Bevimlar

Package Leaflet: Information for the User

Bevimlar, 15 mg, film-coated tablets

Bevimlar, 20 mg, film-coated tablets

Treatment Initiation Pack

Do not use in children.
Rivaroxaban

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

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for you. 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, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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:

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

Bevimlar belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Important information before taking Bevimlar

When not to take Bevimlar

• 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 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 to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Bevimlar, and 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 you have an increased risk of bleeding, such as: severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in the body, taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) during switching of anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery (see "Bevimlar and other medicines"), bleeding disorders, very high blood pressure that does not decrease despite treatment, diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (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 enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if you have a disorder 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 doctor

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

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Bevimlar at a specific time before or after surgery
• if catheterization or spinal puncture (e.g., for epidural or spinal anesthesia or pain relief) is planned: it is very important to take Bevimlar before and after the puncture or catheter removal at a specific time, as instructed by your doctor, and to immediately inform your doctor if, after the anesthesia, you experience symptoms such as numbness or weakness of the legs, bowel or bladder dysfunction, as immediate treatment may be necessary.

Children and adolescents

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

Bevimlar and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• If you are taking: certain antifungal medicines (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 antibacterial medicines (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 Bevimlar, as the effect of Bevimlar may be increased. Your doctor will decide whether to use 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, inform your doctor

before taking Bevimlar, as the effect of Bevimlar may be reduced. Your doctor will decide whether to use Bevimlar and whether you should be closely monitored.

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 during treatment with Bevimlar. If you become pregnant during treatment with 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 bicycle, or operate tools or machines.

Bevimlar contains lactose

If you have 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 it is essentially "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. Bevimlar should be taken with food. Swallow the tablet(s) whole, preferably with water. If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Bevimlar. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. After such a mixture, you should eat the meal immediately. If necessary, your doctor may give you a crushed Bevimlar tablet through a gastric tube.

How many tablets to take

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

When to take Bevimlar

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

Taking a higher dose of Bevimlar than recommended

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

Missing a dose of Bevimlar

• If you are taking one 15 mg tablet twice a day and you miss a dose, 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) in one day. The next day, 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, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once a day.

Stopping treatment with Bevimlar

Do not stop taking Bevimlar without first discussing it with your doctor, as Bevimlar 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, this medicine can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Bevimlar may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These signs of bleeding are not always obvious or visible.

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. Seek medical help immediately!), prolonged or excessive bleeding, unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, bleeding into the eye (including bleeding from the white part of the eye), bleeding into tissues or body cavities (hematoma, bruising), coughing up blood (hemoptysis), bleeding from the skin or bleeding under the skin, bleeding after surgery, oozing of blood or fluid from the wound after surgery, swelling of the limbs, limb pain, kidney problems (which can be seen 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 weakness and lack of energy (weakness, fatigue), headache, dizziness, rash, itching, increased activity of some liver enzymes, which can be seen in blood test results.

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 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 intestines, 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 part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• coughing up blood (hemoptysis) during coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen 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 weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching,
• 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 problems (which can be seen 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 flow obstruction), 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 blood cell granulocyte 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 therapy),
• increased pressure in the muscles of the legs and arms 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, pharmacist, or nurse. 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, PL-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 this 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 storage. 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bevimlar contains

The active substance is rivaroxaban. Bevimlar 15 mg film-coated tablets: One film-coated tablet contains 15 mg of rivaroxaban. Bevimlar 20 mg film-coated tablets: One film-coated tablet contains 20 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, iron oxide red (E172).

What Bevimlar looks like and contents of the pack

Bevimlar 15 mg film-coated tablets: Red, round, biconvex film-coated tablets, approximately 6 mm in size. Bevimlar 20 mg film-coated tablets: Brown-red, round, biconvex film-coated tablets, approximately 7 mm in size. Treatment initiation pack for the first 4 weeks of treatment: Each pack of 49 film-coated tablets for the first 4 weeks of treatment contains: 42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban, 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 about this medicine, 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 package leaflet: