Dabigatran etexilate G.l.

Leaflet accompanying the packaging: patient information

Dabigatran etexilate G.L., 75 mg, hard capsules
Dabigatranum etexilatum
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dabigatran etexilate G.L. and what is it used for
• 2. Important information before taking Dabigatran etexilate G.L.
• 3. How to take Dabigatran etexilate G.L.
• 4. Possible side effects
• 5. How to store Dabigatran etexilate G.L.
• 6. Contents of the packaging and other information

1. What is Dabigatran etexilate G.L. and what is it used for

Dabigatran etexilate G.L. contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action is based on blocking the substance in the body responsible for blood clot formation.
Dabigatran etexilate G.L. is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.

Dabigatran etexilate G.L. is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Dabigatran etexilate G.L.

When not to take Dabigatran etexilate G.L.

• 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 an internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. It can 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 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 through a procedure called catheter ablation for atrial fibrillation.
• if you have severe liver impairment or liver disease that can 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 that prevents the rejection of a transplanted organ.
• 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 been fitted with an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran etexilate G.L., you should discuss it with your doctor. If you experience any symptoms during treatment with this medicine or if you have undergone surgery, you should consult your doctor.
You should tell your doctorif 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 had bleeding.
• if you have had a 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 esophageal or stomach inflammation.
• if you have stomach acid reflux.
• if you are taking medicines that may increase the risk of bleeding. See also "Dabigatran etexilate G.L. and other medicines" below.
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if you have a heart infection (bacterial endocarditis).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing less urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case 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 medicine is not recommended.

When to be particularly careful when taking Dabigatran etexilate G.L.

• if you need to undergo surgery: In this case, it is necessary to stop taking Dabigatran etexilate G.L. due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate G.L. before and after surgery exactly as your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spinal canal (e.g. for spinal or epidural anesthesia or to relieve pain):
• it is very important to take Dabigatran etexilate G.L. before and after surgery exactly as your doctor has instructed.
• you should immediately inform your doctor if you 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 required.
• if you have fallen or injured yourself while taking the medicine, especially if you have injured your head. You should seek medical help immediately. The doctor will examine you to see if there is an increased risk of bleeding.
• if you have a condition called 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.

Dabigatran etexilate G.L. and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, you should tell your doctor before taking Dabigatran etexilate G.L. 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 these medicines 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 Dabigatran etexilate G.L., depending on the disease for which it was prescribed to the patient. See also section 3.
• medicines that prevent organ rejection after transplantation (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

The effect of Dabigatran etexilate G.L. on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy unless your doctor considers it safe.
Women of childbearing age should avoid becoming pregnant while taking Dabigatran etexilate G.L.
You should not breastfeed while taking Dabigatran etexilate G.L.

Driving and using machines

Dabigatran etexilate G.L. has no or negligible influence on the ability to drive and use machines.

3. How to take Dabigatran etexilate G.L.

Dabigatran etexilate G.L. capsules can be used in adults and children aged 8 years or older who can swallow the capsules whole.
There are other age-appropriate strengths and pharmaceutical forms for the treatment of children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor.

You should take Dabigatran etexilate G.L. as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reduced by more than halfor if you are 75 years old or older, 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 Dabigatran etexilate G.L. is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking medicines containing verapamil, with reduced kidney function by more than half, should take a reduced dose of 75 mgof this medicine due 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 on the day after surgery, it should be started with a dose of 2 capsules once a day.
After knee replacement surgery
Treatment with Dabigatran etexilate G.L. should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate G.L. should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate G.L. 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 age and body weight. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. You should continue to take all other medicines, unless your doctor instructs you to stop taking any of them.

Table 1: Dabigatran etexilate dosing table in capsule form

Doses requiring the splitting of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule and one 150 mg capsule or one 110 mg capsule and two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule and one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate G.L.

Dabigatran etexilate G.L. can be used in adults and children aged 8 years or older who can swallow the capsules whole.
Dabigatran etexilate G.L. 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 your anticoagulant medicine without receiving detailed instructions from your doctor.

Taking a higher dose of Dabigatran etexilate G.L. than recommended

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

Missing a dose of Dabigatran etexilate G.L.

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Dabigatran etexilate G.L. at the same time the next day. Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children.
The missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours left until the next scheduled dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Dabigatran etexilate G.L.

