Mirexan

Package Leaflet: Information for the Patient

Mirexan, 110 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section
• 4.

Table of Contents of the Package 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 medications called anticoagulants. Its action involves blocking the substance in the body responsible for blood clot formation.
Mirexan is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent their recurrence.

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 medication (listed in section 6).
• if you have severe kidney impairment.
• if you are currently bleeding.
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. This can be congenital, of unknown cause, or caused by the use of other medications.
• if you are taking anticoagulant medications (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 maintain catheter patency, or when restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver impairment or liver disease that can lead to death.
• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent organ rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Mirexan, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with Mirexan, consult your doctor.
The patient should inform the doctorif they 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 undergone 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 esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medications that may increase the risk of bleeding. See below "Mirexan and other medications".
• if you are taking anti-inflammatory medications such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have kidney impairment or are dehydrated (feeling thirsty, passing less urine, dark-colored urine).
• if you are over 75 years old.
• if you weigh 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 you have liver disease that affects blood test results. In such cases, the use of Mirexan is not recommended.

When to exercise special caution when taking Mirexan

• if you need to undergo surgery: In such cases, it is necessary to discontinue 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 prescribed by your doctor.

with an increased risk of bleeding during and after surgery. It is very important to take Mirexan before and after surgery exactly as prescribed by your doctor.
When the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or to reduce pain):

• It is very important to take Mirexan before and after surgery exactly as prescribed by your doctor.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should immediately seek medical attention. 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 medications

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

Before taking Mirexan, tell your doctor if you are taking any of the following medications:

• Anticoagulant medications (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only topically.
• Medications used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Mirexan, depending on the condition for which it was prescribed. See section 3.
• Medications used to prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain medications (e.g., aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal medication used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medications used to treat AIDS (e.g., ritonavir).
• Certain medications 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 taken during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Mirexan.
Do not breastfeed while taking Mirexan.

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 capsules whole. There are other age-appropriate formulations for the treatment of children under 8 years of age.
This medication should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor.

Take Mirexan as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patients taking medications containing amiodarone, quinidine, or verapamilshould take a reduced dose of Mirexan, 150 mg once daily(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medications with reduced kidney function(more than half reduced) should take a reduced dose of Mirexan, 75 mg, due to the increased risk of bleeding.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.
After hip replacement surgery
Take the first dose of Mirexan within 1 to 4 hours after the end of surgery. Then take 2 capsules once daily for a total of 28 to 35 days.
After knee replacement surgery
Take the first dose of Mirexan within 1 to 4 hours after the end of surgery. Then take 2 capsules once daily for a total of 10 days.
Prevention of blood clots in the brain and body due to irregular heart rhythm and treatment of blood clots in the legs and lungs and prevention of their recurrence
The recommended dose is 300 mgtaken as 1 capsule of 150 mg twice daily.
In patients 80 years of age or older, the recommended dose of Mirexan is 220 mgtaken as 1 capsule of 110 mg twice daily.
Patient taking verapamil-containing medicationsshould take a reduced dose of Mirexan, 220 mgtaken as 1 capsule of 110 mg twice daily, due to the increased risk of bleeding.
In patients at increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as 1 capsule of 110 mg twice daily.
Continuation of Mirexan treatment can be considered if there is a need to restore normal heart rhythm using a procedure called cardioversion. Take Mirexan as prescribed by your 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 Mirexan treatment after the doctor has confirmed that blood clotting is under control. Take Mirexan as prescribed by your doctor.
Treatment of blood clots and prevention of their recurrence in children
Take Mirexan 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. Continue taking all other medications unless the doctor advises you to stop taking any of them.
Table 1 shows the single and total daily doses of Mirexan in milligrams (mg). Doses are based on the patient's 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: 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. Swallow the capsules 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.

Changing anticoagulant medication

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

Taking more than the recommended dose of Mirexan

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

Missing a dose of Mirexan

Prevention of blood clots after hip or knee replacement surgery
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.
Use in adults: Prevention of blood clots in the brain and body due to irregular heart rhythm and treatment of blood clots in the legs and lungs and prevention of their recurrence
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 treatment with Mirexan

Mirexan should be taken as prescribed by your doctor. Do not stop taking Mirexan without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Mirexan.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, 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 major or severe bleeding, which are the most serious side effects and can be life-threatening or lead to disability or death, regardless of location. In some cases, these bleedings may not be visible.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to closely monitor you or change your medication.
In case of severe allergic reactions that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below by frequency of occurrence:

• Frequent (may occur in up to 1 in 10 patients):
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

Infrequent (may occur in up to 1 in 100 patients):

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Bruises or hematomas after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased red blood cell percentage
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Wound exudate (discharge from the surgical wound)
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems

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

• Bleeding
• Bleeding may occur into the brain, from the surgical wound, from the injection site, or from the catheter insertion site
• Wound exudate (discharge from the catheter insertion site)
• Coughing up blood or bloody sputum
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Difficulty swallowing
• Wound exudate (discharge from the surgical wound)

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

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infection)
• 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.
Treatment of blood clots in the legs and lungs and prevention of their recurrence
Frequent (may occur in up to 1 in 10 patients):

• Bleeding may occur from the nose, into the stomach or intestines, from the anus, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Nausea

Infrequent (may occur in up to 1 in 100 patients):

• Bleeding
• Bleeding may occur into the joint, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding from hematomas
• Coughing up blood or bloody sputum
• Decreased red blood cell count
• Bruises
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• 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 occur in up to 1 in 1,000 patients):

• Bleeding may occur from the surgical wound, from the injection site, or from the catheter insertion site or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing
• Decreased red blood cell percentage

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Decreased white blood cell count (which helps fight infection)
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems
• 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 found in patients treated with dabigatran compared to those treated with placebo.
Treatment of blood clots and prevention of their recurrence in children
Frequent (may occur in up to 1 in 10 patients):

• Decreased red blood cell count
• Decreased platelet count
• Skin rash with red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Bruises
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

Infrequent (may occur in up to 1 in 100 patients):

• Decreased white blood cell count (which helps fight infection)
• Bleeding may occur into the stomach or intestines, into the brain, from the anus, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell percentage
• Itching
• Coughing up blood or bloody sputum
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice (yellowing of the skin or whites of the eyes) due to liver or blood problems

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

• Absence of white blood cells (which help fight infection)
• 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 the joint, from the wound, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 medication.

5. How to store Mirexan

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton or blister after EXP. The expiration date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medications should not be disposed of via wastewater. Ask your pharmacist how to dispose of medications that are no longer needed. 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 110 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), and indigo carmine (E 132).

What Mirexan looks like and contents of the pack

Mirexan 110 mg is a blue hard capsule, size 1, filled with pellets that are almost white to light yellow in color.
This medication is available in packs containing 10, 30, or 60 hard capsules in perforated blisters of aluminum/OPA/aluminum/PVC in a cardboard box.
A multipack 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
Phone: +48 61 66 51 500
e-mail: biofarm@biofarm.pl

Manufacturer

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

For more detailed information, please 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 medicinal product 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.