Mirexan

Leaflet accompanying the packaging: patient information

Mirexan, 150 mg, hard capsules, Dabigatranum etexilatum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section
• 4.

Table of contents of the leaflet:

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

1. What is Mirexan and what is it used for

Mirexan contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body responsible for the formation of blood clots.
Mirexan is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not associated with a valve defect and at least one additional risk factor.
• treat blood clots in the legs and lungs and prevent the recurrence of blood clots in the legs and lungs.

Mirexan is used in children to:

• treat blood clots and prevent their recurrence.

2. Important information before taking Mirexan

When not to take Mirexan

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney dysfunction.
• if you are currently bleeding.
• if you have a disease of any internal organ that increases the risk of significant bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if you have an increased tendency to bleed. It may be congenital, of unknown cause, or caused by the use of other medicines.
• if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except in cases of: changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or restore normal heart function through a procedure called catheter ablation in atrial fibrillation.

if you have severe liver dysfunction or liver disease that may lead to death.

• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine that prevents the rejection of a transplanted organ.
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been implanted with an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Mirexan, you should discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with Mirexan, you should consult your doctor.
You should inform your doctor if you have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently experienced bleeding.
• if you have had a surgical biopsy within the last month.
• if you have had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if you have esophageal or stomach inflammation.
• if you have stomach acid reflux into the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See "Mirexan and other medicines" below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you have a heart infection (bacterial endocarditis).
• if you have kidney dysfunction or are dehydrated (feeling thirsty, passing less urine, dark-colored urine).
• if you are over 75 years old.
• if you are an adult and weigh 50 kg or less.
• only in the case of use in children: if the child has a brain or spinal cord infection.
• in the case of a heart attack or if you have been diagnosed with conditions that increase the risk of a heart attack.
• if you have liver disease that affects blood test results. In such cases, the use of Mirexan is not recommended.

When to be particularly careful when taking Mirexan

• if you need to undergo surgery: In such cases, it is necessary to discontinue the use of Mirexan due to the increased risk of bleeding during and after surgery. It is very important to take Mirexan before and after surgery exactly as your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or pain relief):
• It is very important to take Mirexan before and after surgery exactly as your doctor has instructed.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is necessary.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to determine if there is an increased risk of bleeding.
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Mirexan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, before taking Mirexan, you should tell your doctor if you are taking any of the following medicines:

Mirexan and other 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 they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil).
• In patients taking medicines containing verapamil, the doctor will recommend a lower dose of Mirexan. See section 3.
• Medicines that prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• 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 called selective serotonin or 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

The effect of dabigatran on pregnancy and the unborn child is not known. Mirexan should not be used during pregnancy unless your doctor considers it safe.
Women of childbearing age should avoid becoming pregnant while taking Mirexan.
While taking Mirexan, you should not breastfeed.

Driving and using machines

Mirexan has no or negligible influence on the ability to drive and use machines.

3. How to take Mirexan

Mirexan capsules can be used in adults and children aged 8 years or older who can swallow the capsules whole. There are other age-appropriate pharmaceutical forms for the treatment of children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor.

Mirexan should be taken as follows:

• to prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not associated with a valve defect and at least one additional risk factor.
• to treat blood clots in the legs and lungs and prevent the recurrence of blood clots in the legs and lungs.

The recommended dose is 300 mg taken in the form of 1 capsule of 150 mg twice a day.
In patients aged 80 years or older, the recommended dose of Mirexan is 220 mg taken in the form of 1 capsule of 110 mg twice a day.
Patient taking medicines containing verapamil should take a reduced dose of Mirexan to 220 mg taken in the form of 1 capsule of 110 mg twice a daydue to the increased risk of bleeding.
In patients with an increased risk of bleeding, the doctor may recommend taking Mirexan at a dose of 220 mg taken in the form of 1 capsule of 110 mg twice a day.
Taking Mirexan can be continued if the patient needs to restore normal heart function through a procedure called cardioversion or catheter ablation in atrial fibrillation. Mirexan should be taken exactly as your doctor has instructed.
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 Mirexan after the doctor has determined that adequate blood clotting control has been achieved. Mirexan should be taken exactly as your doctor has instructed.
Treatment of blood clots and prevention of recurrence of blood clots in children
Mirexan should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on weight and age. The doctor will determine the appropriate dose. The doctor may adjust the dose as treatment progresses. You should continue taking all other medicines unless your doctor instructs you to stop.
Table 1 shows the single and total daily doses of Mirexan in milligrams (mg).
Doses are based on body weight in kilograms (kg) and patient age.

Doses requiring the combination of more than one capsule:
300 mg: two 150 mg capsules or four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or two 75 mg capsules

How to take Mirexan

Mirexan can be taken with or without food. The capsules should be swallowed whole, washed down with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed, or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

Do not change your anticoagulant medicine without receiving detailed instructions from your doctor.

Taking a higher dose of Mirexan than recommended

Taking too much Mirexan increases the risk of bleeding. If you have taken too many Mirexan capsules, you should contact your doctor immediately. There are specific treatment methods available.

Missing a dose of Mirexan

A missed dose of dabigatran etexilate can be taken up to 6 hours before the next scheduled dose. If there are less than 6 hours until the next scheduled dose, you should not take the missed dose.
You should not take a double dose to make up for a forgotten dose.

Stopping treatment with Mirexan

Mirexan should be taken exactly as your doctor has instructed. You should not stop taking Mirexan without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. You should contact your doctor if you experience indigestion after taking Mirexan.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mirexan can cause side effects, although not everybody gets them.
Mirexan affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. It is not possible to rule out the occurrence of significant or severe bleeding, which is the most serious side effect and can be life-threatening or lead to disability or death, regardless of location. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), you should contact your doctor immediately. Your doctor may decide to monitor you closely or change your medicine.
If you experience severe allergic reactions that can cause breathing difficulties or dizziness, you should contact your doctor immediately.
The following side effects are listed by frequency of occurrence:

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from hematomas, into the brain, from the anus, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Hematoma formation
• Coughing up blood or blood-stained sputum
• Decreased platelet count
• Decreased hemoglobin level in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophageal and stomach inflammation
• Acid reflux from the stomach into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site
• Severe allergic reactions that can cause breathing difficulties or dizziness
• Severe allergic reactions that can cause facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Decreased red blood cell count
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Breathing difficulties or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

In clinical trials, the number of heart attacks with Mirexan was higher than with warfarin. The overall number of events was low.
Treatment of blood clots in the legs and lungs and prevention of recurrence of blood clots in the legs and 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 urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematoma formation
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer
• Esophageal and stomach inflammation
• Acid reflux from the stomach into the esophagus
• Nausea
• Vomiting
• Abdominal or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from a surgical incision, from an injection site, or from a catheter insertion site into a vein or brain
• Decreased platelet count
• Severe allergic reactions that can cause breathing difficulties or dizziness
• Severe allergic reactions that can cause facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Breathing difficulties or wheezing
• Decreased hemoglobin level in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Decreased white blood cell count (which helps fight infections)
• Hair loss

In clinical trials, the number of heart attacks with Mirexan was higher than with warfarin. The overall number of events was low. No difference in the number of heart attacks was found between patients treated with dabigatran and those treated with placebo.
Treatment of blood clots and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Hematoma formation
• Nosebleeds
• Acid reflux from the stomach into the esophagus
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the anus, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin level in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal or stomach pain
• Esophageal and stomach inflammation
• Allergic reaction
• Difficulty swallowing
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Decreased white blood cell count (which helps fight infections)
• Severe allergic reactions that can cause breathing difficulties or dizziness
• Severe allergic reactions that can cause facial or throat swelling
• Breathing difficulties or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from a surgical incision, from an injection site, or from a catheter insertion site into a vein
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mirexan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Mirexan contains

• The active substance of Mirexan is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15cps), dimethicone 350 cS, talc, and hydroxypropylcellulose (100 cps).
• The capsule shell contains: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6cps), indigo carmine (E 132).

What Mirexan looks like and contents of the pack

Mirexan 150 mg is a hard capsule with a light blue cap and a white or almost white body, size 0, filled with pellets that are almost white to light yellow in color.
This medicine is available in packs of 30 or 60 hard capsules in perforated blisters of aluminum/OPA/aluminum/PVC in a cardboard box.
A collective pack containing 3 packs of 60 hard capsules (180 hard capsules) in perforated blisters of aluminum/OPA/aluminum/PVC in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.

Wałbrzyska Street 13
60-198 Poznań
tel.: +48 61 66 51 500
e-mail: [email protected]

Manufacturer

Galenicum Health, S.L.
Cornellá Avenue 144, 7th-1st floor, LEKLA building,

• 08950 – Esplugues de Llobregat (Barcelona) Spain

SAG Manufacturing S.L.U
N-I Road, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain
Biofarm Sp. z o.o.
Wałbrzyska Street 13,
60-198 Poznań
Poland

Date of last revision of the leaflet:

To obtain more detailed information, you should contact your local representative of the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta
Mirexan 150 mg hard capsules
Mirexan 110 mg hard capsules
Mirexan 75 mg hard capsules
Poland
Mirexan, 75 mg, hard capsules
Mirexan, 110 mg, hard capsules
Mirexan, 150 mg, hard capsules
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/ and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.