Patient Information Leaflet: Information for the User

Rivaroxaban Viatris 2.5 mg Film-coated Tablets

rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rivaroxaban Viatris is and what it is used for
What you need to know before taking Rivaroxaban Viatris
How to take Rivaroxaban Viatris
Possible side effects
How to store Rivaroxaban Viatris
Contents of the pack and other information

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

You have been given Rivaroxaban Viatris because

you have been diagnosed with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe form of chest pain) and blood tests have shown an increase in certain cardiac markers. In adults, Rivaroxaban Viatris reduces the risk of another heart attack or the risk of dying due to a heart- or blood vessel-related disease. Rivaroxaban Viatris will not be given to you alone. Your doctor will also prescribe:
- acetylsalicylic acid, or
- acetylsalicylic acid plus clopidogrel or ticlopidine.

you have been diagnosed with a high risk of developing blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban Viatris reduces, in adults, the risk of clot formation (atherothrombotic events). Rivaroxaban Viatris will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid.

In some cases, if you need to take Rivaroxaban Viatris following a procedure
used to widen a narrowed or blocked artery in the leg, in order to restore blood
flow, your doctor may also prescribe clopidogrel, which you will need to take for a short
period in combination with acetylsalicylic acid.
Rivaroxaban Viatris contains the active substance rivaroxaban and belongs to a group of medicines
called antithrombotic agents. Its action is due to the inhibition of a clotting factor
(factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you need to know before taking 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 experiencing excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g., stomach ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have acute coronary syndrome and previously had bleeding or a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and previously had bleeding in the brain (stroke), or a blockage of the small arteries supplying blood to the deep brain tissues (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rivaroxaban Viatris and inform your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Viatris.
Rivaroxaban Viatris must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except acetylsalicylic acid and clopidogrel/ticlopidine.
Be especially careful with Rivaroxaban Viatris

if you have an increased risk of bleeding, such as in the following cases:
- severe kidney disease, because kidney function may affect the amount of active medicine in your body
- if you are taking other medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
- disorders of blood clotting
- very high blood pressure, uncontrolled with medication
- diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours located in the stomach or intestine or in the genital or urinary tract
- a blood vessel disorder in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous history of lung bleeding
- if you are over 75 years old
- if you weigh less than 60 kg
- if you suffer from coronary artery disease with severe symptomatic heart failure
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Viatris. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If you are scheduled for surgery

it is very important to take Rivaroxaban Viatris before and after surgery exactly as directed by your doctor.
If your surgery involves the use of a catheter or an injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Rivaroxaban Viatris before and after the injection or removal of the catheter exactly as directed by your doctor
- 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 treatment may be required.

Children and adolescents
Rivaroxaban Viatris 2.5 mg tablets are not recommended for people under 18 years of age. There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are taking
certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g., clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g., ritonavir)
other medicines used to reduce blood clotting (e.g., enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”))
anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat abnormal heart rhythm
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described 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 to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking
certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St John's wort (Hypericum perforatum), a herbal medicine used for depression
rifampicin, an antibiotic

If any of the conditions described 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 to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If 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, who will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban Viatris may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Viatris contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Rivaroxaban Viatris

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban Viatris at the same time each day (for example, one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris in another way. The tablet may be crushed and mixed with a small amount of water or apple puree, immediately before taking it.
If necessary, your doctor may administer the crushed Rivaroxaban Viatris tablet through a tube inserted into the stomach.
Rivaroxaban Viatris will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you. If you are taking Rivaroxaban Viatris after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rivaroxaban Viatris following a procedure used to dilate a narrowed or blocked leg artery to restore blood flow, your doctor may prescribe clopidogrel as well, which you will take for a short period in combination with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).
When to start Rivaroxaban Viatris
After an acute coronary syndrome, treatment with Rivaroxaban Viatris should be started as soon as possible after stabilization of the acute coronary syndrome, no sooner than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will tell you when to start treatment with Rivaroxaban Viatris.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Viatris than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Viatris tablets. If you have taken an excessive amount of Rivaroxaban Viatris, the risk of bleeding increases.
If you forget to take Rivaroxaban Viatris
Do not take a double dose to make up for a forgotten dose. If you miss a dose, take the next dose at your usual time.
If you stop taking Rivaroxaban Viatris
Take Rivaroxaban Viatris regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Viatris without first discussing it with your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or dying from heart or blood vessel disease may increase.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding, which may potentially be life-threatening. Severe bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be visible.
Contact your doctor immediately if you notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.
Signs of severe skin reactions
- widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect 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 breathing difficulties; 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).
Complete list of possible side effects
Common (may affect up to 1 in 10 people)

reduced number of red blood cells, which may cause paleness and lead to weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
loss of blood or fluid from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general reduction in strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased liver enzymes in blood tests

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 (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from the available data)

kidney failure following severe bleeding
kidney bleeding sometimes with blood in urine leading to kidney dysfunction (anticoagulant nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or
bottle after Exp./EXP. The expiry date refers to the last day of that month.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Viatris contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, yellow iron oxide [E172], magnesium stearate. See section 2 “Rivaroxaban Viatis contains lactose and sodium”. Film coating: polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Rivaroxaban Viatris and pack contents
The 2.5 mg film-coated tablets of Rivaroxaban Viatris are light yellow to yellow in colour, round, biconvex, with bevelled edges (diameter 5.4 mm), and marked with “RX” on one side of the tablet and “1” on the other side.
The tablets are supplied in:

blisters in packs of 10, 28, 56, 60, 100 or 196 film-coated tablets, or
unit-dose packs in boxes of 28 × 1, 30 × 1, 56 × 1, 60 × 1 or 90 × 1 film-coated tablets, or
bottles containing 98, 100, 196 or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел: +359 2 44 55 400 Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft
Tel: + 420 222 004 400 Tel: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tel: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 210 0 100 002 Tel: +43 1 416 2418
España Polska
Viatris Pharmaceuticals, S.L.U Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 (0) 87 11600
Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy Puh/Tel: +358 20 720 9555
Tel: + 39 02 612 46921
Κύπρος Sverige
GPA Pharmaceuticals Ltd Varnavas Viatris AB
Τηλ: +357 22863100 Tel: + 46 8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 +353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Package leaflet: information for the user

Rivaroxaban Viatris 10 mg film-coated tablets

rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rivaroxaban Viatris is and what it is used for
What you need to know before taking Rivaroxaban Viatris
How to take Rivaroxaban Viatris
Possible side effects
How to store Rivaroxaban Viatris
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 to

prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because, after surgery, there is an increased risk of blood clots forming.
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.

Rivaroxaban Viatris belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before taking 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 have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

if you have a high risk of bleeding, which may occur in situations such as:
- moderate or severe kidney disease, because kidney function can affect the amount of active medicine in your body
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
- disorders of blood coagulation
- very high blood pressure not controlled with medication
- stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, intestine, genital tract, or urinary tract
- a blood vessel disorder in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous history of bleeding from your lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Viatris. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If you are scheduled for surgery

it is very important to take Rivaroxaban Viatris exactly as directed by your doctor, both before and after surgery.
If the surgical procedure involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Rivaroxaban Viatris exactly as directed by your doctor
- 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 intervention may be required.

Children and adolescents
Rivaroxaban Viatris 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient information on the use of this medicine in children and adolescents.
Other medicines and Rivaroxaban Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are taking
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat abnormal heart rhythm
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking
- certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
- St John's wort (Hypericum perforatum), a herbal remedy for depression
- rifampicin, an antibiotic

If any of the conditions described 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 to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a 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, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Viatris may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Viatris contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Viatris

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
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 10 mg Rivaroxaban Viatris tablet once daily.

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

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you Rivaroxaban Viatris 10 mg once daily.

Swallow the tablet preferably with some water.
Rivaroxaban Viatris can be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer the crushed Rivaroxaban Viatris tablet through a tube inserted into the stomach.
When to take Rivaroxaban Viatris
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the tablets for 2 weeks.
If you take more Rivaroxaban Viatris than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Viatris tablets. If you have taken an excessive amount of Rivaroxaban Viatris, your risk of bleeding increases.
If you forget to take Rivaroxaban Viatris
If you forget a dose, take it as soon as you remember. Take the next tablet the following day and then continue taking one tablet per day as before.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Rivaroxaban Viatris
Do not stop taking Rivaroxaban Viatris without first talking to your doctor, as Rivaroxaban Viatris helps prevent serious conditions.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Viatris can cause bleeding which could potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
Signs of serious skin reactions
- widespread and intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect 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 breathing difficulties; 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).

Complete list of possible side effects
Common (may affect up to 1 in 10 people)

reduced number of red blood cells, which may cause paleness and lead to weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from the skin or under the skin
bleeding after surgery
loss of blood or fluid from the surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing)
general loss of strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased levels of certain liver enzymes in blood tests

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 (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced bile flow, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a cardiac procedure 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

Frequency not known (cannot be estimated from the available data)

kidney impairment following severe bleeding
kidney bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
compartment syndrome in the muscles of the arms or legs following bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 outer packaging and on each blister or
bottle after Exp./EXP. The expiry date refers to the last day of that month.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Viatris contains

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, 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), red iron oxide (E172).

Description of the appearance of Rivaroxaban Viatris and contents of the pack
The 10 mg film-coated tablets of Rivaroxaban Viatris are light pink to pink in colour, round, biconvex, with bevelled edges (diameter 5.4 mm), and are marked with “RX” on one side of the tablet and “2” on the other side.
The tablets are supplied in:

Blister packs in cartons containing 10, 30 or 100 film-coated tablets, or
Unit dose divisible blisters in cartons containing 10 × 1, 28 × 1, 30 × 1, 50 × 1, 98 × 1 or 100 × 1 film-coated tablets, or
Bottles containing 98, 100 or 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел: +359 2 44 55 400 Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ.s.r.o. Viatris Healthcare EPD Kft
Tel: + 420 222 004 400 Tel: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tel: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 210 0 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 (0) 87 11600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy Puh/Tel: +358 20 720 9555
Tel: + 39 02 612 46921

Κύπρος Sverige
GPA Pharmaceuticals Τηλ: +357 22863100 Viatris AB
Tel: + 46 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 +353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/

Package leaflet: information for the user

Rivaroxaban Viatris 15 mg film-coated tablets, 20 mg film-coated tablets

rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rivaroxaban Viatris is and what it is used for
What you need to know before taking Rivaroxaban Viatris
How to take Rivaroxaban Viatris
Possible side effects
How to store Rivaroxaban Viatris
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.
Rivaroxaban Viatris is used in adults to:

prevent the formation of blood clots in the brain (stroke) and 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 the recurrence of blood clots 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 body weight equal to or greater than 30 kg to:
treat blood clots and prevent their recurrence in 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 Viatris belongs to a group of medicines called antithrombotic agents. Its
action is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you need to know before taking 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 have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcer, wounds or bleeding in the brain, recent brain or eye surgery)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

if you have an increased risk of bleeding, such as in the following cases:
- severe kidney disease in adults and moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
- coagulation disorders
- very high blood pressure not controlled by medication
- stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, intestine, genital tract or urinary tract
- a blood vessel disorder in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned

it is very important to take Rivaroxaban Viatris exactly at the times indicated by your doctor, both before and after the procedure.
If the surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take Rivaroxaban Viatris exactly at the times indicated by your doctor, both before and after the injection or removal of the catheter
- inform your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anaesthesia, as urgent intervention may be 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 take any other medicines, including those not requiring a prescription.

If you are taking
- certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
- ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
- certain antibiotics (e.g. clarithromycin, erythromycin)
- certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
- other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
- anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
- dronedarone, a medicine used to treat abnormal heart rhythm
- certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If you are taking
- certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
- St John's Wort (Hypericum perforatum), a herbal remedy used for depression
- rifampicin, an antibiotic

If any of the conditions described 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 to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a 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, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Viatris may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Viatris contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Viatris

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Viatris should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris in another way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before administration. The mixture should be followed immediately by food intake. If necessary, your doctor may administer the crushed Rivaroxaban Viatris tablet through a tube inserted into the stomach.

What dose to take
Adults

To prevent blood clots in the brain (stroke) and 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 to undergo a procedure to treat blocked blood vessels in your heart (called PCI – Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Viatris tablet once daily (or one 10 mg Rivaroxaban Viatris tablet if your kidneys do not function 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 recurrence of clots: The recommended dose is one 15 mg Rivaroxaban Viatris tablet twice daily for the first 3 weeks. 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 the dose after 3 weeks to one 15 mg Rivaroxaban Viatris tablet once daily if your risk of bleeding is greater than the risk of developing a new blood clot.

Children and adolescents
The dose of Rivaroxaban Viatris depends on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg Rivaroxaban Viatris tablet once daily.
The recommended dose for children and adolescents with a body weight equal to or greater than 50 kg 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: please observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban Viatris is based on body weight, it is important to attend scheduled appointments with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Viatris by yourself. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide a dose. If a lower dose is required, use the alternative formulation Rivaroxaban Viatris granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, use Rivaroxaban Viatris granules for oral suspension.
If the oral suspension is not available, the Rivaroxaban Viatris tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken after administering this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Viatris tablet via a gastric tube.

If you spit out the dose or vomit

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 your next dose of Rivaroxaban Viatris at the usual time.

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

When to take Rivaroxaban Viatris
Take the tablet or tablets every day until your doctor tells you to stop.
Try to take the tablet or tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent the formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat needs to be restored to normal through a procedure called cardioversion, take Rivaroxaban Viatris exactly as your doctor instructed.

If you forget to take Rivaroxaban Viatris
Adults, children and adolescents:
If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in the same day to make up for a missed dose. Take the next tablet the following day and continue with one tablet once daily.

Adults:
If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The next day, continue with one 15 mg tablet twice daily.

If you take more Rivaroxaban Viatris than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Viatris tablets. If you have taken an excessive amount of Rivaroxaban Viatris, your risk of bleeding increases.

If you stop taking Rivaroxaban Viatris
Do not stop taking Rivaroxaban Viatris without first discussing it with your doctor, as Rivaroxaban Viatris treats serious conditions and helps prevent their occurrence.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding, which may potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, seizures, reduced level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding
- unusual weakness, fatigue, paleness, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
Signs of severe skin reactions
- widespread and intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect 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 breathing difficulties; 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).

Complete list of possible side effects observed in adults, children and adolescents
Common (may affect up to 1 in 10 people)

reduced number of red blood cells, which may cause paleness and lead to weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
blood or fluid leakage from the surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing)
general loss of strength and energy (weakness, fatigue), headache, dizziness
skin rash, itching
increased levels of certain liver enzymes in blood tests

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 (reduced number of platelets, which are blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through blood tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain pancreatic or liver enzymes, or increased number of platelets
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling, formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

eosinophilia, an accumulation of a type of granulocyte white blood cells causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from the available data):

kidney failure following severe bleeding
kidney bleeding sometimes with blood in urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Side effects in children and adolescents
In general, side effects observed in children and adolescents treated with rivaroxaban have been similar to those seen in adults and have mainly been mild to moderate in severity.
Side 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 increased bilirubin (a bile pigment)
thrombocytopenia (reduced platelets, which are blood cells that help blood to clot)
heavy menstrual bleeding
Uncommon (may affect up to 1 in 100 people)
blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or
bottle after Exp./EXP.
The expiry date refers to the last day of that month.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rivaroxaban Viatris Contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”.
Tablet coating: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide red (E172).

Description of the Appearance of Rivaroxaban Viatris and Contents of the Pack
Rivaroxaban Viatris 15 mg film-coated tablets are pink to brick-red in colour, round, biconvex, with bevelled edges (diameter 6.4 mm), and marked with “RX” on one side and “3” on the other side of the tablet.
The tablets are supplied in:

blisters in packs of 14, 28, 30, 42, 98 or 100 film-coated tablets, or
unit-dose divisible blisters in packs of 14 × 1, 28 × 1, 30 × 1, 42 × 1, 50 × 1, 98 × 1 or 100 × 1 film-coated tablets, or
bottles containing 30, 98, 100 or 250 film-coated tablets.

Rivaroxaban Viatris 20 mg film-coated tablets are reddish-brown in colour, round, biconvex, with bevelled edges (diameter 7.0 mm), and marked with “RX” on one side and “4” on the other side of the tablet.
The tablets are supplied in:

blisters in packs of 14, 28, 30, 98 or 100 film-coated tablets, or
unit-dose divisible blisters in packs of 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 blisters in packs of 14, 28 or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Viatris Viatris
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ.s.r.o. Viatris Healthcare Kft
Tel: + 420 222 004 400 Tel: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tel: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 210 993 6410 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00

France Portugal
Viatris Santé Tél: +33 4 37 25 75 00 Mylan, Lda.
Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 (0) 87 11600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy Puh/Tel: +358 20 720 9555
Tel: + 39 02 612 46921

Κύπρος Sverige
GPA Pharmaceuticals Ltd Varnavas Tel: +357 22863100 Viatris AB
Tel: + 46 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 +353 18711600

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Package leaflet: information for the user

Rivaroxaban Viatris 15 mg film-coated tablets, 20 mg film-coated tablets

Initial treatment pack
Not for use in children
rivaroxaban
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rivaroxaban Viatris is and what it is used for
What you need to know before taking Rivaroxaban Viatris
How to take Rivaroxaban Viatris
Possible side effects
How to store Rivaroxaban Viatris
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:

treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Viatris belongs to a group of medicines called antithrombotic agents. Its action is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you need to know before taking 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 have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

if you have an increased risk of bleeding, such as in the following cases:
- severe kidney disease, because kidney function may alter the amount of active medicine in your body
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
- coagulation disorders
- very high blood pressure not controlled with medicines
- diseases of the stomach or intestine that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, intestine, genital tract or urinary tract
- a blood vessel disorder in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned

it is very important to take Rivaroxaban Viatris before and after surgery exactly as directed by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
- it is very important to take Rivaroxaban Viatris before and after the injection or catheter removal exactly as directed by your doctor
- inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

Children and adolescents
The starter pack of Rivaroxaban Viatris is not recommended for people 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.
Other medicines and Rivaroxaban Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are taking
- certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only on the skin
- ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
- certain antibiotics (e.g. clarithromycin, erythromycin)
- certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
- other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
- anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
- dronedarone, a medicine used to treat abnormal heart rhythm
- certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described 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 to be closely monitored.
If your doctor believes you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking
- certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
- St. John’s wort (Hypericum perforatum), a herbal medicine used for depression
- rifampicin, an antibiotic

If any of the conditions described 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 to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a possibility you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Viatris.
If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Viatris may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machines.
Rivaroxaban Viatris contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Viatris

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Viatris should be taken with food.
Swallow the tablet or tablets with some water, preferably.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris in another way. The tablet may be crushed and mixed with water or apple puree immediately before taking. The mixture should be followed immediately by food.
If necessary, your doctor may administer the crushed Rivaroxaban Viatris tablet through a tube inserted into the stomach.

What dose to take
The recommended dose is one 15 mg Rivaroxaban Viatris tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Viatris tablet once daily.
This starter pack containing 15 mg and 20 mg Rivaroxaban Viatris tablets is intended for use only during the first 4 weeks of treatment. After completing this pack, treatment will continue with one 20 mg Rivaroxaban Viatris tablet once daily, as directed by your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Viatris tablet once daily, if the risk of bleeding is greater than the risk of developing a new blood clot.

When to take Rivaroxaban Viatris
Take the tablet(s) every day until your doctor tells you to stop.
Try to take the tablet(s) at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.

If you forget to take Rivaroxaban Viatris
If you are taking one 15 mg tablet twice daily and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The following day, continue with one 15 mg tablet twice daily.
If you are taking one 20 mg tablet once daily and have missed a dose, take it as soon as you remember. Do not take more than one tablet in the same day to make up for the missed dose. Take the next tablet the following day, and then continue with one tablet once daily.

If you stop taking Rivaroxaban Viatris
Do not stop taking Rivaroxaban Viatris without first talking to your doctor, because Rivaroxaban Viatris treats serious conditions and helps prevent their occurrence.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody will experience them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Viatris can cause bleeding which may potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Inform your doctor immediately if you notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
Signs of severe skin reactions
- widespread and intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic illnesses (DRESS syndrome). The frequency of these side effects is very rare (may affect 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 breathing difficulties; 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).

Complete list of possible side effects:
Common (may affect up to 1 in 10 people):

reduction in red blood cell count, which may cause paleness and lead to weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
loss of blood or fluid from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased liver enzymes in blood tests

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 (decrease in the number of platelets, which are cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced bile flow, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from the available data):

kidney failure following severe bleeding
kidney bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 outer carton and on each blister or
wallet container after Exp./EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water and apple puree for up to 2 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Viatris contains

The active substance is rivaroxaban. Each tablet contains either 15 mg or 20 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”. Tablet coating: polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of Rivaroxaban Viatris and package contents
Rivaroxaban Viatris 15 mg film-coated tablets are pink to brick-red in colour, round, biconvex, with bevelled edges (diameter 6.4 mm), and marked with “RX” on one side of the tablet and “3” on the other side.
Rivaroxaban Viatris 20 mg film-coated tablets are reddish-brown in colour, round, biconvex, with bevelled edges (diameter 7.0 mm), and marked with “RX” on one side of the tablet and “4” on the other side.
Initial treatment pack for the first 4 weeks: each pack containing 49 film-coated tablets for the first 4 weeks of treatment includes:
One box containing 42 film-coated tablets of 15 mg rivaroxaban (three blisters of 14 tablets of 15 mg with sun and moon symbols) and one box containing 7 film-coated tablets of 20 mg rivaroxaban (marked day 22, day 23, day 24, day 25, day 26, day 27 and day 28).