Dabigatran etexilate +pharma

Package Leaflet: Information for the Patient

Dabigatran Etexilate +pharma, 150 mg, Hard Capsules

Dabigatran Etexilate

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

• Keep this package 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dabigatran Etexilate +pharma and what is it used for
• 2. Important information before taking Dabigatran Etexilate +pharma
• 3. How to take Dabigatran Etexilate +pharma
• 4. Possible side effects
• 5. How to store Dabigatran Etexilate +pharma
• 6. Contents of the pack and other information

1. What is Dabigatran Etexilate +pharma and what is it used for

Dabigatran Etexilate +pharma 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 the formation of blood clots.

Dabigatran Etexilate +pharma is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs

Dabigatran Etexilate +pharma is used in children to:

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

2. Important information before taking Dabigatran Etexilate +pharma

When not to take Dabigatran Etexilate +pharma

• 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 congenital, of unknown cause or caused by the use of other medicines
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation
• if you have severe liver problems or liver disease that can lead to death
• if you are taking oral ketoconazole or itraconazole - medicines used to treat fungal infections
• if you are taking oral cyclosporine - a medicine that prevents the rejection of a transplanted organ
• if you are taking dronedarone - a medicine used to treat heart rhythm disorders
• if you are taking a combination medicine containing glecaprevir and pibrentasvir - an antiviral medicine used to treat hepatitis C
• if you have been fitted with an artificial heart valve that requires continuous anticoagulation

Warnings and precautions

Before starting treatment with Dabigatran Etexilate +pharma, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment, consult your doctor.

You should tell 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. bone 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 also "Dabigatran Etexilate +pharma and other medicines" below.
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam
• if you have an infection of the heart (bacterial endocarditis)
• 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 case of a history of heart attack or if you have been diagnosed with conditions that increase the risk of heart attack
• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful when taking Dabigatran Etexilate +pharma

• if you need to undergo surgery. In this case, it is necessary to stop taking Dabigatran Etexilate +pharma due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate +pharma 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. to perform spinal or epidural anesthesia or to reduce pain)
• it is very important to take Dabigatran Etexilate +pharma 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 intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself during treatment, especially if you have injured 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 Etexilate +pharma and other medicines

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

Particularly, tell your doctor if you are taking any of the following medicines:

• anticoagulant medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• 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, the doctor may recommend a lower dose of Dabigatran Etexilate +pharma, depending on the condition for which the medicine was prescribed. See also section 3.
• medicines that prevent the rejection of a transplanted organ (e.g. tacrolimus, cyclosporine)
• a combination medicine containing glecaprevir and pibrentasvir - an antiviral medicine used to treat hepatitis C
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort (a herbal medicine used to treat depression)
• antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors
• rifampicin or clarithromycin (antibiotics)
• antiviral medicines used to treat AIDS (e.g. ritonavir)
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effect of Dabigatran Etexilate +pharma on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy unless your doctor considers it safe.

Women of childbearing age should avoid becoming pregnant while taking Dabigatran Etexilate +pharma.

Do not breastfeed while taking Dabigatran Etexilate +pharma.

Driving and using machines

Dabigatran Etexilate +pharma has no or negligible influence on the ability to drive and use machines.

Dabigatran Etexilate +pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".

3. How to take Dabigatran Etexilate +pharma

Dabigatran Etexilate +pharma capsules can be taken by adults and children aged 8 years or older who can swallow capsules whole.

There are other age-appropriate pharmaceutical forms for the treatment of children under 8 years of age.

This medicine should always be taken exactly as your doctor has instructed.

In case of doubt, consult your doctor.

Take Dabigatran Etexilate +pharma as follows:

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart rhythm, and treatment of blood clots in the veins of the legs and lungs, and prevention of recurrence of blood clots in the veins of the legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

In patients aged 80 years or older, the recommended dose of the medicine is 220 mg taken as one 110 mg capsule twice a day.

Patient taking medicines containing verapamilshould receive a reduced dose of Dabigatran Etexilate +pharma, 220 mg, taken as one 110 mg capsule twice a day, due to the possible increased risk of bleeding.

In patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice a day.

Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or catheter ablation in atrial fibrillation.

Dabigatran Etexilate +pharma should be taken as instructed by your 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 Etexilate +pharma after the doctor has confirmed that normal blood clotting control has been achieved.

Dabigatran Etexilate +pharma should be taken as instructed by your doctor.

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

Dabigatran Etexilate +pharma should be taken twice a day, 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 the age and weight of the patient.

The doctor will determine the correct dose.

The doctor may adjust the dose during treatment.

Continue to take all other medicines, unless your doctor instructs you to stop taking any of them.

A single dose of Dabigatran Etexilate +pharma to be taken twice a day, in milligrams (mg), depending on the patient's weight in kilograms (kg) and age in years:

Age in years

8 to <9 9 to <10< h4>

17

to
<18
>81

300 mg

71 to <81

as two 150 mg capsules

10

to
<11

11

to
<12

12

to
<13

13

to
<14

14

to
<15

15

to
<16

16

to
<17

or
four 75 mg capsules

61 to <71

260 mg

as one 110 mg capsule plus one 150 mg capsule

51 to <61 or

as one 110 mg capsule plus two 75 mg capsules

Body weight [kg]

41 to <51

220 mg

as two 110 mg capsules

31 to <41

185 mg

as one 75 mg capsule plus one 110 mg capsule

26 to <31

150 mg

as one 150 mg capsule
or
two 75 mg capsules

21 to <26

16 to <21

One 110 mgcapsule

13 to <16

One
capsule

11 to <13

75 mg

This means that no dosing instructions can be given.

How to take Dabigatran Etexilate +pharma

Dabigatran Etexilate +pharma 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, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• To open the bottle, press and turn the cap.
• After removing the capsule and taking the dose, immediately close the bottle tightly with the cap.

Changing anticoagulant medicine

Do not change your anticoagulant medicine without receiving detailed instructions from your doctor.

Taking a higher dose of Dabigatran Etexilate +pharma than recommended

Taking too much of this medicine increases the risk of bleeding.

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

Specific treatments are available.

Missing a dose of Dabigatran Etexilate +pharma

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

If there are less than 6 hours 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 Etexilate +pharma

Dabigatran Etexilate +pharma should be taken as instructed by your doctor.

Do not stop taking this medicine without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely.

Contact your doctor if you experience indigestion after taking Dabigatran Etexilate +pharma.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dabigatran Etexilate +pharma can cause side effects, although not everybody gets them.

Dabigatran Etexilate +pharma affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.

Severe or heavy bleeding can occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location, and in some cases, these bleeds may not be visible.

If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (extreme weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately.

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

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

Side effects are grouped by frequency as follows:

Common(may affect up to 1 in 10 people)

• bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• reduced number of red blood cells in the blood
• abdominal pain or stomach pain
• indigestion
• diarrhea
• nausea

Uncommon(may affect up to 1 in 100 people)

• bleeding
• bleeding may occur from hematomas, from the rectum, or from the urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• formation of hematomas
• coughing up blood or sputum discolored with blood
• reduced number of platelets in the blood
• reduced hemoglobin content in the blood (a substance in red blood cells)
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis or gastritis
• gastroesophageal reflux disease
• vomiting
• difficulty swallowing
• abnormal liver function test results
• increased liver enzyme activity

Rare(may affect up to 1 in 1,000 people)

• bleeding may occur into a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site into a vein
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing facial or throat swelling
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• reduced red blood cell count
• increased liver enzyme activity
• jaundice of the skin or whites of the eyes due to liver or blood disease

Frequency not known(frequency cannot be estimated from the available data)

• difficulty breathing or wheezing
• reduced white blood cell count (which helps fight infections)
• reduced hemoglobin content in the blood (a substance in red blood cells)
• reduced red blood cell count
• hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in patients taking warfarin.

The overall number of occurrences was small.

Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

Common(may affect up to 1 in 10 people)

• bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• indigestion

Uncommon(may affect up to 1 in 100 people)

• bleeding
• bleeding may occur into a joint or due to injury
• bleeding may occur from hematomas
• reduced number of red blood cells in the blood
• formation of hematomas
• coughing up blood or sputum discolored with blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis or gastritis
• gastroesophageal reflux disease
• nausea
• vomiting
• abdominal pain or stomach pain
• diarrhea
• abnormal liver function test results
• increased liver enzyme activity

Rare(may affect up to 1 in 1,000 people)

• bleeding may occur from a surgical incision, from an injection site, or from a catheter insertion site into a vein, or bleeding into the brain
• reduced number of platelets in the blood
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing facial or throat swelling
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• difficulty swallowing

Frequency not known(frequency cannot be estimated from the available data)

• difficulty breathing or wheezing
• reduced hemoglobin content in the blood (a substance in red blood cells)
• reduced red blood cell count
• reduced white blood cell count (which helps fight infections)
• jaundice of the skin or whites of the eyes due to liver or blood disease
• hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in patients taking 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 who received placebo.

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

Common(may affect up to 1 in 10 people)

• reduced number of red blood cells in the blood
• reduced number of platelets 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
• nasal bleeding
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increased liver enzyme activity

Uncommon(may affect up to 1 in 100 people)

• reduced white blood cell count (which helps fight infections)
• bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• reduced hemoglobin content in the blood (a substance in red blood cells)
• reduced red blood cell count
• itching
• coughing up blood or sputum discolored with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice of the skin or whites of the eyes due to liver or blood disease

Frequency not known(frequency cannot be estimated from the 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 a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site into a vein
• bleeding may occur from hematomas
• stomach or intestinal ulcers (including esophageal ulcers)
• abnormal liver function test results

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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 Etexilate +pharma

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 or bottle after "EXP".

The expiry date refers to the last day of the month stated.

Blister

Store in the original package to protect from moisture.

Do not put the capsules in containers or pill boxes unless they are in the original package.

Bottle

Shelf life after first opening the bottle: 4 months.

Store the bottle tightly closed.

Store in the original package to protect from moisture.

Do not put the capsules in containers or pill boxes.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Dabigatran Etexilate +pharma contains

• The active substance is dabigatran etexilate.
• Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: capsule contents: microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid (granule), hydroxypropylcellulose, mannitol, magnesium stearate, talc; capsule shell: red iron oxide (E 172), titanium dioxide (E 171), black ink for printing: shellac, propylene glycol, ammonia solution, iron oxide black (E 172), potassium hydroxide.

What Dabigatran Etexilate +pharma looks like and contents of the pack

Dabigatran Etexilate +pharma is available in the form of non-transparent, pink, hard capsules, with the imprint "DA150".

This medicine is available in packs of 10, 30, and 60 hard capsules, in collective packs containing 3 packs of 60 hard capsules (180 hard capsules) or in collective packs containing 2 packs of 50 hard capsules (100 hard capsules) in aluminum, perforated blisters with a desiccant, in a cardboard box.

This medicine is also available in white, non-transparent, polyethylene (plastic) bottles containing 60 hard capsules, closed with a white polypropylene cap, with a desiccant, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma Arzneimittel GmbH

Hafnerstrasse 211

8054 Graz

Austria

Importer

TOWA Pharmaceutical Europe, S.L.

C/de Sant Martí 75-97

08107 Martorelles

Barcelona

Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Malta - PLA3000 Paola

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Dabigatran etexilate +pharma
Croatia:
Dabigatran etexilate Genericon 150 mg hard capsules
Austria:
Dabigatran etexilate Genericon 150 mg hard capsules