Dabigatran etexilate +pharma

Package leaflet: Information for the user

Dabigatran etexilate +pharma, 110 mg, hard capsules
Dabigatran etexilate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dabigatran etexilate +pharma is and what it is used for
2. What you need to know before taking Dabigatran etexilate +pharma
3. How to take Dabigatran etexilate +pharma
4. Possible side effects
5. How to store Dabigatran etexilate +pharma
6. Contents of the pack and other information

1. What Dabigatran etexilate +pharma is and what it is used for

Dabigatran etexilate +pharma 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 that is involved in blood clot formation.

Dabigatran etexilate +pharma is used in adults for:

• preventing blood clots in the veins after hip or knee replacement surgery
• preventing strokes and other blood clots in the body 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 legs and lungs, and preventing recurrence of blood clots in the legs and lungs

Dabigatran etexilate +pharma is used in children for:

• treating blood clots and preventing recurrence of blood clots

2. Important information before using Dabigatran etexilate +pharma

When not to use Dabigatran etexilate +pharma

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe kidney 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. stomach 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 through the catheter to maintain patency, or during a procedure called catheter ablation for atrial fibrillation
• if the patient has severe liver impairment or liver disease that may lead to death
• if the patient is taking oral ketoconazole or itraconazole – antifungal medicines
• 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 had a mechanical heart valve implanted, which requires ongoing use of blood-thinning medicines

Warnings and precautions
Before starting treatment with Dabigatran etexilate +pharma, discuss this with your doctor. If
you have experienced symptoms or undergone a surgical procedure while being treated with this
medicine, consult your doctor.
The patient should inform the doctor if they currently 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 (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 etexilate +pharma and other medicines”.
  • if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), 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)/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 previously had a heart attack or has conditions diagnosed to 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 using Dabigatran etexilate +pharma

• if the patient needs to undergo surgery
  In such a case, temporary discontinuation of Dabigatran etexilate +pharma is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate +pharma exactly as directed by the doctor both before and after surgery.
• if surgery 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 +pharma exactly as directed by the doctor both before and after surgery.
  • the patient must immediately inform the doctor if numbness or weakness in the legs or problems with bowel or bladder function occur after the anaesthesia wears off, as urgent medical attention is required.
• if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention is required. 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 the doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate +pharma and other medicines
Inform 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, inform the doctor if the
patient is 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 applied only to 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 +pharma depending on the condition for which the medicine has been prescribed. See also section 3.
• medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine)
• 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 (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 etexilate +pharma has on pregnancy or the unborn child. This
medicine should not be taken during pregnancy unless the doctor considers it safe. Women of
childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate +pharma.
Breastfeeding must not be undertaken while taking Dabigatran etexilate +pharma.

Driving and operating machinery
Dabigatran etexilate +pharma has no effect or has a negligible effect on the ability to drive and
use machines.

Dabigatran etexilate +pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning this medicine is considered "sodium-free".

3. How to take Dabigatran etexilate +pharma

Dabigatran etexilate +pharma capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are available for treating children under 8 years of age.
This medicine must always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Take Dabigatran etexilate +pharma as follows:
Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If kidney 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 +pharma is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medicines with reduced kidney function (by more than half) should take a reduced dose of 75 mg of Dabigatran etexilate +pharma due to increased bleeding risk.
In both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be started by the next day after surgery, it should be initiated at a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran etexilate +pharma should begin with one capsule taken 1 to 4 hours after completion of surgery. Then, take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate +pharma should begin with one capsule taken 1 to 4 hours after completion of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.
Prevention of blood clots in blood vessels of the brain and body by preventing clot formation due to irregular heart rhythm, and treatment and prevention of recurrence of blood clots in 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 verapamil-containing medicines should receive a reduced dose of Dabigatran etexilate +pharma of 220 mg taken as one 110 mg capsule twice daily due to possible increased bleeding risk.
In patients with potentially increased bleeding risk, 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 through a procedure called cardioversion. Dabigatran etexilate +pharma should be taken as directed by the doctor.
In case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran etexilate +pharma after the doctor confirms adequate control of blood coagulation. Dabigatran etexilate +pharma should be taken as directed by the doctor.
Treatment and prevention of recurrence of blood clots in children
Dabigatran etexilate +pharma 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 age and body weight. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Single dose of Dabigatran etexilate +pharma to be administered twice daily, in milligrams (mg), according to the patient's body weight in kilograms (kg) and age in years:
Age in years
8 to <9 9 to 10 11 12 13 14 15 16 17
<10 to to to to to to to to
<11 <12 <13 <14 <15 <16 <17 <18
>81 300 mg

71 to <81 as two 150 mg capsules
Body weight [kg]
or
61 to <71
four 75 mg capsules
260 mg
as one 110 mg capsule plus one 150 mg capsule
51 to <61
or
one 110 mg capsule plus two 75 mg capsules
220 mg
41 to <51
as two 110 mg capsules
185 mg
31 to <41
as one 75 mg capsule plus one 110 mg capsule
150 mg
26 to <31
as one 150 mg capsule
or

21 to <26
two 75 mg capsules
16 to <21

One capsule 110 mg
13 to <16

One

11 to <13 capsule
75 mg
Indicates that dosing recommendations cannot be provided.

How to take Dabigatran etexilate +pharma
Dabigatran etexilate +pharma may be taken with or without food. Capsules should be swallowed whole with a glass of water to aid 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 the bottle

• To open the bottle, press down and turn the cap.
• After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

Switching anticoagulant medicines
Do not switch anticoagulant medicines without specific instructions from your doctor.
Taking more than the recommended dose of Dabigatran etexilate +pharma
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 +pharma
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran etexilate +pharma at the usual time on the following day. Do not take a double dose to make up for a missed dose.
Use in adults: Prevention of blood clots in blood vessels of the brain and body by preventing clot formation due to irregular heart rhythm, and treatment and prevention of recurrence of blood clots in the legs and lungs.
Use in children: Treatment and prevention of recurrence of blood clots
A missed dose may be taken if there are more than 6 hours before the next scheduled dose.
If less than 6 hours remain until 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 etexilate +pharma
Dabigatran etexilate +pharma should be taken as prescribed by your doctor. Do not stop taking this medicine without consulting your doctor first, 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 +pharma.
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 +pharma affects the blood clotting system; therefore, most adverse effects involve symptoms such as bruising or bleeding. Severe or extensive 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 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 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 occur in up to 1 in 10 patients)

• Decreased haemoglobin levels (a substance in red blood cells) in blood
• Abnormal liver function test results

Uncommon (may occur in up to 1 in 100 patients)

• Bleeding which may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, following injury or after a surgical procedure
• Formation of bruises or haematomas after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (oozing of fluid from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

Rare (may occur in up to 1 in 1000 patients)

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in blood
• Decreased number of red blood cells in blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of 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
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks was numerically higher with dabigatran etexilate than with warfarin. The overall number of events was low.

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

Common (may occur in up to 1 in 10 patients)

• Bleeding may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased number of red blood cells in blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

Uncommon (may occur in up to 1 in 100 patients)

• Bleeding
• Bleeding may occur from haemorrhoids, rectum, or into the brain
• Formation of bruises
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in blood
• Decreased haemoglobin levels in 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

Rare (may occur in up to 1 in 1000 patients)

• Bleeding into joints, from the surgical incision site, wound, injection site, or 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• Decreased proportion of blood cells
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

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

• Difficulty breathing or wheezing
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks was numerically higher with dabigatran etexilate 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 occur in up to 1 in 10 patients)

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

Uncommon (may occur in up to 1 in 100 patients)

• Bleeding
• Bleeding may occur into joints or following injury
• Bleeding from haemorrhoids may occur
• Decreased number of red blood cells in 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
• Increased liver enzyme activity

Rare (may occur in up to 1 in 1000 patients)

• Bleeding from the surgical incision site, injection site, site of intravenous catheter insertion, or bleeding into the brain
• Decreased platelet count in blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of 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
• Decreased haemoglobin levels in blood (a substance in red blood cells)
• Decreased proportion of blood cells
• Decreased number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes caused by liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks was numerically 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 of blood clots and prevention of recurrent blood clots in children

Common (may occur in up to 1 in 10 patients)

• Decreased number of red blood cells in blood
• Decreased platelet count in blood
• Skin rash consisting of 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 occur in up to 1 in 100 patients)

• Decreased number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decreased haemoglobin levels in blood (a substance in red blood cells)
• Decreased proportion of blood cells
• 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 caused by liver or blood disease

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 joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding from haemorrhoids may occur
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

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 of the 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate +pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle
after: "EXP". The expiry date refers to the last day of the stated month.

Blister
Store in the original packaging to protect from moisture. Do not transfer
capsules to other containers or pill organizers unless the capsules are kept
in their original packaging.

Bottle
Shelf life after first opening the bottle: 4 months.
Keep the bottle tightly closed. Store the medicine in the original packaging
to protect from moisture.
Do not transfer capsules to other containers or pill organizers.

Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate +pharma contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• Other ingredients are: capsule contents: microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid (granulate), hydroxypropylcellulose, mannitol, magnesium stearate, talc.
  capsule shell: iron oxide red (E 172), titanium dioxide (E 171), hypromellose, black printing ink: shellac, propylene glycol, concentrated ammonium hydroxide, iron oxide black (E 172), potassium hydroxide.

What Dabigatran etexilate +pharma looks like and contents of the pack
Dabigatran etexilate +pharma is a hard capsule, opaque and pink in colour, printed with "DA110".
This medicine is available in packs of 10, 30 and 60 hard capsules, in multipacks containing 3 packs of 60 hard capsules (180 hard capsules) or in multipacks containing 2 packs of 50 hard capsules (100 hard capsules), in aluminium, perforated blisters with a desiccant, packed in a cardboard carton.
This medicine is also available in white, opaque polyethylene (plastic) bottles containing 60 hard capsules, closed with a white polypropylene cap, with a desiccant, all contained in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Importer
TOWA Pharmaceutical Europe, S.L.
C/de Sant Martí 75-97
08107 Martorelles
Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Malta - PLA3000 Paola

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Dabigatran etexilát +pharma
Croatia: Dabigatraneteksilat Genericon 110 mg tvrde kapsule
Austria: Dabigatranetexilat Genericon 110 mg Hartkapseln

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]