and stored in the original bottle or blister package to prevent breakdown and loss of potency.

Avoid the use of Pradaxa if a patient has a mechanical prosthetic heart valve, active pathological bleeding, or a history of hypersensitivity reaction to Pradaxa. It also emphasizes the risk of spinal and epidural hematomas in certain medical procedures.

How should I store Pradaxa?

• Store Pradaxa at room temperature between 59F to 86F (15C to 30C). After opening the bottle, use Pradaxa within 4 months. Safely throw away any unused Pradaxa after 4 months.
• Keep Pradaxa in the original bottle or blister package to keep it dry (protect the capsules from moisture).
• Do not put Pradaxa in pill boxes or pill organizers.
• Tightly close your bottle of Pradaxa right away after you take your dose.
• Keep PRADAXA and all medicines out of the reach of children.