Dabigatran etexilate G.L. should be taken as instructed by your doctor. You should not stop taking this medicine without first consulting your doctor, as the risk of blood clot formation may be higher if treatment is stopped too early. You should contact your doctor if you experience indigestion after taking Dabigatran etexilate G.L.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

The risk of blood clot formation may be higher if treatment is stopped too early. You should contact your doctor if you experience indigestion after taking Dabigatran etexilate G.L.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate G.L. affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.
Major or severe bleeding can occur, which is the most serious side effect and can lead to disability, threaten life, or even be 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, paleness, dizziness, headache or unexplained swelling), you should contact your doctor immediately. The doctor may decide to monitor you closely or change your medicine.
If you experience a severe allergic reaction that can cause breathing difficulties or dizziness, you should contact your doctor immediately.
Possible side effects listed below are grouped by frequency of occurrence:

• Common (may affect up to 1 in 10 people):
• 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 that can occur from the nose, stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), from hemorrhoids, under the skin, into a joint, due to injury or after surgery
• formation of hematomas or bruising that occurs after surgery
• blood in the stool, as detected by laboratory tests
• decreased red blood cell count
• decreased hematocrit
• allergic reaction
• nausea and vomiting
• diarrhea
• presence of wound exudate (oozing of fluid from the surgical wound)
• increased liver enzyme activity
• jaundice 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 into the brain, from the surgical site, from the injection site or from the catheter insertion site into a vein
• blood-tinged discharge from the catheter insertion site into a vein
• coughing up blood or sputum tinged with blood
• decreased platelet count
• decreased red blood cell count after surgery
• severe allergic reaction causing breathing difficulties 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)
• esophageal and stomach inflammation
• acid reflux
• abdominal pain or stomach pain
• indigestion
• difficulty swallowing
• wound exudate
• wound exudate from the surgical wound

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

• difficulty breathing or wheezing
• decreased 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
• acid reflux
• nausea and vomiting
• diarrhea
• indigestion
• hair loss
• increased liver enzyme activity

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

• decreased white blood cell count
• bleeding that can occur into the stomach or intestines, brain, anus, penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or under the skin
• decreased hemoglobin levels in the blood
• decreased hematocrit
• itching
• coughing up blood or sputum tinged with blood
• abdominal pain or stomach pain
• esophageal and stomach inflammation
• allergic reaction
• difficulty swallowing
• jaundice of the skin or whites of the eyes due to liver or blood disease

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

• absence of white blood cells
• severe allergic reaction causing breathing difficulties or dizziness
• severe allergic reaction causing facial or throat swelling
• difficulty breathing or wheezing
• bleeding
• bleeding into a joint, from a wound, from the surgical site, from the injection site or from the catheter insertion site into a vein
• bleeding from hemorrhoids
• 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, you should tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
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 medicine.

5. How to store Dabigatran etexilate G.L.

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 and blister or label on the bottle after: EXP. The expiry date refers to the last day of the month stated.
Aluminum blister with a moisture-absorbing coating – Aluminum (OPA/Alu/PE//PE/Alu/LDPE):
There are no special precautions for storing the medicine.
Aluminum-Aluminum blister (oPA/Alu/PVC//Alu): Do not store above 30°C.
White HDPE bottle: Store in the original packaging to protect from moisture.
Storage conditions are given on the packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran etexilate G.L. contains

• The active substance of the medicine is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesylate in an amount equivalent to 75 mg of dabigatran etexilate.

Other ingredients are:

• capsule contents: acetic acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• capsule shell: carrageenan, potassium chloride, titanium dioxide (E 171) and hypromellose.

What Dabigatran etexilate G.L. looks like and contents of the pack

The capsules are approximately 18.0 mm in diameter, with a white, opaque cap and a white, opaque body, size "2", filled with granules of a color ranging from white to yellow.
The capsules are packaged in aluminum blisters with a moisture-absorbing coating – Aluminum (OPA/Alu/PE//PE/Alu/LDPE) and Aluminum-Aluminum (oPA/Alu/PVC//Alu) or a plastic bottle with a desiccant in silica gel in a screw cap (PP).
Pack sizes
Blister packs containing: 10, 10x1 (single-dose blister), 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100 and 180 hard capsules.
White bottle containing 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Laboratorios Liconsa, S.A.
Avda. Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

For more information about this medicine, you should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: