Bevimlar

Leaflet accompanying the packaging: information for the user

Bevimlar, 10 mg, coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Bevimlar and what is it used for
• 2. Important information before taking Bevimlar
• 3. How to take Bevimlar
• 4. Possible side effects
• 5. How to store Bevimlar
• 6. Contents of the pack and other information

1. What is Bevimlar and what is it used for

Bevimlar 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. The doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Bevimlar 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 Bevimlar

When not to take Bevimlar

• 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 Bevimlar, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

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

When to be particularly careful when taking Bevimlar

• if the patient has an increased risk of bleeding, such as: moderate or severe kidney disease, as kidney function may affect the amount of medicine acting 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 "Bevimlar and other medicines"), bleeding disorders, very high blood pressure that does not decrease despite taking medicines, diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestines and stomach 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 genital or urinary system, disease of the blood vessels in the back of the eye (retinopathy), lung disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with heart valve prostheses,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

before taking Bevimlar. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• it is very important to follow the doctor's instructions regarding the intake of Bevimlar at a strictly specified time before or 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 Bevimlar at a strictly specified time, according to the doctor's instructions, and immediately inform the doctor if, after the end of anesthesia, the patient experiences symptoms such as: numbness or weakness of the legs, disorders of bowel or bladder function, as in such cases, immediate treatment is necessary.

Children and adolescents

Bevimlar, 10 mg, coated tablets are not recommended for persons under 18 years of age. There are insufficient data on the use of the medicine in children and adolescents.

Bevimlar 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 for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines for bacterial infections (e.g., clarithromycin, erythromycin),

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

their doctorbefore taking Bevimlar, as the effect of Bevimlar may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring. If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use treatment to prevent ulcers.

• If you are taking: certain medicines for 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 the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Bevimlar, as the effect of Bevimlar may be reduced. The doctor will decide whether to use Bevimlar and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

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

Driving and using machines

Bevimlar 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.

Bevimlar contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Bevimlar contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Bevimlar

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 Bevimlar tablet taken once a day.
• For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of 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 Bevimlar 10 mg once a day. The tablet should be swallowed whole, preferably with water. Bevimlar can be taken with or without food. If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways of taking Bevimlar. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. If necessary, your doctor may administer the crushed Bevimlar tablet through a gastric tube.

When to take Bevimlar

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 is easier to remember. Your doctor will decide how long to continue the treatment. To prevent blood clots in the veins of the legs after hip or knee replacement surgery: The first tablet should be taken 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 a higher dose of Bevimlar than recommended

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

Missing a dose of Bevimlar

If you forget to take a dose, you should take the tablet as soon as you remember. The next tablet should be taken the next day, and then the tablets should be taken as usual, once a day. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Bevimlar

Do not stop taking Bevimlar without first consulting your doctor, as Bevimlar prevents a serious disease. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bevimlar can cause side effects, although not everybody gets them. Like other medicines with a similar effect of reducing blood clot formation, Bevimlar may cause bleeding, which can potentially 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.

You should immediately inform your doctor 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. 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 pectoris The doctor may decide to monitor the patient very closely or change the treatment.

Signs of severe skin reactions

widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., 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 severe 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 white of the eye),
• 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 disorders (can be observed in tests performed by the 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(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 disorders (can be observed in tests performed by the 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 stasis), 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 granular white blood cell that causes 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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 Bevimlar

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 stated. 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 Bevimlar contains

The active substance of Bevimlar is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban. The other ingredients are:

• Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K-30, corn starch, crospovidone type B, sodium lauryl sulfate, magnesium stearate. See section 2 "Bevimlar contains lactose".
• Coating: hypromellose 2910, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172).

What Bevimlar looks like and contents of the pack

Pale red, round, biconvex coated tablets, approximately 6 mm in size. The coated tablets are available in blisters containing 10, 30 tablets in a carton. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. For more information on this medicine, please contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20.

Manufacturer/Importer:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Laboratorios Liconsa S.A., Avenida Miralcampo 7, Polígono Industrial Miralcampo, ES-19200 Guadalajara, Spain.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Bevimlar, Czech Republic: Bevimlar, Hungary: Bevimlar, Poland: Bevimlar, Slovakia: Bevimlar.

Date of last revision of the leaflet: