Dabigatran Eteksilan Stada

Leaflet attached to the packaging: patient information

Dabigatran Eteksylan Stada, 110 mg, hard capsules

Dabigatranum etexilatum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, tell the 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 medicines called anticoagulants. Its action is to block the substance in the body responsible for the formation of blood clots.
Dabigatran Eteksylan Stada 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 form of irregular heart rhythm called atrial fibrillation not associated with a valve defect 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 Eteksylan Stada is used in children to:

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

2. Important information before taking Dabigatran Eteksylan Stada

When not to take Dabigatran Eteksylan Stada

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney impairment.
• if the patient is currently bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer disease, brain injury or bleeding into the brain, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. It can be congenital, of unknown cause or caused by the use of other medicines.
• if the patient is 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 the patient has severe liver impairment or liver disease that can lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent organ rejection.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if the patient has been implanted with an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran Eteksylan Stada, discuss it with your doctor. If symptoms occurred during treatment with Dabigatran Eteksylan Stada or the patient underwent surgery, consult a doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently had bleeding.
• if the patient has had a surgical biopsy within the last month.
• if the patient has had a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See below "Dabigatran Eteksylan Stada and other medicines".
• if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection of the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling of thirst and decreased amount of dark (concentrated) / foamy urine).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 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 the patient has been diagnosed with conditions that increase the risk of a heart attack.
• if the patient has liver disease affecting blood test results. In such cases, the use of Dabigatran Eteksylan Stada is not recommended.

When to be particularly careful when taking Dabigatran Eteksylan Stada

• if the patient needs to undergo surgery: In this case, it is necessary to discontinue the use of 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 prescribed by the 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 prescribed by the doctor.
• The doctor should be informed immediately if the patient experiences 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 the patient has fallen or injured themselves during treatment, especially if the patient has injured their head. Medical attention should be sought immediately. The doctor will examine the patient to see if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Dabigatran Eteksylan Stada and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take. In particular, before taking Dabigatran Eteksylan Stada, tell the doctor if the patient is taking
any of the following medicines:

• Medicines that thin the blood (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 Eteksylan Stada, depending on the disease for which Dabigatran Eteksylan Stada was prescribed to the patient. See section 3.
• Medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• 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

It is not known what effect Dabigatran Eteksylan Stada has on pregnancy and the unborn child. Dabigatran Eteksylan Stada should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran Eteksylan Stada.
During treatment with Dabigatran Eteksylan Stada, breastfeeding should be avoided.

Driving and using machines

Dabigatran Eteksylan Stada has no effect or negligible effect 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 pharmaceutical forms for the treatment of children under 8 years of age.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor.

Dabigatran Eteksylan Stada should be used as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or in patients aged 75 or over,
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 Eteksylan Stada is 150 mg once a day(taken in the form of 2 capsules of 75 mg each).
Patients taking verapamil-containing medicines, whose kidney function is reduced by more than half, should take a reduced dose of Dabigatran Eteksylan Stada of 75 mgdue 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 the day after surgery, it should be started with a dose of 2 capsules once a day.
After knee replacement surgery
Treatment with Dabigatran Eteksylan Stada should be started with a single 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 Eteksylan Stada should be started with a single 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.
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 mgtaken as one 150 mg capsule twice a day.
In patients aged 80 or over, the recommended dose of Dabigatran Eteksylan Stada is 220 mgtaken as one 110 mg capsule twice a day.
Patients taking verapamil-containing medicinesshould receive a reduced dose of Dabigatran Eteksylan Stada of 220 mgtaken as one 110 mg capsule twice a daydue to the possible increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend taking Dabigatran Eteksylan Stada at a dose of 220 mgtaken as one 110 mg capsule twice a day.
Treatment with Dabigatran Eteksylan Stada can be continued if the patient needs to restore normal heart function using a procedure called cardioversion.
Dabigatran Eteksylan Stada should be taken as prescribed by the 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 confirmed that coagulation control has been achieved. Dabigatran Eteksylan Stada should be taken as prescribed by the 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 medicines should be continued, unless the doctor recommends stopping any of them.
A single dose of Dabigatran Eteksylan Stada, which should 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

Indicates that no dosing instructions can be given.

How to take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada can be taken with or without food. The capsules should be swallowed whole, washed down 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 anticoagulant medicine without receiving detailed instructions from the doctor.

Taking a higher dose of Dabigatran Eteksylan Stada than recommended

Taking too much Dabigatran Eteksylan Stada increases the risk of bleeding. If the patient has taken too many Dabigatran Eteksylan Stada capsules, they should contact a doctor immediately. There are specific treatments available.

