Rivaroxaban Vivanta 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivaroxaban Vivanta 15 mg film-coated tablets EFG

Rivaroxaban Vivanta 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents

1. What Rivaroxaban Vivanta is and what it is used for
2. What you need to know before taking Rivaroxaban Vivanta
3. How to take Rivaroxaban Vivanta
4. Possible side effects
5. How to store Rivaroxaban Vivanta
6. Contents of the pack and other information

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

Rivaroxaban Vivanta contains the active substance rivaroxaban.

Rivaroxaban 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 known as 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 reoccurring in the blood vessels of the legs and/or lungs.

Rivaroxaban 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, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to clot.

2. What you need to know before taking Rivaroxaban Vivanta

Do not take Rivaroxaban Vivanta

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or condition affecting an organ in your body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or hemorrhage, or recent surgery on the brain or eyes)
• if you are taking medications to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching treatments
• anticoagulant therapy or while heparin is being administered through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rivaroxaban.

Take special care with Rivaroxaban Vivanta

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

• severe renal impairment in adults and moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of drug active 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 to prevent blockage (see section “Other medicines and Rivaroxaban Vivanta”)

• bleeding disorders

• very high blood pressure not controlled by medical treatment

• stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease [a condition where stomach acid moves up into the esophagus]), or tumors in the stomach, intestines, genital tract, or urinary tract

• a blood vessel problem at the back of your eyes (retinopathy)

• a lung disease in which the bronchi are widened and filled with pus (bronchiectasis) or prior lung bleeding

• if you have a heart valve prosthesis

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be needed

• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo a surgical procedure to remove a blood clot from your lungs

Inform your doctor if any of these situations apply to you before taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery

• It is very important to take rivaroxaban before and after surgery exactly at the times your doctor instructs.

• If your procedure requires placement of a catheter or injection into your spine (e.g., for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban before and after the injection or catheter removal exactly at the times your doctor has specified.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after anesthesia, as urgent medical attention is required.

Children and adolescents

Rivaroxaban is not recommended in children with body weight below 30 kg. There is insufficient information on the use of rivaroxaban in children and adolescents for adult indications.

Other medicines and Rivaroxaban Vivanta

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

• If you are taking

• any medication for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, where 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 drugs and pain relievers (e.g., naproxen or acetylsalicylic acid)

• dronedarone, a medication used to treat irregular heartbeat

• certain antidepressants (selective serotonin reuptake inhibitors [SSRIs] or serotonin-norepinephrine reuptake inhibitors [SNRIs])

If any of the above situations apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If your doctor considers you at higher risk of developing a stomach or intestinal ulcer, they may recommend additional preventive treatment.

• If you are taking
  • any medication for epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression
  • rifampicin, an antibiotic

If any of the above situations apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately; they will decide on appropriate treatment.

Driving and use of machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4 “Possible side effects”). You should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rivaroxaban Vivanta contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Rivaroxaban Vivanta

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

You should take rivaroxaban with food.

Swallow the tablets whole, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before administration. This mixture must be followed immediately by food.

If necessary, your doctor may also administer crushed rivaroxaban tablets 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 in the body: The recommended dose is one 20 mg rivaroxaban tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once daily.

If you need a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting reducing the dose to one 15 mg rivaroxaban tablet once daily (or one 10 mg rivaroxaban tablet once daily if your kidneys do not function properly), in addition to an antiplatelet medication such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of blood clots:

The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg rivaroxaban tablet once daily after 3 weeks, if your risk of bleeding is higher than the risk of developing another blood clot.

• Children and adolescents

The dose of rivaroxaban 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 kg is one 15 mg rivaroxaban tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

Take each dose of rivaroxaban with a drink (e.g., water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to help you remember.

For parents or caregivers: Observe the child to ensure they take the full dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as body weight changes.

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

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, other pharmaceutical forms are available.

For children and adolescents who cannot swallow the tablets whole, use the oral suspension granules.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before administration. After taking this mixture, consume food. If necessary, your doctor may also administer crushed rivaroxaban tablets through a tube inserted into the stomach.

