RIVAROXABAN 2.5 мг Таблетки

Содержание инструкции

1. Rivaroxaban Viatris 2.5 mg film-coated tablets
   1. What is Rivaroxaban Viatris 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. Package contents and other information
2. Rivaroxaban Viatris 10 mg film-coated tablets
   1. What is Rivaroxaban Viatris and what is it 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. Package contents and other information
3. Rivaroxaban Viatris 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Rivaroxaban Viatris and what it is used for
   2. What you need to know before taking Rivaroxaban Viatris
4. Rivaroxaban Viatris tablets are not recommended in children of body weight less than
   1. How to take Rivaroxaban Viatris
   2. Possible side effects
   3. How to store Rivaroxaban Viatris
   4. Package contents and other information
5. Rivaroxaban Viatris 15 mg film-coated tablets, 20 mg film-coated tablets
6. rivaroxaban
   1. What is Rivaroxaban Viatris and what is it 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. Package contents and other information

Rivaroxaban Viatris 2.5 mg film-coated tablets

rivaroxaban

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Rivaroxaban Viatris is and what it is used for
• 2. What you need to know before you take 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 is Rivaroxaban Viatris and what it is used for

Rivaroxaban Viatris has been given to you because

• you have been diagnosed with acute coronary syndrome (a set 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 from a heart or blood vessel related illness. Rivaroxaban Viatris will not be given to you alone. Your doctor will also prescribe:
• acetylsalicylic acid or
• acetylsalicylic acid plus clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral artery disease that causes symptoms. Rivaroxaban Viatris reduces the risk of clots (atherothrombotic events) forming in adults. 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 blocking of a coagulation factor
(factor Xa) followed by a 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 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 a part of the body that increases the risk of serious bleeding (e.g., stomach ulcer, wounds or bleeding in the brain, recent surgery to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant therapy or when you are receiving heparin through a venous or arterial catheter to keep it open
• if you have an acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke) or if there has been a blockage of the small arteries that carry blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) in 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 tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Viatris.
Rivaroxaban Viatris should not be used in combination with certain medicines that reduce blood
clotting such as prasugrel or ticagrelor except acetylsalicylic acid and
clopidogrel/ticlopidine.

Take special care with Rivaroxaban Viatris

• if you have an increased risk of bleeding, such as may be the case if:
• you have severe kidney disease, because kidney function can change the amount of active medicine in the body
• you are taking other medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), when changing anticoagulant therapy or when you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
• you have blood clotting disorders
• you have very high blood pressure, not controlled with medicines
• you have diseases of the stomach or intestines that can cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the esophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• you have a disorder of the blood vessels in the back of the eye (retinopathy)
• you have a lung disease with dilated and pus-filled bronchi (bronchiectasis), or have previously had bleeding from the lungs
• you are over 75 years of age
• you weigh less than 60 kg
• 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 autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy.

If any of the conditions described apply to you, tellyour doctor before taking Rivaroxaban
Viatris. The doctor will decide whether you should be treated with this medicine and whether you should be
closely monitored.

If you are going to have surgery

• it is very important to take Rivaroxaban Viatris before and after surgery exactly as indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):
• it is very important to take Rivaroxaban Viatris before and after the injection or removal of the catheter exactly as indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia, because urgent intervention may be necessary.

Children and adolescents
Rivaroxaban Viatris 2.5 mg tabletsare not recommended in people under 18 years of age
.There is not enough information on its use 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 available without a prescription.

• If you are taking
• some medicines against fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• some medicines against bacterial infections (e.g., clarithromycin, erythromycin)
• some antiviral medicines against 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 heartbeat
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Viatris, because the effect of Rivaroxaban Viatris may be increased. The doctor will decide whether you should
be treated with this medicine and whether you should be closely monitored.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment against ulcers .

• If you are taking
• some medicines for the treatment of 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 apply to you, tell your doctorbefore taking Rivaroxaban
Viatris, as the effect of Rivaroxaban Viatris may be reduced. The doctor will decide whether you should be
treated with Rivaroxaban Viatris and whether you should be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a possibility of
becoming pregnant, use a reliable method of contraception while taking
Rivaroxaban Viatris. If you become pregnant while taking this medicine, tell your
doctor immediately, who will decide how to continue treatment.

