Mibrex

Package Leaflet: Information for the Patient

Mibrex, 10 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 you only. 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 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

2. Important information before taking Mibrex

When not to take Mibrex:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

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

Warnings and precautions

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

Be particularly careful when taking Mibrex:

• if you have an increased risk of bleeding, such as:
• moderate or 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Mibrex and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal inflammation (e.g. due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital or urinary tract,
• retinopathy (disease of the blood vessels in the back of the eye),
• pulmonary disease with dilated bronchi and bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with artificial 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 abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform your

doctorbefore taking Mibrex. The doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• follow your doctor's instructions carefully regarding the intake of Mibrex at a strictly specified 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 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

Mibrex 10 mg is not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Mibrex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.
If you are taking
some antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
some antibacterial medicines (e.g. clarithromycin, erythromycin),
some 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,
some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform your

doctorbefore taking Mibrex, as the effect of Mibrex may be increased. The doctor will decide whether to use this medicine and whether you should be under close observation.
If the 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
some 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, inform your

doctorbefore taking Mibrex, as the effect of Mibrex may be reduced. The doctor will decide whether to use Mibrex and whether you should be under close observation.

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 effective contraception while taking Mibrex. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Mibrex may cause dizziness (common 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 some 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 exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg Mibrex tablet taken once a day.
• To treat blood clots in the veins of the legs, blood clots in the lungs and to prevent the recurrence of blood clots:

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Mibrex 10 mg once a day for you.
Swallow the tablet, preferably with water.
Mibrex can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your 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, your doctor may administer the crushed Mibrex tablet through a gastric tube.

When to take Mibrex

Take one tablet 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 will be easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after surgery.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking more Mibrex than prescribed

If you have taken more Mibrex than prescribed, contact your doctor immediately. Taking too much Mibrex increases the risk of bleeding.

Missing a dose of Mibrex

If you have missed a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed dose.

Stopping Mibrex treatment

Do not stop taking Mibrex without first consulting your doctor, as Mibrex prevents a serious disease.
If you have any further questions about taking this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Mibrex can cause side effects, although not everybody gets them.
As with other medicines that reduce blood clotting, Mibrex may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
Tell your doctor immediatelyif 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. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering or changes to 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 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 paleness and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding into the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) when 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 disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and 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 inside the 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 disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, 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 cardiac 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 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
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, you can help provide more information on the safety of this medicine.

5. How to store Mibrex

Keep the medicine out of the 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. Ask your 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 10 mg of rivaroxaban.
• The other ingredients are: tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. tablet coating (Opadry II Pink 33G34170 ) : hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172) .

What Mibrex looks like and contents of the pack

Mibrex 10 mg is a pink, round, biconvex film-coated tablet, with the number "10" embossed on one side.
The tablets are in transparent blisters of aluminum/PVC/PVDC foil, packed in cardboard boxes containing 5, 10, 14, 28, 30, 56, 60 or 98 film-coated tablets or in single-dose perforated blisters of aluminum/PVC/PVDC foil, 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

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

Date of last revision of the leaflet: