DABIGATRAN 110 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Dabigatran Etexilate Polpharma, 110 mg, Hard Capsules
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Dabigatran Etexilate Polpharma and What is it Used For
4. Important Information Before Taking Dabigatran Etexilate Polpharma
   1. When Not to Take Dabigatran Etexilate Polpharma
   2. Pregnancy and Breastfeeding
   3. Driving and Using Machines
5. How to Take Dabigatran Etexilate Polpharma
   1. Take Dabigatran Etexilate Polpharma as Follows:
   2. How to Take Dabigatran Etexilate Polpharma
   3. Instructions for Opening Blister Packs
   4. Changing Anticoagulant Medication
   5. Taking More Than the Recommended Dose of Dabigatran Etexilate Polpharma
   6. Missing a Dose of Dabigatran Etexilate Polpharma
   7. Stopping Dabigatran Etexilate Polpharma
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Dabigatran Etexilate Polpharma
8. Contents of the Package and Other Information
   1. What Dabigatran Etexilate Polpharma Contains
   2. What Dabigatran Etexilate Polpharma Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Dabigatran Etexilate Polpharma, 110 mg, Hard Capsules

Dabigatranum Etexilatum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package 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 medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.

Dabigatran Etexilate Polpharma is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heart rhythm called atrial fibrillation not caused by heart valve problems 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 Polpharma is used in children to:

• treat blood clots and prevent the 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 medication (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 disease, brain injury or bleeding into the brain, recent brain or eye surgery).
• If you have an increased tendency to bleed. This may be congenital, of unknown cause, or caused by the use of other medications.

about taking any other medications, including those you are currently taking or have recently taken, as well as any medications you plan to take.

• medications that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid);
• medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin;
• medications used to prevent organ rejection (e.g., tacrolimus, cyclosporine);
• a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C virus infection;
• medications used to treat inflammatory or painful conditions (e.g., acetylsalicylic acid, ibuprofen, diclofenac);
• St. John's Wort, a herbal medication used to treat depression;
• antidepressants called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors;
• rifampicin or clarithromycin (both antibiotics);
• antiviral medications used to treat AIDS (e.g., ritonavir);
• certain medications 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. Do not take this medication during pregnancy unless your doctor considers it safe. Women of childbearing age should prevent pregnancy 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 formulations for the treatment of children under 8 years of age.

This medication should always be taken as directed by your doctor. If you have any doubts, consult 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 daily (taken as 2 capsules of 110 mg each).

If kidney function is severely impaired 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).

Patients taking medications containing amiodarone, quinidine, or verapamil should receive a reduced dose of Dabigatran Etexilate Polpharma of 150 mg once daily (taken as 2 capsules of 75 mg each).

Prevention of Blood Clots in the Brain and Body Due to Irregular Heartbeat

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

For patients 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

Patients taking medications containing verapamil should receive a reduced dose of Dabigatran Etexilate Polpharma of 220 mg taken as one 110 mg capsule twice daily due to the potential increased risk of bleeding.

Treatment of Blood Clots in the Legs and Lungs and Prevention of Recurrence

The recommended dose is 300 mg taken as one 150 mg capsule twice daily for patients with a body weight of 50 kg or more, and 220 mg taken as one 110 mg capsule twice daily for patients with a body weight of less than 50 kg.

How to Take Dabigatran Etexilate Polpharma

Dabigatran Etexilate Polpharma can be taken with or without food. Swallow the capsules whole with a glass of water to facilitate passage into the stomach. Do not crush, chew, or open the capsules, as this may increase the risk of bleeding.

Instructions for Opening Blister Packs

The following diagram illustrates how to remove Dabigatran Etexilate Polpharma capsules from the blister pack.

Remove the protective foil and take out the capsule.

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

Changing Anticoagulant Medication

Do not change your anticoagulant medication without first consulting your doctor.

Taking More Than the Recommended Dose of Dabigatran Etexilate Polpharma

Taking more than the recommended dose of Dabigatran Etexilate Polpharma 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.

Prevention of Blood Clots in the Brain and Body Due to Irregular Heartbeat and Treatment of Blood Clots in the Legs and Lungs

Missed doses 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 Dabigatran Etexilate Polpharma

Dabigatran Etexilate Polpharma should be taken as directed by your doctor. Do not stop taking this medication without first consulting your doctor, as the risk of blood clot formation may be higher if treatment is stopped prematurely.

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

If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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 can 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, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medication.

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

The following side effects are grouped by frequency of occurrence.

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 discoloration due to blood), or bleeding under the skin
• 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
• Frequent loose or liquid stools
• Nausea
• Wound secretion
• Increased liver enzyme activity
• Jaundice 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
• Blood-tinged secretion from the catheter insertion site
• Coughing up blood or blood-tinged 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 with 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 (GERD)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound secretion
• Surgical wound secretion

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

Prevention of Blood Clots in the Brain and Body Due to Irregular Heartbeat

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 discoloration due to blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease (GERD)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into the joint, from the surgical wound, from the injection site, or from the catheter insertion site
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Decreased hematocrit
• 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
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Treatment of Blood Clots in the Legs and Lungs and Prevention of Recurrence

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 discoloration due to blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into the joint or due to trauma
• Bleeding from hematomas
• Decreased red blood cell count
• Formation of hematomas
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease (GERD)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical wound, from the injection site, or from the catheter insertion site, or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with 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
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased 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 frequency was low.

Treatment of Blood Clots and Prevention of Recurrence in Children

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

• Decreased red blood cell count
• Decreased platelet count
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease (GERD)
• Vomiting
• Nausea
• Frequent 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 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 discoloration due to 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 blood-tinged 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 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 the joint, from the wound, from the surgical wound, 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 package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 medication.

5. How to Store Dabigatran Etexilate Polpharma

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry date stated on the blister pack and carton after EXP.

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

The notation 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.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Dabigatran Etexilate Polpharma Contains

• The active substance is dabigatran etexilate. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesylate) equivalent to 110 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 Etexilate Polpharma Looks Like and Contents of the Package

Dabigatran Etexilate Polpharma 110 mg is a blue hard capsule, size 1, containing almost white to light yellow pellets.

This medication is available in packs containing 10 x 1, 30 x 1, or 60 x 1 hard capsule in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.

A collective pack containing 3 packs of 60 x 1 hard capsule (180 hard capsules) or a collective pack containing 2 packs of 50 x 1 hard capsule (100 hard capsules) in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.

Not all pack sizes may be marketed.

Marketing Authorization Holder

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 Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

France: Dabigatran etexilate Galenicum Axium 110 mg, gélule

Spain: Dabigatrán etexilato Normon 110 mg, cápsulas duras EFG

Malta: Dabigatran etexilate Galenicum Axium 110 mg, hard capsule

Germany: Dabigatranetexilat Galenicum Axium 110 mg, Hartkapseln

Date of Last Revision of the Package Leaflet: