Bevimlar

Package leaflet: Information for the user

Bevimlar, 10 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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

Bevimlar contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins following hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots 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 to 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. 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 has 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 medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• 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 the patient suspects that any of the above conditions apply.

Warnings and precautions

Discuss use of Bevimlar with your doctor or pharmacist before starting treatment.

When to exercise particular caution when using Bevimlar

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • 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 switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Bevimlar with other medicines"),
  • blood clotting 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 oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines or in the reproductive or urinary system,
  • disease of blood vessels at the back of the eye (retinopathy),
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions apply, inform the doctor before taking Bevimlar. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding when to take Bevimlar before or after surgery,
• if during surgery a catheter is planned or a spinal puncture is performed (e.g. for epidural or spinal anaesthesia or pain relief):
  • it is very important to take Bevimlar at the exact time specified by the doctor,
  • inform the doctor immediately if, after the anaesthesia wears off, the patient experiences symptoms such as: numbness or weakness in the legs, bowel or bladder dysfunction, as immediate treatment is required in such cases.

Children and adolescents

Bevimlar 10 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

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

• If the patient is taking:
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
  • ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
  • certain antibiotics (e.g. clarithromycin, erythromycin),
  • certain antiviral medicines used in HIV infection or AIDS treatment (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 antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions apply, inform the doctor before taking Bevimlar, as the effect of Bevimlar may be increased. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment for peptic ulcer disease may be prescribed.

• If the patient is taking:
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
  • St John's wort (Hypericum perforatum), a herbal remedy used for depression,
  • rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, inform the doctor before taking Bevimlar, as the effect of Bevimlar may be reduced. The doctor will decide whether to use Bevimlar and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding

Do not use Bevimlar if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Bevimlar. If the patient becomes pregnant while taking this medicine, inform the doctor immediately. The doctor 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 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 an 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; therefore, it is considered "sodium-free".

3. How to use Bevimlar

This medicine should always be taken as directed by the physician. If in doubt, consult your
doctor or pharmacist.
How many tablets to take

• To prevent the formation of blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of Bevimlar 10 mg taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots:

After at least 6 months of treatment for blood clots, the recommended dose is either one tablet of 10 mg once daily or one tablet of 20 mg once daily. The doctor has prescribed Bevimlar 10 mg once daily for the patient.
The tablet should be swallowed whole, preferably with water.
Bevimlar may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods 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.
When to take Bevimlar
Take one tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Use of a higher than recommended dose of Bevimlar
If the patient has taken more than the prescribed dose of Bevimlar, contact the doctor immediately. Taking too high a dose of Bevimlar increases the risk of bleeding.
Missed dose of Bevimlar
If the patient forgets to take a dose, take the tablet as soon as remembered. Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for the missed tablet.
Stopping Bevimlar treatment
Do not stop taking Bevimlar without first consulting your doctor, as Bevimlar helps prevent a serious medical condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
Like other medicines with a similar anticoagulant effect, Bevimlar may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Bleeding may not always present obvious or visible signs.
You should immediately inform your doctor if any of the following adverse effects 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 medical emergency. Seek immediate medical help!)
  o Prolonged or excessive bleeding,
  o Unusual weakness, fatigue, paleness, 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 Widespread, acute skin rash, formation of blisters 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 effects 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 effects:
Common (may occur in 1 out of 10 people)

• Decrease in red blood cell count, which may cause skin pallor 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 conjunctival hemorrhage),
• 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 blood pressure (symptoms may include dizziness or fainting upon standing),
• Generalized weakness and 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)

• Intracranial hemorrhage or bleeding within the skull (see bleeding signs above),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, blood cells involved in 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)

• Muscle bleeding,
• Cholestasis (bile stasis), hepatitis including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Blood collection (hematoma) in the groin as a complication of cardiac catheterization procedure, when a 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 granulocytic white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be determined from available data)

• Kidney failure following severe bleeding,
• Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• Increased pressure in 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 effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 the outer carton
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Crushed tablets
Crushed tablets are stable in water or apple puree 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.
One coated tablet contains 10 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 (E 172).

What Bevimlar looks like and contents of the pack
Pale pink, round, biconvex coated tablets, approximately 6 mm in size.
Coated tablets are available in blister packs containing 10 or 30 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicinal product, please 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