RIVAROXABAN ZENTIVA 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban Zentiva 15 mg Hard Capsules

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Zentiva and what is it used for
2. What you need to know before taking Rivaroxaban Zentiva
3. How to take Rivaroxaban Zentiva
4. Possible side effects
5. Storage of Rivaroxaban Zentiva
6. Package Contents and Additional Information

1. What is Rivaroxaban Zentiva and what is it used for

Rivaroxaban Zentiva contains the active ingredient rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• 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 these blood clots from occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban Zentiva is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after initial treatment of at least 5 days with injectable medications used to treat blood clots.

Rivaroxaban Zentiva belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and, therefore, reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Zentiva

Do not take Rivaroxaban Zentiva

• if you are allergic to rivaroxaban or to any of the other ingredients of this medication (listed in section 6);
• if you have excessive bleeding;
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain or recent surgery in the brain or eyes);
• if you are taking medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become clogged;
• if you have a liver disease that increases the risk of bleeding;
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Zentiva and inform your doctor if any of these circumstances apply to you.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rivaroxaban Zentiva.

Be careful with Rivaroxaban Zentiva

• if you have an increased risk of bleeding, as may occur in the following situations:

• severe kidney failure, as kidney function may affect the amount of medication that acts in the body;
• if you are taking other medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become clogged (see section "Other medications and Rivaroxaban Zentiva");
• bleeding disorder;
• very high blood pressure, not controlled by medical treatment;
• diseases of the stomach or intestine that may cause bleeding, such as intestinal or stomach inflammation, or tumors located in the stomach, intestines, genital tract, or urinary tract;
• a problem in the blood vessels of the back of your eyes (retinopathy);
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding;

• if you have a heart valve prosthesis;
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if it may be necessary to modify the treatment;
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Tell your doctorif you have any of these situationsbefore taking Rivaroxaban Zentiva. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery:

• it is very important to take Rivaroxaban Zentiva before and after surgery, exactly at the times indicated by your doctor.
• if your operation requires the placement of a catheter or injection in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• it is very important to take Rivaroxaban Zentiva before and after the injection or removal of the catheter, exactly at the times indicated by your doctor;
• tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and Adolescents

Rivaroxaban Zentiva capsules are not recommended in children with a body weight below 30 kg. There is not enough information about the use of rivaroxaban in children and adolescents for adult indications.

Other medications and Rivaroxaban Zentiva

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

• If you are taking

• any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin;
• • tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces an excess of cortisol);
  • any medication for bacterial infections (e.g., clarithromycin, erythromycin);
• any antiviral medication for HIV/AIDS (e.g., ritonavir);
• other medications to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol);
• anti-inflammatory medications and pain relievers (e.g., naproxen or acetylsalicylic acid);
• dronedarone, a medication for the treatment of irregular heartbeat;
• certain medications for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If any of the above circumstances apply to you, tell your doctorbefore taking Rivaroxaban Zentiva, as the effect of Rivaroxaban Zentiva may be increased. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, they may recommend that you also use a treatment to prevent ulcers.

• If you are taking:

• any medication for the treatment of epilepsy(phenytoin, carbamazepine, phenobarbital);
• St. John's Wort(Hypericum perforatum), a herbal remedy for the treatment of depression;
• rifampicin, an antibiotic.

If any of the above circumstances apply to you,tell your doctorbefore taking Rivaroxaban Zentiva, as the effect of Rivaroxaban Zentiva may be reduced. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

Pregnancy and Breastfeeding

Do not take Rivaroxaban Zentiva if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxaban Zentiva. If you become pregnant while taking this medication, tell your doctor immediately, who will decide how you should be treated.

Driving and Using Machines

Rivaroxaban Zentiva may cause dizziness (frequent side effect) or fainting (uncommon side effect) (see section 4 "Possible side effects"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Zentiva 15 mg contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Rivaroxaban Zentiva 15 mg contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially "sodium-free".

3. How to take Rivaroxaban Zentiva

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You must take Rivaroxaban Zentiva with food.

Swallow the capsule(s) whole, preferably with water.

If you have difficulty swallowing the capsule whole, consult your doctor about other ways to take Rivaroxaban Zentiva. The contents of the capsule can be mixed with water or apple sauce immediately before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may also administer the contents of the Rivaroxaban Zentiva capsule sprinkled through a gastric tube.

What dose to take

• Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body

The recommended dose is one Rivaroxaban Zentiva 20 mg capsule once a day.

If you have kidney problems, the dose may be reduced to one Rivaroxaban Zentiva 15 mg capsule once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to reduce the dose to one Rivaroxaban Zentiva 15 mg capsule once a day (or to one Rivaroxaban Zentiva 10 mg capsule once a day in case your kidneys do not function properly) in addition to an antiplatelet medication such as clopidogrel.

• Totreatblood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from occurring again

The recommended dose is one Rivaroxaban Zentiva 15 mg capsule twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Zentiva 20 mg capsule once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg capsule once a day or one 20 mg capsule once a day.

If you have kidney problems and are taking one Rivaroxaban Zentiva 20 mg capsule once a day, your doctor may decide to reduce the treatment dose to one Rivaroxaban Zentiva 15 mg capsule once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

• Childrenand Adolescents

The dose of Rivaroxaban Zentiva depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kgis one Rivaroxaban Zentiva 15 mgcapsule once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis 20 mg of rivaroxabanonce a day.

Take each dose of Rivaroxaban Zentiva with a drink (e.g., water or juice) during a meal. Take the capsules every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure they take the entire dose.

Since the dose of Rivaroxaban Zentiva is based on body weight, it is essential to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of Rivaroxaban Zentiva on your own. Your doctor will adjust the dose if necessary.

Do not pour the contents of the capsule in an attempt to provide a fraction of the capsule dose. If a lower dose is required, use the alternative product that contains rivaroxaban in the form of oral suspension granules.

For children and adolescents who cannot swallow the capsules whole, use a product that contains rivaroxaban in the form of oral suspension granules.

If the oral suspension is not available, you can pour the contents of the Rivaroxaban Zentiva capsule and mix it with water or apple sauce immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the contents of the Rivaroxaban Zentiva capsule sprinkled through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Zentiva, take a new dose.
• more than 30 minutes after taking Rivaroxaban Zentiva, do not take a new dose. In this case, take the next dose of Rivaroxaban Zentiva at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Zentiva.

When to take Rivaroxaban Zentiva

Take the capsules every day, until your doctor tells you to stop.

Try to take the capsules at the same time every day to remember when to take them.

Your doctor will decide how long you should continue taking the treatment.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heartbeat through a procedure called cardioversion, take Rivaroxaban Zentiva at the times indicated by your doctor.

If you take more Rivaroxaban Zentiva than you should

Call your doctor immediately if you have taken too many Rivaroxaban Zentiva capsules. Taking too much Rivaroxaban Zentiva increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rivaroxaban Zentiva

• Adults, children, and adolescents:

If you are taking one 15 mg capsule and forget to take a dose, take it as soon as you remember. Do not take more than one capsule in one day to make up for a forgotten dose. Take the next capsule the next day and, after that, continue taking one capsule every day.

• Adults:

• If you are taking one 15 mg capsule twice a day and forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in one day. If you forget to take a dose, you can take two 15 mg capsules at the same time, for a total of two capsules (30 mg) in one day. The next day, you should continue taking one 15 mg capsule twice a day.

If you stop taking Rivaroxaban Zentiva

Do not stop taking Rivaroxaban Zentiva without consulting your doctor first, as Rivaroxaban Zentiva treats and prevents the development of a serious condition.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Rivaroxaban Zentiva can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, Rivaroxaban Zentiva can cause bleeding that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tell your doctor immediately if you or your child suffers from any of the following adverse effects:

• Signs of bleeding
• • bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Go to the doctor immediately!)

• prolonged and excessive bleeding.
• • exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor will decide to keep you under closer observation or modify your treatment.

• Signs of severe skin reactions
• • intense skin rashes that spread, blisters, or lesions on the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

The frequency of these adverse 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; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible adverse effects found in adults, children, and adolescents

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• bloody cough
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness, or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• increased heart rate
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 people)

• bleeding into a muscle
• cholestasis (decrease in bile flow), hepatitis, including hepatocellular injury (inflammation of the liver, including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery in which a catheter is inserted into the leg artery (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 lung (eosinophilic pneumonia)

Frequency Not Known(cannot be estimated from available data)

• renal failure after severe bleeding
• increase in pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

Adverse Effects in Children and Adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed in children and adolescents:

Very Frequent(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Frequent(may affect up to 1 in 10 people)

• accelerated heartbeats
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Zentiva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on each blister after "CAD". The expiration date is the last day of the month indicated.

Alu/Alu blisters: No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban Zentiva

• The active ingredient is rivaroxaban. Each capsule contains 15 mg of rivaroxaban.
• The other components are:

Capsule content: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium laurilsulfate, and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and black iron oxide (E 172).

White ink: esterified lacquer, propylene glycol (E 1520), and titanium dioxide (E 171).

Appearance of the Product and Package Contents

Rivaroxaban Zentiva 15 mg capsules are a white to off-white powder that is packaged in size "1" (19.4 ± 0.3 mm in length) capsules with a light brown opaque cap and body with the imprint "15" on the cap with white ink.

The hard capsules are packaged in PVC/PVdC/Alu or Alu/Alu blisters.

Rivaroxaban Zentiva 15 mg is available in packages of 14, 28, 30, 42, 98, and 100 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130,

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Zentiva SA

B-dul Theodor Pallady nr. 50, sector 3,

Bucharest,

032266 Romania

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Germany, and Italy: Rivaroxaban Zentiva

France: Rivaroxaban ZENTIVA

Portugal: Rivaroxabano Zentiva

Date of the Last Revision of this Prospectus:October 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es