Dabigatran Eteksilan Stada

Patient Information Leaflet: Information for the Patient

Dabigatran Eteksylan Stada, 150 mg, Hard Capsules

Dabigatranum etexilatum

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dabigatran Eteksylan Stada and what is it used for
• 2. Important Information Before Taking Dabigatran Eteksylan Stada
• 3. How to Take Dabigatran Eteksylan Stada
• 4. Possible Side Effects
• 5. How to Store Dabigatran Eteksylan Stada
• 6. Contents of the Pack and Other Information

1. What is Dabigatran Eteksylan Stada and what is it used for

Dabigatran Eteksylan Stada contains dabigatran etexilate as the active substance and belongs to a group of medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.
Dabigatran Eteksylan Stada is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent repeated formation of blood clots in the veins of the legs and lungs.

Dabigatran Eteksylan Stada is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important Information Before Taking Dabigatran Eteksylan Stada

When Not to Take Dabigatran Eteksylan Stada

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney impairment.
• if you are currently bleeding.
• if you have a disease of any 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. This can be congenital, of unknown cause, or caused by the use of other medications.
• if you are taking anticoagulant medications (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 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, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication that prevents organ rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and Precautions

Before starting treatment with Dabigatran Eteksylan Stada, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with Dabigatran Eteksylan Stada, consult your doctor.
The patient should inform the doctorif they 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 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 medications that may increase the risk of bleeding. See "Dabigatran Eteksylan Stada and Other Medications" below.
• if you are taking anti-inflammatory medications, such as diclofenac, ibuprofen, piroxicam.
• if you have an infection of the heart (bacterial endocarditis).
• if you have decreased 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 history of heart attack or if the patient has been diagnosed with conditions that increase the risk of heart attack.
• if you have liver disease affecting blood test results. In such cases, the use of Dabigatran Eteksylan Stada is not recommended.

When to Exercise Particular Caution When Taking Dabigatran Eteksylan Stada

• if you need to undergo surgery: In this case, it is necessary to discontinue Dabigatran Eteksylan Stada due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as directed by your doctor.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for spinal or epidural anesthesia or to reduce pain):
• It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as directed by your doctor.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should immediately seek medical attention. Your doctor will examine you to determine 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 Eteksylan Stada and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. In particular, you should
tell your doctor before taking Dabigatran Eteksylan Stada if you are taking any of the following medications:

• Anticoagulant medications (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin.
• Medications used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Dabigatran Eteksylan Stada, depending on the condition for which Dabigatran Eteksylan Stada was prescribed. See section 3.
• Medications that prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal remedy used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• -Antiviral medications used to treat AIDS (e.g., ritonavir).
• -Some medications used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and Breastfeeding

The effect of Dabigatran Eteksylan Stada on pregnancy and the unborn child is not known. You should not take Dabigatran Eteksylan Stada during pregnancy unless your doctor considers it safe. Women of childbearing age should prevent pregnancy while taking Dabigatran Eteksylan Stada.
Do not breastfeed while taking Dabigatran Eteksylan Stada.

Driving and Using Machines

Dabigatran Eteksylan Stada has no or negligible influence on the ability to drive and use machines.

3. How to Take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada can be used in adults and children aged 8 years or older who can swallow the capsules whole. There are other age-appropriate formulations for the treatment of children under 8 years of age.
This medication should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor.

Take Dabigatran Eteksylan Stada as Follows:

Prevention of blood clots in the brain and body by preventing the formation of clots that occur during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of repeated formation of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
For patients aged 80 years or older, the recommended dose of Dabigatran Eteksylan Stada is 220 mg taken as one 110 mg capsule twice a day.
Patients taking medications containing verapamilshould receive reduced-dose Dabigatran Eteksylan Stada at 220 mg taken as one 110 mg capsule twice a daydue to the potential increased risk of bleeding.
For patients with potentially increased risk of bleeding, the doctor may recommend taking Dabigatran Eteksylan Stada at a dose of 220 mg taken as one 110 mg capsule twice a day.
Taking Dabigatran Eteksylan Stada can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation. Dabigatran Eteksylan Stada should be taken as directed 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 Eteksylan Stada after the doctor has determined that coagulation control has been achieved. Dabigatran Eteksylan Stada should be taken as directed by your doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Dabigatran Eteksylan Stada should be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on the age and weight of the patient. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medications should be continued unless the doctor recommends stopping any of them.
A single dose of Dabigatran Eteksylan Stada to be administered twice a day, in milligrams (mg), depending on the patient's weight in kilograms (kg) and age in years:

