Bevimlar

Package leaflet: Information for the user

Bevimlar, 15 mg, coated tablets
Bevimlar, 20 mg, coated tablets
Initiation treatment pack
Do not use in children.
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, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects 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

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 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 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 medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter
• 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 circumstances apply.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bevimlar.
When to take special care with Bevimlar

• if the patient has an increased risk of bleeding, such as: severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, since kidney function may affect the amount of medicine acting in the patient's body; when taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) during a switch in anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section "Bevimlar with other medicines"); bleeding disorders; very high blood pressure that does not decrease despite medication; stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach and intestines or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system; disease of blood vessels at the back of the eye (retinopathy); lung disease with dilated and pus-filled bronchi (bronchiectasis) or previous lung bleeding
• in patients with prosthetic heart valves
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary
• 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 that any of the above conditions apply, inform the 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 surgery:

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

Children and adolescents
The Bevimlar starter pack is not recommended for patients under 18 years of age,
as it is specifically designed for initiating treatment in adult patients and is not
suitable for use in children and adolescents.
Bevimlar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking:
  some medicines used for fungal infections (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)
  some antibiotics used for bacterial infections (e.g. clarithromycin, erythromycin)
  some 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
  some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).
  If the patient suspects that any of the above conditions apply, inform the 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, they may prescribe treatment to prevent peptic ulcer disease.

• 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 that any of the above conditions apply, inform the 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 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, who will 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 contact the doctor before taking the medicine.
Bevimlar contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Bevimlar

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Bevimlar should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Bevimlar with
your doctor. The tablet may be crushed and mixed with water or soft food, such as apple puree,
immediately before administration. After taking this mixture, a meal should be consumed promptly. If
necessary, your doctor may administer crushed Bevimlar tablets via a gastric tube.
How many tablets to take
The recommended dose is one 15 mg Bevimlar tablet twice daily for the first 3 weeks. The recommended
maintenance dose after 3 weeks is one 20 mg Bevimlar tablet once daily.
The starter pack containing Bevimlar 15 mg and 20 mg tablets is intended for the first 4 weeks of
treatment only. After completing the tablets from this pack, treatment will continue with Bevimlar 20 mg
once daily, following consultation with your doctor.
If a patient has impaired kidney function, the doctor may decide to reduce the dose after 3 weeks of
treatment to one 15 mg Bevimlar tablet once daily, if the risk of bleeding is greater than the risk of
developing further blood clots.
When to take Bevimlar
Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
Taking more Bevimlar than prescribed
If a patient has taken more Bevimlar than prescribed, contact your doctor immediately. Taking too high
a dose of Bevimlar increases the risk of bleeding.
Missed dose of Bevimlar

• If a patient is taking one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets within one day. If a dose was forgotten, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, resume taking one 15 mg tablet twice daily.
• If a patient is taking one 20 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, and continue taking one tablet once daily thereafter.

Stopping Bevimlar treatment
Do not stop taking Bevimlar without first consulting your doctor, as Bevimlar helps prevent a serious
condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Like other medicines with a similar mechanism of action that reduce blood clot formation, Bevimlar may cause bleeding, which potentially could 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 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.
  A serious, sudden medical emergency. Immediate medical help must be called!),
  o Prolonged or excessive bleeding,
  o Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina.

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, blistering 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) causing 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 patients)

• Decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath,
• Gastrointestinal or intestinal bleeding, bleeding from the urogenital system (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the sclera),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) during coughing,
• Bleeding from the skin or subcutaneous bleeding,
• Bleeding after surgery,
• Oozing of blood or fluid from the surgical wound,
• Swelling of limbs,
• 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, itching of the skin,
• Increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 out of 100 patients)

• Bleeding into the brain or inside the skull (see signs of bleeding listed above),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, 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 patients)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Accumulation of blood (hematoma) in the groin area 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 not known (frequency cannot be estimated 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 lead to 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, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps 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 cardboard packaging
after: EXP. The expiry date refers to the last day of the stated month.
No special storage precautions 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.
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, monohydrate lactose, 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 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
Brownish-red, round, biconvex film-coated tablets, approximately 7 mm in size.
Starting pack for the first 4 weeks of treatment: each pack 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 cardboard box.
Not all pack sizes may be marketed.

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, please contact the representative of the Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Sweden: Bevimlar
Czech Republic: Bevimlar
Hungary: Bevimlar
Poland: Bevimlar
Slovakia: Bevimlar