Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran etexilate Polpharma, 110 mg, hard capsules
dabigatran etexilate
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with 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. 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 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 the formation of blood clots in veins following hip or knee replacement surgery.
• preventing blood clots in the brain (stroke) and in other blood vessels in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs, and preventing recurrence of such clots.

Dabigatran etexilate Polpharma is used in children for:

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

2. Important information before taking Dabigatran etexilate Polpharma

When not to take Dabigatran etexilate Polpharma

• if the patient is allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe impairment of kidney function.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organs 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, which 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 via the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe impairment of liver function 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 transplanted organs.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Polpharma, discuss this with your doctor.
If symptoms occur during treatment with this medicine or if the patient undergoes a surgical procedure, consult your doctor.
The patient should inform the doctor if they currently have or have had in the past 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 (biopsy) within the last month.
  • if the patient has sustained 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 etexilate Polpharma and other medicines”.
  • if the patient is taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
  • if the patient has an infection in the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or the patient 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.
• if the patient has had a heart attack or if the patient has been diagnosed with conditions that increase 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 taking Dabigatran etexilate Polpharma

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran etexilate Polpharma is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Polpharma exactly as directed by the doctor before and after surgery.
• if a surgical procedure requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• It is very important to take Dabigatran etexilate 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 bowel or bladder disturbances after the anaesthesia wears off, as urgent medical care is required.
  • if the patient falls or sustains an injury during treatment, especially if the head is injured. The patient should seek immediate medical attention. The doctor will assess whether there is an increased risk of bleeding.
  • if the patient has a condition 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 etexilate 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 tell the doctor before taking Dabigatran etexilate 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 medicines 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 the medicine was prescribed. See section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A fixed-dose 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 unknown what effect Dabigatran etexilate 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 potential should use effective contraception to prevent pregnancy while taking Dabigatran etexilate Polpharma.
Breastfeeding is not recommended during treatment with Dabigatran etexilate Polpharma.

Driving and operating machinery
Dabigatran etexilate Polpharma has no influence on the ability to drive or operate machinery.

3. How to take Dabigatran etexilate Polpharma

Dabigatran etexilate Polpharma capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate pharmaceutical forms are available for treating children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Take Dabigatran etexilate Polpharma exactly as directed below:

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).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (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 daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced renal function (by more than half) should take a reduced dose of 75 mg of Dabigatran etexilate Polpharma due to increased risk of bleeding.

Treatment should not be initiated if there is active bleeding from the surgical site. If treatment cannot be started within the first day after surgery, it should be initiated with a dose of 2 capsules once daily.

After knee joint replacement surgery
Treatment with Dabigatran etexilate Polpharma should be started by taking one capsule within 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 10 days.

After hip joint replacement surgery
Treatment with Dabigatran etexilate Polpharma should be started by taking one capsule within 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Prevention of thromboembolic events in blood vessels of the brain and body by preventing clot formation due to irregular heart function, and treatment and prevention of recurrent blood clots in the veins of the legs and lungs
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 Dabigatran etexilate Polpharma at a reduced dose of 220 mg taken as one 110 mg capsule twice daily due to the potential increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend treatment with 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. Dabigatran etexilate Polpharma should be taken as directed by the doctor.

In patients undergoing implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, treatment with Dabigatran etexilate Polpharma may be given once the doctor confirms adequate control of blood coagulation. Dabigatran etexilate Polpharma should be taken as directed by the doctor.

Treatment and prevention of recurrent blood clots in children
Dabigatran etexilate 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 prescribed medicines unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran etexilate 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 etexilate Polpharma capsules

Single doses requiring 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 etexilate Polpharma
Dabigatran etexilate Polpharma 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 blister packs
The following pictogram illustrates how to remove Dabigatran etexilate Polpharma capsules from the blister pack.

Detach the single dose along the perforated line.

Peel back the protective foil from the blister and remove the capsule.

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

Switching anticoagulant medication
Do not switch anticoagulant medication without first obtaining detailed instructions from your doctor.

