Dabigatran etexilate G.l.

Leaflet included in the packaging: patient information

Dabigatran etexilate G.L., 110 mg, hard capsules
Dabigatranum etexilatum
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• 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 to you by a doctor for a specific person. Do not pass it on to others. The medicine 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 to block the substance in the body responsible for the formation of blood clots.

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

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 one of the internal organs 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 using a procedure called catheter ablation in 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 organ rejection after transplantation.
• 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 implanted 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 or have undergone surgery during treatment with this medicine, you should consult your doctor.

You should inform 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 esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• 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 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 use in children: if the child has an infection around or in the brain.
• in the case of a history of myocardial infarction or if you have been diagnosed with conditions that increase the risk of myocardial infarction.
• if you have liver disease that affects blood test results. In such cases, 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 temporarily 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 bowel or bladder problems after anesthesia has worn off, as urgent medical attention is required.
• if you fall or injure yourself during treatment, especially if you hit your head. You should seek medical help immediately. Your doctor will examine you to see 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.

Dabigatran etexilate G.L. and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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 condition for which the medicine was prescribed. 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 or 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

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 prevent pregnancy 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.

In case of doubt, you should consult your doctor.

You should take Dabigatran etexilate G.L. 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 reduced by more than half or if you are over 75 years old, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).

Patients taking medicines containing amiodarone, quinidine or verapamil should take a dose of 150 mg once daily (taken as 2 capsules of 75 mg each).

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 daily.

After knee replacement surgery

Treatment with Dabigatran etexilate G.L. should be started with a single capsule within 1 to 4 hours after the end of surgery.

Then, 2 capsules should be taken once daily for 10 days.

After hip replacement surgery

Treatment with Dabigatran etexilate G.L. should be started with a single capsule within 1 to 4 hours after the end of surgery.

Then, 2 capsules should be taken once daily for 28 to 35 days.

Prevention of blood clots in the brain and body due to irregular heart rhythm 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 over 80 years old, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran etexilate G.L. of 220 mg taken as one 110 mg capsule twice daily due to the increased risk of bleeding.

In patients with potentially increased bleeding risk, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice daily.

Treatment with this medicine can be continued if the patient needs to restore normal heart function using a procedure called cardioversion.

Dabigatran etexilate G.L. should be taken as instructed by your doctor.

In the 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, the patient may receive treatment with Dabigatran etexilate G.L. after the doctor has confirmed that adequate blood clotting control has been achieved.

Dabigatran etexilate G.L. should be taken as instructed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children

Dabigatran etexilate G.L. should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time each 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 them.

Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg).

The doses depend on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dabigatran etexilate dosing table in capsule form

Doses that require combining 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 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 anticoagulant medicine

Do not change your anticoagulant medicine without first getting 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.

Specific treatments are available.

Missing a dose of Dabigatran etexilate G.L.

Prevention of blood clots after hip or knee replacement surgery

Continue taking the missed daily dose at the same time the next day.

Do not take a double dose to make up for the missed dose.

Prevention of blood clots in the brain and body due to irregular heart rhythm 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

Use in adults: Prevention of blood clots in the brain and body due to irregular heart rhythm 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

Use in children: Treatment of blood clots and prevention of recurrence of blood clots

A 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.

Do not stop taking this medicine without first consulting your doctor, as the risk of blood clots 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, Dabigatran etexilate G.L. 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.

Severe or massive 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 bleeding events 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 bruising), you should contact your doctor immediately.

Your doctor may decide to monitor you closely or change your medicine.

If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, you should contact your doctor immediately.

Side effects are grouped by frequency as follows:

Prevention of blood clots after hip or knee replacement surgery

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 may occur from the nose, stomach or intestines, from the anus, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Formation of hematomas or bruising that occurs after surgery
• Blood in the stool detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Wound secretion (oozing of fluid from the wound)
• 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 joint, from the surgical site, from the injection site or from the catheter insertion site
• Blood-tinged sputum or coughing up blood
• Decreased platelet count
• 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 caused by an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound secretion
• Wound secretion after surgery

Unknown frequency (frequency cannot be estimated from available data):

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

Prevention of blood clots in the brain and body due to irregular heart rhythm

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

• Bleeding may occur from the nose, stomach or intestines, from the anus, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from hematomas or from the anus
• Bleeding into the brain
• Blood-tinged sputum or coughing up blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into the joint, from the surgical site, from the injection site or from the catheter insertion site, or bleeding into the brain
• 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 caused by an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice of the skin or eyes due to liver or blood disease

Unknown frequency (frequency cannot be estimated from available data):

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

In clinical trials, the number of heart attacks in patients taking Dabigatran etexilate G.L. was higher than in patients taking warfarin.

The overall number of events was small.

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

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

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

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

• Bleeding
• Bleeding may occur into the joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Formation of hematomas
• Blood-tinged sputum or coughing up blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical site, from the injection site or from the catheter insertion site, or bleeding into the brain
• Decreased platelet count
• 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 caused by an allergic reaction
• Difficulty swallowing

Unknown frequency (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice of the skin or eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks in patients taking Dabigatran etexilate G.L. was higher than in patients taking warfarin.

The overall number of events was small.

No difference in the number of heart attacks was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of recurrence of 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 caused by an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• 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 from the stomach or intestines, from the brain, from the anus, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Blood-tinged sputum or coughing up blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice of the skin or eyes due to liver or blood disease

Unknown frequency (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 facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the joint, from the wound, from the surgical site, from the injection site or from the catheter insertion site
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• 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 of the Office for Registration 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.

Medicines should be kept out of the 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 foil with a moisture-absorbing coating - Aluminum (OPA/Alu/PE//PE/Alu/LDPE):

No special precautions for storage are necessary.

Aluminum foil - 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 required.

This will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran etexilate G.L. contains

• The active substance is dabigatran etexilate.

Each capsule contains dabigatran etexilate in the form of mesylate in an amount equivalent to 110 mg of dabigatran etexilate.

Other ingredients are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• Capsule shell: indigotine, aluminum lake (E 132), 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 19.0 mm in length, with a light blue, opaque cap and a light blue, opaque body, size "1", filled with granules that are white to yellowish in color.

The capsules are packaged in aluminum foil with a moisture-absorbing coating - Aluminum (OPA/Alu/PE//PE/Alu/LDPE) or Aluminum-Aluminum (blister OPA/Alu/PVC//Alu) or a plastic bottle with a desiccant in a polyethylene plug (PP).

Pack sizes

Blisters 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 further information about this medicine, you should contact 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

[email protected]

Date of last revision of the leaflet: