Dabigatran etexilate stada

Package leaflet: Information for the patient

Dabigatran Etexilate Stada, 110 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents

1. What Dabigatran Etexilate Stada is and what it is used for
2. What you need to know before taking Dabigatran Etexilate Stada
3. How to take Dabigatran Etexilate Stada
4. Possible side effects
5. How to store Dabigatran Etexilate Stada
6. Contents of the pack and other information

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

Dabigatran Etexilate 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 responsible for blood clot formation.
Dabigatran Etexilate Stada is used in adults for:

• preventing the formation of blood clots in veins after hip or knee replacement surgery.
• preventing blood clots in the brain (stroke) and in other blood vessels in the body in patients who have a type of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the legs and lungs and preventing recurrence of blood clots in the legs and lungs.

Dabigatran Etexilate Stada is used in children for:

• treatment of blood clots and prevention of 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
surgical procedure, consult a doctor.
The patient should inform the doctor if 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 experienced bleeding.
• if the patient has undergone a surgical tissue 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 (acid reflux 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 such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection within or around the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing small 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, 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 administration of an 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 bowels or bladder after the anaesthesia wears off, as urgent medical care may be required.

• 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 condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether any change in treatment is needed.

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

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, tikagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are applied only to 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 condition for which Dabigatran Eteksylan Stada was prescribed. See section 3.
• Medicines used to prevent rejection of transplanted organs (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-noradrenaline reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran Eteksylan Stada has on pregnancy and the unborn child. Do not take Dabigatran Eteksylan Stada during pregnancy unless the doctor determines it is safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran Eteksylan Stada.
Breastfeeding is not recommended during treatment with Dabigatran Eteksylan Stada.

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

3. How to take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada may be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are 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 recommended below:
Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran Eteksylan Stada is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medications containing verapamil who also have reduced renal function by more than half should receive a reduced dose of Dabigatran Eteksylan Stada of 75 mg due to increased risk of bleeding.
In both types of surgery, treatment should not be initiated if there is active bleeding from the surgical site. If treatment cannot be started by the next day after surgery, it should be initiated at a dose of 2 capsules once daily.
After knee joint replacement surgery
Initiate Dabigatran Eteksylan Stada by taking one capsule within 1 to 4 hours after completion of surgery. Then take 2 capsules once daily for a total of 10 days.
After hip joint replacement surgery
Initiate Dabigatran Eteksylan Stada by taking one capsule within 1 to 4 hours after completion of surgery. Then take 2 capsules once daily for a total of 28 to 35 days.
Prevention of thromboembolic events in blood vessels of the brain and body by preventing clot formation due to irregular heart function, treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in 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 of Dabigatran Eteksylan Stada is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medications containing verapamil should receive Dabigatran Eteksylan Stada at a reduced dose of 220 mg taken as one 110 mg capsule twice daily due to potential increased risk of bleeding.
In 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 via a procedure called cardioversion.
Dabigatran Eteksylan Stada should be taken as prescribed by your doctor.
In 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 placement, the patient may receive Dabigatran Eteksylan Stada treatment after the doctor confirms adequate control of blood coagulation. Dabigatran Eteksylan Stada should be taken as prescribed by your 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 and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Single dose of Dabigatran Eteksylan Stada to be administered twice daily, in milligrams (mg), depending on 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
Body weight [kg]
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
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 and close the bottle tightly.
Switching anticoagulant medication
Do not switch anticoagulant medications 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
Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Dabigatran Eteksylan Stada at the usual time the next day.
Do not take a double dose to make up for a missed dose.
Use in adults: Prevention of thromboembolic events in blood vessels of the brain and body by preventing clot formation due to irregular heart function, and treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs
Use in children: Treatment of blood clots and prevention of recurrent blood clots
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain 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 treatment with Dabigatran Eteksylan Stada
Dabigatran Eteksylan Stada should be taken as prescribed by your doctor. Do not stop taking Dabigatran Eteksylan Stada without first consulting your doctor, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if gastrointestinal discomfort occurs after taking Dabigatran Eteksylan Stada.
If you have any further questions about using 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 Etexilate Stada affects the blood clotting 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, these bleedings 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 blood clots after hip or knee replacement surgery
Common (may occur in up to 1 in 10 people):
- Decrease in haemoglobin levels in the blood (the substance in red blood cells)
- Abnormal liver function test results in laboratory analyses

Uncommon (may occur in 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 pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, due to injury or after injury or surgical procedure
- Formation of bruises or bruising occurring after a surgical procedure
- Blood in stool detected in laboratory tests
- Decrease in the number of red blood cells in the blood
- Decrease in blood cell count
- Allergic reaction
- Vomiting
- Frequent passage of loose or liquid stools
- Nausea
- Discharge from wound (fluid leakage from surgical wound)
- Increased liver enzyme activity
- Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

Rare (may occur in up to 1 in 1,000 people):
- Bleeding
- Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
- Blood-tinged discharge from the site of intravenous catheter insertion
- Coughing up blood or blood-stained sputum
- Decrease in platelet count in the blood
- Decrease in red blood cell count after surgery
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing facial or throat swelling
- Skin rash consisting of dark red, raised, itchy bumps due to an 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)
- Abdominal pain or stomach pain
- Indigestion
- Difficulty swallowing
- Fluid discharge from wound
- Fluid discharge from surgical wound

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

Prevention of blood clots in the brain and other blood vessels, by preventing clots that form 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 urine due to presence of blood), or under the skin
- Decrease in red blood cell count 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
- Coughing up blood or blood-stained sputum
- Decrease in platelet count 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 analyses

Rare (may occur in up to 1 in 1,000 people):
- Bleeding may occur into joints, from the surgical incision site, wound, injection site, or site of intravenous catheter insertion
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing facial or throat swelling
- Skin rash consisting of dark red, raised, itchy bumps due to 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 studies, the number of heart attacks with Dabigatran Etexilate Stada was numerically higher than with warfarin. The overall number of occurrences was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrent 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 urine due to presence of blood), or under the skin
- Indigestion

Uncommon (may occur in up to 1 in 100 people):
- Bleeding
- Bleeding may occur into joints or due to injury
- Bleeding from haemorrhoids may occur
- Decrease in red blood cell count in the blood
- Formation of bruises
- 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 analyses
- Increased liver enzyme activity

Rare (may occur in up to 1 in 1,000 people):
- Bleeding may occur from the surgical incision site, injection site, site of intravenous catheter insertion, or bleeding into the brain
- Decrease in platelet count in the blood
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing facial or throat swelling
- Skin rash consisting of dark red, raised, itchy bumps due to 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 studies, the number of heart attacks with Dabigatran Etexilate Stada was numerically higher than with warfarin. The overall number of occurrences was low.
No difference in the number of heart attacks was observed in patients treated with dabigatran compared to patients receiving placebo.

Treatment of blood clots and prevention of recurrent blood clots in children
Common (may occur in up to 1 in 10 people):
- Decrease in red blood cell count in the blood
- Decrease in platelet count in the blood
- Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
- Sudden change in skin colour and appearance
- Formation of bruises
- 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 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 pink or red urine due to presence of 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 facial or throat swelling
- Difficulty breathing or wheezing
- Bleeding
- Bleeding may occur into joints, from wounds, from the surgical incision site, injection site, or site of intravenous catheter insertion
- Bleeding from haemorrhoids may occur
- Stomach or intestinal ulcer (including oesophageal ulceration)
- Abnormal liver function test results in laboratory analyses

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 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 authorisation holder. By reporting adverse effects, additional information on the safety of the medicine can be collected.

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, blister pack or bottle after:
"Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
Blister pack: Do not store above 30°C. Keep in the original packaging to protect from moisture.
Bottle: Do not store above 30°C. Keep 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 the sewage system. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 110 mg of dabigatran etexilate (as mesilate).
• 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 white to pale yellowish pellets contained in size 1 blue hard capsules.
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.
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.
A multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC.
A multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in non-perforated blisters made of Aluminium/OPA/Aluminium/PVC.
This medicine is also available in a high-density polyethylene (plastic) bottle with a child-resistant closure and a desiccant, sealed with a foil 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 representative of the Marketing Authorisation Holder:
Stada 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

Detailed information on this medicinal product is available on the URPL website
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.

Dabigatran Eteksylan Stada has been prescribed by your 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
Treatment information:

• Dabigatran Eteksylan Stada 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 miss 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 granules 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.
• In case of a fall or injury, especially head injury, seek immediate medical advice.
• It is very important to take Dabigatran Eteksylan Stada exactly as prescribed by your doctor before and after surgery.
• Inform your doctor immediately if the patient experiences numbness or weakness in the lower limbs or problems with the bowel 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).

• Dabigatran Eteksylan Stada may need to be discontinued appropriately in advance of surgical or other invasive procedures.

• In 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 using the specific reversal agent idarucizumab in children and adolescents have not been established. 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 primarily eliminated 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: