What it is and what it is used for

for

These capsules contain the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation. Dabigatran etexilate is used in adults to: • prevent the formation of blood clots in the veins after knee or hip replacement surgery. Dabigatran etexilate is used in children to: • treat blood clots and to prevent blood clots from reoccurring. 2.

What you need to know before you take it

e 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). • have severely reduced kidney function. • are currently bleeding. • have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes). • have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines. • are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation. • have a severely reduced liver function or liver disease which could possibly cause death. • are taking oral ketoconazole or itraconazole, medicines to treat fungal infections. • are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation. • are taking dronedarone, a medicine used to treat abnormal heart beat. • are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to 1

•

treat hepatitis C. have received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions Talk to your doctor before taking Dabigatran etexilate. You may also need to talk to your doctor during treatment with this medicine 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 an increased bleeding risk, such as :

• 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. See 'Other medicines and Dabigatran etexilate' below.
• 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 decreased kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured. (concentrated)/foaming urine).
• if you are older than 75 years.
• if you are an adult patient and weigh 50 kg or less.
• only if used in children: if the child has an infection around or within the brain.

•

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 have a liver disease that is associated with changes in the blood tests. The use of Dabigatran etexilate is not recommended in this case.

Take special care with Dabigatran etexilate •

if you need to have an operation: In this case Dabigatran etexilate will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation. It is very important to take Dabigatran etexilate before and after the operation exactly at the times you have been told by your doctor.

•

if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

• it is very important to take Dabigatran etexilate before and after the operation exactly at the times you have been told by your doctor.
• tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

•

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 2

immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. Other medicines and Dabigatran etexilate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular you should tell your doctor before taking Dabigatran etexilate, if you are taking one of the medicines listed below: • • • • • • • • • • • •

Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid). Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin. Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor will tell you to use a reduced dose of Dabigatran etexilate depending on the condition for which it is being prescribed. See also section 3. Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine). A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C). Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac). St. John ́s wort, a herbal medicine for depression. Antidepressant medicines called selective serotonin re-uptake inhibitor or serotoninnorepinephrine re-uptake inhibitors. Rifampicin or clarithromycin (twoantibiotics). Anti-viral medicines for AIDS (e.g. ritonavir). Certain 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 this medicine 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

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other age appropriate dose forms for the treatment of children below 8 years. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Take Dabigatran etexilate as recommended for the following conditions: Prevention of blood clot formation after knee or hip replacement surgery The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg). 3

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. 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. 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. Treatment of blood clots and prevention of blood clots from reoccurring in children Dabigatran etexilate should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible. The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Keep using all other medicines, unless your doctor tells you to stop using any. Table 1 shows single and total daily Dabigatrin etexilate doses in milligrams (mg). The doses depend on weight in kilograms (kg) and age in years of the patient. Table 1: Dosing table for Dabigatrin etexilate capsules Weight/age combinations Weight in kg Age in years 11 to less than 13 kg 8 to less than 9 years 13 to less than 16 kg 8 to less than 11 years 16 to less than 21 kg 8 to less than 14 years 21 to less than 26 kg 8 to less than 16 years 26 to less than 31 kg 8 to less than 18 years 31 to less than 41 kg 8 to less than 18 years 41 to less than 51 kg 8 to less than 18 years 51 to less than 61 kg 8 to less than 18 years 61 to less than 71 kg 8 to less than 18 years 71 to less than 81 kg 8 to less than 18 years 81 kg or greater 10 to less than 18 years

Single dose in mg 75 110 110 150 150 185 220 260 300 300 300

Total daily dose in mg 150 220 220 300 300 370 440 520 600 600 600

Single doses requiring combinations of more than one capsule: 300 mg: two 150 mg capsules or four 75 mg capsules 260 mg: one 110 mg plus one 150 mg capsule or one 110 mg plus two 75 mg capsules 4

220 mg: 185 mg: 150 mg:

as two 110 mg capsules as one 75 mg plus one 110 mg capsule as one 150 mg capsule or two 75 mg capsules

How to take it

Dabigatran etexilate Dabigatran etexilate can be taken with or without food. The capsules should be swallowed as a whole with a glass of water, and not opened because this may increase the risk of bleeding. Instructions for opening the blisters • • • •

Tear off one individual blister from the blister card along the perforated line Peel off the backing foil and remove the capsule. Do not push the capsules through the blister foil. Do not peel off the blister foil until a capsule is required.

Change of anticoagulant treatment Without specific guidance from your doctor do not change your anticoagulant treatment. If you take more Dabigatran etexilate than you should Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available. If you forget to take Dabigatran etexilate Prevention of blood clot formation after knee or hip replacement surgery 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 a forgotten dose. Treatment of blood clots and prevention of blood clots from reoccurring in children A forgotten dose can still be taken up to 6 hours prior to the next due dose. A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Dabigatran etexilate Take Dabigatran etexilate exactly as prescribed. Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate. 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. 5

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.

Possible 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 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, from 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 blood cells. • Allergic reaction. • Vomiting. • Frequent loose or liquid bowel movements. • Feeling sick. • Wound secretion (liquid exuding from the surgical wound). • Liver enzymes increased. • Yellowing of the skin or whites of the eyes, caused by liver or blood problems. 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 avein. • 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. • Decrease in the number or even lack of white blood cells (which help to fight infections). • Hair loss. 6

Treatment of blood clots and prevention of blood clots from reoccurring in children Common (may affect up to 1 in 10 people): • A fall in the number of red cells in the blood. • A fall in the number of platelets in the blood. • 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. • Haematoma formation. • Nosebleed. • Reflux of gastric juices into the gullet. • Vomiting. • Feeling sick. • Frequent loose or liquid bowel movements. • Indigestion. • Hair loss. • Liver enzymes increased. Uncommon (may affect up to 1 in 100 people): • Decrease in the number of white blood cells (which help to fight infections). • Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin. • A fall in the amount of haemoglobin in the blood (the substance in the red blood cells). • A decrease in the proportion of blood cells. • Itching. • Coughing of blood or blood stained sputum. • Belly ache or stomachache. • Inflammation of the gullet and stomach. • Allergic reaction. • Difficulty in swallowing. • Yellowing of the skin or whites of the eyes, caused by liver or blood problems. Not known (frequency cannot be estimated from the available data): • Lack of white blood cells (which help to fight infections). • Serious allergic reaction which causes difficulty in breathing or dizziness. • Serious allergic reaction which causes swelling of the face or throat. • Difficulty in breathing or wheezing. • Bleeding. • Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein. • Bleeding may happen from piles. • Ulcer in the stomach or bowel (incl. ulcer in the gullet). • Unusual laboratory test results on liver function. 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5

How to store it

Dabigatran etexilate 7

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 or blister after "EXP". The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater. 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 etexilate. Each hard capsule contains 75 mg dabigatran etexilate (as mesilate). The other ingredients are tartaric acid, acacia, hypromellose, dimeticone, talc and hydroxypropyl cellulose. The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), and hypromellose. What Dabigatran etexilate looks like and contents of the pack Dabigatran etexilate 75 mg are hard capsules off white to pale yellow coloured pellets filled in white to off white hard capsule size 2. Dabigatran etexilate is available in packs containing 1 x 10, 3 x 10 or 6 x 10 hard capsules in perforated Aluminium /OPA-ALU-PVC blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder: Biocon Pharma UK Limited 16 Great Queen Street, Covent Garden London, WC2B5AH United Kingdom Manufacturers: Galenicum Health, S.L. Sant Gabriel, 50 Esplugues de Llobregat, 08950 Barcelona, Spain or SAG Manufacturing S.L.U, Crta. N-I, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain This leaflet was last revised in January 2025 8