Mibrex

Package Leaflet: Information for the Patient

Mibrex, 2.5 mg, Film-Coated Tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, 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 medicine has been prescribed for a specific person. 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 those 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 pack and other information

1. What is Mibrex and what is it used for

The patient has been given Mibrex because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. Mibrex reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Mibrex will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Mibrex reduces the risk of blood clots (atherothrombotic events) in adults. Mibrex will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is taking Mibrex after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Mibrex contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Mibrex

When not to take Mibrex:

Do not take Mibrex, and also inform your doctorif the patient suspects that they have any of the above conditions.

Warnings and precautions

Before starting to take Mibrex, the patient should discuss it with their doctor or pharmacist. Mibrex should not be taken in combination with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

Special care should be taken when taking Mibrex:

• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's 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 section "Mibrex and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that can 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 airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• coronary artery disease with severe symptomatic heart failure,
• in patients with artificial heart valves,

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Mibrex. The doctor will decide whether to use this medicine and whether the patient should be monitored more closely.

If the patient needs to undergo surgery:

• they should follow their doctor's instructions regarding taking Mibrex at a specific time before or after surgery,
• it is very important to take Mibrex before and after the puncture or catheter removal, as instructed by the doctor;
• due to the need for special care, the patient should immediately inform their doctor if they experience numbness or weakness in their legs, bowel or bladder problems after anesthesia.

Children and adolescents

Mibrex 2.5 mg tablets are not recommended for people under 18 years old. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Mibrex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those that are available without a prescription.

• If the patient is taking certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines for bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")), anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Mibrex, as the effect of Mibrex may be increased. The doctor will decide whether to use this medicine and whether the patient should be monitored more closely.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.
If the patient is taking certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
rifampicin, which is an antibiotic.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Mibrex, as the effect of Mibrex may be reduced. The doctor will decide whether to use Mibrex and whether the patient should be monitored more closely.

Pregnancy and breastfeeding

Do not take Mibrex if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Mibrex. If the patient becomes pregnant while taking this medicine, they should immediately inform their 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 bike, or operate tools or machines.

Mibrex contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 exactly as instructed by the doctor. If the patient has any doubts, they should ask their doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Mibrex should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). The medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Mibrex. The tablet can be crushed and mixed with water or apple sauce, just before taking it. If necessary, the doctor may administer the crushed Mibrex tablet through a gastric tube.
Mibrex will not be given to the patient as the only medicine.
The doctor will instruct the patient to also take aspirin. If the patient is taking Mibrex after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine.
If the patient is taking Mibrex after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
The doctor will tell the patient what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Mibrex

Treatment with Mibrex after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the earliest 24 hours after hospital admission and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Mibrex if they have been diagnosed with coronary artery disease or peripheral arterial disease.
The doctor will decide how long to continue treatment.

Taking more Mibrex than prescribed

If the patient has taken more Mibrex than prescribed, they should immediately contact their doctor. Taking too much Mibrex increases the risk of bleeding.

Missing a dose of Mibrex

Do not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping Mibrex

Mibrex should be taken regularly and for the time prescribed by the doctor.
Do not stop taking Mibrex without first consulting the doctor. If the patient stops taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
If the patient has any further doubts about taking this medicine, they should ask their doctor.

4. Possible side effects

Like all medicines, Mibrex can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Mibrex can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
The patient should immediately inform their doctorif they experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or 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. The patient should immediately seek medical help!),
• long or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The doctor may decide to monitor the patient more closely or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 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)

• reduction in red blood cell count, which can 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 conjunctiva),
• 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 the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be observed in tests performed by the doctor),
• fever,
• stomach pain, 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 some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

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

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.

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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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, more information can be collected on the safety of the 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mibrex contains

• The active substance of Mibrex is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. tablet coating (Opadry Yellow 03F12967): hypromellose, titanium dioxide (E 171), talc, macrogol 8000, yellow iron oxide (E 172).

What Mibrex looks like and contents of the pack

Mibrex 2.5 mg is a light yellow, round, biconvex film-coated tablet, with the number "2.5" embossed on one side.
The tablets are in transparent blisters of aluminum/PVC/PVDC, packed in cardboard boxes, containing 14, 20, 28, 30, 56, 60, 98, 168, or 196 film-coated tablets or in single-dose blisters of aluminum/PVC/PVDC, packed in cardboard boxes, containing 10 x 1 tablet or 100 x 1 tablet or in bulk packs containing 10 boxes, each containing 10 x 1 film-coated tablet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: