Dabigatran etexilate medreg

Package leaflet: Information for the patient

Dabigatran Etexilate Medreg, 75 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 share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

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

1. What Dabigatran Etexilate Medreg is and what it is used for

Dabigatran Etexilate Medreg contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body responsible for blood clot formation.
Dabigatran Etexilate Medreg is used in adults to:

• prevent the formation of blood clots in veins following hip or knee replacement surgery.

Dabigatran Etexilate Medreg is used in children to:

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

2. Important information before taking Dabigatran Etexilate Medreg

When not to take Dabigatran Etexilate Medreg

• if the patient is allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney function impairment.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ which 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 during a procedure called catheter ablation for atrial fibrillation.
• 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 a mechanical heart valve implanted, which requires ongoing use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Medreg, discuss this with your doctor.
If symptoms occur during treatment with this medicine or if the patient has undergone surgery, consult a 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 surgical tissue removal (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 which may increase the risk of bleeding. See below “Dabigatran Etexilate Medreg and other medicines”.
• if the patient is taking anti-inflammatory medicines 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] or frothy urine).
• if the patient is over 75 years of age.
• if the patient is an adult with a body weight of 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 has conditions diagnosed as increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise particular caution when taking Dabigatran Etexilate Medreg

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran Etexilate Medreg is necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate Medreg 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 Medreg exactly as directed by the doctor both before and after surgery.
• The patient should immediately inform the doctor if numbness or weakness in the lower limbs or problems with bowel or bladder function occur after the anaesthesia wears off, as urgent medical care will be required.
• if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical evaluation is required. The doctor will assess whether there may be 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 Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, the patient should tell the doctor before taking Dabigatran Etexilate Medreg 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 Medreg 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 Medreg 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 Medreg.
Breastfeeding is not recommended during treatment with Dabigatran Etexilate Medreg.

Driving and operating machinery
Dabigatran Etexilate Medreg has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take Dabigatran Etexilate Medreg

Dabigatran Etexilate Medreg capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole.
Other medicines in formulations suitable for treating children under 8 years of age are available.
This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.
Take Dabigatran Etexilate Medreg 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 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 Medreg is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking verapamil-containing medications who also have reduced renal function (by more than half) should take a reduced dose of 75 mg of Dabigatran Etexilate Medreg 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 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 Medreg should begin with one capsule taken 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran Etexilate Medreg should begin with one capsule taken 1 to 4 hours after completion of surgery. Then, two capsules should be taken once daily for a total of 28 to 35 days.

Treatment and prevention of recurrent blood clots in children
Dabigatran Etexilate Medreg should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. The doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medications unless your doctor advises otherwise.

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

Table 1: Dosing table for Dabigatran Etexilate Medreg

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

How to take Dabigatran Etexilate Medreg
Dabigatran Etexilate Medreg can be taken with or without food. The capsule should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters
The following pictogram illustrates how to remove Dabigatran Etexilate Medreg capsules from the blister pack.

Separate the single dose along the perforated line.

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

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

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

Taking more Dabigatran Etexilate Medreg 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 Etexilate Medreg
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Dabigatran Etexilate Medreg at the usual time the next day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrent blood clots in children
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 Medreg
Dabigatran Etexilate Medreg 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 you experience gastrointestinal discomfort after taking Dabigatran Etexilate Medreg.
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 Medreg affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect, and regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding that does not stop spontaneously occurs, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In the event of a severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

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

Prevention of blood clots after surgery (hip or knee replacement)

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

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

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

• Bleeding 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, due to injury or after injury or surgical procedure
• Development of bruises or haematomas following surgical procedure
• Blood in stool detected in laboratory tests
• Decrease in number of red blood cells in blood
• Decrease in blood cell volume fraction (decreased haematocrit)
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from wound (fluid leaking from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from intravenous catheter insertion site
• Coughing up blood or blood-tinged sputum
• Decrease in number of platelets in blood
• Decrease in number of red blood cells in blood after surgical procedure
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash consisting of dark red, raised, itchy bumps due to 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 unknown (frequency cannot be estimated from available data):

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

Treatment and prevention of recurrence of blood clots in children

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

• Decrease in number of red blood cells in blood
• Decrease in number of platelets in blood
• Skin rash consisting of dark red, raised, itchy bumps due to 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 affect up to 1 in 100 people):

• Decrease in number of white blood cells (which help fight infections)
• Bleeding may occur from 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
• Decrease in haemoglobin concentration in blood (a substance present in red blood cells)
• Decrease in blood cell volume fraction (decreased haematocrit)
• 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 unknown (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 facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into joints, from wounds, surgical incision sites, injection sites, or intravenous catheter insertion sites
• 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 of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 provide more information on the safety of this medicine.

5. How to store Dabigatran Etexilate Medreg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"Expiry (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Dabigatran Etexilate Medreg contains

• The active substance is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (in the form of mesilate), equivalent to 75 mg of dabigatran etexilate.
• The other components are: tartaric acid, arabic gum, hypromellose type 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171) and hypromellose type 2910.

What Dabigatran Etexilate Medreg looks like and contents of the pack
Dabigatran Etexilate Medreg 75 mg is a white to off-white hard capsule of size 2, filled with pellets ranging from white to pale yellow in colour.
This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules in unit-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15
Nové Město 110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

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 Agustín Del Guadalix
Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Malta: Dabigatran Etexilate Medreg 75 mg hard capsules
Poland: Dabigatran Etexilate Medreg