Missing a dose of Dabigatran Eteksylan Stada

Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran Eteksylan Stada at the same time the next day.
Do not take a double dose to make up for the missed dose.
Use in adults: 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
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 Eteksylan Stada

Dabigatran Eteksylan Stada should be taken as prescribed by the doctor. Do not stop taking Dabigatran Eteksylan Stada without consulting a doctor first, as the risk of blood clots may be higher if treatment is stopped too early. Contact a doctor if nausea occurs after taking Dabigatran Eteksylan Stada.
In case of further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 bleedings 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 a doctor immediately. The doctor may decide to closely monitor the patient or change the medicine.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, contact a doctor immediately.
Side effects are listed below by frequency:

Prevention of blood clots after hip or knee replacement surgery
Frequent (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, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration to pink or red due to the presence of blood), or bleeding under the skin
­
Formation of hematomas occurring after surgery
­
Blood in the stool detected by laboratory tests
­
Decreased red blood cell count
­
Decreased hematocrit
­
Allergic reaction
­
Vomiting
­
Diarrhea
­
Nausea
­
Wound secretion (oozing of fluid from the 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 may occur into the brain, from the surgical site, from the injection site or the site of catheter insertion into a vein
­
Secretion from the catheter insertion site into a vein, discolored with blood
­
Coughing up blood or sputum discolored 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 occurring as a result of 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
­
Nausea
­
Difficulty swallowing
­
Wound secretion (oozing of fluid from the wound)
­
Wound secretion after surgery

Unknown frequency (cannot be estimated from the available data):
­
Breathing difficulties or wheezing
­
Decreased white blood cell count (which help fight infections)
­
Hair loss

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function
Frequent (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 discoloration to pink or red due to the presence of blood), or bleeding under the skin
­
Decreased red blood cell count
­
Abdominal pain or stomach pain
­
Nausea
­
Diarrhea
­
Vomiting

Uncommon (may affect up to 1 in 100 people):
­
Bleeding
­
Bleeding may occur from hematomas, from the anus, or into the brain
­
Formation of hematomas
­
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 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 the site of catheter insertion into a vein, 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 occurring as a result of an allergic reaction
­
Decreased hematocrit
­
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 the available data):
­
Breathing difficulties or wheezing
­
Decreased white blood cell count (which help fight infections)
­
Hair loss

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
Frequent (may affect up to 1 in 10 people):
­
Bleeding may occur from the nose, into the stomach or intestines, from the anus, from the penis/vagina or urinary tract (including urine discoloration to pink or red due to the presence of blood), or bleeding under the skin
­
Nausea

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
­
Coughing up blood or sputum discolored with 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
­
Diarrhea
­
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 the site of catheter insertion into a vein, or bleeding into the brain
­
Decreased platelet count
­
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 occurring as a result of an allergic reaction
­
Difficulty swallowing
­
Wound secretion (oozing of fluid from the wound)

Unknown frequency (cannot be estimated from the available data):
­
Breathing difficulties or wheezing
­
Decreased hemoglobin levels in the blood (a substance in red blood cells)
­
Decreased hematocrit
­
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 small.
Treatment of blood clots and prevention of recurrence of blood clots in children
Frequent (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 occurring as a result of an allergic reaction
­
Sudden change in skin color or appearance
­
Formation of hematomas
­
Nosebleeds
­
Gastroesophageal reflux disease
­
Vomiting
­
Nausea
­
Diarrhea
­
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, into the brain, from the anus, from the penis/vagina or urinary tract (including urine discoloration to pink or red 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
­
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 the available data):
­
Absence of white blood cells (which help fight infections)
­
Severe allergic reaction causing breathing difficulties or dizziness
­
Severe allergic reaction causing facial or throat swelling
­
Breathing difficulties or wheezing
­
Bleeding
­
Bleeding may occur into the joint, from the wound, from the surgical site, from the injection site or the site of catheter insertion into a vein, or bleeding from hematomas.
­
Stomach or intestinal ulcer (including esophageal ulceration)
­
Abnormal liver function test results

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction 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, more information can be collected on the safety of the medicine.

5. How to store Dabigatran Eteksylan Stada

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister packs or sachets after "Expiry Date"/"EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 of the medicine is dabigatran. Each hard capsule contains 110 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 110 mg is a white to light yellow pellet contained in a blue hard capsule, size 1.
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
Germany
For more information, contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +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, Medical Devices and Biocidal 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.

Treatment with Dabigatran Eteksylan Stada has been prescribed by the 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 the treatment, so it should always be carried with you. You should also always inform the doctor about taking Dabigatran Eteksylan Stada.

Dabigatran Eteksylan Stada: Information for the patient/caregiver

Treatment information:

• 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 the doctor's instructions when taking Dabigatran Eteksylan Stada. Never miss a dose or stop taking Dabigatran Eteksylan Stada without consulting a doctor.
• Tell the doctor about all medicines currently being taken.
• Inform the doctor about taking Dabigatran Eteksylan Stada before any surgical procedures/invasive procedures.
• Dabigatran Eteksylan Stada capsules can be taken with or without food.
• The capsules should be swallowed whole, washed down with water. The capsules should not be crushed or chewed, and the pellets should not be spilled from the capsule.

When to seek medical advice?

• Taking Dabigatran Eteksylan Stada may increase the risk of bleeding. Contact a doctor immediately if symptoms of bleeding occur, such as exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling.
• If the patient falls or injures themselves during treatment, especially if the patient injures their head, seek medical attention immediately. The doctor will examine the patient to see if there is an increased risk of bleeding.
• It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as prescribed by the doctor.
• Inform the doctor immediately if the patient experiences 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.

Dabigatran Eteksylan Stada: Information for healthcare professionals

• Dabigatran Eteksylan Stada is an oral anticoagulant (direct thrombin inhibitor).
• It may be necessary to discontinue Dabigatran Eteksylan Stada before surgical procedures or other invasive procedures.
• In case of major 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 excreted mainly by the kidneys. It is necessary to drink sufficient fluids. Dabigatran Eteksylan Stada can be removed by dialysis.

  Please fill in this section or ask the doctor to fill it in.

  Patient's details

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