Abagat

Leaflet accompanying the packaging: patient information

ABAGAT, 110 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this 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 veins after hip or knee replacement surgery.
• reduce the risk of vessel narrowing in the brain and body due to blood clots in adult patients with irregular heart rhythm (atrial fibrillation) and additional risk factors.
• treat blood clots in the veins of the legs and lungs and prevent recurrent blood clots in the veins of the legs and lungs.

ABAGAT is used in children to:

• treat blood clots and prevent recurrent 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 significant 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. It 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.
• 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 a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting ABAGAT, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with this medicine, consult your 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 suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has esophageal or stomach inflammation.
• if the patient has stomach acid reflux into the esophagus.
• 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 a heart infection (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing a small amount of dark, concentrated 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 case of a heart attack or if the patient has been diagnosed with conditions that increase the risk of a heart attack.
• if the patient has liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to exercise special caution when taking ABAGAT

If the patient is 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.

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 pain relief):

• 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 patient should immediately inform the doctor if they experience numbness or weakness of the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is necessary.

ABAGAT and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

In particular, before taking ABAGAT, the patient should tell the doctor if they are taking any of the following medicines:

if the patient is taking one of the following medicines:

• Anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of ABAGAT, depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine 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 selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain 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.
ABAGAT 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 instructed by the doctor. In case of doubts, consult a doctor.

ABAGAT should be taken as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or in patients aged 75 or over,
the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of ABAGAT is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking verapamilwith reduced kidney function by more than half should take a reduced dose of ABAGAT of 75 mgdue to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once a day.
After knee replacement surgery
ABAGAT treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once a day for a total of 10 days.
After hip replacement surgery
ABAGAT treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once a day for a total of 28 to 35 days.
Prevention of vessel narrowing in the brain and body due to blood clots that form during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of recurrent blood clots in the veins of the legs and lungs
The recommended dose is 300 mgtaken as 1 capsule of 150 mg twice a day.
In patients aged 80 or over, the recommended dose of ABAGAT is 220 mgtaken as 1 capsule of 110 mg twice a day.
Patients taking verapamilshould take a reduced dose of ABAGAT of 220 mgtaken as 1 capsule of 110 mg twice a daydue to the increased risk of bleeding.
In patients with increased risk of bleeding, the doctor may recommend taking ABAGAT at a dose of 220 mgtaken as 1 capsule of 110 mg twice a day.
Treatment of blood clots and prevention of recurrent blood clots in children
ABAGAT should be taken twice a day, 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 patient's age and weight. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. The patient should continue to take all other medicines unless the doctor advises to stop taking any of them.
A single dose of ABAGAT that requires combining more than one capsule

Table 1. ABAGAT dosing

A single dose requiring the combination of more than one capsule

300 mg: two capsules of 150 mg each or
four capsules of 75 mg each
260 mg: one capsule of 110 mg plus one capsule of 150 mg or
one capsule of 110 mg plus two capsules of 75 mg each
220 mg: two capsules of 110 mg each
185 mg: one capsule of 75 mg plus one capsule of 110 mg
150 mg: one capsule of 150 mg or
two capsules of 75 mg each

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 the 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 their doctor immediately. Specific treatments are available.

Missing a dose of ABAGAT

Prevention of blood clots after knee or hip replacement surgery
The remaining daily doses of ABAGAT should be taken at the same time the next day. Do not take a double dose to make up for a missed dose.
Prevention of vessel narrowing in the brain and body due to blood clots that form during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of recurrent blood clots in the veins of the legs and lungs
Treatment of blood clots and prevention of recurrent blood clots in children
A missed dose can be taken up to 6 hours before the next scheduled dose. If there are less than 6 hours until the next scheduled dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

Stopping ABAGAT treatment

ABAGAT should be taken as instructed by the doctor. Do not stop taking this medicine without consulting the doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Consult the doctor if the patient experiences indigestion after taking ABAGAT.
In case of any further doubts about the use of this medicine, consult a 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 heavy bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location.
In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) occur, the patient should contact their doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
If a severe allergic reaction occurs that can cause difficulty breathing or dizziness, the patient should contact their doctor immediately.
Side effects are grouped by frequency:

• Frequent (may affect up to 1 in 10 people):
• Blood count changes (decrease in hemoglobin, a substance 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, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Blood clots or bruising after surgery
• Blood in the stool, detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit (percentage of red blood cells)
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Diarrhea
• Nausea
• Wound discharge (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Rare (may affect up to 1 in 1,000 people):
• Bleeding
• Bleeding that may occur into the brain, from the surgical site, from the injection site, or from the catheter insertion site
• Discharge from the catheter insertion site into a vein
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Red, raised, itchy skin rash due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophageal or stomach inflammation
• Acid reflux from the stomach into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound discharge or surgical wound discharge
• Frequency not known (frequency cannot be estimated from available data):
• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infection)
• Hair loss

Prevention of vessel narrowing in the brain and body due to blood clots that form during irregular heart rhythm
Frequent (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding that may occur from hematomas, from the rectum, into the brain
• Blood clot formation
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased hemoglobin level 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)
• Esophageal or stomach inflammation
• Acid reflux from the stomach into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding that may occur into the joint, from the surgical site, from the wound, from the injection site, or from the catheter insertion site into a vein
• Severe allergic reactions causing difficulty breathing or dizziness
• Severe allergic reactions causing facial or throat swelling
• Red, raised, itchy skin rash due to an allergic reaction
• Decreased red blood cell count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Difficulty breathing or wheezing

Treatment of blood clots in the veins of the legs and lungs and prevention of recurrent blood clots in the veins of the legs and lungs
Frequent (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding that may occur into the joint or due to injury
• Bleeding from hematomas
• Decreased red blood cell count
• Blood clots
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer
• Esophageal or stomach inflammation
• Acid reflux from the stomach into the esophagus
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding that may occur from the surgical site, from the injection site, or from the catheter insertion site into a vein, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Red, raised, itchy skin rash due to an allergic reaction
• Difficulty swallowing
• Decreased red blood cell count

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

• Difficulty breathing or wheezing
• Decreased hemoglobin level in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which helps fight infection)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks with dabigatran etexilate was higher than with warfarin. The overall number of events was low.
Treatment of blood clots and prevention of recurrent blood clots in children
Frequent (may affect up to 1 in 10 people):

• Decreased red blood cell count
• Decreased platelet count
• Red, raised, itchy skin rash due to an allergic reaction
• Sudden change in skin color or appearance
• Blood clots
• Nosebleeds
• Acid reflux from the stomach into the esophagus
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which helps fight infection)
• Bleeding that may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin level in the blood (a substance in red blood cells)
• Decreased hematocrit (percentage of red blood cells)
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophageal or stomach inflammation
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Decreased white blood cell count (which helps fight infection)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur into the joint, from the wound, from the surgical site, from the injection site, or from the catheter insertion site into a vein
• Bleeding 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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 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 or household waste. Ask a pharmacist how to dispose of medicines no longer required. 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 110 mg of dabigatran etexilate (as mesylate).
• Other ingredients: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350 cS, talc, and hydroxypropylcellulose.
• Capsule shell: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps), indigo carmine (E 132).

What ABAGAT looks like and contents of the pack

ABAGAT, 110 mg, is a blue hard capsule, size 1, filled with 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