Mibrex

Leaflet attached to the packaging: patient information

Mibrex. 15 mg. film-coated tablets

Mibrex, 20 mg. film-coated tablets

Starting treatment packaging

Do not use in children.

Rivaroxaban

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 further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Mibrex and what is it used for
• 2. Important information before taking Mibrex
• 3. How to take Mibrex
• 4. Possible side effects
• 5. How to store Mibrex
• 6. Contents of the packaging and other information

1. What is Mibrex and what is it used for

Mibrex contains the active substance rivaroxaban and is used in adults to:

• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Mibrex belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Mibrex

When not to take Mibrex:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Mibrex, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Mibrex, you should discuss it with your doctor or pharmacist.

Be particularly careful when taking Mibrex:

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Mibrex and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• 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 the treatment,
• if you have been diagnosed with abnormal blood pressure or are scheduled to undergo surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you should

inform your doctorbefore taking Mibrex. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored.

If you need to undergo surgery:

• you should carefully follow your doctor's instructions regarding taking Mibrex at a specific time before and after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Mibrex before and after the puncture or catheter removal, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

The Mibrex starting treatment packaging is not recommended for persons under 18 years of age, as it is specifically designed for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

Mibrex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.

• If you are taking

certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines used to treat bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir), other medicines used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, you should

inform your doctorbefore taking Mibrex, as the effect of Mibrex may be enhanced. Your doctor will decide whether to prescribe this medicine and whether you should be closely monitored. If your doctor considers that you have an increased risk of stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If you are taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, you should

inform your doctorbefore taking Mibrex, as the effect of Mibrex may be reduced. Your doctor will decide whether to prescribe Mibrex and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take Mibrex if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception while taking Mibrex. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Mibrex may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Mibrex contains lactose and sodium

If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the product is considered "sodium-free".

3. How to take Mibrex

This medicine should always be taken according to your doctor's instructions. If you are unsure, you should consult your doctor or pharmacist. Mibrex should be taken during meals. The tablet(s) should be swallowed, preferably with water. If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways of taking Mibrex. The tablet can be crushed and mixed with water or apple sauce, just before taking it. After such a mixture, you should immediately eat a meal. If necessary, your doctor may administer the crushed Mibrex tablet through a gastric tube.

How many tablets to take

The recommended dose is one 15 mg Mibrex tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Mibrex tablet once a day. The Mibrex starting treatment packaging of 15 mg and 20 mg is intended only for the first 4 weeks of treatment. After taking the tablets from this packaging, treatment will be continued with the 20 mg Mibrex once a day regimen after consultation with your doctor. If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Mibrex tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

When to take Mibrex

The tablet(s) should be taken every day until your doctor decides to stop the treatment. It is best to take the tablet at the same time every day, as it is easier to remember. Your doctor will decide how long to continue the treatment.

Taking a higher dose of Mibrex than recommended

If you have taken a higher dose of Mibrex than recommended, you should immediately contact your doctor. Taking too much Mibrex increases the risk of bleeding.

Missing a dose of Mibrex

• If you are taking one 15 mg tablet twice a day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, you should continue taking one 15 mg tablet twice a day.
• If you are taking one 20 mg tablet once a day and you miss a dose, you should take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. You should take the next tablet the next day, and then take one tablet once a day.

Stopping Mibrex treatment

You should not stop taking Mibrex without first consulting your doctor, as Mibrex prevents the occurrence of a serious disease. If you have any further doubts about taking this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, Mibrex can cause side effects, although not everybody gets them. Like other medicines with a similar action that reduces blood clot formation, Mibrex can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding. You should immediately inform your doctorif you experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes in the mucous membrane, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (maximum 1 in 10,000 people).
• Signs of serious allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; hives, and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,

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

• bleeding into the muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mibrex

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 and blister. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. There are no special precautions for storing the medicine. Crushed tablets: Crushed tablets are stable in water or apple sauce for up to 4 hours. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mibrex contains

• The active substance of Mibrex is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate; 15 mg tablet coating (Opadry II Pink 33G240024): hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172), iron oxide black (E 172); 20 mg tablet coating (Opadry II Red 33G250007): hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172).

What Mibrex looks like and contents of the packaging

Mibrex, 15 mg, are pink, round, biconvex film-coated tablets with the number "15" embossed on one side. Mibrex, 20 mg, are brown-red, round, biconvex film-coated tablets with the number "20" embossed on one side. The starting treatment packaging for the first 4 weeks of treatment: each packaging with 49 film-coated tablets for the first 4 weeks of treatment contains 42 film-coated Mibrex 15 mg tablets and 7 film-coated Mibrex 20 mg tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01. Date of last revision of the leaflet:November 2023.