Dabigatran etexilate polpharma

Package leaflet: Information for the patient

Dabigatran etexilate Polpharma, 110 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dabigatran etexilate Polpharma is and what it is used for
2. What you need to know 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 that is involved in blood clot formation.

Dabigatran etexilate Polpharma is used in adults to:

• prevent the formation of blood clots in veins after hip or knee replacement surgery.
• prevent the occurrence of blood clots in the brain (stroke) and in other blood vessels in patients who have a type of 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 such clots.

Dabigatran etexilate Polpharma is used in children to:

• treat blood clots and to prevent recurrence of 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 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 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 when heparin is administered through the catheter to maintain its patency, or restoring normal heart rhythm by a procedure called catheter ablation in 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 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 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 Dabigatran etexilate Polpharma or if the patient
needs to undergo a surgical procedure, consult a doctor.
The patient should inform the doctor if they 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 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 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 or around 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.
• after a previous myocardial infarction or if the patient has been diagnosed with conditions increasing 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 using 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 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 Polpharma exactly as directed by the doctor before and after surgery.

• the patient should inform the doctor immediately if they experience numbness or weakness in the lower limbs, or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care is required.

• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention should be sought. The doctor will assess whether there may be an increased risk of bleeding.

• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing an 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, tell the doctor before taking Dabigatran etexilate Polpharma 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 are applied only to the skin;
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil); for 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 also 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 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 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 avoid becoming pregnant while taking Dabigatran etexilate Polpharma.
Breastfeeding should not be undertaken while taking Dabigatran etexilate Polpharma.

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

3. How to take Dabigatran eteksylan Polpharma

Dabigatran eteksylan Polpharma capsules can be used in adults, adolescents, 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 exactly as prescribed by the doctor. If in doubt, consult the doctor.
Take Dabigatran eteksylan Polpharma exactly as directed below:

Prevention of blood clots after surgery (hip or knee replacement)
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 medications containing amiodarone, quinidine, or verapamil, the recommended dose of Dabigatran eteksylan Polpharma is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medications with reduced kidney function (by more than half) should take a reduced dose of 75 mg of Dabigatran eteksylan Polpharma due to 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 by the next day after surgery, it should be initiated with a dose of 2 capsules once daily.

After knee replacement surgery
Initiate Dabigatran eteksylan Polpharma by taking one capsule within 1 to 4 hours after completion of surgery. Then take two capsules once daily for a total of 10 days.

After hip replacement surgery
Initiate Dabigatran eteksylan Polpharma by taking one capsule within 1 to 4 hours after completion of surgery. Then take two 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 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 verapamil-containing medications should receive a reduced dose of Dabigatran eteksylan Polpharma of 220 mg, taken as one 110 mg capsule twice daily, due to possible 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 continue if the patient requires restoration of normal heart rhythm through a procedure called cardioversion. Dabigatran eteksylan Polpharma 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 eteksylan Polpharma after the doctor confirms adequate control of blood coagulation. Dabigatran eteksylan Polpharma should be taken as directed by the doctor.

Treatment of blood clots and prevention of recurrence in children
Dabigatran eteksylan 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 ideally be 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 medications unless the doctor advises otherwise.

Table 1 shows the single and total daily doses of Dabigatran eteksylan 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 eteksylan Polpharma
| Body weight and age ranges | | | | |
|---|---|---|---|---|
| Body weight in kg | Age in years | Single dose in mg | Total daily dose in mg |
| 11 to less than 13 kg | 8 to less than 9 years | 75 | 150 |
| 13 to less than 16 kg | 8 to less than 11 years | 110 | 220 |
| 16 to less than 21 kg | 8 to less than 14 years | 110 | 220 |
| 21 to less than 26 kg | 8 to less than 16 years | 150 | 300 |
| 26 to less than 31 kg | 8 to less than 18 years | 150 | 300 |
| 31 to less than 41 kg | 8 to less than 18 years | 185 | 370 |
| 41 to less than 51 kg | 8 to less than 18 years | 220 | 440 |
| 51 to less than 61 kg | 8 to less than 18 years | 260 | 520 |
| 61 to less than 71 kg | 8 to less than 18 years | 300 | 600 |
| 71 to less than 81 kg | 8 to less than 18 years | 300 | 600 |
| 81 kg or more | 10 to less than 18 years | 300 | 600 |

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 eteksylan Polpharma
Dabigatran eteksylan Polpharma can be taken with or without food. 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 blister packs
The following pictogram illustrates how to remove Dabigatran eteksylan Polpharma capsules from the blister pack.

Peel off the individual blister from the strip along the perforated line.

Remove the protective foil and take out the capsule.

• Do not push the capsules through the blister foil.
• Do not remove the foil from the blister until the capsule is needed.

Switching anticoagulant medication
Do not switch anticoagulant medications without detailed instructions from the doctor.

Taking more Dabigatran eteksylan Polpharma than prescribed
Taking too high a dose of Dabigatran eteksylan Polpharma increases the risk of bleeding. If a patient has taken too many capsules, contact the doctor immediately. Specific treatments are available.

Missed dose of Dabigatran eteksylan Polpharma
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran eteksylan Polpharma at the usual time the next day.
Do not take a double dose to make up for the 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 function, 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
A missed dose may be taken if there is at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Dabigatran eteksylan Polpharma
Dabigatran eteksylan Polpharma should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without consulting the doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely.
Contact the doctor if gastrointestinal discomfort occurs after taking Dabigatran eteksylan Polpharma.
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 etexilate Polpharma affects the blood coagulation 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, it 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, pallor, 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 severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The 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 affect up to 1 in 10 people):

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

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

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, from the rectum, under the skin, into joints, following injury or after a surgical procedure
• Development of haematomas or bruising occurring 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 liquid stools
• Nausea
• Discharge from wound (fluid oozing 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 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 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 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
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of blood clots in blood vessels of the brain and the rest of the 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
• Decreased number of red blood cells in blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or liquid 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 haematomas
• 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 affect up to 1 in 1,000 people):

• Bleeding into joints, 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
• Decreased proportion of blood cells
• 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
• Decreased number or even absence of white blood cells (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks with dabigatran etexilate was higher than with warfarin. The overall frequency 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 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 into joints or following injury
• Bleeding from haemorrhoids may occur
• Decreased number of red blood cells in 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 liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding from the surgical incision site, from the injection site, from the site of intravenous catheter insertion, or 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 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
• 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 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):

• Decreased number of red blood cells in blood
• Decreased platelet count in blood
• Skin rash with 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 liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 this 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 blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Do not store above 30°C.
Store in the original packaging 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Dabigatran eteksylan Polpharma contains

• The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 mg of dabigatran etexilate.
• The other components are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc, hydroxypropylcellulose (100 cps); the capsule shell contains: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps), indigo carmine (E 132).

What Dabigatran eteksylan Polpharma looks like and contents of the pack
Dabigatran eteksylan Polpharma 110 mg is blue, hard capsules of size 1, containing pellets that are almost white to pale yellow.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
Hospital pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or hospital pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC foil.
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
Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain
SAG Manufacturing, S.L.U.
Carretera Nacional 1 Km 36
28750 San Agustin de Guadalix, Madrid
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
France: Dabigatran etexilate Galenicum Axium 110 mg, gélule
Spain: Dabigatrán etexilato Normon 110 mg, cápsulas duras EFG
Malta: Dabigatran etexilate Galenicum Axium 110 mg, hard capsule
Germany: Dabigatranetexilat Galenicum Axium 110 mg, Hartkapseln