Abagat

Package leaflet: Information for the patient

ABAGAT, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as 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 only. 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 formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and to prevent recurrence of blood clots in the veins of 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 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 haemorrhage, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking 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 through the catheter to maintain its patency, or restoring normal heart rhythm by a procedure called catheter ablation in 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 rejection of transplanted organs.
• 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 implant, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting ABAGAT, discuss this with your doctor. If you have experienced any symptoms during treatment with this medicine or have undergone surgery, consult your doctor.
You should inform your doctor if you currently have or have previously had any medical conditions or diseases, especially the following:

• if you have an increased risk of bleeding, such as:
  • if you have recently experienced bleeding.
  • if you have undergone surgical tissue removal (biopsy) within the last month.
  • if you have sustained 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 with other medicines”.
  • if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection in the heart (bacterial endocarditis).
  • if you have reduced kidney function or are dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or frothy urine).
  • if you are over 75 years of age.
  • if you are an adult weighing 50 kg or less.
  • only when used 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 increasing 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 be cautious when taking ABAGAT
If you need to undergo surgery:

• temporary discontinuation of ABAGAT may be necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take ABAGAT exactly as prescribed by your doctor before and after surgery.
• if the surgical procedure 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 prescribed 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 may be needed.
• 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 autoimmune disorder increasing the risk of blood clots), inform your doctor, who will decide whether any change in treatment is necessary.

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

• Medicines that reduce blood clotting (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 medicines containing verapamil, the dose of ABAGAT should be reduced to 220 mg, taken as one 110 mg capsule twice daily, due to 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 applied topically only.
• Medicines used to prevent rejection of transplanted organs (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
It is not known what effect ABAGAT has on pregnancy and the unborn child. Do not take this medicine during pregnancy unless your doctor considers it safe. Women of childbearing potential should use contraception to prevent pregnancy while taking ABAGAT.
Breastfeeding is not recommended during treatment with ABAGAT.
Driving and operating machinery
ABAGAT has no or negligible effect on the ability to drive and operate machinery.
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 prescribed by your doctor. If in doubt, consult your doctor.
Take ABAGAT as follows:
Prevention of thromboembolism in blood vessels of the brain and body by preventing formation of clots due to abnormal heart function, 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 older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive ABAGAT at a reduced dose 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 bleeding, your doctor may recommend treatment with a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with this medicine may continue if you require restoration of normal heart rhythm by a procedure called cardioversion or by a procedure called catheter ablation in atrial fibrillation. Take ABAGAT as prescribed by your doctor.
In 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, you may receive treatment with ABAGAT after your doctor confirms adequate control of blood coagulation. Take ABAGAT as prescribed by your 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 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 administered twice daily in milligrams (mg), depending on 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); doses depend 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 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: as one 150 mg capsule or
two 75 mg capsules

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

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

Accidental overdose of ABAGAT
Taking more than the recommended 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.

Stopping ABAGAT treatment
ABAGAT should be taken as prescribed by the 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 gastrointestinal discomfort occurs after taking ABAGAT.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
ABAGAT affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect, 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 you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence:

Prevention of thromboembolic events in the brain and throughout the body by preventing the formation of blood clots that occur due to abnormal heart function

Common (may occur in 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 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 pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

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

• Bleeding
• Bleeding may occur from haemorrhoids, from the rectum, or into the brain
• Formation of bruises (haematomas)
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• 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)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory analyses

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

• Bleeding into a joint, from a surgical incision site, from a wound, or from the site of injection or insertion of an intravenous catheter
• 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
• Decrease in blood cell count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

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

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

In clinical trials, the number of heart attacks observed with ABAGAT was numerically higher than with warfarin. The overall number of events was small.

Treatment of venous thrombosis in the legs and lungs, and prevention of recurrence of venous thromboembolism in the legs and lungs

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

• Bleeding may occur from the nose, into the stomach or intestines, from the anus, from the 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 people):

• Bleeding
• Bleeding may occur into a joint or following injury
• Bleeding from haemorrhoids may occur
• Decrease in the number of red blood cells in the blood
• Formation of bruises (haematomas)
• Coughing up blood or blood-stained sputum
• 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)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results in laboratory analyses
• Increased liver enzyme activity

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

• Bleeding from a surgical incision site, or from an injection site or 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

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

• Difficulty breathing or wheezing
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Decrease in 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 disease
• Hair loss

In clinical trials, the number of heart attacks observed with ABAGAT was numerically higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

Treatment of blood clots 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
• Formation of bruises (haematomas)
• 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, into the brain, from the anus, from the 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 (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain 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 disease

Frequency not known (frequency cannot be estimated 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 a joint, from a wound, from a surgical incision site, from an injection site or site of intravenous catheter insertion
• Bleeding from haemorrhoids may occur
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory analyses

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store ABAGAT

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

6. Contents of the packaging and other information

What ABAGAT contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• 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) and indigo carmine (E 132).

What ABAGAT looks like and contents of the pack
ABAGAT 150 mg is a hard capsule of size 0, with a blue cap and a white to off-white body, filled with off-white to pale yellow pellets.
ABAGAT is available in packs containing
3 x 10 capsules
or
6 x 10 capsules
in perforated blisters made of Aluminium/OPA/Aluminium/PVC foil, 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