Bevimlar

Leaflet accompanying the packaging: information for the user

Bevimlar, 2.5 mg film-coated tablets

Rivaroxaban

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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

You have been given Bevimlar because

• you 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. Bevimlar reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Bevimlar will not be given to you as the only medicine. Your doctor will also prescribe you to take: either acetylsalicylic acid or acetylsalicylic acid and clopidogrel or ticlopidine or
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Bevimlar reduces the risk of blood clots (atherothrombotic events) in adults. Bevimlar will not be given to you as the only medicine. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are taking Bevimlar after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to acetylsalicylic acid.

Bevimlar 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 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 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 changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Bevimlar and other medicines"),
• if you have been diagnosed with acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have been diagnosed with coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the tissues in the deep structures of the brain (sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are 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 to take Bevimlar, you should discuss it with your doctor or pharmacist.
Bevimlar should not be taken in combination with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for acetylsalicylic acid, clopidogrel, or ticlopidine.

When to be particularly careful when taking Bevimlar

• if you have an increased risk of bleeding, such as: severe kidney disease, as kidney function may affect the amount of medicine that works in your body, taking other blood clotting inhibitors (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, stomach or intestinal diseases 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, intestines, genital, or urinary system, vascular disease of 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, if you are over 75 years old, if you weigh less than 60 kg, coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic 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 on possible treatment changes.

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

before taking Bevimlar. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the intake of Bevimlar at a strictly defined 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 before and after the puncture or catheter removal, according to your doctor's instructions, you should immediately inform your doctor if, after the anesthesia is finished, you experience symptoms such as: numbness or weakness of the legs, bowel or bladder dysfunction, as in such cases, immediate treatment is necessary.

Children and adolescents

Bevimlar 2.5 mg film-coated tablets are not recommended for persons under 18 years of age. There are no sufficient data on the use of the medicine in children and adolescents.

Bevimlar and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take, including those that are available 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 that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel, and ticagrelor (see "Warnings and precautions")), 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 you suspect that you have any of the above conditions, you should 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 under close observation.
If your doctor believes that you are at increased risk of developing 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, you should 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 under close observation.

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 (common 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 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

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Bevimlar should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should 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 it. If necessary, your doctor may administer the crushed Bevimlar tablet through a gastric tube.
Bevimlar will not be given to you as the only medicine.
Your doctor will also prescribe you to take acetylsalicylic acid. If you are taking Bevimlar after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Bevimlar after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to acetylsalicylic acid.
Your doctor will tell you how much of these medicines to take (usually 75-100 mg of acetylsalicylic acid per day or a daily dose of 75-100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Bevimlar

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

Taking a higher dose of Bevimlar than recommended

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

Missing a dose of Bevimlar

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

Stopping treatment with Bevimlar

Bevimlar should be taken regularly and for the time prescribed by your doctor.
Do not stop taking Bevimlar without first consulting your doctor. If you stop taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
If you have any further questions about the use of this medicine, you should 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 with similar blood clotting-reducing effects, Bevimlar may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.

You should immediately inform your doctor if you 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. You should immediately seek medical help!), prolonged or excessive bleeding, unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina,
Your doctor may decide to monitor you closely or change the treatment.

Signs of severe skin reactions

widespread, severe 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, blood 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)

• reduced 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 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 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 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 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 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(may affect up to 1 in 1,000 people)

• bleeding into 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 (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 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 not listed in this leaflet, you should 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
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 Bevimlar

The medicine should be stored out of 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.
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. You should 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 film-coated tablet contains 2.5 mg of rivaroxaban.
The other ingredients are:

• Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K-30, cornstarch, 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

Yellow, round, biconvex film-coated tablets, approximately 6 mm in size.
Film-coated tablets are available in blisters containing 28 tablets in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +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:
Poland:
Bevimlar
Bevimlar
Slovakia:
Bevimlar

Date of last revision of the leaflet: