Pradaxa 75 mg hard capsules

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.

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.

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.

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.

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 Pradaxa contains

The active substance is dabigatran, which is administered in the form of 75 mg or 110 mg dabigatran etexilate given as mesilate.

The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and
hydroxypropylcellulose.

The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, sunset yellow, hypromellose and purified water.

The black printing ink contains shellac, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, iron oxide black, purified water and propylene glycol.

What Pradaxa looks like and contents of the pack

Pradaxa is a hard capsule.

Pradaxa 75 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body. The Boehringer Ingelheim logo is printed on the cap and ?R75? on the body of the capsule.

Pradaxa 110 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body. The Boehringer Ingelheim logo is printed on the cap and ?R110? on the body of the capsule.

Pradaxa 75 mg and 110 mg hard capsules are available in packs containing 10 x 1, 30 x 1, 60 x 1capsules in aluminium perforated unit dose blisters.

Pradaxa 75 mg and 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien SCS. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11 LuxembourgLuxemburg SCS. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11

359 2 958 79 98 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel 36 1 299 8900

eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 88 Nederland Boehringer Ingelheim b.v. Tel 31 0 800 22 55 889

Deutschland Boehringer Ingelheim Pharma GmbH Co. KG Tel 49 0 800 77 90 900 Norge Boehringer Ingelheim Norway KS Tlf 47 66 76 13 00

Österreich Boehringer Ingelheim RCV GmbH Co KG Tel 43 1 80 105-0 Eesti Boehringer Ingelheim Pharma GmbH Eesti Filiaal Tel 372 60 80 940

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Polska Boehringer Ingelheim Sp.zo.o. Tel 48 22 699 0 699

España Boehringer Ingelheim España S.A. Tel 34 93 404 51 00 Portugal Boehringer Ingelheim, Lda. Tel 351 21 313 53 00

France Boehringer Ingelheim France S.A.S. Tél 33 3 26 50 45 33 România Boehringer Ingelheim RCV GmbH Co KG Viena - Sucursala Bucuresti Tel 40 21 330 99 63

Ireland Boehringer Ingelheim Ireland Ltd. Tel 353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH Co KG, podrunica Ljubljana Tel 386 1 586 40 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH Co KG, organizaná zloka Tel 421 2 5810 1211

Italia Boehringer Ingelheim Italia S.p.A. Tel 39 02 5355 1 SuomiFinland Boehringer Ingelheim Finland Ky PuhTel 358 10 3102 800

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Sverige Boehringer Ingelheim AB Tel 46 8 721 21 00

United Kingdom Boehringer Ingelheim Ltd. Tel 44 1344 424 600 Latvija Boehringer Ingelheim Pharma GmbH Prstvniecba Latvij Tel 371 67 240 068

Lietuva
Boehringer Ingelheim Pharma Ges mbH
Atstovyb- Lietuvoje
Tel: +370 37 473922

This leaflet was last approved in XX/YYYY