Pradaxa 75 mg hard capsules

 

What is it and how is it used?

What is Pradaxa:

Pradaxa is a medicine which is used to prevent the formation of blood clots. It works by blocking a substance in the body which is involved in blood clot formation.

What Pradaxa is used for:

Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery.

What do you have to consider before using it?

Do NOT take Pradaxa

  • if you are allergic to dabigatran etexilate, dabigatran or any of the other ingredients of Pradaxa.
  • if you have severely reduced kidney function.
  • if you are currently bleeding.
  • if you have a disease in an organ of the body that increases the risk of serious bleeding.
  • if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
  • if you have a severely reduced liver function or liver disease which could possibly cause death.
  • if you are taking oral ketoconazole, a medicine to treat fungal infections.

Take special care with Pradaxa

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

  • if you have a liver disease that is associated with changes in the blood tests, the use of Pradaxa is not recommended.
  • if you have an increased bleeding risk, as could be the case in the following situations: if you have had a surgical tissue removal (biopsy) in the past month. if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment). if you are receiving treatments which could increase the risk of bleeding. if you are taking anti-inflammatory medicines. if you are suffering from an infection of the heart (bacterial endocarditis). if you have a moderately impaired kidney function. Pradaxa should not be used in children.
  • if you have a tube (catheters) inserted into the back: A tube can be inserted into your back e.g. for anesthesia or pain relief during or after surgery. If you are administered Pradaxa after removal of a catheter your doctor will examine you regularly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. For instance:

  • Blood thinners (e.g. warfarin, heparin)
  • Non-steroidal anti-inflammatory medicines
  • St. John´s wort, a herbal product for depression
  • Rifampicin or clarithromycin, two antibiotics
  • Medicines to treat abnormal heart beats ( e.g. Amiodarone, quinidine, verapamil) If you are taking amiodarone-, quinidine- or verapamil-containing medicines you should be treated with a reduced dose of 150 mg Pradaxa because your bleeding risk may be increased. Pradaxa and these medicines should be taken at the same time. If you are taking verapamil containing medicines and your kidney function is decreased by more than half you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.
  • Fungal infections (e.g. ketoconazole, itraconazole, fluconazole), unless they are only applied to the skin
  • Anti-viral medicines for AIDS (e.g. ritonavir)
  • Medicines for treatment of epilepsy (e.g. carbamazepine)

Taking Pradaxa with food and drink

Pradaxa can be taken with or without food.
Do not open the capsule.

Pregnancy and breast-feeding

The effects of Pradaxa on pregnancy and the unborn child are not known. You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.

You should not breast-feed while you are taking Pradaxa.

Driving and using machines

The effect of Pradaxa on the ability to drive and use machines is not known. Your doctor will tell you when you can start to drive.

Important information about some of the ingredients of Pradaxa

Pradaxa hard capsules contain a colorant with the name sunset yellow, which may cause allergic reactions.

How is it used?

When taking Pradaxa capsules out of the blister pack, please observe the following instructions

  • take the capsules by peeling off the backing foil of the blister card.
  • do not push the capsules through the blister foil.
  • do not peel off the blister foil until a capsule is required.
  • do not open the capsule.

When taking Pradaxa capsules out of the bottle, please observe the following instructions

  • push and turn for opening.
  • do not open the capsule.

The generally recommended dose of Pradaxa is 220 mg once a day (taken as 2 capsules of 110 mg).

If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking amiodarone-, quinidine- or verapamil-containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking verapamil containing medicines and your kidney function is decreased by more than half you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.

After knee replacement surgery

You should start treatment with Pradaxa within 1 – 4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 10 days.

After hip replacement

You should start treatment with Pradaxa within 1 – 4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 28 – 35 days.

For both surgery types, treatment should not be started if there is bleeding from the site of operation. If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once daily.

Always take Pradaxa exactly as your doctor has told you. You should check with your doctor if you are not sure. The capsule should be swallowed with some water. Do not chew the capsule.

Changing from treatment with Pradaxa to anticoagulant treatment given by injection Do not start treatment with injectable anticoagulant medicines (for example, heparin) until 24 hours after the final dose of Pradaxa.

Changing from anticoagulant treatment given by injection to treatment with Pradaxa Stop the treatment by injection and then start taking Pradaxa at the time you would have had the next injection.

If you take more Pradaxa than you should
If you take more Pradaxa than recommended, you may have an increased risk of bleeding. Your doctor can perform a blood test to assess the risk of bleeding.
Inform your doctor as soon as possible if you take more than the prescribed dose of Pradaxa. If bleeding occurs, surgical treatment or treatment with blood transfusions may be required.

If you forget to take Pradaxa
Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Do not take a double dose to make up for missed individual doses.

If you stop taking Pradaxa
Do not stop taking Pradaxa without first consulting your doctor, since the risk of developing a blood clot in a vein could be higher if you stop treatment early.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Pradaxa can cause side effects, although not in all patients.

As this medicine affects blood clotting, most side effects are related to signs such as bruising or bleeding. Although rarely reported in clinical trials, major or severe bleeding may occur and, regardless of location, may become disabling, life-threatening or even lead to death.

The side effects are listed below, grouped by how likely they are to happen:

With Pradaxa the following side effects are known:

Common side effects (affects 1 to 10 users in 100):

  • A fall in the number of red cells in the blood
  • A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
  • Nosebleed
  • Bleeding into the stomach or bowel
  • Belly ache or stomache ache
  • Frequent loose or liquid bowel movements
  • Indigestion
  • Feeling sick

Uncommon side effects (affects 1 to 10 users in 1,000):

  • Bleeding
  • Bleeding into a joint
  • A fall in the number of platelets in the blood
  • Bleeding from piles
  • Bleeding into the rectum
  • Blood in the urine that stains the urine pink or red
  • Bleeding under the skin
  • Blood-stained discharge from the site of entry of a catheter into a vein
  • Blood detected in the stools by a laboratory test
  • A decrease in the proportion of red cells in the blood
  • Unusual laboratory test results on liver function
  • Allergic reaction
  • Itching
  • Sudden change of the skin which affects its colour and appearance
  • Bleeding in the brain
  • Haematoma formation
  • Bleeding from an injury
  • Bleeding after an injury
  • Blain in the alimentary tract
  • Inflammation of the gullet and stomach
  • Reflux of gastric juice into the gullet
  • Vomiting
  • Difficulty in swallowing
  • Blood found in the urine on laboratory testing
  • Bruising occuring after an operation
  • Bleeding occuring after an operation
  • A fall in the number of red cells in the blood after an operation
  • Exudation of a small amount of liquid from the incision made for a surgical procedure
  • Wound secretion (liquid exuding from the surgical wound)
  • Fluid exiting a wound

Rare side effects (affects 1 to 10 in 10,000):

  • Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
  • Bleeding from the site of entry of an injection
  • Bleeding from the site of entry of a catheter into a vein
  • Bleeding from a surgical incision
  • Fluid exiting a wound after an operation

Not known (cannot be estimated from the available data):

  • Difficulty in breathing or wheezing

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Pradaxa after the expiry date which is stated on the carton, blister or bottle. The expiry date refers to the last day of that month.

Blister: Store in the original package in order to protect from moisture.
Bottle: Once opened, the product must be used within 30 days. Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Pradaxa is a medicine containing the active substance dabigatran etexilate. It is available as capsules (75 mg and 110 mg).

What is it used for?

Pradaxa is used to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee.
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Pradaxa should start with one 110 mg capsule taken one to four hours after the end of the operation. Treatment then continues with two 110 mg capsules (220 mg) once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement. The start of the treatment should be delayed in patients who are still bleeding from the site of surgery. If treatment is not started on the day of the operation, it should start with two capsules once a day. The capsules should be swallowed whole with water.
A lower dose (150 mg once a day) is used in patients with mild or moderate kidney problems, in patients over 75 years of age, and in patients taking amiodarone (a medicine used to regulate the heart rhythm). Pradaxa should not be used in patients who have severe problems with their kidneys and it is not recommended for use in patients with signs of existing liver problems. Pradaxa should be used with caution in patients at risk of bleeding or who could have high blood levels of the medicine, such as those who have moderate problems with their kidneys. Patients weighing less than 50 kg or more than 110 kg should be closely monitored for signs of bleeding or anaemia (low red blood cell counts).

How does it work?

Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins. These clots, which include deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs or the brain. The active substance in Pradaxa, dabigatran etexilate, is a ‘prodrug’ of dabigatran. This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting). It blocks a substance called thrombin, which is central to the process of blood clotting, reducing the risk of blood clots forming in the veins.

How has it been studied?

The effects of Pradaxa were first tested in experimental models before being studied in humans. The effectiveness of Pradaxa was studied in two main studies, both of which compared Pradaxa (either 220 or 150 mg a day) with enoxaparin (another anticoagulant). The first study involved a total of 2,101 patients who had had a knee replacement operation, and the second involved a total of 3,494 patients who had had a hip replacement. In both studies, the main measure of effectiveness was the number of patients who formed blood clots in the veins or who died of any cause during the treatment period. In most cases, blood clot formation was detected using scans of the veins or by looking for signs of blood clots in the lungs.

What benefits has it shown during the studies?

In both studies, Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death. In the study of patients undergoing knee replacement, blood clots were detected in 182 (36%) of the 503 patients taking the 220-mg dose of Pradaxa, compared with 192 (38%) of the 512 receiving enoxaparin. There was only one death in each group (less than 1%).
After hip replacement, blood clots were detected in 50 (6%) of the 880 patients taking 220 mg Pradaxa, compared with 60 (7%) of the 897 receiving enoxaparin. Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
In both studies, the 220-mg dose showed a trend towards being more effective than the 150-mg dose.

What is the risk associated?

The most common side effect with Pradaxa (seen in more than 1 patient in 10) is bleeding. For the full list of all side effects reported with Pradaxa, see the Package Leaflet.
Pradaxa should not be used in people who may be hypersensitive (allergic) to dabigatran etexilate or any of the other ingredients. It should not be used in patients who have severe problems with their kidneys, active significant bleeding, tissue damage that could lead to bleeding, problems with the blood clotting process (this may be inborn, of unknown cause or due to other medicines), or liver problems that could be life-threatening. Pradaxa should also not be used in patients taking quinidine (another medicine used to regulate the heart rhythm).

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Pradaxa’s benefits are greater than its risks for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. The Committee recommended that Pradaxa be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa to Boehringer Ingelheim International GmbH on 18 March 2008.