Dabigatran etexilate medreg

Patient Information Leaflet

Dabigatran Etexilate Medreg, 150 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Dabigatran Etexilate Medreg is and what it is used for
2. What you need to know 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 that is involved in blood clot formation.
Dabigatran Etexilate Medreg is used in adults to:

• prevent blood clots in the brain (stroke) and in other blood vessels in the body in patients who have 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 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 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 or duodenal 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 the use of 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 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 fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has a mechanical heart valve requiring lifelong anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Medreg, the patient should discuss this with their doctor.
If symptoms occur during treatment with this medicine or if the patient has undergone surgery, they should contact their doctor.
The patient should inform their 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 inflammation of the oesophagus or stomach.
• if the patient has gastro-oesophageal reflux (acid reflux).
• if the patient is taking medicines that may increase the risk of bleeding. See section below “Dabigatran Etexilate Medreg 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 within or around the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing less urine, which is dark [concentrated] or frothy).
• 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 previous heart attack or has conditions diagnosed to increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special 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 the 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 administration of an 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 their doctor if they experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical care may be needed.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical evaluation is required. The doctor will assess whether there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran Etexilate Medreg and other medicines
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should tell their 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 verapamil, the doctor may recommend a lower dose of Dabigatran Etexilate Medreg depending on the condition for which the medicine was prescribed. See section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A fixed-dose 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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat HIV/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 on the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Dabigatran Etexilate Medreg.
Breastfeeding should not be undertaken during treatment with Dabigatran Etexilate Medreg.

Driving and operating machinery
Dabigatran Etexilate Medreg has no effect or 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 formulations are available for the treatment of 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 Medreg exactly as directed below:
Prevention of blood clots in blood vessels of the brain and throughout the body by preventing the formation of clots that may occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as prevention of recurrence of such clots.
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 a reduced dose of Dabigatran Etexilate Medreg of 220 mg taken as one 110 mg capsule twice daily due to a potentially 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 through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran Etexilate Medreg should be taken as directed by the doctor.
In case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran Etexilate Medreg after the doctor has confirmed adequate control of blood coagulation. Dabigatran Etexilate Medreg should be taken as directed by the doctor.
Treatment of blood clots 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. All other prescribed medications should be continued unless the 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 required 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 remove the foil until the capsule is needed.

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

Taking more than the recommended dose of Dabigatran Etexilate Medreg
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
A missed dose may be taken if there is still at least 6 hours before the next scheduled dose.
If less than 6 hours remain until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Dabigatran Etexilate Medreg
Dabigatran Etexilate Medreg should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation may increase 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Dabigatran etexilate Medreg affects the blood coagulation system; therefore, most adverse reactions are related to symptoms such as bruising or bleeding. Severe or extensive 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, 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. Your doctor may decide to place you under close observation or change your 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 thromboembolism in blood vessels of the brain and body by preventing the formation of clots that occur due to irregular heart function

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 haemorrhoids, from the rectum, or into the brain
• Formation of bruises (haematomas)
• Coughing up blood or bloody sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin concentration in the blood (a substance present in red blood cells)
• Allergic reaction
• Sudden change in skin color 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 analyses

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

• Bleeding may occur into a joint, from a surgical incision site, from a wound, from an 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
• Decrease in blood cell count (decreased haematocrit)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Not known (frequency cannot be estimated from available data):

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

In clinical studies, the number of heart attacks with Dabigatran etexilate Medreg was numerically higher than with warfarin. The overall number of events was small.

Treatment of blood clots in the legs and lungs, and prevention of recurrence of blood clots in the legs and lungs

Common (may occur in up to 1 in 10 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
• Decrease in the number of red blood cells in the blood
• Formation of bruises (haematomas)
• Coughing up blood or bloody sputum
• Allergic reaction
• Sudden change in skin color 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 analyses
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision site, from an injection site, from the site of intravenous catheter insertion, or from the brain
• Decrease in the number of platelets 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

Not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in haemoglobin concentration in the blood (a substance present in red blood cells)
• Decrease in blood cell count (decreased haematocrit)
• Decrease in 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 studies, the number of heart attacks with Dabigatran etexilate Medreg was numerically 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 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 bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of bruises (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, from 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 concentration in the blood (a substance present in red blood cells)
• Decrease in blood cell count (decreased haematocrit)
• Itching
• Coughing up blood or bloody 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

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 a surgical incision site, from an 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 analyses

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 181 C, 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 authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dabigatran Etexilate Medreg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"Expiry date (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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran Etexilate Medreg contains

• The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate), equivalent to 150 mg of dabigatran etexilate.
• The other components are: tartaric acid, gum arabic, hypromellose type 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose type 2910 and Indigocarmine (E 132).

What Dabigatran Etexilate Medreg looks like and contents of the pack
Dabigatran Etexilate Medreg 150 mg consists of pellets ranging from whitish to pale yellow, contained in hard capsules with a blue cap and a white to whitish body, size 0 (approx. 21.7 mm).
This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules, in perforated single-dose blisters made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
A multiple pack contains 3 packs of 60 × 1 hard capsules (180 hard capsules) or 2 packs of 50 × 1 hard capsules (100 hard capsules), in perforated single-dose blisters made of Aluminium/OPA/Aluminium/PVC, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid
Spain

This medicine is authorised for marketing in the Member States of the European Economic Area under the following names:
Malta: Dabigatran Etexilate Medreg 150 mg hard capsules
Poland: Dabigatran Etexilate Medreg