Abagat

Package leaflet: information for the patient

ABAGAT, 75 mg, hard capsules
Dabigatran etexilate
Please read this leaflet carefully before taking this 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, 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 reactions, 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. What you need to know 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 that is responsible for blood clot formation.
ABAGAT is used in adults for:

• prevention of blood clots in the veins following hip or knee replacement surgery.

ABAGAT is used in children for:

• treatment of blood clots and prevention of recurrence of blood clots.

2. What you need to know 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 are currently experiencing 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 inherited, 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, antifungal 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 that requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting ABAGAT, discuss this with your doctor. If you experience symptoms or have undergone surgery while taking this
medicine, consult 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 (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 disease (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 are dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or frothy urine).
• if you are aged 75 years or older.
• if you are an adult and weigh 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 conditions that 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 particular caution when taking ABAGAT
If you need to undergo surgery:

• temporary discontinuation of ABAGAT may be necessary due to 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 surgery involves 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 by your doctor.
• you should inform your doctor immediately if you experience numbness or weakness in the lower limbs or problems with your bowel or bladder after the anaesthetic wears off, as urgent medical attention 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), you should inform your doctor, who will decide whether a change in treatment is necessary.

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 should inform 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 topically to the skin only.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, your doctor may recommend a lower dose of ABAGAT depending on the condition for which it was prescribed. 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.
• Antidepressants known as selective serotonin reuptake inhibitors or serotonin-noradrenaline 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 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.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
You should 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, in whom kidney function is reduced by
more than half, should take a reduced dose of 75 mg of ABAGAT due to increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with ABAGAT should begin with one capsule taken 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 10 days.
After hip replacement surgery
Treatment with ABAGAT should begin with one capsule taken 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 28 to 35 days.
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. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor advises otherwise.
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 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: as 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 facilitate passage into the stomach. Do not break, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Changing an anticoagulant medicine
Do not change your anticoagulant medicine 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 you have taken too many capsules, contact your 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 at the usual time on the next day. Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of 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, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping ABAGAT treatment
Take ABAGAT exactly as prescribed 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
ABAGAT affects the blood clotting system; therefore, most of the side effects are related to symptoms such as bruising or bleeding.
Severe or major bleeding may occur, which is the most serious side effect, and regardless of location, it may lead to disability, be life-threatening, or even result in death.
In some cases, such bleeding 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), you should contact your doctor immediately. The 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, you should contact your doctor immediately.

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

Prevention of blood clots after hip or knee replacement surgery

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

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

Uncommon (may occur in up to 1 in 100 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), from haemorrhoids, from the rectum, under the skin, into a joint, following injury or after a surgical procedure
• Development of haematomas or bruising occurring after surgery
• Blood in the stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from the wound (fluid seeping 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 into the brain, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• Decreased platelet count in the blood
• Decreased red blood cell count after surgery
• 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 lumps 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
• Fluid discharge from the wound
• Fluid discharge from the surgical wound

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

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

Treatment and prevention of recurrence of blood clots in children

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

• Decreased number of red blood cells in the blood
• Decreased platelet count in the blood
• Skin rash consisting of dark red, raised, itchy lumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of 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):

• Decreased white blood cell count (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
• Decreased haemoglobin levels in the blood (the substance in red blood cells)
• Decreased proportion of blood cells
• 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 disease or blood disorders

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 swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into a joint, from a wound, from the surgical incision site, from the injection site, or from the site of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine 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 pack following 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 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).
• Other components of the medicine: tartaric acid, gum arabic, 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 of size 2, white to off-white in colour, 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