PRADAXA®
Dabigatran
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Pradaxa. It does not contain all the information that is known about Pradaxa. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Pradaxa is used for
Pradaxa contains dabigatran etexilate (as dabigatran etexilate mesilate). After oral use, dabigatran etexilate is rapidly converted in the body to its active form dabigatran. Dabigatran inhibits a specific protein in the blood, called thrombin. Thrombin contributes to the formation of blood clots. Dabigatran prevents the formation of blood clots.
This type of medication is called an anticoagulant. Some people refer to anticoagulant medicines as "blood thinners". Excessive clotting sometimes occurs when physical mobility is low such as following major orthopaedic surgery of the lower limb and due to a heart condition called atrial fibrillation in which the heart beats irregularly.
If excessive clotting is not prevented, it can lead to serious health problems such as strokes.
Before you take Pradaxa
When you must not take it
Do not take Pradaxa if you have:
severely reduced kidney function. Your doctor will know how to determine your kidney function
an increased tendency of bleeding complications, be it inherited, acquired or caused by other medicines
medical conditions which increase your risk of bleeding, including brain bleeding within the last 6 months, active stomach ulcers
stomach bleeding in the past year, unless it has been fixed
a history of bleeding in the head, eyes, spine and joints
indwelling spinal or epidural catheters , and during the first two hours after their removal. Your doctor will know about the kind of catheters and precautionary measures
liver problems or liver disease
you are currently taking oral ketoconazole, a medicine used to treat fungal infections.
Do not start Pradaxa and verapamil treatment at the same time.
Do not start verapamil if you are currently taking Pradaxa and have just undergone major orthopaedic surgery.
Do not take Pradaxa if you are allergic to:
Dabigatran etexilate or any of the ingredients in Pradaxa listed at the end of this leaflet.
Pradaxa contains sunset yellow FCF CI15985, which may cause allergic reactions.
Some of the symptoms of an allergic reaction may include:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or troubled breathing.
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine.
The active ingredient in Pradaxa passes into breast milk.
Do not give this medicine to a child or adolescent.
There is no experience with its use in children or adolescents under 18 years old.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal. I