Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran etexilate Polpharma, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dabigatran etexilate Polpharma is and what it is used for
2. What you need to know 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 Dabigatran etexilate Polpharma is and what it is used for

Dabigatran etexilate Polpharma 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 responsible for blood clot formation.
Dabigatran etexilate Polpharma is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body in patients who have a type of irregular heart rhythm called non-valvular atrial fibrillation and at least one additional risk factor.
• 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.

Dabigatran etexilate Polpharma is used in children for:

• treatment of blood clots and prevention of recurrence of blood clots.

2. Important information before taking Dabigatran eteksylan Polpharma

When not to take Dabigatran eteksylan Polpharma

• If the patient is allergic to dabigatran eteksylan or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe kidney function impairment.
• 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 liver function impairment 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 an artificial heart valve that requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran eteksylan Polpharma, discuss this with your doctor.
If symptoms occur during treatment with Dabigatran eteksylan Polpharma or if the patient needs to undergo a surgical procedure, contact your 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 a surgical tissue 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 Polpharma and other medicines”;
• if the patient is taking anti-inflammatory medicines 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) and/or foamy 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.
• following a heart attack or if the patient has been diagnosed with conditions increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such a case, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran eteksylan Polpharma

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran eteksylan Polpharma is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran eteksylan Polpharma exactly as directed by the doctor before and after surgery.
• if surgery requires insertion of a catheter or administration of an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is very important to take Dabigatran eteksylan Polpharma exactly as directed by the doctor before and after surgery.
• the patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs, or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care is required.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention should be sought. The doctor will assess whether there may be 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 their doctor, who will decide whether a change in treatment is necessary.

Dabigatran eteksylan Polpharma 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 inform the doctor before taking Dabigatran eteksylan Polpharma 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 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 eteksylan Polpharma depending on the condition for which the medicine was prescribed. See also 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 Polpharma has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing age should avoid becoming pregnant while taking Dabigatran eteksylan Polpharma.
Breastfeeding should not be undertaken during treatment with Dabigatran eteksylan Polpharma.

Driving and operating machinery
The effect of Dabigatran eteksylan Polpharma on the ability to drive and operate machinery is unknown.

3. How to take Dabigatran eteksylan Polpharma

Dabigatran eteksylan Polpharma capsules can be used in adults, adolescents, 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 must always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor.
Take Dabigatran eteksylan Polpharma exactly as directed below:
Prevention of blood clots in the blood vessels of the brain and the rest of the body by preventing the formation of clots that occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
In patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran eteksylan Polpharma of 220 mg taken as one 110 mg capsule twice daily due to a potentially increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend treatment with Dabigatran eteksylan Polpharma at a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with this medicine may be continued if the patient requires restoration of normal heart rhythm via a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Dabigatran eteksylan Polpharma should be taken exactly as directed by the doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran eteksylan Polpharma after the doctor has confirmed adequate control of blood coagulation. Dabigatran eteksylan Polpharma should be taken exactly as directed by the doctor.
Treatment of blood clots and prevention of recurrent blood clots in children
Dabigatran eteksylan Polpharma 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 be as close as possible to 12 hours.
The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless the doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran eteksylan Polpharma in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Dabigatran eteksylan Polpharma
Body weight and age ranges
Body weight in kg Age in years Single dose Total daily dose
in mg 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
Single doses requiring combination of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule and one 150 mg capsule, or one 110 mg capsule and two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule and one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran eteksylan Polpharma
Dabigatran eteksylan Polpharma may be taken with or without food. The capsules should 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.

Instructions for opening blister packs
The following pictogram illustrates how to remove Dabigatran eteksylan Polpharma capsules from the blister pack.

Peel off an individual blister from the strip along the perforated line.

Remove the protective foil and take out the capsule.

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

Switching anticoagulant medicines
Do not switch anticoagulant medicines without detailed instructions from the doctor.

Taking more than the recommended dose of Dabigatran eteksylan Polpharma
Taking more than the recommended dose of Dabigatran eteksylan Polpharma increases the risk of bleeding. If a patient has taken too many capsules, contact the doctor immediately. Specific treatment methods are available.

Missing a dose of Dabigatran eteksylan Polpharma
A missed dose may be taken if there is at least 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 Polpharma
Dabigatran eteksylan Polpharma should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting the doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact the doctor if gastrointestinal discomfort occurs after taking Dabigatran eteksylan Polpharma.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Dabigatran etexilate Polpharma affects the blood clotting system, therefore most adverse reactions involve symptoms such as bruising or bleeding.
Severe or major bleeding may occur, which is the most serious adverse reaction and, regardless of location, may lead to disability, be life-threatening, or even result in death.
In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, 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 observation or change the treatment.
In case of a severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

Possible adverse reactions listed below are grouped according to their frequency of occurrence.

Prevention of thromboembolism in blood vessels of the brain and the rest of the body by preventing clots that form due to irregular heart function

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 pink or red urine due to presence of blood), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hemorrhoids, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Inflammation of the esophagus and stomach
• Regurgitation of stomach contents into the esophagus (reflux)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory tests

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

• Bleeding may occur into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of intravenous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
• Decrease in blood cell count
• Increased liver enzyme activity
• 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):

• Difficulty breathing or wheezing
• Decrease in, or even absence of, white blood cells (which help fight infections)
• Hair loss

In clinical studies, the number of heart attacks was higher with dabigatran etexilate than with warfarin. The overall number of events was small.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and (or) lungs

Common (may affect up to 1 in 0 people):

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

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur into a joint or following injury
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Inflammation of the esophagus and stomach
• Regurgitation of stomach contents into the esophagus (reflux)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results in laboratory tests
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision site, or from an injection site or site of intravenous catheter insertion, or bleeding into the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Decrease in, or even absence of, white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical studies, the number of heart attacks was higher with dabigatran etexilate than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

Treatment and prevention of recurrence of blood clots in children

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash characterized by dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of hematomas
• Nosebleeds
• Regurgitation of stomach contents into the esophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people):

• Decrease in the number of white blood cells (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 pink or red urine due to presence of blood), or under the skin
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the esophagus 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 may occur into a joint, from a wound, from a surgical incision site, from an injection site, or from the site of intravenous catheter insertion
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results in laboratory tests

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dabigatran eteksylan Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
The labelling on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Do not store above 30°C.
Keep 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 eteksylan Polpharma contains

• The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate), equivalent to 150 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), indigo carmine (E 132).

What Dabigatran eteksylan Polpharma looks like and contents of the pack
Dabigatran eteksylan Polpharma 150 mg is a hard capsule with a blue cap and a white to almost white body, size 0, filled with almost white to light yellowish pellets.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Dabigatran etexilate Galenicum Axium 150 mg, gélule
Spain: Dabigatrán etexilato Normon 150 mg cápsulas duras EFG
Malta: Dabigatran etexilate Galenicum Axium 150 mg hard capsule
Germany: Dabigatranetexilat Galenicum Axium 150 mg Hartkapseln