Dabigatran etexilate 110 mg Hard Capsules

• 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.

1. What Dabigatran 110 mg Capsules are and what they are used for
2. What you need to know before you take Dabigatran 110 mg Capsules
3. How to take Dabigatran 110 mg Capsules
4. Possible side effects
5. How to store Dabigatran 110 mg Capsules
6. Contents of the pack and other information

• 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 (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
• if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
• if you 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.
• 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 oral cyclosporine, a medicine to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart beat.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have received an artificial heart valve which requires permanent blood thinning.

Talk to your doctor or pharmacist before taking this medicine.

You may also need to talk to your doctor or pharmacist 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’ 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 for 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 this medicine is not recommended in this case.

Talk to your doctor if any of the below applies to you:

• if you need to have an operation:
  In this case dabigatran 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 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 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 immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

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, 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 may tell you to use a reduced dose of dabigatran depending on the condition for which it is prescribed to you. See 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 inhibitors or serotonin-norepinephrine re-uptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Anti-viral medicines for AIDS (e.g. ritonavir)
• Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

The effects of dabigatran 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 this medicine.

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

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

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).

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 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 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 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.

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

If you are 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.

If you are taking verapamil containing medicines, you should be treated with a reduced dabigatran dose of 220 mg taken as one 110 mg capsule twice a day, because your bleeding risk may be increased.

If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of 220 mg taken as one 110 mg capsule twice a day.

You can continue to take this medicine if your heart beat needs to be restored to normal by a procedure called cardioversion. Take dabigatran as your doctor has told you.

If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with dabigatran after your doctor has decided that normal control of blood coagulation is achieved. Take dabigatran as your doctor has told you.

Treatment of blood clots and prevention of blood clots from reoccurring in children

Dabigatran 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 dabigatran doses in milligrams (mg). The doses depend on weight in kilograms (kg) and age in years of the patient.

Table 1: Dosing table for dabigatran capsules

Weight in kg 11 to < 13 / Age in years 8 to < 9

Single dose 75mg / Total daily dose 150mg

Weight in kg 13 to < 16 / Age in years 8 to < 11

Single dose 110mg / Total daily dose 220mg

Weight in kg 16 to < 21 / Age in years 8 to < 14

Single dose 110mg / Total daily dose 220mg

Weight in kg 21 to < 26 / Age in years 8 to < 16

Single dose 150mg / Total daily dose 300mg

Weight in kg 26 to < 31 / Age in years 8 to < 18

Single dose 150mg / Total daily dose 300mg

Weight in kg 31 to < 41 / Age in years 8 to < 18

Single dose 185mg / Total daily dose 370mg

Weight in kg 41 to < 51 / Age in years 8 to < 18

Single dose 220mg / Total daily dose 440mg

Weight in kg 51 to < 61 / Age in years 8 to < 18

Single dose 260mg / Total daily dose 520mg

Weight in kg 61 to < 71 / Age in years 8 to < 18

Single dose 300mg / Total daily dose 600mg

Weight in kg 71 to < 81 / Age in years 8 to < 18

Single dose 300mg / Total daily dose 600mg

Weight in kg > 81 / Age in years 10 to < 18

Single dose 300mg / Total daily dose 600mg

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

220 mg: two 110 mg capsules

185 mg: one 75 mg plus one 110 mg capsule

150 mg: one 150 mg capsule or

two 75 mg capsules

Dabigatran 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.

Without specific guidance from your doctor do not change your anticoagulant treatment.

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.

Prevention of blood clot formation after knee or hip replacement surgery

Continue with your remaining daily doses of dabigatran at the same time of the next day. Do not take a double dose to make up for a forgotten dose.

Use in adults:

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs

Use in children:

Treatment of blood clots and prevention of blood clots from reoccurring

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 double a dose to make up for a forgotten dose.

Take dabigatran 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.

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: 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.

• The active substance is dabigatran. Each hard capsule contains 110 mg dabigatran etexilate (as mesilate)
• The other ingredients are tartaric acid, acacia, hypromellose, talc, dimethicone and hydroxypropylcellulose
• The capsule shell contains titanium dioxide, FD&C BLUE2, hypromellose, carrageenan and potassium chloride
• The black printing ink contains shellac, black iron oxide and potassium hydroxide

Dabigatran 110 mg Capsules are hard capsules (approximately 19 mm long) with an opaque light blue cap and an opaque light blue body. The capsule body is printed with 110.

This medicine is available in packs containing 10 and 60 hard capsules in aluminium blisters.

Not all pack sizes may be marketed.

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