Mirexan

Leaflet accompanying the packaging: patient information

Mirexan, 75 mg, hard capsules

Dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 pack 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 the 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 veins after hip or knee replacement surgery.

Mirexan is used in children to:

• treat blood clots and prevent recurrent blood clots.

2. Important information before taking Mirexan

When not to take Mirexan

• 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 impairment.
• if the patient is currently bleeding.
• if the patient has 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 the patient has an increased tendency to bleed. It 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 changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used in 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 been fitted with an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting Mirexan, discuss it with your doctor. If symptoms occurred during treatment with this medicine or the patient underwent surgery, consult your doctor.
The patient should inform the doctorif they have or have 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 had bleeding.
• if the patient has had a surgical biopsy within the last month.
• if the patient has had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See "Mirexan and other medicines" below.
• if the patient is taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection of the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing less dark, concentrated urine).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a history of myocardial infarction or if the patient has been diagnosed with conditions that increase the risk of myocardial infarction.
• if the patient has liver disease affecting blood test results. In such cases, the use of this medicine is not recommended.

When to exercise special caution when taking Mirexan

• if the patient needs to undergo surgery: In such cases, it is necessary to discontinue Mirexan temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Mirexan before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or to relieve pain):
• it is very important to take Mirexan before and after surgery exactly as the doctor has instructed.
• the patient should immediately inform the doctor if they experience numbness or weakness of the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient falls or injures themselves during treatment, especially if they injure their head. The patient should immediately seek medical attention. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Mirexan and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
In particular, before taking Mirexan, tell your doctor if the patient is taking any of the following
medicines:

• Medicines that prevent blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medicines used in fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are used only on 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 Mirexan, 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. aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal medicine used to treat depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Mirexan on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Mirexan.
During treatment with Mirexan, breastfeeding should be avoided.

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 the doctor has instructed. In case of doubt, consult the doctor.

Take Mirexan as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg).
If kidney function is reducedby more than half or in patients aged 75 years or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Mirexan is 150 mg once daily(taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Mirexan due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Mirexan treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Mirexan treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Mirexan should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor instructs to stop taking any of them.
Table 1 shows the single and total daily doses of Mirexan in milligrams (mg).
Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1 :Mirexan dosing in capsule form

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: as two 110 mg capsules
185 mg: as one 75 mg capsule plus one 110 mg capsule
150 mg: as 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, with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed, or the pellets emptied from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

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

Taking a higher dose of Mirexan than recommended

Taking too much of this medicine increases the risk of bleeding. If the patient has taken too many capsules, they should contact their doctor immediately. Specific treatments are available.

Missing a dose of Mirexan

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Mirexan at the same time the next day.
Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children.
A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Mirexan treatment

Mirexan should be taken as instructed by the doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped too early. Contact your doctor if you experience indigestion after taking Mirexan.
If you have any further doubts about the use of this medicine, 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. Severe or massive bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location. In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop by itself, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
If a serious allergic reaction occurs that can cause breathing difficulties or dizziness, contact your doctor immediately.
Side effects are listed below by frequency of occurrence:

• Decrease in hemoglobin levels in the 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, stomach, or intestines, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin, into a joint, due to injury, or after surgery
• Formation of hematomas or bruising after surgery
• Blood in the stool, as detected by laboratory tests
• Decrease in red blood cell count
• Decrease in hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound exudate
• Increased liver enzyme activity
• Jaundice or yellowing of the skin and eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, from the injection site, or from the site of catheter insertion into a vein
• Exudate discolored with blood from the site of catheter insertion into a vein
• Coughing up blood or sputum discolored with blood
• Decrease in platelet count
• Decrease in red blood cell count after surgery
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis and gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound exudate
• Exudate from the surgical wound

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

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

Treatment of blood clots and prevention of recurrent blood clots in children
Common (may affect up to 1 in 10 people):

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in white blood cell count (which help fight infections)
• Bleeding may occur into the stomach, brain, anus, penis/vagina, or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in hematocrit
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophagitis and gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing of the skin and eyes due to liver or blood disease

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

• Lack of white blood cells (which help fight infections)
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from the surgical site, from the injection site, or from the site of catheter insertion into a vein
• Bleeding may occur from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
phone: +48 22 49-21-301,
fax: +48 22 49-21309,
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Mirexan

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

6. Contents of the pack and other information

What Mirexan contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15cps), dimeticone 350 cS, talc, and hydroxypropylcellulose (100 cps).
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), and hypromellose 2910 (6cps).

What Mirexan looks like and contents of the pack

Mirexan 75 mg is a white or almost white hard capsule, size 2, filled with pellets that are almost white to light yellow in color.
This medicine is available in packs containing 10, 30, or 60 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.
ul. Wałbrzyska 13
60-198 Poznań
Phone: + 48 61 66 51 500
e-mail: [email protected]

Manufacturer

Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª Edificio LEKLA,

• 08950 – Esplugues de Llobregat (Barcelona) Spain

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

Date of last revision of the leaflet:

To obtain more detailed information, 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 website of the European Medicines Agency: http://www.ema.europa.eu/ and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.