Dabigatran eteksilan Polpharma

Leaflet accompanying the packaging: patient information

Dabigatran etexilate Polpharma, 75 mg, hard capsules

Dabigatranum etexilatum

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

• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dabigatran etexilate Polpharma and what is it used for

Dabigatran etexilate Polpharma 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 responsible for the formation of blood clots.
Dabigatran etexilate Polpharma is used in adults to:

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

Dabigatran etexilate Polpharma is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Polpharma

When not to take Dabigatran etexilate Polpharma

• 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 into the brain, recent brain or eye surgery).
• If you have an increased tendency to bleed. It may 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 switching 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 impairment or liver disease that can lead to death.

and other conditions that may increase the risk of bleeding.

• If you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• If you are taking oral cyclosporine, a medicine used to prevent organ 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 Polpharma, discuss it with your doctor.
If symptoms occur during treatment with Dabigatran etexilate Polpharma or if the patient needs to undergo surgery, consult a doctor.
The patient should inform the doctorif 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 had bleeding;
• if the patient has had a surgical biopsy within the last month;
• if the patient has had a serious injury (e.g. fracture, head injury or any injury requiring surgical treatment);
• if the patient has esophagitis or gastritis;
• if the patient has gastroesophageal reflux disease;
• if the patient is taking medicines that may increase the risk of bleeding. See also "Dabigatran etexilate Polpharma and other medicines";
• if the patient is taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam;
• if the patient has infective endocarditis (bacterial infection of the heart);
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing less dark, concentrated urine);
• if the patient is over 75 years old;
• if the patient is an adult and weighs 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 the patient has been diagnosed with conditions that increase the risk of myocardial infarction.
• if the patient has liver disease that affects blood test results. In such cases, the use of this medicine is not recommended.

When to be particularly careful when taking Dabigatran etexilate Polpharma

• if the patient needs to undergo surgery: In this case, it is necessary to discontinue Dabigatran etexilate Polpharma due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran etexilate Polpharma before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or to reduce pain):
• it is very important to take Dabigatran etexilate Polpharma before and after surgery exactly as the doctor has instructed.
• the doctor should be informed immediately if the patient experiences numbness or weakness of the lower limbs, or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if the patient has injured their head.

Medical attention should be sought immediately. The doctor will examine the patient to determine if there is an increased risk of bleeding.

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Dabigatran etexilate Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take.
In particular, tell your doctor before taking Dabigatran etexilate Polpharma if you 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 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 Polpharma, depending on the condition for which it was prescribed to the patient. See also section 3.
• medicines used to prevent organ 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. acetylsalicylic acid, ibuprofen, diclofenac);
• St. John's Wort, a herbal medicine used to treat depression;
• antidepressant medicines called selective serotonin or 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

The effect of Dabigatran etexilate Polpharma on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran etexilate Polpharma.
Do not breastfeed while taking Dabigatran etexilate Polpharma.

Driving and using machines

The effect of Dabigatran etexilate Polpharma on the ability to drive and use machines is not known.

3. How to take Dabigatran etexilate Polpharma

Dabigatran etexilate Polpharma capsules can be used in adults, adolescents and children aged 8 years or older who can swallow the 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 the doctor has instructed. If you are unsure, ask your doctor.

Take Dabigatran etexilate Polpharma as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If kidney function is reducedby more than half or in patients aged 75 years or older,
the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine or verapamil, the recommended dose of Dabigatran etexilate Polpharma is 150 mg once a day(taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medicines, with reduced kidney functionby more than half, should take a reduced dose of 75 mgof Dabigatran etexilate Polpharma 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 a day.
After knee replacement surgery
Dabigatran etexilate Polpharma treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once a day for a total of 10 days.
After hip replacement surgery
Dabigatran etexilate Polpharma treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, two capsules should be taken once a day for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrence of blood clots in children
Dabigatran etexilate Polpharma 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 body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor instructs to stop taking any of them.
Table 1 shows the single and total daily doses of Dabigatran etexilate Polpharma in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dabigatran etexilate Polpharma dosing table