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

Missed 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 usual time on the next day.
Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of blood clots in the brain and other parts of the body by preventing clots caused by irregular heart rhythm, and treatment and prevention of recurrence of blood clots in the veins of the legs and lungs
Use in children: Treatment of blood clots and prevention of recurrence of blood clots

A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken.
Do not take a double dose to make up for a missed dose.

Stopping Dabigatran etexilate Polpharma
Dabigatran etexilate Polpharma should be taken exactly as prescribed by your doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dabigatran etexilate Polpharma affects the blood clotting system, therefore most adverse effects involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect 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 that does not stop spontaneously occurs, 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 serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse effects listed below are grouped according to their frequency of occurrence:

Prevention of blood clots after hip or knee replacement surgery
Common (may affect up to 1 in 10 people):

• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results in laboratory tests.

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 pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into a joint, due to injury or after injury or surgical procedure
• Formation of bruises or haematomas after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell fraction
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid leakage from surgical wound)
• Increased liver enzyme activity
• Yellowing 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 incision site, from the injection site or from the site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decrease in platelet count in the blood
• Decrease in red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound.

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.

Prevention of blood clots in blood vessels of the brain and 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 red blood cell count 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 haemorrhoids, from the rectum, or into the brain
• Formation of bruises
• Coughing up blood or blood-tinged sputum
• Decrease in platelet count in the blood
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (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 the surgical incision site, from a wound, from the 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 with dark red, raised, itchy bumps due to an allergic reaction
• Decrease in blood cell fraction
• 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 trials, the number of heart attacks with Dabigatran etexilate Polpharma was higher than with warfarin. The overall number of events was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in 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 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 due to injury
• Bleeding may occur from haemorrhoids
• Decrease in red blood cell count in the blood
• Formation of bruises
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (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 the surgical incision site, from the injection site or from the site of intravenous catheter insertion, or bleeding into the brain
• Decrease in platelet count in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with 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 haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell fraction
• 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 trials, the number of heart attacks with dabigatran etexilate was higher 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 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 in the blood
• Decrease in platelet count in the blood
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of bruises
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (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 white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell fraction
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus 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 the surgical incision site, from the injection site or from the site of intravenous catheter insertion
• Bleeding may occur from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests.

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

5. How to store Dabigatran etexilate Polpharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Polpharma contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: tartaric acid, acacia gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), hypromellose 2910 and purified water.
• The black printing ink contains shellac, black iron oxide (E 172) and potassium hydroxide.

What Dabigatran etexilate Polpharma looks like and contents of the pack
Dabigatran etexilate Polpharma 110 mg is a hard capsule (approximately 19x7 mm in size) with an opaque light blue cap and an opaque light blue body. The imprint "110" appears on the body of the hard capsule.
The medicine is available in packs containing 10, 30, 60, 100 or 180 hard capsules, in a multipack containing 3 packs of 60 hard capsules (180 hard capsules) or in a multipack containing 2 packs of 50 hard capsules (100 hard capsules), in blisters made of OPA/Aluminium/PVC//Aluminium foil, in a cardboard carton.
Single-dose blisters:
This medicine is available in packs containing 10x1, 30x1, 60x1, 100x1, 180x1 hard capsules, in a multipack containing 3 packs of 60x1 hard capsules (180 hard capsules) or in a multipack containing 2 packs of 50x1 hard capsules, in perforated single-dose blisters made of OPA/Aluminium/PVC//Aluminium foil of the "peel off" type, in a cardboard carton.
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

Importer
Laboratori Fundacio Dau
Poligono Industrial Zona - De La Zona Franca De Barcelona
Carrer Lletra C De La Zona Franca 12-14
08040 Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany: Dabigatran Welding 110mg Kapseln
France: Dabigatran etexilate Welding 110mg gelule
Italy: Dabigatran etexilato Welding Capsules
Luxembourg: Dabigatran Welding 110mg Capsules