Mibrex

Package Leaflet: Information for the User

Mibrex, 10 mg hard capsules

Rivaroxaban
Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of forming blood clots is increased after surgery.
• treat blood clots in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in 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 thus reducing the tendency to form blood clots.

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 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 you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that leads to an increased 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.

• 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,
• ketokonazole 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 noradrenaline reuptake inhibitors (SNRIs)).

Warnings and precautions

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

When to 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 treatment 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 with medicines,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the stomach and intestines or esophagitis (throat and esophagus) e.g., due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or the genital or urinary system,
• vascular disease of 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,
• 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 been found to have unstable blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

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

before taking Mibrex. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must follow your doctor's instructions carefully regarding the intake of Mibrex at a strictly defined time before or after surgery.
• if spinal or epidural anesthesia is planned (e.g., to perform a cesarean section or to relieve pain):
• it is very important to take Mibrex before and after the procedure, as directed by your doctor,
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction after anesthesia.

Children and adolescents

Mibrex 10 mg capsules are not recommended for people under 18 years of age. There is a lack of sufficient data on the use of this 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 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,
• ketokonazole 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 noradrenaline reuptake inhibitors (SNRIs)).

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

before taking Mibrex, as the effect of Mibrex may be increased. Your doctor will decide whether to use this medicine 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 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 (frequent side effects) and 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 10 mg contains lactose monohydrate (a type of sugar) 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 capsule, so it is considered "sodium-free".

3. How to take Mibrex

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many capsules to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one Mibrex 10 mg capsule taken once a day.
• To treat blood clots in the legs, blood clots in the lungs, and to prevent the recurrence of blood clotsAfter at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed Mibrex 10 mg once a day for you.

Swallow the capsule whole, preferably with water.
Mibrex can be taken with or without food.
If you have difficulty swallowing the whole capsule, talk to your doctor about other ways to take Mibrex. The contents of the capsule can be mixed with water or apple sauce, just before taking it.
If necessary, your doctor may administer the contents of the Mibrex capsule through a gastric tube.

When to take Mibrex

Take the capsule every day until your doctor decides to stop the treatment.
It is best to take the capsule at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue the treatment.
To prevent blood clots in the legs after hip or knee replacement surgery:

Take the first capsule 6 to 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee 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 forget to take a dose, take the capsule as soon as you remember.
Take the next capsule the next day, and then take the capsules as usual, once a day.
Do not take a double dose to make up for the missed capsule.

Stopping Mibrex treatment

Do not stop taking Mibrex without first talking to your doctor, as Mibrex prevents a serious disease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.

Tell your doctor immediately if 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, pallor, 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 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 (maximum 1 in 10,000 people).
• Signs of severe allergic reactions:
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema occur in less than 1 in 100 patients).

Full list of possible side effects

Common side effects(occur in less than 1 in 10 patients)

• 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 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 from 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,
• pain in the limbs,
• 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 some liver enzymes, which can be seen in blood test results.

Uncommon side effects(occur in less than 1 in 100 patients)

• 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 function 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 side effects(occur in less than 1 in 1,000 patients)

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

Very rare side effects(occur in less than 1 in 10,000 patients)

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

Side effects of unknown frequency(frequency cannot be estimated from 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 blister and carton after: EXP. The expiry date refers to the last day of the month.
PVC/PVDC/Aluminum blisters: Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Aluminum/OPA/Aluminum/PVC blisters: No special storage precautions are required for the medicine.
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 hard capsule contains 10 mg of rivaroxaban.
• The other ingredients are: Capsule contents: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).

What Mibrex looks like and contents of the pack

Mibrex 10 mg hard capsules are a white or almost white powder, placed in a size 3 (approximately 16 mm long) capsule with a beige opaque cap and body.
The hard capsules are in PVC/PVDC/Aluminum or Aluminum/OPA/Aluminum/PVC blisters, in a carton box.
Mibrex 10 mg is available in packs of 10, 15, 20, 30, and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

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

Importer

Zentiva SA
B-dul Theodor Pallady nr. 50, sector 3
032266 Bucharest
Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA3000
Malta
Date of last revision of the leaflet:February 2024