Body weight and age ranges

Single dose Total daily dose in mg

Body weight in kg Age in years in mg

from 11 to less than 13 kg
from 8 to less than 9 years
75
150
from 13 to less than 16 kg
from 8 to less than 11 years
110
220
from 16 to less than 21 kg
from 8 to less than 14 years
110
220
from 21 to less than 26 kg
from 8 to less than 16 years
150
300
from 26 to less than 31 kg
from 8 to less than 18 years
150
300
from 31 to less than 41 kg
from 8 to less than 18 years
185
370
from 41 to less than 51 kg
from 8 to less than 18 years
220
440

from 51 to less than 61 kg
from 8 to less than 18 years
260
520
from 61 to less than 71 kg
from 8 to less than 18 years
300
600
from 71 to less than 81 kg
from 8 to less than 18 years
300
600
81 kg or more
from 10 to less than 18 years
300
600
Doses requiring the combination of more than one capsule:
300 mg:
two capsules of 150 mg or four capsules of 75 mg
260 mg:
one capsule of 110 mg and one capsule of 150 mg or
one capsule of 110 mg and two capsules of 75 mg
220 mg:
as two capsules of 110 mg
185 mg:
as one capsule of 75 mg and one capsule of 110 mg
150 mg:
as one capsule of 150 mg or two capsules of 75 mg

How to take Dabigatran etexilate Polpharma

Dabigatran etexilate Polpharma can be taken with or without food. The capsules should be swallowed whole, washed down with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters

The following diagram illustrates how to remove Dabigatran etexilate Polpharma capsules from the blister.
Detach a single blister from the blister pack along the perforated line.

Remove the protective foil and take out the capsule.

• Do not push the capsules through the blister foil.
• Do not tear off the blister foil until the capsule is needed.

Changing anticoagulant medicine

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

Taking a higher dose of Dabigatran etexilate Polpharma 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 Polpharma

Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran etexilate Polpharma 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 recurrence of 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 before 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 Polpharma

Dabigatran etexilate Polpharma 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.
Consult your doctor if you experience indigestion after taking Dabigatran etexilate Polpharma.
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 Polpharma can cause side effects, although not everybody gets them.
Dabigatran etexilate Polpharma affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.
Severe or massive bleeding may 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 bleeding occurs that does not stop by itself, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), seek medical attention immediately. The doctor may decide to monitor the patient closely or change the medicine.
If a severe allergic reaction occurs, which can cause difficulty breathing or dizziness, seek medical attention immediately.
Side effects are listed below by frequency:

• 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, stomach or intestines, brain, surgical wound, injection site or catheter insertion site
• formation of hematomas or bruising after surgery
• blood in the stool, as detected by laboratory tests
• decreased red blood cell count
• decreased hematocrit
• allergic reaction
• vomiting
• diarrhea
• nausea
• abdominal pain or stomach pain
• indigestion
• difficulty swallowing
• wound secretion
• wound secretion after surgery

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

• bleeding
• bleeding may occur into the joint, from the wound, from the surgical incision, from the injection site or from the catheter insertion site
• bloody secretion from the catheter insertion site
• coughing up blood or bloody sputum
• decreased platelet count
• decreased 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 and 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 after surgery

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

• difficulty breathing or wheezing
• decreased white blood cell count (which helps 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
• decreased platelet count
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin color and 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):

• decreased white blood cell count (which helps fight infections)
• bleeding may occur into the stomach or intestines, brain, anus, penis/vagina or urinary tract (including urine discoloration 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 bloody sputum
• 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 helps 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 the joint, from the wound, from the surgical incision, 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 any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
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 Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Do not store above 30°C.
Store in the original packaging 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. This will help protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate Polpharma contains

• The active substance is dabigatran etexilate. Each hard capsule contains 86.48 mg of dabigatran etexilate (as mesylate), equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc, hydroxypropylcellulose (100 cps); The capsule shell contains: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps).

What Dabigatran etexilate Polpharma looks like and contents of the pack

Dabigatran etexilate Polpharma 75 mg is a white or almost white, hard capsule, size 2, containing pale yellow pellets.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsule, hard, in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain
SAG Manufacturing, S.L.U.
Carretera Nacional 1 Km 36
28750 San Agustin de Guadalix, Madrid
Spain

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

France: Dabigatran etexilate Galenicum Axium 75 mg, gélule
Spain: Dabigatrán etexilato Normon 75 mg, cápsulas duras EFG
Malta: Dabigatran etexilate Galenicum Axium 75 mg, hard capsule
Germany: Dabigatranetexilat Galenicum Axium 75 mg, Hartkapseln

Date of last revision of the leaflet: