Dabikaste

Italy
Brand name Dabikaste
Form capsules, hard gelatin
Active substance / Dosage
DABIGATRAN ETExILATE MESYLATE
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AE07
Registration number 049846
Manufacturer GLENMARK ARZNEIMITTEL GMBH

Table of Contents

Package leaflet: Information for the user

Dabikaste 75 mg hard capsules

dabigatran etexilate
equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Dabikaste is and what it is used for
  2. What you need to know before taking Dabikaste
  3. How to take Dabikaste
  4. Possible side effects
  5. How to store Dabikaste
  6. Contents of the pack and other information

1. What Dabikaste is and what it is used for

Dabikaste contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body that is involved in blood clot formation.
Dabikaste is used in adults to:

  • prevent the formation of blood clots in the veins following surgery to replace the knee or hip.

Dabikaste is used in children to:

  • treat blood clots and prevent the formation of new blood clots.

2. What you should know before taking Dabikaste

Do not take Dabikaste

  • if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
  • if your kidney function is severely reduced.
  • if you are currently experiencing bleeding.
  • if you have an injury to an organ that increases the risk of severe bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery on the brain or eyes).
  • if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
  • if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal through a procedure called catheter ablation for atrial fibrillation.
  • if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
  • if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
  • if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
  • if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
  • if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
  • if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabikaste. You may also need to consult your doctor during treatment with Dabikaste if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially one of the following:

  • if you are at increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone surgical removal of tissue (biopsy) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux disease (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabikaste” below.
  • if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult and weigh 50 kg or less.
  • for use in children only: 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 of having a heart attack.
  • if you have liver disease associated with abnormal blood test results. In this case, the use of Dabikaste is not recommended.

Take special care with Dabikaste

  • if you are scheduled for surgery: In this case, Dabikaste will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabikaste exactly at the times instructed by your doctor, both before and after surgery.

  • if a procedure involves the placement of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):

  • It is very important to take Dabikaste exactly at the times instructed by your doctor, both before and after the procedure.

  • contact your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be required.

  • if you fall or injure yourself during treatment, especially if you receive a blow to the head. Seek immediate medical attention. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.

  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

Other medicines and Dabikaste
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabikaste if you are taking any of the following medicines:

  • Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
  • Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
  • Medicines to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor will instruct you to use a reduced dose of Dabikaste. See also section 3.
  • Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
  • A combination product containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
  • Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
  • St. John’s wort, a herbal medicine used to treat depression
  • Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
  • Rifampicin or clarithromycin (two antibiotics)
  • Antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • Medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabikaste during pregnancy and on the unborn baby are unknown. You must not take Dabikaste during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabikaste.
You must not breastfeed during treatment with Dabikaste.

Driving and using machines
Dabikaste has no known effect on the ability to drive or operate machinery.

Dabikaste contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Dabikaste

Dabikaste can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Take Dabikaste as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabikaste of 75 mg, as the risk of bleeding may increase.

For both surgeries, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
Begin treatment with Dabikaste within 1–4 hours after completion of the surgical procedure, taking a single capsule. Afterwards, take 2 capsules once daily for a total of 10 days.

After hip replacement surgery
Begin treatment with Dabikaste within 1–4 hours after completion of the surgical procedure, taking a single capsule. Afterwards, take 2 capsules once daily for a total of 28–35 days.

Treatment of blood clots and prevention of recurrence of blood clots in children
Dabikaste should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient’s age and weight. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Single dose of Dabikaste in milligrams (mg) according to patient weight in kilograms (kg) and age in years, to be administered twice daily:

Age in years
300 mg
two capsules of 150 mg
or
four capsules of 75 mg
260 mg
one capsule of 110 mg plus one of 150 mg
or
one capsule of 110 mg plus two of 75 mg
220 mg
Weight [kg]
two capsules of 110 mg
185 mg
one capsule of 75 mg plus one of 110 mg
150 mg
one capsule of 150 mg
or
two capsules of 75 mg
One capsule of 110 mg
One
capsule
of 75 mg
Indicates that dosing recommendations cannot be made.

How to take Dabikaste
Dabikaste capsules may be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening blister packs
The following images illustrate how to remove Dabikaste capsules from the blister

Numbered diagram showing a gray sheet divided by dashed lines being folded toward the

Separate one unit from the entire blister along the perforated line

Diagram with a black arrow pointing toward the

Lift the aluminum foil on the back and remove the capsule.

  • Do not push the capsules through the aluminum foil of the blister.
  • The aluminum foil of the blister should only be lifted when a capsule needs to be removed

Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabikaste than you should
Taking too much Dabikaste increases the risk of bleeding. Contact your doctor immediately if you have taken too many Dabikaste capsules. Specific treatment options are available.

If you forget to take Dabikaste

Prevention of blood clots after knee or hip replacement surgery
It is recommended to continue with the remaining daily doses of Dabikaste at the usual time the following day. Do not take a double dose to make up for a missed dose.

Treatment of blood clots and prevention of recurrence of blood clots in children
The missed dose may still be taken if there are at least 6 hours before the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.

If you stop taking Dabikaste
Take Dabikaste exactly as prescribed. Do not stop taking Dabikaste without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabikaste.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dabikaste acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.

The possible side effects are listed below, grouped according to the frequency with which they occur.

Prevention of blood clots after knee or hip replacement surgery

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

  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Abnormal liver function test results

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

  • Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or following a wound, after surgery
  • Formation of a haematoma or haematoma occurring after surgery
  • Presence of blood in the stool, detected by laboratory testing
  • Decrease in the number of red blood cells in the blood
  • Decrease in the proportion of blood cells
  • Allergic reaction
  • Vomiting
  • Frequent diarrhoea with unformed or liquid stools
  • Feeling unwell
  • Wound discharge (leakage of fluid from the surgical wound)
  • Increased liver enzymes
  • 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 that may occur in the brain, from a surgical incision, injection site or catheter insertion site in a vein
  • Blood-stained discharge from the intravenous catheter insertion site
  • Coughing up blood or blood-stained sputum
  • Decrease in the number of platelets in the blood
  • Decrease in the number of red blood cells in the blood after surgery
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Inflammation of the oesophagus and stomach
  • Reflux of gastric juices into the oesophagus
  • Abdominal or stomach pain
  • Indigestion
  • Difficulty swallowing
  • Fluid leaking from a wound
  • Fluid leaking from a wound after surgery

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

  • Difficulty in breathing or wheezing
  • Decrease in the number or even absence of white blood cells (which help fight infections)
  • Hair loss

Treatment of blood clots and prevention of new blood clots in children

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

  • Decrease in the number of red blood cells in the blood
  • Decrease in the number of platelets in the blood
  • Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Formation of a haematoma
  • Nosebleed
  • Reflux of gastric juices into the oesophagus
  • Vomiting
  • Feeling unwell
  • Diarrhoea with unformed or liquid stools
  • Indigestion
  • Hair loss
  • Increased liver enzymes

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

  • Decrease in the number of white blood cells (which help fight infections)
  • Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Decrease in the proportion of blood cells
  • Itching
  • Coughing up blood or blood-stained sputum
  • Abdominal or stomach pain
  • Inflammation of the oesophagus and stomach
  • Allergic reaction
  • Difficulty 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):

  • Absence of white blood cells (which help fight infections)
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Difficulty in breathing or wheezing
  • Bleeding
  • Bleeding that may occur in a joint or from a wound, surgical incision, injection site or catheter insertion site in a vein
  • Bleeding from haemorrhoids
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabikaste

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box or blister after Exp. The expiry date refers to the last day of that month.
Blister: This medicine does not require any special storage conditions. Do not place the capsules in pill boxes or dispensers unless they can be stored in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information What Dabikaste contains

  • The active substance is dabigatran, which may be administered in the form of dabigatran etexilate (as mesilate) 75 mg.
  • The other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid granules, hydroxypropylcellulose, mannitol, talc and magnesium stearate.
  • The capsule shell contains iron oxide red (E-172), titanium dioxide (E-171) and hypromellose.
  • The printing ink contains shellac, propylene glycol, strong ammonia solution, iron oxide black (E-172) and potassium hydroxide.

Description of the appearance of Dabikaste and pack sizes
Dabikaste 75 mg hard capsules
Dabikaste 75 mg hard capsules are opaque pink capsules with "DA75" printed on them.
Dabikaste 75 mg hard capsules are available in packs containing 10, 30 or 60 capsules in aluminium blisters, divisible into single doses, with desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany

Manufacturer
TOWA Pharmaceutical Europe, S.L., C/ de Sant Martí, 75-97, 08107, Martorelles, Barcelona, Spain
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park Paola, PLA3000, Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Dabikaste 75 mg, cápsulas
Italy: Dabikaste 75 mg hard capsules

Package leaflet: Information for the user

Dabikaste 110 mg hard capsules

dabigatran etexilate
equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Dabikaste is and what it is used for
  2. What you need to know before taking Dabikaste
  3. How to take Dabikaste
  4. Possible side effects
  5. How to store Dabikaste
  6. Contents of the pack and other information

1. What Dabikaste is and what it is used for

Dabikaste contains the active substance dabigatran etexilate and belongs to a group of medicines known as anticoagulants. It blocks the action of a substance in the body involved in blood clot formation.
Dabikaste is used in adults for:

  • preventing the formation of blood clots in the veins following surgery to replace the knee or hip.
  • preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
  • treating blood clots in the veins of the legs and lungs and preventing blood clots from recurring in the veins of the legs and lungs.

Dabikaste is used in children for:

  • treating blood clots and preventing the formation of new blood clots.

2. What you should know before taking Dabikaste

Do not take Dabikaste

  • if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
  • if your kidney function is severely reduced.
  • if you are currently experiencing active bleeding.
  • if you have an organ lesion that increases the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent surgery on the brain or eyes).
  • if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
  • if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal via a procedure called catheter ablation for atrial fibrillation.
  • if you have severely reduced liver function or a liver disease that could potentially lead to death.
  • if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
  • if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
  • if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
  • if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
  • if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabikaste. You may also need to consult your doctor during treatment with Dabikaste if you develop symptoms or if you are scheduled for surgery.
Inform your doctor if you have or have had any medical condition or illness, especially any of the following:

  • if you have an increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you underwent surgical removal of tissue (biopsy) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgical intervention).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabikaste” below.
  • if you are taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use 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 of having a heart attack.
  • if you have liver disease associated with abnormal blood test results. In this case, the use of Dabikaste is not recommended.

Take special care with Dabikaste

  • if you are scheduled for surgery:

In this case, Dabikaste will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabikaste exactly at the times instructed by your doctor, both before and after surgery.

  • if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
  • It is very important to take Dabikaste exactly at the times instructed by your doctor, both before and after the procedure.
  • inform your doctor immediately if you experience numbness or weakness in the legs, or bowel or bladder problems after the anaesthesia wears off, as urgent medical treatment may be required.
  • if you fall or injure yourself during treatment, especially if you receive a blow to the head. Seek immediate medical attention. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabikaste
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabikaste if you are taking any of the following medicines:

  • Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
  • Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
  • Medicines to treat irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may instruct you to take a reduced dose of Dabikaste depending on the condition for which Dabikaste has been prescribed. See section 3.
  • Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
  • A combination product containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
  • Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
  • St. John’s wort, a herbal remedy used for depression
  • Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
  • Rifampicin or clarithromycin (two antibiotics)
  • Antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabikaste during pregnancy and on the fetus are unknown. You must not take Dabikaste during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you must avoid pregnancy during treatment with Dabikaste.
You must not breastfeed during treatment with Dabikaste 110 mg hard capsules.

Driving and using machines
Dabikaste has no known effect on the ability to drive or operate machinery.

Dabikaste contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dabikaste

Dabikaste capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

Take Dabikaste as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Dabikaste of 75 mg, because the risk of bleeding may increase.

For both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
Begin treatment with Dabikaste within 1–4 hours after completion of surgery, taking one single capsule. Then take two capsules once daily for a total of 10 days.

After hip replacement surgery
Begin treatment with Dabikaste within 1–4 hours after completion of surgery, taking one single capsule. Then take two capsules once daily for a total of 28–35 days.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg of Dabikaste taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabikaste of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg of Dabikaste taken as one 110 mg capsule twice daily.

You may continue taking Dabikaste if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabikaste as directed by your doctor.

If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabikaste after your doctor has determined that normal blood clotting control has been achieved. Take Dabikaste as directed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children
Dabikaste should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's age and weight. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you otherwise.

Single dose of Dabikaste in milligrams (mg) according to patient weight in kilograms (kg) and age, to be administered twice daily:

Age in years
300 mg
two 150 mg capsules
or
four 75 mg capsules
260 mg
one 110 mg capsule plus one 150 mg capsule
or
one 110 mg capsule plus two 75 mg capsules
220 mg
Weight [kg]
two 110 mg capsules
185 mg
one 75 mg capsule plus one 110 mg capsule
150 mg
one 150 mg capsule
or
two 75 mg capsules
One 110 mg capsule
One
capsule
of 75 mg
Indicates that dosing recommendations cannot be formulated.

How to take Dabikaste
Dabikaste capsules can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening blister packs
The following images illustrate how to remove Dabikaste capsules from the blister

Numbered diagram showing a gray sheet divided by dashed lines being opened toward the

Separate one unit of the blister from the entire blister along the perforated line

Numbered diagram showing a black arrow directed toward the

Lift the aluminium foil on the back and remove the capsule.

  • Do not push the capsules through the aluminium foil of the blister.
  • The aluminium foil of the blister should be lifted only when a capsule needs to be removed.

Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabikaste than you should
Taking too much Dabikaste increases the risk of bleeding. Contact your doctor immediately if you have taken too many Dabikaste capsules. Specific treatment options are available.

If you forget to take Dabikaste
Prevention of blood clots after knee or hip replacement surgery
It is recommended to continue with the remaining daily doses of Dabikaste at the usual time the next day. Do not take a double dose to make up for the missed dose.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs
Treatment of blood clots and prevention of recurrence of blood clots in children
The missed dose may still be taken if it is at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not take a double dose to make up for the missed dose.

If you stop taking Dabikaste
Take Dabikaste exactly as prescribed. Do not stop taking Dabikaste without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabikaste.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dabikaste acts on the blood coagulation system; therefore, most of the side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.

The possible side effects are listed below, grouped according to their frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Abnormal liver function test results

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

  • Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
  • Haematoma formation or haematoma occurring after surgery
  • Presence of blood in the stool, detected by laboratory testing
  • Decrease in the number of red blood cells in the blood
  • Decrease in the proportion of blood cells
  • Allergic reaction
  • Vomiting
  • Diarrhoea with loose or watery stools
  • Feeling unwell
  • Wound secretion (oozing of fluid from the surgical wound)
  • Increased liver enzymes
  • Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

  • Bleeding
  • Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the catheter insertion site into a vein
  • Blood-stained discharge from the venous catheter insertion site
  • Coughing up blood or blood-stained sputum
  • Decrease in the number of platelets in the blood
  • Decrease in the number of red blood cells in the blood after surgery
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Prominent skin rash with red, swollen, itchy nodules due to an allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Inflammation of the oesophagus and stomach
  • Reflux of gastric juices into the oesophagus
  • Abdominal or stomach pain
  • Indigestion
  • Difficulty swallowing
  • Fluid leaking from a wound
  • Fluid leaking from a wound after surgery

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

  • Difficulty in breathing or wheezing
  • Decrease in number or even absence of white blood cells (which help fight infections)
  • Hair loss

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots arising from irregular heartbeat
Common (may affect up to 1 in 10 people):

  • Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
  • Decrease in the number of red blood cells in the blood
  • Abdominal or stomach pain
  • Indigestion
  • Diarrhoea with loose or watery stools
  • Feeling unwell

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

  • Bleeding
  • Bleeding that may occur from haemorrhoids, rectum or brain
  • Haematoma formation
  • Coughing up blood or blood-stained sputum
  • Decrease in the number of platelets in the blood
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Inflammation of the oesophagus and stomach
  • Reflux of gastric juices into the oesophagus
  • Vomiting
  • Difficulty swallowing
  • Abnormal liver function test results

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

  • Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the catheter insertion site into a vein
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Prominent skin rash with red, swollen, itchy nodules due to an allergic reaction
  • Decrease in the proportion of blood cells
  • Increased liver enzymes
  • Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

  • Difficulty in breathing or wheezing
  • Decrease in number or even absence of white blood cells (which help fight infections)
  • Hair loss

In a clinical study, the rate of heart attacks was higher with Dabikaste than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

  • Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red) or under the skin
  • Indigestion

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

  • Bleeding
  • Bleeding that may occur in a joint or from a wound
  • Bleeding that may occur from haemorrhoids
  • Decrease in the number of red blood cells in the blood
  • Haematoma formation
  • Coughing up blood or blood-stained sputum
  • Allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer
  • Inflammation of the oesophagus and stomach
  • Reflux of gastric juices into the oesophagus
  • Feeling unwell
  • Vomiting
  • Abdominal or stomach pain
  • Diarrhoea with loose or watery stools
  • Abnormal liver function test results
  • Increased liver enzymes

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

  • Bleeding that may occur from a surgical incision, injection site, catheter insertion site into a vein, or brain
  • Decrease in the number of platelets in the blood
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Prominent skin rash with red, swollen, itchy nodules due to an allergic reaction
  • Difficulty swallowing

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

  • Difficulty in breathing or wheezing
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Decrease in the proportion of blood cells
  • Decrease in number or even absence of white blood cells (which help fight infections)
  • Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
  • Hair loss

In the clinical study programme, the rate of heart attacks was higher with Dabikaste than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

  • Decrease in the number of red blood cells in the blood
  • Decrease in the number of platelets in the blood
  • Prominent skin rash with red, swollen, itchy nodules due to an allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Haematoma formation
  • Nosebleeds
  • Reflux of gastric juices into the oesophagus
  • Vomiting
  • Feeling unwell
  • Diarrhoea with loose or watery stools
  • Indigestion
  • Hair loss
  • Increased liver enzymes

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

  • Decrease in the number of white blood cells (which help fight infections)
  • Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red) or under the skin
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Decrease in the proportion of blood cells
  • Itching
  • Coughing up blood or blood-stained sputum
  • Abdominal or stomach pain
  • Inflammation of the oesophagus and stomach
  • Allergic reaction
  • Difficulty swallowing
  • Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

  • Absence of white blood cells (which help fight infections)
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Difficulty in breathing or wheezing
  • Bleeding
  • Bleeding that may occur in a joint or from a wound, surgical incision, injection site or catheter insertion site into a vein
  • Bleeding that may occur from haemorrhoids
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabikaste

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 box or blister pack after Exp. The
expiry date refers to the last day of that month.
Blister packs: This medicine does not require any special storage conditions. Do not put the
capsules into pill organisers or dispensers unless they can be stored in the original
packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information What Dabikaste contains

  • The active substance is dabigatran, which may be administered in the form of dabigatran etexilate (as mesilate) 10 mg.
  • The other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid granules, hydroxypropylcellulose, mannitol, talc and magnesium stearate.
  • The capsule shell contains iron oxide red (E-172), titanium dioxide (E-171) and hypromellose.
  • The printing ink black contains shellac, propylene glycol, strong ammonia solution, iron oxide black (E-172) and potassium hydroxide.

Description of the appearance of Dabikaste and contents of the pack
Dabikaste 110 mg hard capsules
Dabikaste 110 mg hard capsules are opaque pink capsules with "DA110" printed on them.
Dabikaste 110 mg hard capsules are available in packs containing 10, 30, 60 hard capsules, a multiple pack containing 3 packs of 60 hard capsules (180 hard capsules) and a multiple pack containing 2 packs of 50 hard capsules (100 hard capsules), in aluminium blisters divisible for single dose with desiccant.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany
Manufacturer
TOWA Pharmaceutical Europe, S.L., C/ de Sant Martí, 75-97, 08107, Martorelles, Barcelona, Spain
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park Paola, PLA3000, Malta
This medicinal product is authorized in the European Economic Area countries under the following
names:
Portugal: Dabikaste 110 mg, cápsulas
Italy: Dabikaste 110 mg hard capsules

Package leaflet: Information for the user

Dabikaste 150 mg hard capsules

dabigatran etexilate
equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Dabikaste is and what it is used for
  2. What you need to know before taking Dabikaste
  3. How to take Dabikaste
  4. Possible side effects
  5. How to store Dabikaste
  6. Contents of the pack and other information

1. What Dabikaste is and what it is used for

Dabikaste contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It blocks the action of a substance in the body that is involved in blood clot formation.

Dabikaste is used in adults to:

  • prevent blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one other risk factor.
  • treat blood clots in the veins of the legs and lungs, and to prevent blood clots from forming again in the veins of the legs and lungs.

Dabikaste is used in children to:

  • treat blood clots and prevent new blood clots from forming.

2. What you need to know before taking Dabikaste

Do not take Dabikaste

  • if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
  • if your kidney function is severely reduced.
  • if you are currently experiencing bleeding.
  • if you have an organ injury that increases the risk of severe bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent brain or eye surgery).
  • if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
  • if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal through a procedure called trans-catheter ablation for atrial fibrillation.
  • if you have severely reduced liver function or a liver disease that could potentially lead to death.
  • if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
  • if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
  • if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
  • if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
  • if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabikaste. You may also need to consult your doctor during treatment with Dabikaste if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially any of the following:

  • if you have an increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone surgical removal of tissue (biopsy) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you suffer from inflammation of the oesophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabikaste” below.
  • if you are taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an infection around or within the brain.
  • if you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.
  • if you have liver disease associated with abnormal blood test results. In this case, the use of Dabikaste is not recommended.

Take special care with Dabikaste

  • if you are scheduled for surgery:

In this case, Dabikaste will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabikaste exactly at the time instructed by your doctor, both before and after surgery.

  • if a procedure involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
  • It is very important to take Dabikaste exactly at the time instructed by your doctor, both before and after the procedure.
  • inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be required.
  • if you fall or injure yourself during treatment, especially if you receive a blow to the head. Seek immediate medical attention. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabikaste
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabikaste if you are taking any of the following medicines:

  • Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
  • Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
  • Medicines to treat abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of Dabikaste. See section 3.
  • Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
  • A combination product containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
  • Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
  • St. John’s wort, a herbal medicine used to treat depression
  • Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
  • Rifampicin or clarithromycin (two antibiotics)
  • Antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabikaste during pregnancy and on the foetus are unknown. You must not take Dabikaste if you are pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabikaste.
You must not breastfeed during treatment with Dabikaste.
Driving and using machines
Dabikaste has no known effects on the ability to drive or operate machinery.
Dabikaste contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dabikaste

Dabikaste capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Take Dabikaste as recommended for the following conditions:
Prevention of blockage in blood vessels of the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.

The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabikaste of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg of Dabikaste taken as one 110 mg capsule twice daily.

You may continue taking Dabikaste if your heart rhythm needs to be restored to normal through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take Dabikaste as instructed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabikaste after your doctor has determined that normal control of blood clotting has been achieved. Take Dabikaste as instructed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children
Dabikaste should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's age and weight. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Single dose of Dabikaste in milligrams (mg) according to patient weight in kilograms (kg) and age in years, to be administered twice daily:

Age in years
300 mg
two 150 mg capsules
or
four 75 mg capsules
260 mg
one 110 mg capsule plus one 150 mg capsule
or
one 110 mg capsule plus two 75 mg capsules
220 mg
Weight [kg]
two 110 mg capsules
185 mg
one 75 mg capsule plus one 110 mg capsule
150 mg
one 150 mg capsule
or
two 75 mg capsules
One 110 mg capsule
One
capsule
from
75 mg
Means that dosing recommendations cannot be formulated.

How to take Dabikaste
Dabikaste capsules may be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening blister packs
The following images illustrate how to remove Dabikaste capsules from the blister

Numbered diagram showing a gray sheet divided by dashed lines being folded toward the

Separate one unit from the entire blister along the perforated line

Numbered diagram with number 2 showing a black arrow directed toward the

Lift the aluminium foil on the back and remove the capsule.

  • Do not push the capsules through the aluminium foil of the blister.
  • The aluminium foil of the blister should only be lifted when a capsule needs to be removed.

Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabikaste than you should
Taking too much Dabikaste increases the risk of bleeding. Contact your doctor immediately if you have taken too many Dabikaste capsules. Specific treatment options are available.

If you forget to take Dabikaste
The missed dose can still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

If you stop taking Dabikaste
Take Dabikaste exactly as prescribed. Do not stop taking Dabikaste without first talking to your doctor, because the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking Dabikaste.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabikaste acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots arising from irregular heartbeat

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

  • Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
  • Decrease in the number of red blood cells in the blood
  • Abdominal or stomach pain
  • Indigestion
  • Frequent diarrhoea with unformed or liquid stools
  • Feeling unwell

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

  • Bleeding
  • Bleeding that may occur from haemorrhoids, rectum, or in the brain
  • Formation of haematoma
  • Coughing up blood or blood-stained sputum
  • Decrease in the number of platelets in the blood
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Allergic reactions
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Inflammation of the oesophagus and stomach
  • Gastric acid reflux into the oesophagus
  • Vomiting
  • Difficulty swallowing
  • Abnormal liver function test results

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

  • Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
  • Decrease in the proportion of blood cells
  • Increased liver enzymes
  • Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

  • Difficulty breathing or wheezing
  • Decrease in the number or even absence of white blood cells (which help fight infections)
  • Hair loss

In a clinical study, the rate of heart attacks was higher with Dabikaste than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of re-formation of blood clots in the veins of the legs and/or lungs

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

  • Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
  • Indigestion

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

  • Bleeding
  • Bleeding that may occur in a joint or from a wound
  • Bleeding that may occur from haemorrhoids
  • Decrease in the number of red blood cells in the blood
  • Formation of haematoma
  • Coughing up blood or blood-stained sputum
  • Allergic reactions
  • Sudden skin changes altering its colour and appearance
  • Itching
  • Stomach or intestinal ulcer
  • Inflammation of the oesophagus and stomach
  • Gastric acid reflux into the oesophagus
  • Feeling unwell
  • Vomiting
  • Abdominal or stomach pain
  • Diarrhoea with unformed or liquid stools
  • Abnormal liver function test results
  • Increased liver enzymes

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

  • Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or in the brain
  • Decrease in the number of platelets in the blood
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
  • Difficulty swallowing

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

  • Difficulty breathing or wheezing
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Decrease in the number of blood cells
  • Decrease in the number or even absence of white blood cells (which help fight infections)
  • Yellowing of the skin or whites of the eyes, caused by liver or blood problems
  • Hair loss

In the clinical study programme, the rate of heart attacks was higher with Dabikaste than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of re-formation of blood clots in children

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

  • Decrease in the number of red blood cells in the blood
  • Decrease in the number of platelets in the blood
  • Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
  • Sudden skin changes altering its colour and appearance
  • Formation of haematoma
  • Nosebleeds
  • Gastric acid reflux into the oesophagus
  • Vomiting
  • Feeling unwell
  • Diarrhoea with unformed or liquid stools
  • Indigestion
  • Hair loss
  • Increased liver enzymes

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

  • Decrease in the number of white blood cells (which help fight infections)
  • Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
  • Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
  • Decrease in the proportion of blood cells
  • Itching
  • Coughing up blood or blood-stained sputum
  • Abdominal or stomach pain
  • Inflammation of the oesophagus and stomach
  • Allergic reactions
  • Difficulty swallowing
  • Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

  • Absence of white blood cells (which help fight infections)
  • Severe allergic reaction causing difficulty in breathing or dizziness
  • Severe allergic reaction causing swelling of the face or throat
  • Difficulty breathing or wheezing
  • Bleeding
  • Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
  • Bleeding that may occur from haemorrhoids
  • Stomach or intestinal ulcer (including oesophageal ulcer)
  • Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabikaste

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box or blister pack after "Exp." The expiry date refers to the last day of that month.
Blister packs: This medicine does not require any special storage conditions. Do not place the capsules in pill organisers or dispensers unless they can be stored in the original packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information What Dabikaste contains

  • The active substance is dabigatran, which may be administered in the form of dabigatran etexilate (as mesilate) 150 mg.
  • The other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid granules, hydroxypropylcellulose, mannitol, talc and magnesium stearate.
  • The capsule shell contains red iron oxide (E-172), titanium dioxide (E-171) and hypromellose.
  • The printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide (E-172) and potassium hydroxide.

Description of the appearance of Dabikaste and contents of the pack
Dabikaste 150 mg hard capsules
Dabikaste 150 mg hard capsules are opaque pink capsules with the imprint “DA150”.
Dabikaste 150 mg hard capsules are available in packs containing 10, 30, 60 hard capsules, a multiple pack containing 3 packs of 60 hard capsules (180 hard capsules), and a multiple pack containing 2 packs of 50 hard capsules (100 hard capsules), in aluminium blisters divisible into unit doses with desiccant.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany

Manufacturer
TOWA Pharmaceutical Europe, S.L., C/ de Sant Martí, 75-97, 08107, Martorelles, Barcelona, Spain
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA3000, Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Dabikaste 150 mg, cápsulas
Italy: Dabikaste 150 mg capsule rigide