Dabigatran etexilate medical valley

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any 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 someone else, 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.

Contents of the leaflet

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

1. What Dabigatran etexilate Medical Valley is and what it is used for

Dabigatran etexilate Medical Valley 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 Medical Valley is used in adults to:

• prevent the formation of blood clots in veins after hip or knee replacement surgery.
• prevent blood clots in the brain (stroke) and in other blood vessels in the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and to prevent recurrence of such clots.

Dabigatran etexilate Medical Valley is used in children to:

• treat blood clots and to prevent recurrence of blood clots.

2. Important information before taking Dabigatran etexilate Medical Valley

When not to take Dabigatran etexilate Medical Valley

• 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 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 during transition of anticoagulant therapy, insertion of 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 to restore normal heart rhythm.
• if the patient has severe liver function impairment or liver disease which 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 had an artificial heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran etexilate Medical Valley, discuss this with your doctor.
If the patient has experienced symptoms or undergone a surgical procedure while being treated with this medicine, the patient should contact the 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 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 oesophagitis or gastritis.
  • 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 Medical Valley 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 is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) and/or frothy 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 a condition that increases the risk of myocardial infarction.
• 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 Medical Valley

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran etexilate Medical Valley is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Medical Valley exactly as directed by the doctor both before and after surgery.

• if the surgical procedure requires insertion of a catheter or administration of a spinal injection (e.g. for epidural or spinal anaesthesia or for pain relief):

  • It is very important to take Dabigatran etexilate Medical Valley exactly as directed by the doctor both 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 anaesthetic wears off, as urgent medical care may be required.

• if the patient has fallen or sustained an injury during treatment, especially if the head was injured. 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 an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

Dabigatran etexilate Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient should tell the doctor before taking Dabigatran etexilate Medical Valley 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 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 Medical Valley depending on the condition for which the medicine was prescribed. See 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 selective 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 etexilate Medical Valley has on pregnancy or the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran etexilate Medical Valley.
Breastfeeding should not be undertaken while taking Dabigatran etexilate Medical Valley.

Driving and using machines
Dabigatran etexilate Medical Valley has no effect or a negligible effect on the ability to drive and use machines.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate strengths and 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 Medical Valley exactly as described below:

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 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 medications containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran etexilate Medical Valley is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medications containing verapamil who also have reduced renal function by more than half should receive a reduced dose of 75 mg of Dabigatran etexilate Medical Valley 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 day following surgery, it should be initiated with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran etexilate Medical Valley should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, two capsules should be taken once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran etexilate Medical Valley should begin with one capsule taken 1 to 4 hours after the end 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 recurrence of 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 medications containing verapamil should receive a reduced dose of Dabigatran etexilate Medical Valley 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.

This medicine may be continued if the patient requires restoration of normal heart rhythm through a procedure called cardioversion. Dabigatran etexilate Medical Valley should be taken 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 etexilate Medical Valley after the doctor confirms adequate control of blood coagulation. Dabigatran etexilate Medical Valley should be taken as directed by the doctor.

Treatment and prevention of recurrence of blood clots in children
Dabigatran etexilate Medical Valley 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 ideally be 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 prescribed medications unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of dabigatran etexilate 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 in capsule form

Single doses requiring combination of more than one capsule:
300 mg: two capsules of 150 mg or four capsules of 75 mg
260 mg: one capsule of 110 mg and one capsule of 150 mg or
one capsule of 110 mg and two capsules of 75 mg
220 mg: as two capsules of 110 mg
185 mg: as one capsule of 75 mg and one capsule of 110 mg
150 mg: as one capsule of 150 mg or two capsules of 75 mg

How to take Dabigatran etexilate Medical Valley
Dabigatran etexilate Medical Valley can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
Dabigatran etexilate Medical Valley may 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.

Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.

Accidental overdose of Dabigatran etexilate Medical Valley
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 options are available.

Missed dose of Dabigatran etexilate Medical Valley
Prevention of blood clots after surgery (hip or knee replacement)
Continue taking the missed daily dose of Dabigatran etexilate Medical Valley 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 thromboembolic events in the brain and elsewhere in the body by preventing formation of clots due to abnormal heart rhythm, and treatment of blood clots in the legs and lungs, as well as prevention of recurrence of such clots.
Use in children: Treatment of blood clots and prevention of recurrent 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 Medical Valley
Dabigatran etexilate Medical Valley should be taken exactly as prescribed by the 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 gastrointestinal discomfort occurs after taking Dabigatran etexilate Medical Valley.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Dabigatran etexilate Medical Valley affects the blood clotting system; therefore, most of the side effects are related to symptoms such as bruising or bleeding. Severe or extensive bleeding may occur, which is the most serious side effect and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings 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), 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 in breathing or dizziness, contact your doctor immediately.

Possible side 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 people):

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

Uncommon (may occur in 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 haemorrhoidal nodules, from the rectum, under the skin, into the joint, following injury or after a surgical procedure
• Formation of haematomas or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in the number of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (leakage of fluid from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disorders

Rare (may occur in 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 the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy nodules, occurring as a result of 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
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

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

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

Prevention of blood clots in the brain and elsewhere in the body by preventing clots forming due to irregular heart rhythm
Common (may occur in 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 occur in up to 1 in 100 people):

• Bleeding
• Bleeding may occur from haemorrhoidal nodules, from the rectum or into the brain
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets 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

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

• Bleeding may occur into the 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 in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy nodules, occurring as a result of an allergic reaction
• Decrease in the number of blood cells
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disorders

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

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

In clinical studies, the number of myocardial infarctions was higher with dabigatran than with warfarin. The overall number of occurrences was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrent blood clots in the legs and lungs
Common (may occur in 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 occur in up to 1 in 100 people):

• Bleeding
• Bleeding may occur into the joint or following injury
• Bleeding may occur from haemorrhoidal nodules
• Decrease in the number of red blood cells in the blood
• Formation of haematomas
• 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 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 the number of platelets in the blood
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash consisting of dark red, raised, itchy nodules, occurring as a result of 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 the number of blood cells
• Decrease in the number of, 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 disorders
• Hair loss

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

Treatment and prevention of recurrence of blood clots in children
Common (may occur in 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 consisting of dark red, raised, itchy nodules, occurring as a result of an allergic reaction
• Sudden change in skin colour and appearance
• Formation of haematomas
• 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 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 haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in the number 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 due to liver or blood disorders

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the 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 haemorrhoidal nodules
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side 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, Tel.: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder. Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Dabigatran etexilate Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Aluminium-Aluminium (OPA/Aluminium/PVC//Aluminium) foil blisters: Do not store above 30°C.
Aluminium with moisture-absorbing layer-Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) foil blisters: No special requirements for storage of the medicine.
White HDPE bottle: Store in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Dabigatran etexilate Medical Valley contains

• The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesilate, equivalent to 110 mg of dabigatran etexilate.

The other ingredients are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose, talc.
• Capsule shell: indigo carmine, aluminium lake (E 132), carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose.

What Dabigatran etexilate Medical Valley looks like and contents of the pack
Capsules of size 1, approximately 19 mm long, with a light blue, opaque cap and a light blue, opaque body, filled with white to pale yellow pellets.
The capsules are packed in moisture-absorbing foil blisters – Aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) and Aluminium foil blisters – Aluminium (OPA/Aluminium/PVC//Aluminium) or in a white HDPE bottle with a moisture absorber in the form of silica gel in the cap (PP).
Pack sizes
Blister packs containing 10, 10x1 (single-dose blister), 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100 and 180 hard capsules, in cardboard boxes.
Bottle containing 100 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]
Importer/Manufacturer
Laboratorios Liconsa S.A
Avda. Miralcampo 7
Polígono Industrial Miralcampo
Azuqueca de Henares
19200 Guadalajara
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia Dabigatraneteksilat Liconsa 110 mg tvrde kapsule
Denmark Dabigatran etexilate Medical Valley
Spain Dabigatran etexilate Liconsa 110 mg
Netherlands Dabigatran etexilaat Xiromed 110 mg harde capsules
Iceland Dabigatran etexilate Medical Valley 110 mg hörð hylki
Ireland Dabigatran Etexilate Rowa 110 mg hard capsules
Germany Dabigatranetexilat AXiromed 110 mg Hartkapseln
Norway Dabigatran etexilate Medical Valley
Poland Dabigatran etexilate Medical Valley
Romania Dabigatran etexilate Liconsa 110 mg capsule
Sweden Dabigatran etexilate Medical Valley 110 mg hårda kapslar