Bevimlar

Package leaflet: Information for the user

Bevimlar 2.5 mg film-coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Bevimlar is and what it is used for
2. What you need to know 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 Bevimlar is and what it is used for

You have been prescribed Bevimlar because

• you have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Bevimlar reduces the risk of subsequent heart attack or the risk of death due to heart- or blood vessel-related disease in adults. Bevimlar will not be given to you as a single medicine. Your doctor will also prescribe you: either acetylsalicylic acid or acetylsalicylic acid together with clopidogrel or ticlopidine; or
• you are at high risk of developing blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Bevimlar reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Bevimlar will not be given to you as a single medicine. Your doctor will also prescribe you acetylsalicylic acid. In some cases, if you are receiving Bevimlar after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Bevimlar contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency to form blood clots.

2. Important information before using Bevimlar

When not to use Bevimlar

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had a brain hemorrhage (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischemic, non-lacunar stroke) within the last month,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Bevimlar and inform your doctor if you suspect that any of the above conditions apply to you.
Warnings and precautions
Discuss with your doctor or pharmacist before starting Bevimlar.
Bevimlar should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when using Bevimlar

• if the patient has an increased risk of bleeding, such as in the following conditions: o severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body, o use of other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Bevimlar with other medicines"), o coagulation disorders, o very high blood pressure that does not decrease despite treatment with medicines, o 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 (acid reflux into the esophagus) or tumors located in the stomach or intestines or in the genital or urinary system, o retinal vascular disease (retinopathy), o lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding, o if the patient is over 75 years of age, o if the patient weighs less than 60 kg, o coronary artery disease with severe symptomatic heart failure,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If you suspect that any of the above conditions apply to you, inform your doctor
before using Bevimlar. The doctor will decide whether to use this medicine and whether the patient
should be placed under particularly close observation.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of Bevimlar administration before or after surgery,
• if catheterization or spinal puncture (e.g. for epidural or intrathecal anesthesia or pain relief) is planned during surgery: o it is very important to take Bevimlar before and after the puncture or catheter removal as directed by the doctor, o immediately inform the doctor if, after anesthesia ends, the patient experiences symptoms such as: numbness or weakness in the legs, bowel or bladder dysfunction, as immediate treatment will be required.

Children and adolescents
Bevimlar 2.5 mg film-coated tablets are not recommended for patients under 18 years of age. There is
insufficient data on the use of this medicine in children and adolescents.
Bevimlar with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, and any medicines
you plan to use, including those available without a prescription.

• If the patient is taking: o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin, o ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol), o certain antibacterial medicines (e.g. clarithromycin, erythromycin), o certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir), o other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions"), o anti-inflammatory and pain medicines (e.g. naproxen or acetylsalicylic acid), o dronedarone, a medicine used to treat heart rhythm disorders, o certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI))

If you suspect that any of the above conditions apply to you, inform your doctor
before using Bevimlar, as the effect of Bevimlar may be enhanced. The doctor will decide whether to
use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal
ulcers, he may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking: o certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), o St. John's wort ( Hypericum perforatum ), a herbal remedy used for depression, o rifampicin, an antibiotic

If you suspect that any of the above conditions apply to you, inform your doctor
before using Bevimlar, as the effect of Bevimlar may be reduced. The doctor will decide whether to
use Bevimlar and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Bevimlar if you are pregnant or breastfeeding. If there is a risk that you may become pregnant,
you should use an effective method of contraception during treatment with Bevimlar. If you become
pregnant while taking this medicine, inform your doctor immediately, so that he can decide on further
treatment.
Driving and operating machinery
Bevimlar may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Bevimlar contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Bevimlar contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Bevimlar

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.

How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Bevimlar should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). This medicine may be taken with or without food.

If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Bevimlar with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. If necessary, the doctor may administer crushed Bevimlar tablets via a gastric tube.

Bevimlar will not be given to the patient as the only medication.

The doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving Bevimlar after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.

If the patient is receiving Bevimlar after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.

The doctor will advise how much of these medicines to take (usually 75–100 mg acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).

When to start taking Bevimlar
Treatment with Bevimlar after acute coronary syndrome should be initiated as soon as possible after stabilization of the acute event, no earlier than 24 hours after hospital admission and at the time when parenteral (by injection) antithrombotic treatment would normally be discontinued.

The doctor will advise when to start treatment with Bevimlar if coronary artery disease or peripheral arterial disease has been diagnosed.

The doctor will decide how long treatment should continue.

Taking more Bevimlar than recommended
If the patient has taken more Bevimlar than recommended, contact the doctor immediately. Taking too high a dose of Bevimlar increases the risk of bleeding.

If a dose of Bevimlar is missed
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the scheduled time.

Stopping Bevimlar
Bevimlar should be taken regularly and for the duration recommended by the doctor.

Do not stop taking Bevimlar without first consulting the doctor. Stopping this medicine may increase the risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar anticoagulant effect, Bevimlar may cause bleeding, which potentially can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following adverse reactions occur:

• Signs of bleeding o bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. This is a serious, acute medical emergency. Immediate medical assistance must be sought!), o prolonged or excessive bleeding, o unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
• Signs of severe skin reactions o extensive, acute skin rash, blister formation or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis), o drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of severe allergic reactions o swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; 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 adverse reactions:
Common (may occur in 1 out of 10 people)

• decrease in the number of red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding from the conjunctiva of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 out of 100 people)

• bleeding into the brain or within the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, platelets being blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• urticaria.

Rare (may occur in 1 out of 1,000 people)

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

Very rare (may occur in 1 out of 10,000 people)

• accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency unknown (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bevimlar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Bevimlar contains
The active substance is rivaroxaban.
Each coated tablet contains 2.5 mg of rivaroxaban.
The other ingredients are:

• Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K-30, maize 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 yellow (E172).

What Bevimlar looks like and contents of the pack
Yellow, round, biconvex coated tablets, approximately 6 mm in size.
Coated tablets are available in blisters containing 28 tablets per cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
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 medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Bevimlar
Czech Republic: Bevimlar
Hungary: Bevimlar
Poland: Bevimlar
Slovakia: Bevimlar