Dabigatran etexilate stada: detailed information

Package leaflet: Information for the patient

Dabigatran Etexilate Stada, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet

What Dabigatran Etexilate Stada is and what it is used for
What you need to know before taking Dabigatran Etexilate Stada
How to take Dabigatran Etexilate Stada
Possible side effects
How to store Dabigatran Etexilate Stada
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 that is responsible for blood clot formation.

Dabigatran Etexilate Stada is used in adults for:

prevention of blood clots in veins following hip or knee replacement surgery.

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 has undergone 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 surgical tissue sampling (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 (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 frothy 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 previously had a heart attack or 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 particular 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 numbness or weakness in the legs, or problems with the bowel or bladder occur after the anaesthesia wears off, as urgent medical care is required.
if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention is required. 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 the 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 or has recently taken, as well as any medicines the patient 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 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 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-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 or the unborn child. Do not take Dabigatran Eteksylan Stada during pregnancy unless your doctor determines it is safe. Women of childbearing potential 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 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 after hip or knee replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If kidney 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 medicines 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 medicines containing verapamil who also have reduced kidney function (by more than half) should take a reduced dose of 75 mg of Dabigatran Eteksylan Stada due to an increased risk of bleeding.

In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If treatment cannot be initiated by the day after surgery, it should be started with a dose of 2 capsules once daily.

After knee replacement surgery
Start taking Dabigatran Eteksylan Stada by taking one capsule within 1 to 4 hours after the end of surgery. Then take two capsules once daily for a total of 10 days.

After hip replacement surgery
Start taking Dabigatran Eteksylan Stada by taking one capsule within 1 to 4 hours after the end of surgery. Then take two capsules once daily for a total of 28 to 35 days.

Treatment and prevention of recurrence of 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 ideally be 12 hours.

The recommended dose depends on age and body weight. Your 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 taken twice daily, in milligrams (mg), according to 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
Body weight [kg]
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 capsule 110 mg
13 to <16
One
11 to <13 capsule
75 mg
Indicates that dosing recommendations cannot be provided.

How to take Dabigatran Eteksylan Stada
Dabigatran Eteksylan Stada may be taken with or without food. The capsules must be swallowed whole with a glass of water to help them pass into the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Switching from another anticoagulant medicine
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 you have taken too many capsules of Dabigatran Eteksylan Stada, contact your doctor immediately. Specific treatment methods are available.

Missed 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 usual time the next day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before 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 prescribed by your 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 gastrointestinal discomfort 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 clotting system, therefore most adverse effects involve symptoms such as bruising or bleeding.
Severe or major bleeding may occur, which is the most serious adverse effect, and regardless of location, it may lead to disability, be life-threatening, or even result in death.
In some cases, such bleeding may not be visible.
If bleeding that does not stop spontaneously occurs, 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 monitoring 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 surgery (hip or knee replacement)
Common (may occur in up to 1 in 10 people):
- Decreased haemoglobin levels in blood (a substance in red blood cells)
- Abnormal liver function test results

Uncommon (may occur in up to 1 in 100 people):
- Bleeding may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, following trauma or after a surgical procedure
- Formation of bruises or haematomas after surgery
- Blood in stool detected in laboratory tests
- Decreased number of red blood cells in blood
- Decreased blood cell count
- Allergic reaction
- Vomiting
- Frequent passage of loose or watery stools
- Nausea
- Discharge from wound (fluid leakage from surgical wound)
- Increased liver enzyme activity
- Yellowing of the skin or whites of the eyes due to liver or blood disease

Rare (may occur in up to 1 in 1,000 people):
- Bleeding
- Bleeding into the brain, at the surgical incision site, at the injection site, or at the site of intravenous catheter insertion
- Blood-tinged discharge from the site of intravenous catheter insertion
- Coughing up blood or blood-tinged sputum
- Decreased number of platelets in blood
- Decreased number of red blood cells in blood after surgery
- 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 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

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

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

Uncommon (may occur in up to 1 in 100 people):
- Decreased number of white blood cells (which help fight infections)
- Bleeding may occur into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
- Decreased haemoglobin levels in blood (a substance in red blood cells)
- Decreased blood cell count
- Itching
- Coughing up blood or blood-tinged 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 due to liver or blood disease

Frequency 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 into joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
- Bleeding from haemorrhoids
- Stomach or intestinal ulcer (including oesophageal ulceration)
- Abnormal liver function test results

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 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.
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of this 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.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system. Ask your pharmacist how to dispose of medicines you no longer use. This will 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 75 mg of dabigatran etexilate (as mesilate).
The other ingredients are: tartaric acid, gum arabic, hypromellose, dimethicone 350, talc and hydroxypropyl cellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171) and hypromellose.

What Dabigatran Eteksylan Stada looks like and contents of the pack
Dabigatran Eteksylan Stada 75 mg is white to off-white pellets contained in white or off-white hard capsules of size 2.
Dabigatran Eteksylan Stada is available in packs containing 3 x 10 hard capsules in perforated blisters made of Aluminium/OPA/Aluminium/PVC foil, packed in a cardboard box.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information, 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 your doctor. To ensure safe use of Dabigatran Eteksylan Stada, please read the important information provided in the Patient Leaflet.
This Card contains important information about your treatment and should always be kept with you. 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 is a blood thinner. 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 attention 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 help 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 effect of anaesthesia wears off, as urgent medical care may be 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 procedures or other invasive procedures.
In the event 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 recommendations 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: