Dabigatran etexilate stada

Package leaflet: Information for the patient

Dabigatran Eteksylan Stada, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Dabigatran Eteksylan Stada contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.

Dabigatran Eteksylan Stada is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels in the body when the patient has an irregular heart rhythm known as non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs, and preventing recurrence of such clots.

Dabigatran Eteksylan Stada is used in children for:

• treating blood clots and preventing 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 impairment of kidney function.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe impairment of liver function or liver disease that may 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 rejection of a transplanted organ.
• 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 virus infection.
• if the patient has had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Eteksylan Stada, discuss this with your doctor. If
symptoms occur during treatment with Dabigatran Eteksylan Stada or if the patient undergoes
surgery, consult a doctor.
The patient should inform the doctor if they have or have previously 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 experienced bleeding.
• if the patient has undergone a surgical tissue biopsy (biopsy) within the last month.
• if the patient has suffered a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
• if the patient has inflammation of the oesophagus or stomach.
• if the patient has gastro-oesophageal reflux (regurgitation of stomach acid into the oesophagus).
• 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 non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection within the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or foamy urine).
• if the patient is over 75 years of age.
• if the patient is an adult weighing 50 kg or less.
• only when used in children: if the child has an infection around or within the brain.
• if the patient has had a heart attack or if the patient has been diagnosed with conditions increasing the risk of 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 exercise special caution when taking Dabigatran Eteksylan Stada

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran Eteksylan Stada is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Eteksylan Stada exactly as directed by the doctor both before and after surgery.
• if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• It is very important to take Dabigatran Eteksylan Stada exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care may be needed.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention should be sought. The doctor will assess whether there is an increased risk of bleeding.
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran Eteksylan Stada and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient should tell the doctor before taking Dabigatran Eteksylan Stada if they 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 applied topically to the skin only.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For patients taking medicines 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.
• Medicines used to prevent rejection of a transplanted organ (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 known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran Eteksylan Stada has on pregnancy or the unborn child. Dabigatran Eteksylan Stada should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran Eteksylan Stada.
Breastfeeding should not be undertaken while taking Dabigatran Eteksylan Stada.

Driving and operating machinery
Dabigatran Eteksylan Stada has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada can be used in adults and children aged 8 years or older
who are able to swallow capsules whole. There are other age-appropriate formulations
available for treating children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult
your doctor.
Take Dabigatran Eteksylan Stada exactly as directed below:
Prevention of blood clots in blood vessels of the brain and body by preventing
the formation of clots caused by irregular heart function, and treatment of blood clots
in the veins of the legs and lungs, as well as 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.
For patients aged 80 years or above, the recommended dose of Dabigatran Eteksylan Stada is 220 mg
taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of
Dabigatran Eteksylan Stada of 220 mg taken as one 110 mg capsule twice daily
due to the potential increased risk of bleeding.
For patients with potentially increased risk of bleeding, the doctor may recommend treatment with
Dabigatran Eteksylan Stada at a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with Dabigatran Eteksylan Stada may be continued if the patient requires restoration of
normal heart rhythm through a procedure called cardioversion or through a procedure called
catheter ablation for atrial fibrillation. Dabigatran Eteksylan Stada should be taken as directed 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 confirms adequate control
of blood coagulation. Dabigatran Eteksylan Stada should be taken as directed by the doctor.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran Eteksylan Stada should be taken twice daily, one dose in the morning and one in the
evening, approximately at the same time each day. The interval between doses should be as close
as possible to 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. Continue taking all other medications unless the
doctor advises otherwise.
Single dose of Dabigatran Eteksylan Stada to be administered twice daily, in milligrams (mg), based on
the patient's body weight in kilograms (kg) and age in years:
Age in years
8 to <9 9 to 10 11 12 13 14 15 16 17
<10 to to to to to to to to
<11 <12 <13 <14 <15 <16 <17 <18
>81 300 mg

71 to <81 as two 150 mg capsules
or
61 to <71
four 75 mg capsules
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
220 mg
41 to <51
Body weight [kg]
as two 110 mg capsules
185 mg
31 to <41
as one 75 mg capsule plus one 110 mg capsule
150 mg
26 to <31
as one 150 mg capsule
or

21 to <26
two 75 mg capsules
16 to <21

One 110 mg capsule
13 to <16

11 to <13
Indicates that dosing recommendations cannot be provided.

How to take Dabigatran Eteksylan Stada
Dabigatran Eteksylan Stada may be taken with or without food. Capsules should be
swallowed whole with a glass of water to help them pass into the stomach. Do not crush,
chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.
Instructions for opening blister packs
The following pictogram illustrates how to remove Dabigatran Eteksylan Stada capsules from the blister.

Separate the single dose along the perforated line.
Peel back the protective foil from the blister and remove the capsule.

• Do not push capsules through the foil.
• Do not peel back the foil until the capsule is needed.

Instructions for the bottle:
To open, press down and turn the cap.
After removing a capsule, immediately replace the cap on the bottle and close tightly.
Switching anticoagulant medicines
Do not switch anticoagulant medicines without receiving specific instructions from your doctor.
Taking more than the recommended dose of Dabigatran Eteksylan Stada
Taking too high a dose of Dabigatran Eteksylan Stada increases the risk of bleeding. If a patient
has taken too many Dabigatran Eteksylan Stada capsules, contact a doctor immediately. Specific
treatment methods are available.
Missing a dose of Dabigatran Eteksylan Stada
A missed dose may be taken if there is still at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken.
Do not take a double dose to make up for a 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 first consulting your doctor, as the risk of developing a blood
clot may be higher if treatment is stopped prematurely. Contact your doctor if you experience
indigestion after taking Dabigatran Eteksylan Stada.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dabigatran Eteksylan Stada affects the blood coagulation system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence:

Prevention of thromboembolism in blood vessels of the brain and body by preventing the formation of clots occurring due to irregular heart function

Common (may occur in 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 pink or red discoloration of urine due to blood), or under the skin
- Decrease in the number of red blood cells in the blood
- Abdominal pain or stomach pain
- Indigestion
- Frequent passage of loose or liquid stools
- Nausea

Uncommon (may occur in up to 1 in 100 people):
- Bleeding
- Bleeding may occur from haemorrhoids, from the rectum, or into the brain
- Formation of bruises (haematomas)
- Coughing up blood or blood-stained sputum
- Decrease in the number of platelets in the blood
- Decrease in haemoglobin levels in the blood (the substance in red blood cells)
- Allergic reaction
- Sudden change in skin colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulceration)
- Inflammation of the oesophagus and stomach
- Regurgitation of stomach contents into the oesophagus (reflux)
- Vomiting
- Difficulty swallowing
- Abnormal liver function test results in laboratory tests

Rare (may occur in up to 1 in 1,000 people):
- Bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of intravenous catheter insertion
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
- Decrease in blood cell count
- Increased liver enzyme activity
- Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Not known (frequency cannot be estimated from available data):
- Difficulty breathing or wheezing
- Decrease in number or even absence of white blood cells (which help fight infections)
- Hair loss

In clinical trials, the number of heart attacks observed with Dabigatran Eteksylan Stada was numerically higher than with warfarin. The overall number of events was small.

Treatment of venous blood clots in the legs and lungs, and prevention of recurrence of venous blood clots in the legs and lungs

Common (may occur in 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 pink or red discoloration of urine due to blood), or under the skin
- Indigestion

Uncommon (may occur in up to 1 in 100 people):
- Bleeding
- Bleeding may occur into a joint or following injury
- Bleeding may occur from haemorrhoids
- Decrease in the number of red blood cells in the blood
- Formation of bruises (haematomas)
- Coughing up blood or blood-stained sputum
- Allergic reaction
- Sudden change in skin colour and appearance
- Itching
- Stomach or intestinal ulcer (including oesophageal ulceration)
- Inflammation of the oesophagus and stomach
- Regurgitation of stomach contents into the oesophagus (reflux)
- Nausea
- Vomiting
- Abdominal pain or stomach pain
- Frequent passage of loose or liquid stools
- Abnormal liver function test results in laboratory tests
- Increased liver enzyme activity

Rare (may occur in up to 1 in 1,000 people):
- Bleeding may occur from a surgical incision site, injection site, or site of intravenous catheter insertion, or bleeding from the brain
- Decrease in the number of platelets in the blood
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
- Difficulty swallowing

Not known (frequency cannot be estimated from available data):
- Difficulty breathing or wheezing
- Decrease in haemoglobin levels in the blood (the substance in red blood cells)
- Decrease in blood cell count
- Decrease in number or even absence of white blood cells (which help fight infections)
- Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders
- Hair loss

In clinical trials, the number of heart attacks observed with Dabigatran Eteksylan Stada was numerically higher than with 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 patients who received placebo.

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

Common (may occur in up to 1 in 10 people):
- Decrease in the number of red blood cells in the blood
- Decrease in the number of platelets in the blood
- Skin rash consisting of dark red, raised, itchy bumps occurring as a result of an allergic reaction
- Sudden change in skin colour and appearance
- Formation of bruises (haematomas)
- Nosebleeds
- Regurgitation of stomach contents into the oesophagus (reflux)
- Vomiting
- Nausea
- Frequent passage of loose or liquid stools
- Indigestion
- Hair loss
- Increased liver enzyme activity

Uncommon (may occur in up to 1 in 100 people):
- Decrease in the number of white blood cells (which help fight infections)
- Bleeding may occur into the stomach or intestines, from the brain, from the anus, from the penis/vagina or urinary tract (including pink or red discoloration of urine due to blood), or under the skin
- Decrease in haemoglobin levels in the blood (the substance in red blood cells)
- Decrease in blood cell count
- Itching
- Coughing up blood or blood-stained sputum
- Abdominal pain or stomach pain
- Inflammation of the oesophagus and stomach
- Allergic reaction
- Difficulty swallowing
- Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Not known (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 swelling of the face or throat
- Difficulty breathing or wheezing
- Bleeding
- Bleeding may occur into a joint, from a wound, from a surgical incision site, from an injection site, or from the site of intravenous catheter insertion
- Bleeding may occur from haemorrhoids
- Stomach or intestinal ulcer (including oesophageal ulceration)
- Abnormal liver function test results in laboratory tests

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dabigatran Eteksylan Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
Blister: Do not store above 30°C. Store in the original packaging to protect from moisture.
Bottle: Do not store above 30°C. Store in the original packaging to protect from moisture. After opening, the medicine should be used within 4 months. The bottle should be kept tightly closed.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Dabigatran Eteksylan Stada contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: tartaric acid, gum arabic, 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 white to pale yellow pellets contained in hard capsules with a blue cap and a white or whitish body, size 0.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in non-perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in non-perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
This medicine is also available in a high-density polyethylene (plastic) bottle with a child-resistant closure and an included desiccant, sealed with a fibrous membrane, containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
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

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL):
http://www.urpl.gov.pl/pl

PATIENT WARNING CARD
Dabigatran Eteksylan Stada
Hard capsules
dabigatranum etexilatum

• The patient / caregiver should always carry the Patient Warning Card.
• Ensure that the patient / caregiver has the current version of the Patient Warning Card.

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

Dabigatran Eteksylan Stada: Information for patient / caregiver
Information about treatment:

• Dabigatran Eteksylan Stada is a medicine that thins the blood. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
• While taking Dabigatran Eteksylan Stada, follow your doctor's instructions carefully. Never skip a dose or stop taking Dabigatran Eteksylan Stada without consulting your doctor.
• Inform your doctor about all medicines you are currently taking.
• Inform your doctor that you are taking Dabigatran Eteksylan Stada before any surgical procedures / invasive procedures.
• Dabigatran Eteksylan Stada capsules can be taken with or without food.
• Swallow the capsules whole with water. Do not crush or chew the capsules, and do not take the pellets alone.

When to seek medical advice?

• Taking Dabigatran Eteksylan Stada may increase the risk of bleeding. Seek immediate medical advice if you experience signs of bleeding such as unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling.
• If you fall or suffer an injury, especially a head injury, seek medical advice immediately.
• It is very important to take Dabigatran Eteksylan Stada exactly as prescribed by your doctor before and after surgery.
• Immediately inform your doctor if the patient experiences numbness or weakness in the lower limbs or problems with the bowels or bladder after the anaesthetic wears off, as urgent medical care 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 appropriately in advance of surgical or other invasive procedures.

• In the case of serious bleeding, Dabigatran Eteksylan Stada should be discontinued immediately.

• A specific reversal agent (idarucizumab) is available for adult patients. The efficacy and safety of the specific reversal agent, idarucizumab, have not been established in children and adolescents. For detailed information and guidance 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 eliminated mainly via the kidneys. Adequate fluid intake is necessary. Dabigatran Eteksylan Stada may be removed by dialysis.

Please complete this section or ask your doctor to complete it.
Patient details
Patient's name:
Date of birth:
Indication for anticoagulant treatment:
Dose of Dabigatran Eteksylan Stada: