Dabigatran etexilate G.l.

Leaflet included in the packaging: patient information

Dabigatran etexilate G.L., 150 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 personally. Do not give it 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 involves blocking a 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 brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat 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 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 the use of other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, introducing a venous catheter or when heparin is administered to maintain catheter 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 used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if you have a mechanical 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 in 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 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 previous heart attack or if you have been diagnosed with conditions that increase the risk of 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 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 cord (e.g. to perform spinal or epidural anesthesia or to reduce 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 in your lower limbs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you fall or injure yourself while being treated, especially if you hit your head. You should seek medical help immediately. Your doctor will check if you may have 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 medicines you are 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 they 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 it was prescribed. See also section 3.
• medicines used to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine).
• a combination product 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 formulations 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 in the brain and body, by preventing the formation of clots that occur during 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 a reduced dose of Dabigatran etexilate G.L. of 220 mg taken as one 110 mg capsule twice daily, due to the potential increased risk of bleeding.

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

Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation. 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 normal 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, approximately at the same time each day. The interval between doses should be approximately 12 hours.

The recommended dose depends on the age and weight of the child. The doctor will determine the correct dose. The doctor may adjust the dose during treatment.

You should continue to take all other medicines as instructed by your doctor, unless the doctor recommends stopping any of them.

Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dabigatran etexilate dosing table in capsule form

Doses that require splitting 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 emptied, 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.

A missed dose can be taken up to 6 hours before the next scheduled dose.

If there are less than 6 hours until the next scheduled dose, you should not take the missed dose. You should not take a double dose to make up for a 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 consulting your doctor first, 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.

In case of any further doubts regarding the use of this medicine, you should consult 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.

Severe or massive bleeding can occur, which is the most serious side effect and can lead to disability, threaten life or even cause death.

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 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 breathing difficulties or dizziness, you should contact your doctor immediately.

Side effects are listed below by frequency of occurrence:

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

• Bleeding may occur from the nose, stomach or intestines, from the anus, penis/vagina or urinary tract (including urine discolored red or brown due to the presence of blood), or bleeding under the skin.
• Reduced number of red blood cells in the blood.
• Abdominal pain or stomach pain.
• Indigestion.
• Frequent loose or liquid stools.
• Nausea.

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

• Bleeding.
• Bleeding may occur from hemorrhoids or the anus, or into the brain.
• Hematoma formation.
• Coughing up blood or sputum discolored with blood.
• Reduced number of platelets in the blood.
• Reduced hemoglobin content in the blood (a substance in red blood cells).
• Allergic reaction.
• Sudden change in skin color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Esophageal and stomach inflammation.
• Acid reflux.
• Vomiting.
• Difficulty swallowing.
• Abnormal liver function test results.

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

• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site or from a catheter insertion site, or bleeding into the brain.
• 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.
• Reduced number of blood cells.
• Increased liver enzyme activity.
• Yellowing of the skin or whites of the eyes due to liver or blood disease.

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

• Difficulty breathing or wheezing.
• Reduced number of white blood cells (which help 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 low.

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, penis/vagina or urinary tract (including urine discolored red or brown 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 a joint or due to injury.
• Bleeding may occur from hemorrhoids.
• Reduced number of red blood cells in the blood.
• Hematoma formation.
• Coughing up blood or sputum discolored with blood.
• Allergic reaction.
• Sudden change in skin color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Esophageal and stomach inflammation.
• Acid reflux.
• Nausea.
• Vomiting.
• Abdominal pain or stomach pain.
• Frequent 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 a surgical wound, from an injection site or from a catheter insertion site, or bleeding into the brain.
• Reduced number of platelets in the blood.
• 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.
• Difficulty swallowing.

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

• Difficulty breathing or wheezing.
• Reduced hemoglobin content in the blood (a substance in red blood cells).
• Reduced number of blood cells.
• Reduced number of white blood cells (which help fight infections).
• Yellowing of the skin or whites of the 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 low.

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

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

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

• Reduced number of red blood cells in the blood.
• Reduced number of platelets in the blood.
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction.
• Sudden change in skin color and appearance.
• Hematoma formation.
• Nosebleeds.
• Acid reflux.
• Vomiting.
• Nausea.
• Frequent loose or liquid stools.
• Indigestion.
• Hair loss.
• Increased liver enzyme activity.

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

• Reduced number of white blood cells (which help fight infections).
• Bleeding may occur into the stomach or intestines, brain, anus, penis/vagina or urinary tract (including urine discolored red or brown due to the presence of blood), or bleeding under the skin.
• Reduced hemoglobin content in the blood (a substance in red blood cells).
• Reduced number of blood cells.
• Itching.
• Coughing up blood or sputum discolored with blood.
• Abdominal pain or stomach pain.
• Esophageal and stomach inflammation.
• Allergic reaction.
• Difficulty swallowing.
• Yellowing of the skin or whites of the eyes due to liver or blood disease.

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

• Lack of white blood cells (which help fight infections).
• Severe allergic reaction causing breathing difficulties or dizziness.
• Severe allergic reaction causing facial or throat swelling.
• Difficulty breathing or wheezing.
• Bleeding.
• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site or from a catheter insertion site, or bleeding from hemorrhoids.
• 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Jerozolimskie Avenue 181C,

02-222 Warsaw, Poland

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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister or bottle label 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) and Aluminum-Aluminum (blister oPA/Alu/PVC//Alu) or plastic bottle (HDPE) with a desiccant in silica gel:

There are no special precautions for storage.

Aluminum blister: 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 is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesylate, equivalent to 150 mg of dabigatran etexilate.

Other ingredients are:

• capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• capsule shell: indigo carmine, 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 22.0 mm in diameter, with a light blue, opaque cap and a white, opaque body, size "0", filled with granules of a white to yellowish color.

The capsules are packaged in aluminum blisters with a moisture-absorbing coating – Aluminum (OPA/Alu/PE//PE/Alu/LDPE) and Aluminum-Aluminum (blister oPA/Alu/PVC//Alu) or a plastic bottle (HDPE) with a desiccant in silica gel.

Package sizes

Blisters containing: 10, 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100 and 180 hard capsules.

White HDPE 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.

Sienna 75 Street; 00-833 Warsaw, Poland

Tel: 022/ 636 52 23; 636 53 02

[email protected]

Date of last revision of the leaflet: