Abagat

Package leaflet: Information for the patient

ABAGAT, 110 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ABAGAT is and what it is 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 ABAGAT is and what it is used for

ABAGAT contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body responsible for blood clot formation.
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 blockage in blood vessels of 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 legs and lungs, and to prevent recurrence of blood clots in the legs and lungs.

ABAGAT is used in children to:

• treat blood clots and to prevent recurrence of 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 function impairment.
• if you currently have active bleeding.
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or intracranial bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed, which may be congenital, of unknown cause, or caused by other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered via the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if you have severe liver function impairment or liver disease that may 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 heart rhythm disorders.
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if you have a mechanical heart valve, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting ABAGAT, discuss this with your doctor. If you experience any symptoms during treatment or undergo surgery, contact your doctor.
You should inform your doctor if you 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 a surgical tissue biopsy within the last month.
  • if you have suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
  • if you have oesophagitis or gastritis.
  • if you have gastro-oesophageal reflux (acid reflux).
  • if you are taking medicines that may increase the risk of bleeding. See below “ABAGAT and other medicines”.
  • if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you have reduced kidney function or if you are dehydrated (feeling thirsty and passing less urine, which is dark (concentrated) or frothy).
  • if you are over 75 years of age.
  • if you are an adult weighing 50 kg or less.
  • only in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have conditions diagnosed to increase the risk of heart attack.
• if you have liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when taking ABAGAT
If you need to undergo surgery:

• you may need to temporarily stop taking ABAGAT due to increased risk of bleeding during and immediately after surgery. It is very important to take ABAGAT exactly as directed by your doctor before and after surgery.

• if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):

  • it is very important to take ABAGAT exactly as directed by your doctor, at the times recommended.
  • inform your doctor immediately if you experience numbness or weakness in the lower limbs or problems with your bowels or bladder after the anaesthesia wears off, as urgent medical care is required.

• if you fall or injure yourself during treatment, especially if you injure your head. Seek immediate medical attention. Your doctor will assess whether there is an increased risk of bleeding.

• if you have a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), inform your doctor, who will decide whether any change in treatment is needed.

ABAGAT and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, you must tell your doctor before taking ABAGAT if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For patients taking medicines containing amiodarone, quinidine, or verapamil, your doctor may recommend a lower dose of ABAGAT depending on the condition being treated. See also section 3.
• Medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• 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
It is not known what effect ABAGAT has on pregnancy or the unborn child.
Do not take this medicine during pregnancy unless your doctor determines it is safe.
Women of childbearing potential should avoid becoming pregnant while taking ABAGAT.
Do not breastfeed while taking ABAGAT.
Driving and using machines
ABAGAT has no effect or a negligible effect 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 are able to swallow capsules whole. Other age-appropriate formulations are available for children under 8 years of age.
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor.
Take ABAGAT 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).
If kidney function is reduced by more than half or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of ABAGAT is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced kidney function by more than half should take a reduced dose of 75 mg of ABAGAT due to increased risk of bleeding.
Do not start treatment if there is bleeding at the surgical site. If treatment cannot be started the day after surgery, begin with a dose of 2 capsules once daily.
After knee replacement surgery
Start ABAGAT by taking one capsule within 1 to 4 hours after completion of surgery. Then take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Start ABAGAT by taking one capsule within 1 to 4 hours after completion of surgery. Then take 2 capsules once daily for a total of 28 to 35 days.
Prevention of vessel blockage in the brain and body due to blood clots formed during irregular heart function, and treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs
The recommended dose is 300 mg taken as 1 capsule of 150 mg twice daily.
In patients aged 80 years or older, the recommended dose of ABAGAT is 220 mg taken as 1 capsule of 110 mg twice daily.
Patients taking medicines containing verapamil should take a reduced dose of ABAGAT of 220 mg taken as 1 capsule of 110 mg twice daily due to increased risk of bleeding.
In patients with increased risk of bleeding, your doctor may recommend taking ABAGAT at a dose of 220 mg taken as 1 capsule of 110 mg twice daily.
Treatment of blood clots and prevention of recurrence in children
ABAGAT should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on age and body weight. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medicines unless your doctor advises otherwise.
Single dose of ABAGAT to be taken twice daily, in milligrams (mg), according to the patient's body weight in kilograms (kg) and age in years:
Table 1 shows the single and total daily doses of ABAGAT in milligrams (mg), depending on the patient's body weight in kilograms (kg) and age in years.
Table 1. Dosing of ABAGAT

Single dose requiring combination of more than one capsule
300 mg: two capsules of 150 mg or
four capsules of 75 mg
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
220 mg: two capsules of 110 mg
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

How to take ABAGAT
ABAGAT may be taken with or without food. The capsules should be swallowed whole with a glass of water to help them pass into the stomach. Do not break, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

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

Taking more ABAGAT than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of ABAGAT
Prevention of blood clots after knee or hip replacement surgery
Take the remaining daily doses of ABAGAT at the usual time on the following day. Do not take a double dose to make up for the missed dose.

Prevention of vessel narrowing in the brain and body due to blood clots forming during abnormal heart rhythm, and treatment and prevention of recurrence of 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 may be taken up to 6 hours before the next scheduled dose. If less than 6 hours remain before 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 treatment with ABAGAT
ABAGAT should be taken as directed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if you experience gastrointestinal discomfort after taking ABAGAT.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
ABAGAT affects the blood clotting system; therefore, most adverse reactions are related to symptoms such as bruising or bleeding.
Severe or major bleeding may occur, which is the most serious adverse reaction, and regardless of location, it may lead to disability, be life-threatening, or even result in death.
In some cases, these bleedings may not be visible.
If bleeding that does not stop spontaneously occurs, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close monitoring or change the treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse reactions listed below are categorized by their frequency of occurrence:

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

• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Abnormal liver function test results in laboratory tests

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

• Bleeding may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, due to injury or after injury or surgical procedure
• Formation of bruises or bruising after surgical procedure
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (leakage of fluid from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

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

• Bleeding
• Bleeding may occur into the brain, at the surgical incision site, at the injection site, or at the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgical procedure
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

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

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

Prevention of blood vessel blockage in the brain or other organs due to clots caused by heart rhythm disorders
Common (may occur in up to 1 in 10 patients):

• Bleeding may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

Uncommon (may occur in up to 1 in 100 patients):

• Bleeding
• Bleeding may occur from haemorrhoids, rectum, or into the brain
• Formation of haematoma
• Coughing up blood or blood in sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Allergic reaction
• Sudden change in skin colour or appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

Rare (may occur in up to 1 in 1,000 patients):

• Bleeding may occur into joints, at the surgical incision site, wound, injection site, or at the site of intravenous catheter insertion
• Serious allergic reactions causing difficulty breathing or dizziness
• Serious allergic reactions causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Decrease in the number of red blood cells in the blood
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disorders

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

• Difficulty breathing or wheezing

In clinical trials, the number of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall number of events was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs
Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 patients):

• Bleeding
• Bleeding may occur into joints or due to injury
• Bleeding may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin colour or appearance
• Itching
• Stomach or intestinal ulcer
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Nausea
• Vomiting
• Abdominal or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results
• Increased liver enzyme activity

Rare (may occur in up to 1 in 1,000 patients):

• Bleeding may occur at the surgical incision site, injection site, or at the site of intravenous catheter insertion, or bleeding into the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing
• Decrease in the proportion of red blood cells in the blood

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

• Difficulty breathing or wheezing
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Decrease in the number of red blood cells in the blood
• Decrease in the number or even absence of white blood cells (which help fight infection)
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders
• Hair loss

In clinical trials, the number of heart attacks with ABAGAT was numerically higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was demonstrated.

Treatment and prevention of recurrence of blood clots in children
Common (may occur in 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
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Bruising
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (the substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-tinged 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 disease or blood disorders

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps increase the knowledge about the safety of this medicine.

5. How to store ABAGAT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
blister marked EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What ABAGAT contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• Other components of the medicine: 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 of size 1, filled with pellets ranging in colour from white to pale yellow.
ABAGAT is available in packages containing
3 x 10 capsules
or
6 x 10 capsules
in perforated blisters made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Polfarmex S.A.
ul. 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