RIVAROXABAN ZENTIVA 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban Zentiva 10 mg Hard Capsules EFG

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 side effects 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 substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medication because after surgery you have a higher risk of forming blood clots.
• 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 belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thus 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 any of the other ingredients of this medication (listed in section 6)
• if you bleed excessively
• 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 brain or eye surgery)
• if you are taking medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while being administered heparin through a venous or arterial catheter to prevent it from becoming 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 doctorif 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:

• moderate or severe kidney failure, as kidney function may affect the amount of medication that works in your body
• if you are taking other medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin) when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent it from becoming clogged (see section "Other medications and Rivaroxaban Zentiva")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of the 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 clot formation), 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 conditionsbefore 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 exactly at the times indicated by your doctor.
• tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban Zentiva 10 mg hard capsules are not recommended for children under 18 years of age.There is not enough information about its use in children and adolescents.

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 obtained 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 excess 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 or pain relievers (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medication for treating irregular heartbeat
• certain medications for treating 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 will recommend using a preventive treatment for ulcers in addition to Rivaroxaban Zentiva.

• If you are taking:

any medication for treating epilepsy (phenytoin, carbamazepine, phenobarbital)

St. John's Wort (Hypericum perforatum), a medicinal plant for treating 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 Rivaroxaban Zentiva 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 or use machines if you are affected by these symptoms.

Rivaroxaban Zentiva contains lactose and sodium.

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

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

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one Rivaroxaban Zentiva 10 mg capsule once a day.

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

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed Rivaroxaban Zentiva 10 mg once a day.

Swallow the capsule preferably with water.

Rivaroxaban Zentiva can be taken with or without food.

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.

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

When to take Rivaroxaban Zentiva

Take the capsule every day, until your doctor indicates otherwise.

Try to take a capsule at the same time every day, to help you remember.

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

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first capsule 6 to 10 hours after surgery.

If you have undergone major hip surgery, you will usually take the capsules for 5 weeks.

If you have undergone major knee surgery, you will usually take the capsules for 2 weeks.

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

If you forget to take a dose, take it as soon as you remember. Take the next capsule the next day and, after that, take one capsule every day, as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Rivaroxaban Zentiva

Do not stop taking Rivaroxaban Zentiva without talking to your doctor first, as Rivaroxaban Zentiva 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 side effects

Like all medications, Rivaroxaban Zentiva can cause side effects, although not everyone will experience them.

Like other similar medications to reduce blood clot formation, Rivaroxaban Zentiva may cause bleeding, which can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

Tell your doctor immediately if you experience any of the following side 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, pallor, 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 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; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure

The frequency of severe allergic reactions is 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 side effects

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause pallor and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (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)
• coughing up blood
• 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 include 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 in a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clot)
• 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 in a muscle
• cholestasis (decreased bile flow), hepatitis, including hepatocellular injury (liver inflammation, 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)

• kidney failure after severe bleeding
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome due to bleeding)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaroxaban Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on each blister after “EXP”. The expiry date refers to the last day of the month stated.

PVC/PVdC/Alu blisters: Store below 30 °C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban Zentiva

• The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are:

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

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

Black ink: shellac (E 904), black iron oxide (E 172), propylene glycol (E 1520), ammonia solution (E 527), and potassium hydroxide (E 525).

Appearance and Package Contents of the Product

Rivaroxaban Zentiva 10 mg capsules are a white to off-white powder filled in a size “3” capsule (15.9 ± 0.3 mm in length) with an opaque beige cap and body, printed with “10” in black ink on the cap.

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

Rivaroxaban Zentiva 10 mg is available in packs of 5, 10, 15, 20, 30, and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

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

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorised 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 last revision of this leaflet:October 2023

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