Abagat

Leaflet accompanying the packaging: patient information

ABAGAT, 150 mg, hard capsules

Dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is ABAGAT and what is it used for

ABAGAT contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body responsible for the formation of blood clots.
ABAGAT is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not associated with a valve defect and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

ABAGAT is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking ABAGAT

When not to take ABAGAT

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney impairment.
• if the patient is currently bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

if the patient has severe liver impairment or liver disease that may lead to death.

• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if the patient has been implanted with an artificial heart valve that requires continuous anticoagulation therapy.

Warnings and precautions

Before starting ABAGAT, discuss it with your doctor. If symptoms occurred during treatment with this medicine or the patient underwent surgery, consult a doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding.
• if the patient has undergone surgical biopsy within the last month.
• if the patient has had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See "ABAGAT and other medicines" below.
• if the patient is taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if the patient has infective endocarditis (bacterial infection of the heart).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing less urine).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a history of myocardial infarction or if the patient has been diagnosed with conditions that increase the risk of myocardial infarction.
• if the patient has liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful when taking ABAGAT

If the patient needs to undergo surgery:

• in this case, it is necessary to discontinue ABAGAT temporarily, due to the increased risk of bleeding during and after surgery. It is very important to take ABAGAT before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal anesthesia or to reduce pain):
• it is very important to take ABAGAT before and after surgery exactly as the doctor has instructed, at the times specified by the doctor.
• the doctor should be informed immediately if the patient experiences numbness or weakness in the lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. Medical attention should be sought immediately. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

ABAGAT and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
In particular, before taking ABAGAT, tell your doctor if the patient is taking any of the following
medicines:

• Anticoagulant medicines (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban).
• Anti-inflammatory and pain-relieving medicines (e.g. aspirin).
• St. John's Wort, a herbal medicine used to treat depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin, both antibiotics.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil) In patients taking verapamil-containing medicines, the dose of ABAGAT should be reduced to 220 mg taken as one 110 mg capsule twice daily, due to the increased risk of bleeding. ABAGAT and verapamil-containing medicines should be taken at the same time.
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole), unless these medicines are used only on the skin.
• Medicines used to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of ABAGAT on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy, unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking ABAGAT.
During treatment with ABAGAT, breastfeeding should be avoided.

Driving and using machines

ABAGAT has no or negligible influence on the ability to drive and use machines.

3. How to take ABAGAT

ABAGAT capsules can be used in adults and children aged 8 years or older who can swallow capsules whole. There are other age-appropriate pharmaceutical forms for the treatment of children under 8 years of age.
This medicine should always be taken exactly as the doctor has instructed. If in doubt, consult a doctor.

ABAGAT should be taken as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heart rhythm, and treatment of blood clots in the veins of the legs and lungs, and 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.
In patients aged 80 years or olderthe recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking verapamil-containing medicinesshould receive a reduced dose of ABAGAT of 220 mg taken as one 110 mg capsule twice daily, due to the possible increased risk of bleeding.
In patients with potentially increased risk of bleedingthe doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation. ABAGAT should be taken as instructed by the doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive ABAGAT treatment, after the doctor has confirmed that adequate blood clotting control has been achieved. ABAGAT should be taken as instructed by the doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
ABAGAT should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on the age and weight of the child. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor instructs to stop taking any of them.
A single dose of ABAGAT, to be administered twice daily, in milligrams (mg) based on the patient's weight in kilograms (kg) and age in years:

Table 1. ABAGAT dosing

Single dose requiring combination of more than one capsule

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: 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

How to take ABAGAT

ABAGAT can be taken with or without food. The capsules should be swallowed whole, with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed, or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

Do not change anticoagulant medicine without receiving detailed instructions from a doctor.

Taking a higher dose of ABAGAT than recommended

Taking too much of this medicine increases the risk of bleeding. If the patient has taken too many capsules, they should contact a doctor immediately. Specific treatments are available.

Stopping ABAGAT treatment

ABAGAT should be taken as instructed by the doctor. The patient should not stop taking this medicine without consulting a doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. The patient should contact a doctor if they experience nausea after taking ABAGAT.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, ABAGAT can cause side effects, although not everybody gets them.
ABAGAT affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Severe or massive bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location. In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop by itself, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), the patient should contact a doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
In case of a severe allergic reaction that may cause difficulty breathing or dizziness, the patient should contact a doctor immediately.
Possible side effects are listed below by frequency:

• Frequent (may affect up to 1 in 10 people):
• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Nausea
• Diarrhea
• Vomiting

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

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into a joint, due to injury, from a surgical wound, from an injection site, or from a catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Decreased white blood cell count
• Increased liver enzyme activity
• Jaundice or yellowing of the skin or eyes due to liver or blood disease

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

• Difficulty breathing or wheezing
• Decreased white blood cell count (which help fight infections)
• Hair loss

In clinical trials, the number of myocardial infarctions in patients taking ABAGAT was higher than in patients taking warfarin. The overall number of events was small.
Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Nausea

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

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematoma formation
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Abdominal pain or stomach pain
• Diarrhea
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical wound, from an injection site, or from a catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which help fight infections)
• Jaundice or yellowing of the skin or eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of myocardial infarctions in patients taking ABAGAT was higher than in patients taking warfarin. The overall number of events was low. No difference in the number of myocardial infarctions was observed in patients treated with dabigatran compared to patients who received placebo.
Treatment of blood clots and prevention of recurrence of blood clots in children
Frequent (may affect up to 1 in 10 people):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Hematoma formation
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Diarrhea
• Nausea
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing of the skin or eyes due to liver or blood disease

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store ABAGAT

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ABAGAT contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350 cS, talc, and hydroxypropylcellulose.
• The capsule shell: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps), and indigo carmine (E 132).

What ABAGAT looks like and contents of the pack

ABAGAT, 150 mg, is a hard capsule, size 0, with a blue cap and a white or almost white body, filled with white or almost white to pale yellow pellets.
ABAGAT is available in packs containing
3 x 10 capsules
or
6 x 10 capsules
in perforated blisters of aluminum/OPA/aluminum/PVC in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50

• 08950 – Esplugues de Llobregat (Barcelona) Spain (Spain)

SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid
Spain (Spain)
Date of last revision of the leaflet:June 2024