Xarelto 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Xarelto 10mg film-coated tablets

rivaroxaban

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

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

Leaflet contents

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

1. What Xarelto is and what it is used for

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

• preventing blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at higher risk of developing blood clots after surgery.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking Xarelto

Do not take Xarelto

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or organ condition that increases your risk of severe bleeding (for example, stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes)
• if you are taking medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while receiving heparin through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Xarelto.

Take special care with Xarelto

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

• moderate or severe kidney impairment, as kidney function may affect the amount of medicine active in your body

• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent blockage (see section “Other medicines and Xarelto”)

• bleeding disorders

• uncontrolled high blood pressure

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

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

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

• if you have a heart valve prosthesis

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

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

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

If you need surgery

• It is very important to take Xarelto exactly at the times your doctor tells you, both before and after surgery.

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

• It is very important to take Xarelto exactly at the times your doctor tells you.

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

Children and adolescents

Xarelto 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient information on the use of this medicine in children and adolescents.

Other medicines and Xarelto

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

• If you are taking

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

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

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

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

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

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

• dronedarone, a medicine used to treat irregular heartbeat

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

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

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

• If you are taking

• any medicine for epilepsy (phenytoin, carbamazepine, phenobarbital)

• St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression

• rifampicin, an antibiotic

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

Pregnancy and breastfeeding

Do not take Xarelto if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking Xarelto. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide how you should be treated.

Driving and using machines

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

Xarelto contains lactose and sodium

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

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

3. How to take Xarelto

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

What dose to take

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

The recommended dose is one Xarelto 10 mg tablet once daily.

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

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

Swallow the tablet, preferably with water.

Xarelto can be taken with or without food.

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

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

When to take Xarelto

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

Try to take one tablet at the same time each day, to help you remember.

Your doctor will decide how long you should continue treatment.

To prevent blood clots in the veins after 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 your next tablet the following day, and then continue taking one tablet each day as usual.

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

If you stop taking Xarelto

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

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

4. Possible adverse effects

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

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

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

• Signs of bleeding

• bleeding in the brain or within the skull (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 immediate medical attention!)

• prolonged or excessive bleeding

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina

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

• Signs of serious skin reactions

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

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

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

• Signs of serious allergic reactions

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

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

General list of possible adverse effects

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

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

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xarelto

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

Do not use this medicine after the expiry date stated on the packaging and on each blister or bottle, following "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Crushed tablets

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xarelto

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (2910), sodium lauryl sulfate, magnesium stearate. See section 2 “Xarelto contains lactose and sodium”.
Film coating: macrogol (3350), hypromellose (2910), titanium dioxide (E 171), iron oxide red (E 172).

Appearance of the product and pack contents

Xarelto 10 mg film-coated tablets are round, biconvex, light red in colour, with the BAYER cross engraved on one side and a “10” and a triangle on the other. They are packaged as follows:

• in blisters in cartons containing 5, 10, 14, 28, 30 or 98 film-coated tablets, or
• in pre-cut single-dose blisters in packs of 10 × 1 or 100 × 1, or
• in multiple packs containing 10 cartons, each containing 10 × 1 film-coated tablets, or
• in bottles containing 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bayer AG
51368 Leverkusen
Germany

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 is available upon request to the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

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