Dabigatran Eteksilan Stada

Patient Information Leaflet: Dabigatran Eteksylan Stada 75 mg, hard capsules

Dabigatran Eteksylan Stada, 75 mg, hard capsules

Dabigatranum etexilatum

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Patient Information 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 a substance in the body that is responsible for blood clotting.

Dabigatran Eteksylan Stada is used in adults to:

• prevent blood clots in the veins after hip or knee replacement surgery.

Dabigatran Eteksylan Stada is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before taking Dabigatran Eteksylan Stada

When not to take Dabigatran Eteksylan Stada

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you are currently bleeding.
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. This can be inherited, of unknown cause or caused by taking other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment, introducing a venous or arterial catheter when heparin is administered to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

... (rest of the translation remains the same, following the exact structure and format as the original, with all medical terminology accurately translated into English.)

Warnings and precautions

Before starting treatment with Dabigatran Eteksylan Stada, you should discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with Dabigatran Eteksylan Stada, you should consult your doctor.

You should inform your doctorif you have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently had bleeding.
• if you have had a surgical biopsy within the last month.
• if you have had a serious injury (e.g. fracture, head injury or any injury requiring surgical treatment).
• if you have esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medicines that may increase the risk of bleeding. See "Dabigatran Eteksylan Stada and other medicines" below.
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and passing less urine than usual).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a history of myocardial infarction or if you have been diagnosed with conditions that increase the risk of myocardial infarction.
• if you have liver disease that affects blood test results. In this case, the use of Dabigatran Eteksylan Stada is not recommended.

When to be particularly careful when taking Dabigatran Eteksylan Stada

• if you need to undergo surgery: In this case, it is necessary to discontinue Dabigatran Eteksylan Stada due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or pain relief):
• It is very important to take Dabigatran Eteksylan Stada before and after surgery exactly as your doctor has instructed.
• You should immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you fall or injure yourself while being treated, especially if you injure your head. You should seek medical attention immediately. Your doctor will examine you to see if you may have an increased risk of bleeding.
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Dabigatran Eteksylan Stada and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

In particular, you should tell your doctor before taking Dabigatran Eteksylan Stada if you are taking any of the following medicines:

• anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they 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, your 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 organ rejection after transplantation (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. aspirin, 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

The use of Dabigatran Eteksylan Stada in pregnancy is not recommended, unless your doctor considers it necessary.

Women of childbearing age should avoid becoming pregnant while taking Dabigatran Eteksylan Stada.

Do not breastfeed while taking Dabigatran Eteksylan Stada.

Driving and using machines

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

3. How to take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada can be taken by adults and children aged 8 years and older who can swallow the capsules whole.

Always take Dabigatran Eteksylan Stada exactly as your doctor has instructed.

How to take Dabigatran Eteksylan Stada:

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 each).

If kidney function is reducedby more than half or if you are 75 years old or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).

For 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 each).

Patients taking medicines containing verapamil, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Dabigatran Eteksylan Stada due 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 daily.

After hip replacement surgery

Treatment with Dabigatran Eteksylan Stada should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery.

Then, take 2 capsules once daily for a total of 28 to 35 days.

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

Dabigatran Eteksylan Stada should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day.

The interval between doses should be approximately 12 hours.

The recommended dose depends on age and body weight.

Your doctor will determine the correct dose.

Your doctor may adjust the dose during treatment.

Continue to take all other medicines as instructed by your doctor.

A single dose of Dabigatran Eteksylan Stada, to be taken twice daily, in milligrams (mg), depending on the patient's body 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< h4>

four 75 mg capsules

61 to <71

260 mg

as one 110 mg capsule plus one 150 mg capsule

51 to <61 or< h4>

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

75 mg

capsule

11 to <13

This indicates that no dosing recommendations can be provided.

How to take Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada can be taken with or without food.

The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach.

Do not crush or chew them, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Switching from another anticoagulant

Do not switch from another anticoagulant without first consulting your doctor.

Taking too much Dabigatran Eteksylan Stada

Taking too much Dabigatran Eteksylan Stada increases the risk of bleeding.

If you have taken too many Dabigatran Eteksylan Stada capsules, contact your doctor immediately.

Specific treatments are available.

Missing a dose of Dabigatran Eteksylan Stada

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 a missed dose.

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

A missed dose can be taken up to 6 hours before the next scheduled dose.

If there are less than 6 hours 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 treatment with Dabigatran Eteksylan Stada

Dabigatran Eteksylan Stada should be taken as instructed by your doctor.

Do not stop taking Dabigatran Eteksylan Stada without first consulting your doctor, as the risk of blood clots may be higher if treatment is stopped too early.

Contact your doctor if you experience indigestion after taking Dabigatran Eteksylan Stada.

If you have any further questions on the use of this medicine, ask your 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 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.

In some cases, these bleedings may not be visible.

If you experience bleeding that does not stop by itself, or signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), you should contact your doctor immediately.

Your doctor may decide to monitor you closely or change your medicine.

If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, you should contact your doctor immediately.

Side effects are listed below by frequency:

Prevention of blood clots after hip or knee replacement surgery

Common (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 discolored pink or red due to the presence of blood), from hemorrhoids, from the anus, bleeding under the skin, into a joint, due to injury or after surgery

­

Formation of hematomas or bruising after surgery

­

Blood in the stool detected by laboratory tests

­

Decreased red blood cell count in the blood

­

Decreased hematocrit

­

Allergic reaction

­

Vomiting

­

Frequent passage of loose or liquid stools

­

Nausea

­

Presence of wound exudate (oozing of fluid from the surgical wound)

­

Increased liver enzyme activity

­

Jaundice or yellowing 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 wound, from the injection site or from the catheter insertion site into a vein

­

Blood-tinged discharge from the catheter insertion site into a vein

­

Coughing up blood or sputum tinged with blood

­

Decreased platelet count in the blood

­

Decreased red blood cell count in the blood after surgery

­

Severe allergic reaction causing difficulty breathing or dizziness

­

Severe allergic reaction causing swelling of the face or throat

­

Skin rash in the form of dark red, raised, itchy bumps due to 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

­

Indigestion

­

Difficulty swallowing

­

Wound exudate

­

Wound exudate from the surgical wound

Unknown frequency (frequency cannot be estimated from available data):

­

Breathing difficulties or wheezing

­

Decreased white blood cell count (which help fight infections)

­

Hair loss

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

Common (may affect up to 1 in 10 people):

­

Decreased red blood cell count in the blood

­

Decreased platelet count in the blood

­

Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction

­

Sudden change in skin color or appearance

­

Formation of hematomas

­

Nosebleeds

­

Gastroesophageal reflux disease

­

Vomiting

­

Nausea

­

Frequent passage of loose or liquid stools

­

Indigestion

­

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 discolored 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 tinged with blood

­

Abdominal pain or stomach pain

­

Esophagitis or gastritis

­

Allergic reaction

­

Difficulty swallowing

­

Jaundice or yellowing of the skin or whites of the eyes due to liver or blood disease

Unknown frequency (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

­

Breathing difficulties or wheezing

­

Bleeding

­

Bleeding may occur into a joint, from a wound, from the surgical wound, from the injection site or from the catheter insertion site into a vein

­

Bleeding may occur from hemorrhoids

­

Stomach or intestinal ulcer (including esophageal ulceration)

­

Abnormal liver function test results

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton, blister and bottle after "EXP".

The expiry date refers to the last day of that 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.

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 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, acacia, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.
• 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 a white or almost white pellet contained in a white or almost white hard capsule, size 2.

Dabigatran Eteksylan Stada is available in packs containing 3 x 10 hard capsules in perforated blisters of aluminum/OPA/Aluminum/PVC in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany