Dabigatran sanexcel

Package leaflet: Information for the patient

Dabigatran SaneXcel, 110 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What Dabigatran SaneXcel is and what it is used for

Dabigatran SaneXcel 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 SaneXcel is used in adults to:

• prevent the formation of blood clots in veins after surgery to replace the hip or knee joint.
• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in patients who have an irregular heart rhythm 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 blood clots in the veins of the legs and lungs.

Dabigatran SaneXcel is used in children to:

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

2. Important information before taking Dabigatran SaneXcel

When not to take Dabigatran SaneXcel

• 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 impairment of kidney function.
• if the patient currently has active bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter where heparin is administered through the catheter to maintain patency, or during a catheter ablation procedure for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe impairment of liver function or a liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has an implanted mechanical heart valve requiring continuous anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran SaneXcel, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone a surgical procedure, consult a 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 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 SaneXcel with other medicines".
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection of the heart (bacterial endocarditis).
• if the patient has reduced kidney function or 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 had a previous heart attack or if conditions increasing the risk of heart attack have been diagnosed.
• if the patient has liver disease affecting blood test results. In such a case, use of this medicine is not recommended.

When to exercise particular caution when taking Dabigatran SaneXcel

• if the patient needs to undergo surgery: In such a case, temporary discontinuation of Dabigatran SaneXcel is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran SaneXcel exactly as directed by the doctor before and after surgery.
• if the 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 SaneXcel exactly as directed by the doctor before and after surgery.
• the patient should immediately inform the doctor if numbness or weakness in the lower limbs, or problems with the bowel or bladder occur 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. Immediate medical help should be sought. Medical consultation may be necessary due to increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

Dabigatran SaneXcel with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor before taking Dabigatran SaneXcel if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these are applied only topically 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 SaneXcel depending on the condition for which the medicine has been 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, an herbal medicine used to treat depression
• Antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine 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 SaneXcel 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 SaneXcel.
Breastfeeding is not recommended during treatment with Dabigatran SaneXcel.

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

3. How to take Dabigatran SaneXcel

Dabigatran SaneXcel capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other medicines containing dabigatran etexilate in an age-appropriate formulation may be used in children under 12 years of age when the child is able to swallow soft foods.

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.

Dabigatran SaneXcel should be taken according to the following recommendations:

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 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 receive a reduced dose of 75 mg of Dabigatran SaneXcel due to an increased risk of bleeding.

In both types of surgery, 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 joint replacement surgery
Treatment with Dabigatran SaneXcel should be started by taking one capsule within 1 to 4 hours after completion of the surgical procedure. Then, two capsules should be taken once daily for a total of 10 days.

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

Prevention of thromboembolic events in blood vessels, including stroke and systemic embolism by preventing clot formation due to irregular heart rhythm, 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 medicines containing verapamil should receive treatment with a reduced dose of Dabigatran SaneXcel of 220 mg taken as one 110 mg capsule twice daily due to a possible increased risk of bleeding.

In patients with a 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 SaneXcel 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 called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran SaneXcel, once the doctor has confirmed adequate control of blood coagulation. Dabigatran SaneXcel should be taken as directed by the doctor.

Treatment and prevention of recurrence of blood clots in children

Dabigatran SaneXcel 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. All other medications should be continued unless the doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran SaneXcel in milligrams (mg). Doses depend on the patient's body weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran SaneXcel capsules

Single doses requiring combination of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule and one 150 mg capsule or
one 110 mg capsule and two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule and one 110 mg capsule
150 mg: one 150 mg capsule or
two 75 mg capsules
How to take Dabigatran SaneXcel
Dabigatran SaneXcel 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 break, 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 medication
Do not switch anticoagulant medication without receiving detailed instructions from your doctor.
Taking more Dabigatran SaneXcel than prescribed
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 SaneXcel
Prevention of blood clots after surgery (joint replacement) of the hip or knee
Continue taking the missed daily dose of Dabigatran SaneXcel at the same 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 blood vessels of the brain and body by preventing formation of clots due to irregular heart rhythm, and treatment of blood clots in the veins of 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 treatment with Dabigatran SaneXcel
Dabigatran SaneXcel should be taken as directed 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 gastrointestinal discomfort after taking Dabigatran SaneXcel.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Dabigatran SaneXcel affects the blood clotting system; therefore, most adverse reactions involve symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse reaction and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings may not be visible.
If bleeding that does not stop spontaneously or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) occur, 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.

Possible adverse reactions 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):

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

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 haemorrhoids, from the rectum, under the skin, into a joint, following injury or after surgery
• Formation of haematomas or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decreased number of red blood cells in the blood
• Decreased proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Presence of discharge from the wound (oozing fluid from the 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 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
• Decreased platelet count in the blood
• Decreased number of red blood cells in the 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 the wound
• Fluid discharge from the 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

Prevention of thromboembolic events in the brain and body by preventing clot formation 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
• Decreased 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 haemorrhoids, from the rectum, or into the brain
• Formation of haematomas
• Coughing up blood or blood-tinged sputum
• Decreased platelet count in the blood
• Decreased 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 occur in 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 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 incidence of heart attacks with Dabigatran SaneXcel was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and/or 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 a joint or following injury
• Bleeding may occur from haemorrhoids
• Decreased 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 in laboratory tests
• 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
• Decreased 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 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 the blood (a substance in red blood cells)
• Decreased number 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 disorders
• Hair loss

In clinical trials, the incidence of heart attacks with Dabigatran SaneXcel was numerically higher than with warfarin. The overall incidence was low.
No difference in the number of heart attacks was observed in patients treated with dabigatran compared to patients receiving placebo.

Treatment and prevention of recurrence of blood clots in children

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

• Decreased number of red blood cells in the blood
• Decreased platelet count in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to 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):

• Decreased 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
• Decreased haemoglobin levels in the 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

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 reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dabigatran SaneXcel

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

Blister made of OPA/Aluminium/PVC/Aluminium foil:
Store in the original packaging to protect from moisture.
Store below 30°C.

Blister made of OPA/Aluminium/PE with desiccant/Aluminium/PE:
Store in the original packaging to protect from moisture.
No special temperature requirements for storage of this medicine.

Bottle: Store in the original packaging to protect from moisture.
Store below 30°C.
After opening, the medicine should be used within 6 months.
Keep the bottle tightly closed to protect from moisture.

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

6. Contents of the pack and other information

What Dabigatran SaneXcel contains

• The active substance is dabigatran etexilate. Each capsule contains 110 mg of dabigatran etexilate (as dabigatran etexilate mesilate).
• The other ingredients are: hydroxypropylcellulose (E 463), talc (E 553b), tartaric acid (in the form of 600 pellets) (E 334), arabic gum (E 414).
• The capsule shell contains FD&C Blue 2/Indigotine, titanium dioxide (E 171), carrageenan, potassium chloride, water (5%) – target moisture level, and hypromellose 2910.
• The black printing ink contains shellac (E 904), iron oxide black (E 172), and potassium hydroxide (E 525).

What Dabigatran SaneXcel looks like and contents of the pack
Dabigatran SaneXcel 110 mg is a hard capsule (measuring 19.1 ± 0.6 mm in length and 6.7 ± 0.3 mm in width), size 1, with a light blue opaque cap and a light blue opaque body, printed in black with "110".
This medicine is available in cardboard boxes containing 10, 30 or 60 hard capsules, in blisters made of OPA/Aluminium/PVC/Aluminium and in blisters made of OPA/Aluminium/PE with a desiccant/Aluminium/PE, as well as in a multipack containing 3 packs of 60 hard capsules (180 hard capsules).
This medicine is also available in white high-density polyethylene (HDPE) bottles with a polypropylene (PP) cap and a moisture-absorbing agent, and in white polypropylene (PP) bottles with a low-density polyethylene (LDPE) cap and a moisture-absorbing agent, containing 60 hard capsules in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer:
Pharmathen S.A.
Dervenakion 6
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture
Building Block No 5
693 00 Rodopi
Greece

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Dabigatran SaneXcel
Czech Republic: Dabigatran etexilate SaneXcel
Slovakia: Dabigartan SaneXcel 75 mg
Dabigartan SaneXcel 110 mg
Dabigartan SaneXcel 150 mg
Bulgaria: Дабигатран SaneXcel 75 mg, 110 mg and 150 mg твърди капсули
Hungary: Dabigartan SaneXcel 75 mg kemény kapszula
Dabigartan SaneXcel 110 mg kemény kapszula
Dabigartan SaneXcel 150 mg kemény kapszula
Romania: Dabigatran etexilat SaneXcel 110 mg capsule
Dabigatran etexilat SaneXcel 150 mg capsule
Dabigatran etexilat SaneXcel 75 mg capsule