If you spit out the dose or vomit

• Less than 30 minutes after taking rivaroxaban, take a new dose.
• More than 30 minutes after taking rivaroxaban, do not take a new dose. In this case, take the next dose of rivaroxaban at the usual time.

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

When to take Rivaroxaban Vivanta

Take the tablets every day, until your doctor tells you otherwise.

Try to take the tablets at the same time each day to help you remember. Your doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels: If it becomes necessary to restore normal heart rhythm through a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you forget to take Rivaroxaban Vivanta

• Adults, children, and adolescents:

If you are taking one 20 mg or one 15 mg tablet once daily and forget a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day, and then continue taking one tablet daily.

• Adults:

If you are taking one 15 mg tablet twice daily and forget a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you missed a dose, you may take two 15 mg tablets at once to achieve a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Vivanta than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you stop treatment with Rivaroxaban Vivanta

Do not stop treatment with rivaroxaban without first consulting your doctor, as rivaroxaban treats and prevents serious conditions.

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

4. Possible adverse effects

Like all medicines, rivaroxaban can cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following symptoms:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)

• prolonged or excessive bleeding

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding.

Your doctor may decide to monitor you more closely or change your treatment.

• Signs of serious skin reactions

• severe skin rashes that spread, blisters or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

• drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

• Signs of serious allergic reactions
  • swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; difficulty breathing; sudden drop in blood pressure.

The frequencies of serious 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 reported in adults, children, and adolescents

Common (may affect up to 1 in 10 people)

• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• bleeding from the stomach or intestines, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or body cavity (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• impaired kidney function (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea
• low blood pressure (symptoms may include feeling dizzy or faint upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in certain liver enzymes

Uncommon (may affect up to 1 in 100 people)

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

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

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including traumatic hepatocellular injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin following a complication from cardiac surgery involving insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare (may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of granulocytic 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 kidney, sometimes with blood in the urine, leading to the kidneys' inability to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms following bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Adverse effects in children and adolescents

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

Adverse effects observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low number of platelets, blood cells that help blood clot)
• 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Vivanta

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

Do not use this medicine after the expiry date stated on the packaging and on each blister or bottle, following “EXP”.

The expiry date refers to the last day of the stated month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple purée for up to 4 hours.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Vivanta

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose (PH 102), sodium croscarmellose, sodium lauryl sulfate, hypromellose 2910, magnesium stearate. See section 2 “Rivaroxaban Vivanta contains lactose and sodium”.

Film coating: 15 mg: hypromellose 2910 (E464), red iron oxide (E172), macrogol 4000 (E1521), titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172).

Film coating: 20 mg: hypromellose 2910 (E464), red iron oxide (E172), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172).

Appearance of the product and pack contents

Rivaroxaban Vivanta 15 mg are brown, film-coated, round, biconvex tablets, engraved with “M” on one side and “R2” on the other.

They are available:

• in blister packs in cartons containing 14, 28, 56 or 98 film-coated tablets (with or without calendar blister), or

in unit-dose blister packs in cartons containing 28 film-coated tablets.

Rivaroxaban Vivanta 20 mg are brown, film-coated, triangular, biconvex tablets, engraved with “R” on one side and “20” on the other.

They are available:

• in blister packs in cartons containing 14, 28, 56 or 98 film-coated tablets (with or without calendar blister), or

in unit-dose blister packs in cartons containing 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice,

19600, Prague 9

Czech Republic

Manufacturer responsible for production

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola,
PLA3000, Malta

or

MSN Labs Europe Limited
KW20A Corradino Park,
Paola, PLA3000, Malta

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Local representative:

Mabo-Farma S.A.
Calle Vía de los Poblados 3, Edificio 6
28033 Madrid
Spain

This medicinal product is authorized in other EEA countries under the following names

Germany	Rivaroxaban Vivanta 15 mg Film-coated tablets Rivaroxaban Vivanta 20 mg Film-coated tablets
Spain	Rivaroxaban Vivanta 15 mg film-coated tablets EFG Rivaroxaban Vivanta 20 mg film-coated tablets EFG
Ireland	Rivaroxaban MSN 15 mg film-coated tablets Rivaroxaban MSN 20 mg film-coated tablets

Date of the last revision of this leaflet:

January 2025

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