Age in Years

8 to <9 9 to <10< h4>

10

to
<11

11

to
<12

12

to
<13

13

to
<14

14

to
<15

15

to
<16

16

to
<17

17

to
<18
>81

300 mg

as two 150 mg capsules

71 to <81 or

four 75 mg capsules

61 to <71

260 mg

as one 110 mg capsule plus one 150 mg capsule

51 to <61 or

one 110 mg capsule plus two 75 mg capsules

Body Weight [kg]

41 to <51

220 mg

as two 110 mg capsules

31 to <41

185 mg

as one 75 mg capsule plus one 110 mg capsule

26 to <31

150 mg

as one 150 mg capsule
or
two 75 mg capsules

21 to <26

16 to <21

One 110 mgcapsule

13 to <16

One
capsule

75 mg

11 to <13

This means that no dosing recommendations can be provided.

How to Take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada 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 crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Changing Anticoagulant Medication

Do not change your anticoagulant medication without receiving detailed instructions from your doctor.

Taking More Than the Recommended Dose of Dabigatran Eteksylan Stada

Taking too much Dabigatran Eteksylan Stada increases the risk of bleeding. If you have taken too many Dabigatran Eteksylan Stada capsules, contact your doctor immediately. Specific treatments are available.

Missing a Dose of Dabigatran Eteksylan Stada

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

Stopping Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada should be taken as directed by your doctor. Do not stop taking Dabigatran Eteksylan Stada without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Contact your doctor if you experience nausea after taking Dabigatran Eteksylan Stada.
If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Dabigatran Eteksylan Stada can cause side effects, although not everybody gets them.
Dabigatran Eteksylan Stada 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, be life-threatening, or even fatal, regardless of location. In some cases, these bleeds may not be visible.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to closely monitor you or change your medication.
In case of a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency of occurrence:

Prevention of Blood Clots in the Brain and Body

Common (may affect 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 urine discolored pink or red due to blood presence) or bleeding under the skin
­
Decreased red blood cell count
­
Abdominal pain or stomach pain
­
Nausea
­
Frequent loose or liquid stools
­
Vomiting
Uncommon (may affect up to 1 in 100 people):
­
Bleeding
­
Bleeding may occur from hematomas, rectum, or brain
­
Hematoma formation
­
Coughing up blood or sputum discolored with 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 ulcer)
­
Esophagitis or gastritis
­
Gastroesophageal reflux disease (reflux)
­
Difficulty swallowing
­
Abnormal liver function test results
Rare (may affect up to 1 in 1,000 people):
­
Bleeding may occur into a joint or due to injury
­
Bleeding may occur from hematomas
­
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 due to an allergic reaction
­
Decreased red blood cell count
­
Increased liver enzyme activity
­
Jaundice of the skin or whites of the eyes due to liver or blood disease
Unknown frequency (cannot be estimated from available data):
­
Difficulty breathing or wheezing
­
Decreased white blood cell count (which help fight infections)
­
Hair loss
In clinical trials, the number of heart attacks in patients taking Dabigatran Eteksylan Stada 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 Repeated Formation 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, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to blood presence), or bleeding under the skin
­
Nausea
Uncommon (may affect up to 1 in 100 people):
­
Bleeding
­
Bleeding may occur into a joint or due to injury
­
Bleeding may occur from hematomas
­
Decreased red blood cell count
­
Hematoma formation
­
Coughing up blood or sputum discolored with blood
­
Allergic reaction
­
Sudden change in skin color or appearance
­
Itching
­
Stomach or intestinal ulcer (including esophageal ulcer)
­
Esophagitis or gastritis
­
Gastroesophageal reflux disease (reflux)
­
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 the surgical wound, injection site, or catheter site in a vein
­
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 due to an allergic reaction
­
Difficulty swallowing
Unknown frequency (cannot be estimated from available data):
­
Difficulty breathing or wheezing
­
Decreased hemoglobin levels in the blood (a substance in red blood cells)
­
Decreased red blood cell count
­
Decreased white blood cell count (which help fight infections)
­
Jaundice 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 Eteksylan Stada 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 who received 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 due to an allergic reaction
­
Sudden change in skin color or appearance
­
Hematoma formation
­
Nosebleeds
­
Gastroesophageal reflux disease (reflux)
­
Vomiting
­
Nausea
­
Frequent loose or liquid stools
­
Nausea
­
Hair loss
­
Increased liver enzyme activity
Uncommon (may affect up to 1 in 100 people):
­
Decreased white blood cell count (which help fight infections)
­
Bleeding may occur into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including urine discolored pink or red due to blood presence), or bleeding under the skin
­
Decreased hemoglobin levels in the blood (a substance in red blood cells)
­
Decreased red blood cell count
­
Itching
­
Coughing up blood or sputum discolored with blood
­
Abdominal pain or stomach pain
­
Esophagitis or gastritis
­
Allergic reaction
­
Difficulty swallowing
­
Jaundice of the skin or whites of the eyes due to liver or blood disease
Unknown 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 a joint, wound, surgical wound, injection site, or catheter site in a vein
­
Bleeding may occur from hematomas
­
Stomach or intestinal ulcer (including esophageal ulcer)
­
Abnormal liver function test results

