ABAGAT 75 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. ABAGAT, 75 mg, Hard Capsules
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is ABAGAT and what is it used for
4. Important information before taking ABAGAT
   1. When not to take ABAGAT
   2. Warnings and precautions
   3. When to exercise special caution when taking ABAGAT
   4. ABAGAT and other medications
   5. In particular, before taking ABAGAT, tell your doctor if you are taking any of the following medications:
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take ABAGAT
   1. Take ABAGAT exactly as follows:
   2. Table 1. ABAGAT dosing
   3. Dosing requiring the combination of more than one capsule
   4. How to take ABAGAT
   5. Changing anticoagulant medication
   6. Taking a higher dose of ABAGAT than recommended
   7. Missing a dose of ABAGAT
   8. Stopping ABAGAT treatment
6. Possible side effects
   1. Reporting side effects
7. How to store ABAGAT
8. Contents of the pack and other information
   1. What ABAGAT contains
   2. What ABAGAT looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the Patient

ABAGAT, 75 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 is to block 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.

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

if you have severe liver impairment or liver disease that may lead to death.

• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication that prevents transplant rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have 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 medication, consult your doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:
If you have an increased risk of bleeding, such as:

• if you have recently experienced bleeding.
• if you have undergone surgical biopsy within the last month.
• if you have had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if you have esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medications that may increase the risk of bleeding. See "ABAGAT and other medications" below.
• if you are taking anti-inflammatory medications, such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have decreased kidney function or are dehydrated (feeling thirsty and producing a small amount of dark, concentrated urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of pediatric use: if the child has an infection around or within the brain.
• In the event of a heart attack or if you have been diagnosed with conditions that increase the risk of a heart attack.
• If you have liver disease that affects blood test results. In this case, the use of this medication is not recommended.

When to exercise special caution when taking ABAGAT

If you need to undergo surgery:

• in such a 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 your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or to reduce pain):
• it is very important to take ABAGAT before and after surgery exactly as your doctor has instructed, at the hours specified by your doctor.
• you should immediately inform your doctor if you experience numbness or weakness of the lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is necessary.
• If you have fallen or injured yourself during treatment, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to determine if there is an increased risk of bleeding.
• If you have antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

ABAGAT and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

In particular, before taking ABAGAT, tell your doctor if you are taking any of the following medications:

if you are taking one of the following medications:

• Anticoagulant medications (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medications used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only topically.
• Medications used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of ABAGAT, depending on the condition for which it was prescribed. See also section 3.
• Medications that prevent transplant rejection (e.g. tacrolimus, cyclosporine).
• A combination product containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain medications (e.g. aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal remedy used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medications used to treat AIDS (e.g. ritonavir).
• Certain medications used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of ABAGAT on pregnancy and the unborn child is not known.
Do not take this medication during pregnancy, unless your doctor considers it safe.
Women of childbearing age should avoid becoming pregnant while taking ABAGAT. Do not breastfeed while taking ABAGAT.

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 medication should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor.

Take ABAGAT exactly as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg each).
If kidney function is severely impairedor in patients aged 75 years or older,
the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of ABAGAT is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medications with severely impaired kidney functionshould take a reduced dose of 75 mgof ABAGAT due to the increased risk of bleeding.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.
After knee replacement surgery
ABAGAT treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
ABAGAT treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Take ABAGAT 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 age and body weight. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue to take all other medications unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of ABAGAT in milligrams (mg) based on the patient's body weight in kilograms (kg) and age in years.

Table 1. ABAGAT dosing

Dosing requiring the combination of more than one capsule

300 mg: 2 capsules of 150 mg each or 4 capsules of 75 mg each
260 mg: 1 capsule of 110 mg and 1 capsule of 150 mg or 1 capsule of 110 mg and 2 capsules of 75 mg each
220 mg: 2 capsules of 110 mg each
185 mg: 1 capsule of 75 mg and 1 capsule of 110 mg
150 mg: 1 capsule of 150 mg or 2 capsules of 75 mg each

How to take ABAGAT

ABAGAT can be taken with or without food. Swallow the capsules whole with a glass of water to help them reach the stomach. Do not crush, chew, or open the capsules, as this may increase the risk of bleeding.

Changing anticoagulant medication

Do not change your anticoagulant medication without receiving detailed instructions from your doctor.

Taking a higher dose of ABAGAT than recommended

Taking too much of this medication increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatments are available.

Missing a dose of ABAGAT

Prevention of blood clots after knee or hip replacement surgery
Take the remaining daily doses of ABAGAT at the same time the next day. Do not take a double dose to make up for a missed dose.
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 before the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping ABAGAT treatment

ABAGAT should be taken exactly as your doctor has instructed. Do not stop taking this medication without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking ABAGAT.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, 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.
In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medication.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency of occurrence:

• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, stomach, or intestines, brain, anus, penis/vagina, or urinary tract (including urine discoloration due to blood presence), or bleeding under the skin
• Formation of hematomas or bruising after surgery
• Blood in the stool detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Diarrhea
• Nausea
• Wound secretion
• Increased liver enzyme activity
• Jaundice of the skin or eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, injection site, or catheter insertion site
• Blood-tinged secretion from the catheter insertion site
• 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
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound secretion
• Wound secretion after surgery

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

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

Treatment of blood clots and prevention of recurrent blood clots in children
Common (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 and appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Diarrhea
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

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

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

• Absent white blood cell count (which helps 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 the joint, wound, surgical site, injection site, or catheter insertion site
• Bleeding from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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
Jerozolimskie Avenue 181 C
02-222 Warsaw
Tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store ABAGAT

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medications should not be disposed of via wastewater. Ask your pharmacist how to dispose of medications 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 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are 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).

What ABAGAT looks like and contents of the pack

ABAGAT 75 mg is a hard capsule, size 2, white to off-white, 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.
Józefów 9
99-300 Kutno
Poland
Tel.: +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

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