Package Leaflet: Information for the User

Xarelto 10 mg Film-Coated Tablets

rivaroxaban

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check the full list of side effects in section 4.

1.What Xarelto is and what it is used for

2.What you need to know before you take Xarelto

3.How to take Xarelto

4.Possible side effects

5.Storage of Xarelto

6.Contents of the pack and other information

Xarelto contains the active ingredient rivaroxaban and is used in adults for:

• preventing the formation of blood clots in veins after a hip or knee replacement surgery. Your doctor has prescribed this medication because after surgery, you have a higher risk of developing blood clots.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent these blood clots from recurring in the blood vessels of the legs and/or lungs.

Xarelto belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thereby reducing the tendency of blood to form clots.

Do not take Xarelto

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section6)
• if you bleed excessively
• if you have a disease or condition in an organ that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury or bleeding, or recent surgery in the brain or eyes)
• if you are taking medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant to another or while receiving heparin through a central venous or arterial catheter, to prevent catheter blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Xarelto and inform your doctorif any of these circumstances apply to your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Xarelto.

Be extra careful with Xarelto

• if you have an increased risk of bleeding, which may occur in the following situations:

• moderate or severe renal insufficiency, as kidney function may affect the amount of medication that acts in your body
• if you are taking other medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant or while receiving heparin through a central venous or arterial catheter, to prevent catheter blockage (see section “Other medications and Xarelto”)
• bleeding disorder
• uncontrolled high blood pressure
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or localized tumors in the stomach, intestines, genital tract, or urinary tract
• problem with blood vessels in the back of the eyes (retinopathy)
• lung disease with dilated and pus-filled bronchi (bronchiectasis) or previous lung bleeding

• if you have a heart valve prosthesis
• if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor to decide if treatment modification is necessary
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo a procedure to remove a blood clot from your lungs

Inform your doctorif you experience any of these situationsbefore taking Xarelto.Your doctor will decide if you should be treated with this medication and if you should be under closer observation.

If you need surgery

• It is very important to take Xarelto before and after surgery, exactly as indicated by your doctor.
• If your operation requires the placement of a catheter or injection in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):

• It is very important to take Xarelto exactly as indicated by your doctor.
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is required.

Children and adolescents

Xarelto 10mg tabletsare not recommended for children under 18 years.No sufficient information is available on its use in children and adolescents.

Other medications and Xarelto

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

• if you are taking

• any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied to the skin
• tablets with ketoconazole (used to treat Cushing's syndrome, where the body produces an excess of cortisol)
• any medication for bacterial infections (e.g., clarithromycin, erythromycin)
• any antiviral medication for HIV/AIDS (e.g., ritonavir)
• other medications to prevent blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medication for treating irregular heartbeats
• some medications for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you,inform your doctorbefore taking Xarelto, as the effect of Xarelto may be increased.Your doctor will decide if you should be treated with this medication and if you should be under closer observation.

If your doctor considers that you have a higher risk of developing stomach ulcers or intestinal ulcers, they will recommend using a preventive treatment for ulcers.

• if you are taking

• any medication for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a medicinal plant for treating depression

?rifampicin, an antibiotic

If any of the above circumstances apply to you, informe your doctorbefore taking Xarelto, as the effect of Xarelto may be reduced. Your doctor will decide if you should be treated with Xarelto and if you should be under closer observation.

Pregnancy and lactation

Do not take Xareltoif you are pregnant or breastfeeding.If there is any possibility of becoming pregnant, use a reliable contraceptive while taking Xarelto. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and operating machinery

Xarelto may cause dizziness (frequent adverse effect) or fainting (infrequent adverse effect) (see section4, “Possible adverse effects”). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Xarelto contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

What dose to take

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

The recommended dose is one 10 mg Xarelto tablet once a day.

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

After at least 6 months of blood clot treatment, the recommended dose is one 10 mg Xarelto tablet once a day or one 20 mg Xarelto tablet once a day. Your doctor has prescribed Xarelto 10 mg once a day.

Swallow the tablet, preferably with water.

Xarelto can be taken with or without food.

If you have difficulty swallowing the entire tablet, consult your doctor about other ways to take Xarelto. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it.

If necessary, your doctor may also administer the crushed Xarelto tablet through a gastric tube.

When to take Xarelto

Take the tablet every day until your doctor tells you to stop.

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

Your doctor will decide how long you should continue treatment.

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

Take the first tablet 6 to 10 hours after surgery.

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

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

If you take more Xarelto than you should

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

If you forget to take Xarelto

If you forget to take a dose, take it as soon as you remember. Take the next tablet the next day and then continue to take one tablet every day as usual.

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

If you interrupt Xarelto treatment

Do not stop Xarelto treatment without first talking to your doctor, as Xarelto prevents the development of a serious condition.

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

Like all medicines, Xarelto can cause side effects, although not everyone will experience them.

Like other medicines that reduce blood clotting, Xarelto can cause bleeding, which can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be apparent.

Inform your doctor immediately if you experience any of the following side effects:

• Bleeding signs

• Brain or intracranial bleeding (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness.This is a serious medical emergency. Seek medical attention immediately!)
• Prolonged or excessive bleeding
• Exceptional weakness, fatigue, pallor, dizziness, headache, unexplained swelling, difficulty breathing, chest pain, or angina

Your doctor will decide whether to keep you under closer observation or modify your treatment.

• Signs of severe skin reactions

• Intense skin eruptions that spread, blisters, or lesions on mucous membranes, for example, in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Medication reaction that causes rash, fever, internal organ inflammation, blood abnormalities, and systemic disease (DRESS syndrome).

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

• Signs of severe allergic reactions

• Swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure.

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

General list of possible side effects

Frequent(may affect up to 1 in 10 people)

• Decreased red blood cells that can cause pallor and weakness or difficulty breathing
• Stomach or intestinal bleeding, hematuria (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• Eye bleeding (including bleeding in the white part of the eye)
• Bleeding into a tissue or cavity of the body (hematoma, ecchymosis)
• Coughing up blood
• Bleeding under the skin
• Bleeding after surgery
• Suppuration of blood or fluid from a surgical wound
• Swelling of the extremities
• Pain in the extremities
• Alteration of kidney function (may be seen in tests performed by your doctor)
• Fever
• Stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting when standing up)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness
• Rash, itching skin
• Blood tests may show an increase in some liver enzymes

Infrequent(may affect up to 1 in 100 people)

• Brain or intracranial bleeding (see above, bleeding signs)
• Bleeding into a joint, which causes pain and swelling
• Thrombocytopenia (low platelet count, cells that help blood clotting)
• Allergic reaction, including skin reaction
• Alteration of liver function (may be seen in tests performed by your doctor)
• Blood tests may show an increase in bilirubin, some pancreatic or hepatic enzymes, or platelet count
• Fainting
• Feeling unwell
• Increased heart rate
• Dry mouth
• Hives

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

• Bleeding into a muscle
• Bile duct obstruction, hepatitis, which includes traumatic liver cell injury (inflammation or liver damage)
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Accumulation of blood (hematoma) in the groin as a complication after cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

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

• Accumulation of eosinophils, a type of granulocytic white blood cell that causes inflammation in the lungs (eosinophilic pneumonia).

Frequency unknown(cannot be estimated from available data)

• Renal insufficiency after severe bleeding.
• Bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to function improperly (anticoagulant-related nephropathy)
• Increased pressure in the muscles of the legs or arms after bleeding, which causes pain, swelling, altered sensitivity, numbness, or paralysis (compartment syndrome due to hemorrhage)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on each blister or bottle, after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Crushed tablets

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Xarelto

-The active ingredient is rivaroxaban. Each tablet contains 10mg of rivaroxaban.

-The other components are:

Core tablet: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose(2910), sodium lauryl sulfate, magnesium stearate. See section2 “Xarelto contains lactose and sodium”.
Coating of the tablet: macrogol (3350), hypromellose(2910), titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the package

Xarelto 10mg film-coated tablets are round, biconvex, and have a light red color. They have the cross BAYER engraved on one side and a “10” and a triangle on the other. They are available in:

• blister packs, in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets, or
• pre-cut single-dose blisters in packs of 10x1 or 100x1, or
• multi-pack containers containing 10 cartons,each containing10x1 film-coated tablets, or
• 100 film-coated tablets in a bottle.

Only some package sizes may be marketed.

Marketing authorization holder

Bayer AG

51368 Leverkusen

Germany

Responsible manufacturer

The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister or bottle:

•If the first and second characters are BX, the manufacturer is

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

•If the first and second characters are IT, the manufacturer is

Bayer HealthCare Manufacturing Srl.

Via delle Groane, 126

20024 Garbagnate Milanese

Italy

•If the first and second characters are BT, the manufacturer is

Bayer Bitterfeld GmbH

Ortsteil Greppin, Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder.

Last update of this leaflet:

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