DABIGATRAN ETEXILATE 75 MG HARD CAPSULES - patient leaflet, side effects, dosage

Dabigatran etexilate 75 mg hard capsules

dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Dabigatran etexilate is and what it is used for

• 2. What you need to know before you take Dabigatran etexilate

• 3. How to take Dabigatran etexilate

• 4. Possible side effects

• 5. How to store Dabigatran etexilate

• 6. Contents of the pack and other information

1. what dabigatran etexilate is and what it is used for

Dabigatran etexilate is a medicine which contains the active substance dabigatran etexilate. It works by blocking a substance in the body which is involved in blood clot formation.

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

2. what you need to know before you take dabigatran etexilate

Do not take Dabigatran etexilate

• – if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).

• – 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 or itraconazole, medicines to treat fungal infections.

• – if you are taking cyclosporine, a medicine to prevent organ rejection after transplantation.

• – if you are taking dronedarone, a medicine used to prevent repetition of your problem of irregular heart beat.

• – if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while having a venous or arterial line and you get heparin through this line to keep it open.

• – if you have received an artificial heart valve

Warnings and precautions

Talk to your doctor before taking Dabigatran etexilate. You may also need to talk to your doctor during treatment with Dabigatran etexilate if you experience symptoms or if you have to undergo surgery. 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 Dabigatran etexilate is not recommended.

• – if you have an increased bleeding risk, as could be the case in the following situations:

• ■ if you have been recently bleeding.

• ■ 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 suffering from an inflammation of the gullet or stomach.

• ■ if you have problems with reflux of gastric juice into the gullet.

• ■ if you are receiving medicines which could increase the risk of bleeding such as aspirin (acetylsalicylic acid), clopidogrel, ticagrelor.

• ■ if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.

• ■ if you are suffering from an infection of the heart (bacterial endocarditis).

• ■ if you know you have impaired kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) urine).

• ■ if you are older than 75 years.

• ■ if you weigh 50 kg or less.

• – if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.

• – if you undergo a planned surgery. Dabigatran etexilate will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation. If possible, Dabigatran etexilate should be stopped at least 24 hours before an operation. In patients with a higher risk for bleeding your doctor may decide to stop treatment earlier.

• – if you need to undergo an unplanned surgery. If possible, a surgery should be delayed until at least 12 hours after the last dose. If surgery cannot be delayed, there may be an increased risk of bleeding. Your doctor will consider this risk of bleeding together with the urgency of the surgery.

• – if you have a tube (catheters) inserted into the back: A tube can be inserted into your back e.g. for anaesthesia or pain relief during or after surgery. If you are administered Dabigatran etexilate after removal of a catheter, your doctor will examine you regularly.

• – if you fall or injure yourself during treatment, especially if you hit your head, please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

• – if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

Children and adolescents

Dabigatran etexilate should not be used in children and adolescents below 18 years old.

Other medicines and Dabigatran etexilate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. For instance:

• – Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban)

• – Anti-inflammatory and pain reliever medicines (e.g. aspirine)

• – St. John's wort, a herbal medicine for depression – Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin- norepinephrine re-uptake inhibitors

• – Rifampicin or clarithromycin, two antibiotics

• – Medicines to treat abnormal heart beats (e.g.

Amiodarone, dronedarone, quinidine, verapamil) If you are taking amiodarone-, quinidine- or verapamil-containing medicines, you should be treated with a reduced dose of 150 mg Dabigatran etexilate taken once a day as 2 capsules of 75 mg, because your bleeding risk may be increased. Dabigatran etexilate 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 Dabigatran etexilate because your bleeding risk may be increased.

• – Medicines to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole), unless they are only applied to the skin

• – Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)

• – Anti-viral medicines for AIDS (e.g. ritonavir)

• – Medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of Dabigatran etexilate on pregnancy and the unborn child are not known. You should not take Dabigatran etexilate 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 Dabigatran etexilate.

You should not breast-feed while you are taking Dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive or use machines.

3. how to take dabigatran etexilate

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose 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 Dabigatran etexilate because your bleeding risk may be increased.

After knee replacement surgery

You should start treatment with Dabigatran etexilate 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 surgery

You should start treatment with Dabigatran etexilate 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 a day.

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach. Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.

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

The following pictogram illustrates how to take Dabisatran etexilate capsules out the blister

’eel off the backing foil and remove tie capsule.

• donotpushthecap­sules through the blister foil.
• do not peel off the blister foil until a capsule is required.
• When taking Dabigatran etexilate capsules out of the bottle, please observe the following instructions push and turn for opening.
• after removing the capsule place the cap back on the bottle and tightly close the bottle right away after you take your dose.

Change of anticoagulant treatment

• - Changing from treatment with Dabigatran etexilate 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 Dabigatran etexilate.

• - Changing from anticoagulant treatment given by injection to treatment with Dabigatran etexilate: Start taking Dabigatran etexilate 0–2 hours before the time you would have had the next injection.

If you take more Dabigatran etexilate than you should If you take more Dabigatran etexilate 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 immediately, if you take more than the prescribed dose of Dabigatran etexilate. If bleeding occurs, surgical treatment or treatment with blood transfusions may be required.

If you forget to take Dabigatran etexilate

Continue with your remaining daily doses of Dabigatran etexilate at the same time of the next day.

Do not take a double dose to make up for forgotten doses.

If you stop taking Dabigatran etexilate

Take Dabigatran etexilate exactly as prescribed. Do not stop taking Dabigatran etexilate without first consulting your doctor.

Stopping Dabigatran etexilate may increase the risk of developing a blood clot in patients treated after hip- or knee-replacement surgery.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dabigatran etexilate affects blood clotting, so most side effects are related to signs such as bruising or bleeding. Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death. In some cases these bleedings may not be obvious.

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under closer observation or change your medicine.

Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.

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

Common (may affect up to 1 in 10 people):

• – A fall in the amount of of haemoglobin in the blood (the substance in the red blood cells)

• – Unusual laboratory test results on liver function

Uncommon (may affect up to 1 in 100 people):

• – Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), from piles, into the rectum, under the skin, into a joint, from or after an injury or after an operation

• – Haematoma formation or bruising occurring after an operation

• – Blood detected in the stools by a laboratory test

• – A fall in the number of red cells in the blood

• – A decrease in the proportion of red cells in the blood

• – Allergic reaction

• – Vomiting

• – Frequent loose or liquid bowel movements

• – Feeling sick

• – Exudation of a small amount of liquid from the incision made for a surgical procedure

• – Wound secretion (liquid exuding from the surgical wound)

Rare (may affect up to 1 in 1,000 people):

• – Bleeding

• – Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein

• – Blood-stained discharge from the site of entry of a catheter into a vein

• – Coughing of blood or blood stained sputum

• – A fall in the number of platelets in the blood

• – A fall in the number of red cells in the blood after an operation

• – Serious allergic reaction which causes difficulty in breathing or dizziness

• – Serious allergic reaction which causes swelling of the face or throat

• – Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction

• – Sudden change of the skin which affects its colour and appearance

• – Itching

• – Ulcer in the stomach or bowel (incl. ulcer in the gullet)

• – Inflammation of the gullet and stomach

• – Reflux of gastric juice into the gullet

• – Belly ache or stomach ache

• – Indigestion

• – Difficulty in swallowing

• – Fluid exiting a wound

• – Fluid exiting a wound after an operation

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

• – Difficulty in breathing or wheezing

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store dabigatran etexilate

Keep this medicine out of the sight and reach of children.

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

Blister: Store in the original package in order to protect from moisture. Do not put the capsules in pill boxes or pill organizers, unless capsules can be maintained in the original package

Bottle: Keep the bottle tightly closed. Store in the original package in order to protect from moisture. Once opened, the medicine must be used within 4 months. Do not put the capsules in pill boxes or pill organizers.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information what dabigatran etexilate contains

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

• – The other ingredients are cellulose microcrystalline, croscarmellose sodium, crospovidone, tartaric acid pellets, hydroxypropyl­cellulose, mannitol (E-421), talc and magnesium stearate.

• – The capsule shell contains red iron oxide (E-172), titanium dioxide (E-171), hypromellose.

• – The black printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.

What Dabigatran etexilate looks like and contents of the pack

Dabigatran etexilate is a hard capsule.

Dabigatran etexilate 75 mg hard capsules are opaque, pink and with “E100” printed on them.

Dabigatran etexilate 75 mg hard capsules are available in packs containing 10, 30, 60 capsules in perforated peelable aluminium blisters with desiccant.

Dabigatran etexilate 75 mg hard capsules are also available in white opaque polyethylene (plastic) bottle containing a desiccant together with a filler, and a white polypropylene cap with 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TOWA Pharmaceutical Europe, S.L. C/ de Sant Marti, 75–97, Martorelles, 08107 Barcelo­na, Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L. C/ de Sant Marti, 75–97, Martorelles, 08107 Barcelo­na, Spain

This leaflet was last approved in 11.2020

MU3594–20–2