Dabigatran Etexilate Accord 110 mg hard capsules – patient leaflet, side effects, dosage

1. What Dabigatran capsules are and what it is used for

Dabigatran capsules contain the active substance dabigatran etexilate and belong to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation.

Dabigatran capsules are used in adults to:

• prevent the formation of blood clots in the veins after knee or hip replacement surgery
• prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor
• treat blood clots in the veins of your legs and lungs and to prevent blood clots from re-occurring in the vein of your legs and lungs.

Dabigatran capsules are used in children to:

• treat blood clots and to prevent blood clots from reoccurring.

2. What you need to know before you take Dabigatran capsules

Do not take Dabigatran capsules 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 heartbeat 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 heartbeat 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.

Warnings and precautions

Talk to your doctor before taking Dabigatran capsules. 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 bleeding recently
  • have had a surgical tissue removal (biopsy) in the past month
  • have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment)
  • are suffering from an inflammation of the gullet or stomach
  • have problems with reflux of gastric juice into the gullet

  • are receiving medicines which could increase the risk of bleeding. See 'Other medicines and Dabigatran

    capsules' below

  • are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam
  • are suffering from an infection of the heart (bacterial endocarditis)

  • 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)

  • are older than 75 years
  • are an adult patient and weigh 50kg or less
  • only if used for children: if the child has an infection around or within the brain
• have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack
• have a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Dabigatran capsules

• if you need to have an operation:

  In this case Dabigatran capsules 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 capsules 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 capsules 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 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.

Other medicines and Dabigatran capsules

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 capsules, 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 heartbeats (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 capsules 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 (Hypericum perforatum), 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).

Pregnancy and breast-feeding

The effects of Dabigatran capsules 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 capsules.

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

Driving and using machines

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

Dabigatran capsules contain sodium

This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially "sodium free".

3. How to take Dabigatran capsules

Dabigatran capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Other appropriate dose form such as coated granules are available for the treatment of children below 12 years as soon as they are able to swallow soft food.

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

Take Dabigatran capsules as recommended for the following conditions:

Prevention of blood clot formation after knee or hip replacement surgery

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

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

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

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 75mg Dabigatran capsules 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 capsules 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 capsules 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 heartbeats 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 300mg taken as one 150mg capsule twice a day.

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

If you are taking verapamil containing medicines, you should be treated with a reduced Dabigatran capsules dose of 220mg taken as one 110mg 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 Dabigatran capsules 220mg taken as one 110mg capsule twice a day.

You can continue to take this medicine if your heartbeat needs to be restored to normal by a procedure called cardioversion. Take Dabigatran capsules as your physician 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 capsules after your physician has decided that normal control of blood coagulation is achieved. Take Dabigatran capsules as your physician has told you.

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

Dabigatran capsules 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 capsules doses in milligrams (mg). The doses depends on weight in kilograms (kg) and age in years of the patient:

Table 1: Dosing table for Dabigatran capsules

Single doses requiring combinations of more than one capsule:

300mg: two 150mg capsules or four 75mg capsules

260mg: one 110mg plus one 150mg capsule or one 110mg plus two 75mg capsules 220mg: two 110mg capsules

185mg: one 75mg plus one 110mg capsule

150mg: one 150mg capsule or two 75mg capsules

How to take Dabigatran capsules

Dabigatran capsules 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.

Puncture the blister cavity from the printed foil side and push the capsule out from the multilayered base foil (plain side).

Change of anticoagulant treatment

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

If you take more Dabigatran capsules 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 capsules

Prevention of blood clot formation after knee or hip replacement surgery

Continue with your remaining daily doses of Dabigatran capsules 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 heartbeats 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.

If you stop taking Dabigatran capsules

Take Dabigatran capsules 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 capsules.

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 capsules affect 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.

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

Prevention of blood clot formation after knee or hip replacement surgery

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 1000 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
• decreases in the number or even lack of white blood cells (which help to fight infections)
• hair loss.

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heartbeats

Common (may affect up to 1 in 10 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), or under the skin
• a fall in the number of red cells in the blood
• belly ache or stomach ache
• indigestion
• frequent loose or liquid bowel movements
• feeling sick.

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

• bleeding
• bleeding may happen from piles, from the rectum, or in the brain
• haematoma formation
• coughing of blood or blood-stained sputum
• a fall in the number of platelets in the blood
• a fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
• 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
• vomiting
• difficulty in swallowing
• unusual laboratory test results on liver function.

Rare (may affect up to 1 in 1000 people):

• bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry of an injection or from the site of entry of a catheter into a vein
• 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
• a decrease in the proportion of blood cells
• liver enzymes increased
• 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):

• difficulty in breathing or wheezing
• decreases in the number or even lack of white blood cells (which help to fight infections)
• hair loss.

In a clinical trial the rate of heart attacks with Dabigatran capsules was numerically higher than with warfarin. The overall occurence was low.

Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs

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

• bleeding may happen from the nose, into the stomach or bowel, 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
• indigestion.

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

• bleeding
• bleeding may happen into a joint or from an injury
• bleeding may happen from piles
• a fall in the number of red cells in the blood
• haematoma formation
• coughing of blood or blood-stained sputum
• 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
• feeling sick
• vomiting
• belly ache or stomach ache
• frequent loose or liquid bowel movements
• unusual laboratory test results on liver function
• liver enzymes increased.

Rare (may affect up to 1 in 1000 people):

• bleeding may happen, 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 or from the brain
• a fall in the number of platelets in the blood
• 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

• difficulty in swallowing.

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

  • difficulty in breathing or wheezing
  • 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
  • decreases in the number or even lack of white blood cells (which help to fight infections)
  • yellowing of the skin or whites of the eyes, caused by liver or blood problems
  • hair loss.

In the trial program the rate of heart attacks with Dabigatran capsules was higher than with warfarin. The overall occurence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran versus patients treated with placebo.

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 juice 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 stomach ache
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.

5. How to store Dabigatran capsules

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 and bottle after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C.

After first opening, bottle may be used for up to 60 days.

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 capsules contain

• The active substance is dabigatran. Each hard capsule contains 110mg dabigatran etexilate (as mesilate)
• The other ingredients are tartaric acid (E334), hypromellose (E464), talc (E553b), hydroxypropylcellulose (E463), croscarmellose sodium (E468) and magnesium stearate (E572) (see section 2 “Dabigatran capsules contain sodium”)
• The capsule shell contains titanium dioxide (E171), and hypromellose (E464)
• The black printing ink contains shellac (E904), propylene glycol (E1520), iron oxide black (E172) and potassium hydroxide (E525).

What Dabigatran capsules look like and contents of the pack

Dabigatran etexilate 110mg hard capsules are size “1” (approx. 19 x 7mm) capsules with a white opaque cap imprinted “MD” and white opaque body imprinted “110” with black ink, containing a blend of white to light yellow coloured pellets and light yellow coloured granulate.

Dabigatran etexilate 110mg hard capsules are available in OPA/Alu/desiccant PE-PET/Alu/PE perforated blisters containing 10, 30, 60, 100 and 180 capsules in a carton.

Dabigatran etexilate 110mg hard capsules are available in OPA/Alu/desiccant PE-PET/Alu/PE perforated unit dose blisters containing 10x1, 30x1, 60x1, 100x1 and 180x1 capsules in a carton.

Dabigatran etexilate 110mg hard capsules are available in polypropylene bottles with child resistant closure containing 60 capsules in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF

United Kingdom

Manufacturers

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Accord-UK Ltd

Whiddon Valley

Barnstaple

Devon

EX32 8NS

This leaflet was last revised in Jun 2024.

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