Rivaroxaban Viatris 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Viatris 20 mg film-coated tablets EFG

rivaroxaban

Read all of this leaflet carefully before you start taking this medicine, because 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 other people, 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 effects not listed in this leaflet. See section 4.

IMPORTANT: The Rivaroxaban Viatris package includes a Patient Information Card containing safety information. Always carry this card with you.

Contents of this leaflet

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

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

Rivaroxaban Viatris contains the active substance rivaroxaban and is used in adults for:

• preventing 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.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring in the blood vessels of the legs and/or lungs.

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

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

Rivaroxaban Viatris 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 form clots.

2. What you need to know before starting to take Rivaroxaban Viatris

Do not take Rivaroxaban Viatris

• 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 (for example, stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while heparin is being administered through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Viatris 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 Viatris.

Take special care with Rivaroxaban Viatris

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

• severe renal impairment in adults or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine active in your body

• if you are taking other medicines to prevent blood clots (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 Viatris”)

• bleeding disorders

• very high blood pressure that is not controlled by medical treatment

• stomach or intestinal diseases that could cause bleeding, such as intestinal or gastric inflammation, oesophageal inflammation (e.g. due to gastroesophageal reflux disease – a condition in which stomach acid rises up into the oesophagus), or tumours located in the stomach, intestines, genital tract, or urinary tract

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

• a lung disease in which the bronchi are widened and filled with pus (bronchiectasis), or previous 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 your treatment needs to be adjusted

• if your doctor determines that your blood pressure is unstable or if 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 Viatris. 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 Viatris before and after surgery exactly at the times your doctor instructs.

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

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

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

Children and adolescents

Rivaroxaban Viatris tablets are not recommended for children weighing less than 30 kg.

There is insufficient information on the use of Rivaroxaban Viatris in children and adolescents for adult indications.

Other medicines and Rivaroxaban Viatris

Tell 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 medicine for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)

• any medicine for bacterial infections (e.g. clarithromycin, erythromycin)

• any antiviral medicine for HIV/AIDS (e.g. ritonavir)

• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol)

• anti-inflammatory medicines and pain relievers (e.g. naproxen or acetylsalicylic acid)

• dronedarone, a medicine used to treat irregular heartbeat

• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, inform your doctor before taking Rivaroxaban Viatris, as the effect of Rivaroxaban Viatris 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 to be at higher risk of developing a gastric or intestinal ulcer, they may recommend you also use preventive treatment.

• If you are taking

• any medicine 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 apply to you, inform your doctor before taking Rivaroxaban Viatris, as the effect of Rivaroxaban Viatris may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Viatris and whether you need closer monitoring.

Pregnancy and breastfeeding

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

Driving and use of machines

Rivaroxaban Viatris may cause dizziness (a common adverse effect) or fainting (an uncommon adverse 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 Viatris contains lactose and sodium

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

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

3. How to take Rivaroxaban Viatris

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

You should take Rivaroxaban Viatris with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking Rivaroxaban Viatris. The tablet may be crushed and mixed with water or apple puree immediately before taking. Then take food.

If necessary, your doctor may also administer the crushed Rivaroxaban Viatris tablet 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 Viatris tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Viatris 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 to reduce the dose to one 15 mg Rivaroxaban Viatris tablet once daily (or to one 10 mg Rivaroxaban Viatris tablet once daily if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.

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

The recommended dose is one 15 mg Rivaroxaban Viatris tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rivaroxaban Viatris 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 Viatris tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg Rivaroxaban Viatris tablet once daily after 3 weeks if your risk of bleeding is greater than your risk of having another blood clot.

Children and adolescents

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

Take each dose of Rivaroxaban Viatris 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 Viatris 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 Viatris 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, please use alternative formulations such as granules for oral suspension. For children and adolescents who cannot swallow whole tablets, please use appropriate pharmaceutical forms such as granules for oral suspension.

If the oral suspension is not available, you may crush the Rivaroxaban Viatris tablet and mix it with water or apple puree immediately before taking. Then take some food after taking this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Viatris tablet through a tube inserted into the stomach.

If you spit out the dose or vomit

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

Call your doctor if you repeatedly spit out or vomit the dose after taking Rivaroxaban Viatris.

When to take Rivaroxaban Viatris

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 when to take them.

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 using a procedure called cardioversion, take Rivaroxaban Viatris at the times your doctor has indicated.

If you forget to take Rivaroxaban Viatris

• Adults, children and adolescents:

If you are taking a 20 mg or a 15 mg tablet once daily and you 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 each day.

• Adults:

If you are taking a 15 mg tablet twice daily and you 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 obtain 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 Viatris than you should

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

If you stop taking Rivaroxaban Viatris

Do not stop treatment with Rivaroxaban Viatris without first consulting your doctor, as Rivaroxaban Viatris 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, this medicine can cause adverse effects, although not everyone will experience them.

Like other similar medicines used to reduce blood clot formation, Rivaroxaban Viatris may cause bleeding that can be life-threatening. Excessive bleeding may cause 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 inside 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, difficulty breathing, 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 and difficulty breathing; sudden drop in blood pressure.

The frequencies of these 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 observed in adults, children and adolescents

Frequent (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
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (may be seen in blood tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or lightheadedness, 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, skin itching
• blood tests may show an increase in certain 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
• impaired liver function (may be seen in blood 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 hepatocellular liver 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 (cannot be estimated from available data)

• kidney failure following severe bleeding
• increased pressure in the muscles of the legs or arms after 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 observed in adults, and their severity was mostly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting

Frequent (may affect up to 1 in 10 people)

• increased heart rate
• 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 adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Viatris

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 packaging and on each blister or bottle after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 2 hours.

Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Viatris

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

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”.

Film coating: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide red (E172).

Appearance of Rivaroxaban Viatris and contents of the pack

Rivaroxaban Viatris 15 mg film-coated tablets are pink to orange-red in colour, round, biconvex, bevel-edged (6.4 mm in diameter), and marked with “RX” on one side and “3” on the other side.

They are packed in:

• Blister packs in cartons containing 14, 28, 30, 42, 98 or 100 film-coated tablets, or
• Unit dose blisters in packs containing 14 × 1, 28 × 1, 30 × 1, 42 × 1, 50 × 1, 98 × 1 or 100 × 1 film-coated tablets, or
• Bottles containing 98 or 100 film-coated tablets.

Rivaroxaban Viatris 20 mg film-coated tablets are reddish-brown in colour, round, biconvex, bevel-edged (7.0 mm in diameter), and marked with “RX” on one side and “4” on the other side.

They are packed in:

• Blister packs in cartons containing 14, 28, 30, 98 or 100 film-coated tablets, or
• Unit dose blisters in packs containing 14 × 1, 28 × 1, 30 × 1, 50 × 1, 90 × 1, 98 × 1 or 100 × 1 film-coated tablets, or
• Bottles containing 98 or 100 film-coated tablets, or
• Calendar blister packs containing 14, 28 or 98 film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Manufacturer

Mylan Germany GmbH
Benzstrasse 1
Bad Homburg,
Hesse,
61352,
Germany

Mylan Hungary Kft,
Mylan utca 1,
Komárom,
H-2900,
Hungary

McDermott Laboratories Limited t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland

Medis International (Bolatice),
Prumyslova 961/16,
Bolatice,
74723,
Czech Republic

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Spain Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712

Date of the most recent review of this leaflet: October 2023

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.