Driving and using machines
Rivaroxaban Viatris can cause dizziness (a common side effect) or lightheadedness (an uncommon side effect)
(see section 4, “Possible side effects”). If you experience these
symptoms, do not drive vehicles, ride a bicycle or use tools or machines.

Rivaroxaban Viatris contains lactose and sodium
If your doctor has diagnosed you with 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

What dose to take
The recommended dose is one 2.5 mg tablet, twice a day. Take Rivaroxaban Viatris
always at the same time of day (e.g., 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 can be crushed and mixed with a little water or with applesauce,
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 administered to you alone.
Your doctor will also prescribe acetylsalicylic acid. If you need to take Rivaroxaban Viatris after an
acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you need to take Rivaroxaban Viatris following a procedure used to widen a narrowed or
blocked artery in the leg to restore blood flow, your doctor may also prescribe
clopidogrel, which you will need to take for a short period in association with acetyl
salicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually from 75 to 100 mg of acetyl
salicylic 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 with Rivaroxaban Viatris
After an acute coronary syndrome, treatment with Rivaroxaban Viatris should begin as
soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after
hospitalization and at the time when parenteral (by injection) anticoagulant therapy 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 to continue your treatment.

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 missed dose. If you forget a dose, take the
next dose at the usual time.

If you stop taking Rivaroxaban Viatris
Take Rivaroxaban Viatris regularly for the entire time prescribed by your doctor.
Do not stop taking Rivaroxaban Viatris without first talking to your doctor. If
you stop taking this medicine, you may increase the risk of a new heart attack or
stroke or death from heart or blood vessel disease.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding which could potentially endanger the patient's life. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Immediately inform your doctor 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, convulsions, decreased level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown origin, 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 severe rash, blisters or lesions of the mucous membranes, for example, in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood, and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in
• 10,000).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure.

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

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

• decreased number of red blood cells, which can cause paleness and cause weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the 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 a cavity of the body (hematoma, 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 the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling unwell or malaise, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general reduction 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 inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (decreased number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives

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

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

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

• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

Frequency not known(the frequency cannot be estimated on the basis of the available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package 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 particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 2 hours.
Do not dispose of any medicine in 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 ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, yellow iron oxide [E172], magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”. Tablet film coating: polyvinyl alcohol, macrogol (3350), talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Rivaroxaban Viatris and package 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 with “RX” imprinted on one
side of the tablet and “1” on the other side.
The tablets are provided in:

• blisters in boxes of 10, 28, 56, 60, 100 or 196 film-coated tablets or
• unit dose boxes of 28  1, 30  1, 56  1, 60  1 or 90  1 film-coated tablets or
• bottles of 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
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ .s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ Tel: + 372 6363 052

Norge
Viatris AS
Tel: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 0 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

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

Polska
Viatris Healthcare Sp. z. o.o.
Tel: + 48 22 546 64 00

France
Viatris Santé
Téel : +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 (0) 87 11600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími : +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals LtdVarnavas
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
+353 18711600
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.

Rivaroxaban Viatris 10 mg film-coated tablets

rivaroxaban

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rivaroxaban Viatris is and what it is used for
• 2. What you need to know before you take 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 is Rivaroxaban Viatris and what is it used for

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

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because, after surgery, the risk of blood clots forming in the blood increases.
• 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 blocking of the coagulation factor (factor Xa) and therefore to the reduction of the 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 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 a part of the body that increases the risk of serious bleeding (e.g. stomach ulcer, wounds or bleeding in the brain, recent surgery to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant therapy or when you are 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

Do not take Rivaroxaban Viatris and tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Viatris.
Rivaroxaban Viatris

Pay particular attention with Rivaroxaban Viatris

• if you have a high risk of bleeding, which can occur in situations such as:
• moderate or severe kidney disease, because kidney function can change the amount of active medicine in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
• blood clotting disorders
• very high blood pressure, not controlled with medicines
• diseases of the stomach or intestine that can cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the esophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• a disorder of the blood vessels in the back of the eye (retinopathy)
• a lung disease with dilated and pus-filled bronchi (bronchiectasis), or a previous bleeding from your lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy
• if the doctor checks that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs.

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Viatris. The doctor will decide whether you should be treated with this medicine and whether you should be kept under
close observation.

If you are going to have surgery

• it is very important to take Rivaroxaban Viatris before and after surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Rivaroxaban Viatris exactly at the times indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, because urgent intervention may be necessary.

Children and adolescents
Rivaroxaban Viatris 10 mgtabletsare not recommended in patients under the age of
18 years. There is not enough information on its use 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 available without a prescription.

• If you are taking
• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against 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 heartbeat
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described apply to you, tell your doctorbefore taking
Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be increased. The doctor
will decide whether you should be treated with this medicine and whether you should be kept under close
observation.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment for ulcers .

• If you are taking
• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort ( Hypericum perforatum) ,a herbal medicine for depression
• rifampicin ,an antibiotic

If any of the conditions described apply to you, tell your doctorbefore taking
Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be reduced. The doctor
will decide whether you should be treated with Rivaroxaban Viatris and whether you should be kept under close
observation.

Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a possibility that
you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Viatris.
If you become pregnant while taking this medicine, tell your doctor immediately, who will decide
how to continue treatment.

Driving and using machines
Rivaroxaban Viatris can cause dizziness (a common side effect) and lightheadedness (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 told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
“sodium-free”.

3. How to take Rivaroxaban Viatris

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 Rivaroxaban Viatris 10 mg tablet once a day.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs and to prevent the recurrence of clots After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Viatris 10 mg once a day.

Swallow the tablet preferably with a little water.
Rivaroxaban Viatris can be taken independently of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris
in another way. The tablet can be crushed and mixed with a little water or as applesauce, immediately before taking it.
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 taking it.
Try to take the tablets always at the same time of day, so you can remember more
easily.
Your doctor will decide how long to continue your treatment.
To prevent the formation of blood clots in the veins after hip or
knee replacement surgery:
Take the first tablet 6-10 hours after the operation.
If you have had major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have had 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, the risk of bleeding increases.

If you forget to take Rivaroxaban Viatris
If you have forgotten a dose, take it as soon as you remember. Take the next tablet the
next day and then continue with one tablet a day, as before.
Do not take a double dose to make up for the missed tablet.

If you stop taking Rivaroxaban Viatris
Do not stop taking Rivaroxaban Viatris without first talking to your doctor, because
Rivaroxaban Viatris prevents a serious condition from occurring.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding which could potentially endanger the patient's life. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

Tell your doctor immediately if you 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, convulsions, decreased level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood counts, and diseases affecting the whole body (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 difficulty breathing; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

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

• reduction in the number of red blood cells, which can cause paleness and cause weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• -bleeding after a surgical procedure
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling unwell or malaise, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general reduction 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 inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including skin allergic reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1000 people)

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

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

• accumulation of eosinophils, a type of white blood cells granulocytic causing inflammation of the lung (eosinophilic pneumonia)

Frequency not known(frequency cannot be estimated on the basis of available data)

• kidney impairment after severe bleeding
• renal bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• insufficiency of pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensitivity, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package 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 particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 2 hours.
Do not dispose of any medicine in 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 ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”. Tablet 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
Rivaroxaban Viatris 10 mg film-coated tablets are from light pink to pink in colour,
round, biconvex, with bevelled edges (diameter 5.4 mm) and with “RX” imprinted on one side of the
tablet and “2” on the other side.
The tablets are supplied in

• blisters in packs of 10, 30 or 100 film-coated tablets or
• divisible unit-dose blisters in packs of 10  1, 28  1, 30  1, 50  1, 98  1 or 100  1 film-coated tablets or
• bottles of 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

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
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare EPD Kft
Tel: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ Tel: + 372 6363 052

Norge
Viatris AS
Tel: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 0 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

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

Polska
Viatris Healthcare Sp. z. o.o.
Tel: + 48 22 546 64 00

France
Viatris Santé
Téel : +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 (0) 87 11600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími : +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
+353 18711600
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

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

rivaroxaban

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rivaroxaban Viatris is and what it is used for
• 2. What you need to know before you take 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 is Rivaroxaban Viatris and what it is used for

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

• preventing 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.
• 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 is used in children and adolescents under 18 years of age and weighing 30 kg or more for:
• treating blood clots and preventing their recurrence in the veins or 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.Its
action is due to the blocking of a coagulation factor (factor Xa) followed by a 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 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 to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant therapy or when you are 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

Do not take Rivaroxaban Viatris and tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Viatris

Pay particular attention with Rivaroxaban Viatris

• if you have an increased risk of bleeding, such as may be the case in:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, because kidney function can change the amount of active medicine in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while taking heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
• blood clotting disorders
• very high blood pressure, not controlled with medicines
• diseases of the stomach or intestines that can cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the esophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestines or the genital tract or urinary tract
• a disorder of the blood vessels in the back of the eye (retinopathy)
• a lung disease with bronchi dilated and full of pus (bronchiectasis), or a 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), tell your doctor, who will decide if it is necessary to change the therapy
• if your doctor checks that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Viatris. The doctor will decide if you need to be treated with this medicine and if you need to be kept under
close observation.

If you are going to have surgery:

• it is very important to take Rivaroxaban Viatris before and after the surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Rivaroxaban Viatris before and after the injection or removal of the catheter exactly at the times indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or bowel or bladder problems at the end of the anesthesia, because urgent intervention is necessary in such cases.

Children and adolescents

Rivaroxaban Viatris tablets are not recommended in children of body weight less than

30 kg.There is not sufficient information available on the use of Rivaroxaban Viatris in children and
adolescents in 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 available without a prescription.

• If you are taking
• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against 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 heartbeat
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described applies to you, tell your doctorbefore 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 should be kept under close
observation.
If your doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe you preventive treatment against ulcers.

• If you are taking
• some medicines for the treatment of 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 applies to you, tell your doctorbefore taking
Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be reduced. Your doctor
will decide whether you should be treated with Rivaroxaban Viatris and whether you should be kept under close
observation.

Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a possibility that
you might become pregnant, use a reliable method of contraception while taking Rivaroxaban Viatris.
If you become pregnant while taking this medicine, tell your doctor immediately, who will decide
how to continue treatment.

Driving and using machines
Rivaroxaban Viatris can cause dizziness (a common side effect) or lightheadedness (an uncommon side
effect) (see section 4, “Possible side effects”). If these symptoms occur, do not drive vehicles, ride a bicycle or use tools or machinery.

Rivaroxaban Viatris contains lactose and sodium
If you have been diagnosed with intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Rivaroxaban Viatris must be taken with a meal.
Swallow the tablet or tablets preferably with a little water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris
in another way. The tablet can be crushed and mixed with a little water or with applesauce immediately before taking it. Taking the mixture should be immediately followed
by taking food. If necessary, your doctor may administer the crushed Rivaroxaban Viatris tablet
through a tube inserted into the stomach.

Which dose to take
Adults

• To prevent blood clots in the brain (stroke) and in other blood vessels of the body, the recommended dose is one Rivaroxaban Viatris 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Rivaroxaban Viatris 15 mg tablet once a day. 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 to support reducing the dose to one Rivaroxaban Viatris 15 mg tablet once a day (or to one 10 mg Rivaroxaban Viatris tablet in case your kidneys are not working 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 the recurrence of clots, the recommended dose is one Rivaroxaban Viatris 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Rivaroxaban Viatris 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with a 10 mg tablet once a day or a 20 mg tablet once a day. If you have kidney problems and are taking a Rivaroxaban Viatris 20 mg tablet once a day, your doctor may decide to reduce the dosage for treatment after 3 weeks to a Rivaroxaban Viatris 15 mg tablet once a day if the risk of bleeding is greater than the risk of having 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 and50 kgis one Rivaroxaban Viatris 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban Viatris 20 mgtablet once a day. Take each dose of Rivaroxaban Viatris with a drink (e.g. water or juice) during a meal. Take the tablets every day at about the same time. Consider setting an alarm to remind yourself. For parents or caregivers:please observe the child to make sure the entire dose is taken.

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

Never adjust the dose of Rivaroxaban Viatris on your own.If necessary, your doctor will
adjust the dose.
Do not split the tablet in an attempt to fraction a dose. If a lower dose is needed,
use the alternative formulation of 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, you can crush the Rivaroxaban Viatris tablet and
mix it with water or applesauce immediately before taking it. Take food after
taking 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 nottake a new dose. In this case, take the 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
taking it.
Try to take the tablet or tablets always at the same time of day, so you can
remember it more easily.
Your doctor will decide how long to continue your treatment.
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 has told you.

If you forget to take Rivaroxaban Viatris
Adults, children and adolescents:
If you are taking a 20 mg or 15 mg tablet oncea day and have
forgotten 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 then continue with one tablet a day.
Adults:
If you are taking a 15 mg tablet twicea day and have forgotten a dose, take it as soon as you remember .Do not take more than two 15 mg tablets in the same
day. If you forget a dose, you can take two 15 mg tablets at the same time to
take a total of two tablets (30 mg) in one day. The next day, continue with a
15 mg tablet twice a day.

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 stop taking Rivaroxaban Viatris
Do not stop taking Rivaroxaban Viatris without first talking to your doctor, because
Rivaroxaban Viatris treats serious conditions and prevents them from occurring.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding which may potentially endanger the patient's life. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

Immediately inform your doctorif you notice the onset of any of the following side effects:

• Signs of bleeding
• bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, convulsions, decreased level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. The doctor may decide to keep you under close observation or modify the treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in
• 10,000).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (including anaphylactic shock; may affect up to 1 in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

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

• reduction in the number of red blood cells, which can cause paleness and cause weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• emission of blood with coughing
• bleeding from the skin or under the skin
• bleeding after surgery
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling or state of unwellness, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general reduction in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching
• increase in certain liver enzymes in blood tests

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 (reduction in the number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including skin allergic reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreas or liver enzymes or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

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

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

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

• accumulation of eosinophils, a type of white blood cells granulocytic that cause inflammation of the lung (eosinophilic pneumonia)

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• kidney failure after severe bleeding
• renal bleeding sometimes with the presence of blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensitivity, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with rivaroxaban
were similar to those observed in adults and were mainly of mild to moderate severity.
Side effects that have been observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting Common(may affect up to 1 in 10 people)
• increased heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (reduction in platelets, which are the cells that allow blood to clot)
• heavy menstrual bleeding Uncommon(may affect up to 1 in 100 people)
• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system reported 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 package 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 particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 2 hours.
Do not dispose of any medicine in 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 ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”. Tablet film coating: macrogol (3350), polyvinyl alcohol, 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 from pink to brick red in color,
round, biconvex, with beveled edges (diameter 6.4 mm) and with “RX” imprinted on one side of the
tablet and “3” on the other side.
The tablets are supplied in

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

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

• blisters in packs of 14, 28, 30, 98 or 100 film-coated tablets or
• divisible unit-dose blisters in packs of 14  1, 28  1, 30  1, 50  1, 90  1, 98  1 or 100  1 film-coated tablets or
• bottles of 98 or 100 film-coated tablets or
• calendar blisters in packs of 14, 28, 98 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
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tel: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 993 6410

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

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

Polska
Viatris Healthcare Sp. z. o.o.
Tel: + 48 22 546 64 00

France
Viatris Santé Téel : +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 (0) 87 11600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími : +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.

Suomi/Finland
Viatris Oy Puh/Tel: +358 20 720 9555
Tel: + 39 02 612 46921

Κύπρος
GPA Pharmaceuticals LtdVarnavas Τηλ: +357
22863100

Sverige
Viatris AB
Tel: + 46 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
+353 18711600
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

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

Starter pack
Not for use in children

rivaroxaban

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rivaroxaban Viatris is and what it is used for
• 2. What you need to know before you take 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 is Rivaroxaban Viatris and what is it used for

Rivaroxaban Viatris contains the active ingredient 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 blocking of a coagulation factor (factor Xa) followed by a 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 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 to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant therapy or when you are 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

Do not take Rivaroxaban Viatris and tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Viatris.

Take special care with Rivaroxaban Viatris

• if you have an increased risk of bleeding, such as may be the case if:
• you have a severe kidney disease, because kidney function may change the amount of active medicine in the body
• you are taking other medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while taking heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Viatris”)
• you have blood clotting disorders
• you have very high blood pressure that is not controlled with medicines
• you have diseases of the stomach or intestines that can cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the esophagus, e.g., caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• you have a disorder of the blood vessels in the back of the eye (retinopathy)
• you have a lung disease with dilated and pus-filled bronchi (bronchiectasis), or a 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), tell your doctor, who will decide if it is necessary to change your therapy
• if your doctor finds that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs

If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Viatris. The doctor will decide if you should be treated with this medicine and if you should be closely monitored.

If you are going to have surgery

• it is very important to take Rivaroxaban Viatris before and after surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia for pain relief):
• it is very important to take Rivaroxaban Viatris before and after the injection or removal of the catheter exactly at the times indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia, because urgent intervention may be necessary.

Children and adolescents
The starter pack of Rivaroxaban Viatrisis not recommended in people under 18 years of age becauseit is specifically designed for the initiation of treatment in adult patients and is not appropriate for use 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 available without a prescription.

• If you are taking
• some medicines against fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• some medicines against bacterial infections (e.g., clarithromycin, erythromycin)
• some antiviral medicines against 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 heartbeats
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described apply to you, tell your doctorbefore taking
Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be increased. The doctor
will decide if you should be treated with this medicine and if you should be closely monitored.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment against ulcers .

• If you are taking
• some medicines for the treatment of 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 apply to you, tell your doctorbefore taking
Rivaroxaban Viatris, because the effect of Rivaroxaban Viatris may be reduced. The doctor
will decide if you should be treated with Rivaroxaban Viatris and if you should be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Viatris during pregnancy or breastfeeding. If there is a possibility that
you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Viatris.
If you become pregnant while taking this medicine, tell your doctor immediately, who will decide
how to continue treatment.

Driving and using machines
Rivaroxaban Viatris can cause dizziness (a common side effect) or lightheadedness (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these
symptoms, do not drive vehicles, 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, 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 have any doubts, ask your doctor or pharmacist.
Rivaroxaban Viatris must be taken with a meal.
Swallow the tablet or tablets preferably with a little water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Viatris
in another way. The tablet can be crushed and mixed with a little water or with applesauce immediately before taking it. Taking the mixture should be immediately followed
by taking 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 Rivaroxaban Viatris 15 mg tablet twice a day for
the first 3 weeks. After 3 weeks, the recommended dose is one Rivaroxaban Viatris
20 mg tablet once a day.
This starter pack of 15 mg and 20 mg Rivaroxaban Viatris is to be used only
for the first 4 weeks of treatment. After this pack is finished, treatment will continue with
Rivaroxaban Viatris 20 mg once a day, as your doctor has told you to do.
If you have kidney problems, your doctor may decide to reduce the dosage for treatment after
3 weeks to one Rivaroxaban Viatris 15 mg tablet once a day if the risk of
bleeding is greater than the risk of having a new blood clot.

When to take Rivaroxaban Viatris
Take the tablet or tablets every day until your doctor tells you to stop
taking them.
Try to take the tablet or tablets at the same time each day, so you can
remember more easily.
Your doctor will decide how long to continue your treatment.

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

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 prevents them from occurring.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Viatris can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Rivaroxaban Viatris can cause bleeding which could potentially endanger the patient's life. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Immediately inform your doctor 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, convulsions, decreased level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood counts and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in
• 10,000).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

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

• decreased number of red blood cells, which can cause paleness and cause weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after a surgical procedure
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected by tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell or malaise, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general reduction 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 inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (decreased number of platelets, which are cells that allow blood to clot)
• allergic reactions, including skin allergic reactions
• liver malfunction (can be detected by tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

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

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

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

• accumulation of eosinophils, a type of white blood cells granulocytic causing inflammation of the lung (eosinophilic pneumonia)

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• renal failure after severe bleeding
• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package 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 applesauce for up to 2 hours.
Do not dispose of any medicine in 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 ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Viatris contains lactose and sodium”. Tablet film 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 from pink to brick red in color,
round, biconvex, with beveled edges (diameter 6.4 mm) and with “RX” imprinted on one side of the
tablet and “3” on the other side.
Rivaroxaban Viatris 20 mg film-coated tablets are reddish brown in color,
round, biconvex, with beveled edges (diameter 7.0 mm) and with “RX” imprinted on one side of the
tablet and “4” on the other side.
Starter pack for the first 4 weeks: each pack of 49 film-coated tablets
for the first 4 weeks of treatment contains:
One box containing 42 film-coated tablets of 15 mg of rivaroxaban (three blisters of
14 tablets of 15 mg with the symbols of the sun and the moon) and one box of 7 film-coated tablets
of 20 mg of rivaroxaban (with the markings day 22, day 23, day 24, day 25, day
26, day 27 and day 28).

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, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel : + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ.s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tel: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 993 6410

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

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

Polska
Viatris Healthcare Sp. z. o.o.
Tel: + 48 22 546 64 00

France
Viatris Santé Téel : +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 0056

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 (0) 87 11600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími : +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
+353 18711600
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/