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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: 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 medication.

5. How to Store Dabigatran Eteksylan Stada

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton, blister pack, or label after "Expiration Date" / "EXP". The expiration date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Dabigatran Eteksylan Stada Contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose, and indigo carmine (E 132).

What Dabigatran Eteksylan Stada Looks Like and Contents of the Pack

Dabigatran Eteksylan Stada 150 mg is a white to light yellow pellet contained in a hard capsule with a blue cap and white or light blue body, size 0.
Dabigatran Eteksylan Stada is available in packs containing 3 x 10 or 6 x 10 hard capsules in perforated blisters of aluminum/OPA/aluminum/PVC in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
GermanyStada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix
Madrid - Spain
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Pharmadox Healthcare Limited
Kkw46 Kordin Industrial Park, Paola, PLA 3000,
Malta

Date of Last Revision of the Leaflet: 05/2024

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products http://www.urpl.gov.pl/pl

PATIENT ALERT CARD

Dabigatran Eteksylan Stada
Hard Capsules
dabigatranum etexilatum

• The patient/caregiver should always carry the Patient Alert Card with them.
• Make sure the patient/caregiver has the current version of the Patient Alert Card.

Dabigatran Eteksylan Stada has been prescribed by your doctor. To ensure the safe use of Dabigatran Eteksylan Stada, read the important information in the Patient Information Leaflet.
This Card contains important information about your treatment, so always carry it with you. You should also always inform your doctor that you are taking Dabigatran Eteksylan Stada.

Dabigatran Eteksylan Stada: Information for the Patient/Caregiver

Information about treatment:

• Dabigatran Eteksylan Stada is a blood thinner. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
• Follow your doctor's instructions when taking Dabigatran Eteksylan Stada. Never miss a dose or stop taking Dabigatran Eteksylan Stada without consulting your doctor.
• Tell your doctor about all medications you are currently taking.
• Inform your doctor that you are taking Dabigatran Eteksylan Stada before any surgical procedures or invasive procedures.
• Dabigatran Eteksylan Stada capsules can be taken with or without food.
• The capsules should be swallowed whole with water. Do not crush, chew, or empty the pellets from the capsule.

When to seek medical advice?

• Taking Dabigatran Eteksylan Stada may increase the risk of bleeding. Contact your doctor immediately if you experience symptoms of bleeding, such as exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling.
• If you fall or injure yourself during treatment, especially if you injure your head, seek medical attention immediately. Your doctor will examine you to determine if there is an increased risk of bleeding.
• It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as directed by your doctor.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.

Dabigatran Eteksylan Stada: Information for Healthcare Professionals

• Dabigatran Eteksylan Stada is an oral anticoagulant (direct thrombin inhibitor).
• There may be a need to discontinue Dabigatran Eteksylan Stada before surgical procedures or other invasive procedures.
• In case of severe bleeding, Dabigatran Eteksylan Stada should be discontinued immediately.
• A specific reversal agent (idarucizumab) is available for adults. The efficacy and safety of the specific reversal agent idarucizumab have not been established in children and adolescents. For detailed information and advice on reversing the anticoagulant effect of Dabigatran Eteksylan Stada, refer to the Summary of Product Characteristics for Dabigatran Eteksylan Stada and idarucizumab.
• Dabigatran Eteksylan Stada is primarily excreted by the kidneys. Adequate fluid intake is necessary. Dabigatran Eteksylan Stada can be removed by dialysis.

Please Fill in This Section or Ask Your Doctor to Fill It in.

Patient's Details

Patient's name:
Date of birth:
Indication for anticoagulant treatment:
Dose of Dabigatran Eteksylan Stada: