Dabigatran etexilate +pharma

Package Leaflet: Information for the Patient

Dabigatran etexilate +pharma, 75 mg, hard capsules

Dabigatran etexilate

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

• 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 the substance in the body responsible for the formation of blood clots.
Dabigatran etexilate +pharma is used in adults to:

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

Dabigatran etexilate +pharma is used in children to:

• treat blood clots and prevent recurrent 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 impairment
• 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, recent brain or eye surgery)
• if you have an increased tendency to bleed. It may be congenital, of unknown cause, or caused by taking 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, or when heparin is administered to maintain catheter patency or restore normal heart function through a procedure called catheter ablation in atrial fibrillation

if you have severe liver impairment 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 transplant rejection
• 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 a mechanical 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 with this medicine, 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. 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 etexilate +pharma 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)
• 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.
• if you have had a heart attack or 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 discontinue the use of Dabigatran etexilate +pharma due to the increased risk of bleeding during and 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. for spinal or epidural anesthesia or pain relief)
• 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 lower limbs or bowel or bladder problems 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 the medicines you are taking, have recently taken, or plan to take.
In particular, before taking Dabigatran etexilate +pharma, tell your doctor if you are taking any of the following medicines:

• medicines that reduce blood clotting (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).
• For 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 transplant rejection (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. 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 (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 formulations for the treatment of children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Take Dabigatran etexilate +pharma as follows:

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 each).
If kidney function is reducedby more than half or if you are 75 years of age 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 etexilate +pharma is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medicines with reduced kidney functionof more than half should take a reduced dose of 75 mgof Dabigatran etexilate +pharma due to increased bleeding risk.
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 knee replacement surgery
Treatment with Dabigatran etexilate +pharma should be started with a single capsule taken within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate +pharma should be started with a single capsule taken within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran etexilate +pharma 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. You should continue to take all other medicines unless your doctor instructs you to stop taking them.
A single dose of Dabigatran etexilate +pharma 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>

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

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

75 mg

11 to <13

This means that no dosing recommendations 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 break, 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 tighten the bottle 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

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Dabigatran etexilate +pharma at the same time the next day.
Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children. The 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 the 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 too early.
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 may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), 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, contact your doctor immediately.
Side effects are listed below by frequency:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)

Common(may affect up to 1 in 10 people)

• decrease in hemoglobin in the blood (a substance in red blood cells)
• abnormal liver function test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding that may occur from the nose, 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

from hematomas, from the anus, bleeding under the skin, from injury, or after surgery

• formation of hematomas or bruising after surgery
• blood in the stool as detected by laboratory tests
• decrease in red blood cell count
• decrease in hematocrit
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion (oozing of fluid from the surgical wound)
• increased liver enzyme activity
• jaundice (yellowing of the skin or whites of the eyes due to liver or blood disease).

Rare(may affect up to 1 in 1000 people)

• bleeding
• may occur bleeding into the brain, from the surgical site, from the injection site, or from the catheter insertion site
• blood-tinged secretion from the catheter insertion site
• coughing up blood or sputum tinged with blood
• decrease in platelet count
• 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 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 secretion
• wound secretion from the surgical wound.

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

• difficulty breathing or wheezing
• decrease in or absence of white blood cells (which help fight infections)
• hair loss.

Treatment of blood clots and prevention of recurrent blood clots in children
Common(may affect up to 1 in 10 people)

• decrease in red blood cell count
• decrease in platelet count
• 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
• diarrhea
• indigestion
• hair loss
• increased liver enzyme activity.

Uncommon(may affect up to 1 in 100 people)

• decrease in white blood cell count (which help fight infections)
• may occur bleeding into the stomach or intestines, brain, anus, penis/vagina, or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• decrease in hemoglobin in the blood (a substance in red blood cells)
• decrease in hematocrit
• itching
• coughing up blood or sputum tinged with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice (yellowing 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
• may occur bleeding into the joint, from the wound, from the surgical site, from the injection site, or from the catheter insertion site
• bleeding from hematomas
• stomach or intestinal ulcer (including esophageal ulceration)
• 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 pack
Store in the original package to protect from moisture. Do not put the capsules in containers or pill organizers unless they are in the original package.
Bottle
Shelf life after first opening the bottle: 4 months.
Store the bottle tightly closed. Keep the medicine in the original package to protect from moisture.
Do not put the capsules in containers or pill organizers.
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. Each hard capsule contains 75 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), hypromellose; black ink for printing: shellac, propylene glycol, concentrated ammonia solution, black iron oxide (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 "DA75".
This medicine is available in packs containing 10, 30, and 60 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 75 mg hard capsules
Austria:
Dabigatran etexilate Genericon 75 mg hard capsules
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:June 2023