Xarelto 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Xarelto 10 mg 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Package leaflet

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 a hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased 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 clot.

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 condition affecting an organ in your body that increases the risk of serious bleeding (for example, stomach ulcer, brain 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 it from becoming blocked
• if you have 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

Consult your doctor or pharmacist before starting to take Xarelto.

Exercise special caution with Xarelto

• if you have an increased risk of bleeding, as may occur in the following situations:
  • moderate or severe renal impairment, since kidney function may affect the amount of drug active in your body
  • if you are taking other medications 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 it from becoming blocked (see section “Other medicines and Xarelto”)
  • hemorrhagic disorders
  • very high blood pressure not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestines, inflammation of the esophagus (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid moves up into the esophagus]), or tumors located in the stomach, intestines, genital tract, or urinary tract
  • a blood vessel disorder in the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or a previous history of lung bleeding
• if you have a heart valve prosthesis
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be necessary
• if your doctor determines that your blood pressure is unstable, or if you are scheduled to receive another treatment or undergo a surgical procedure to remove a blood clot from your lungs

Inform your doctor if you are in any of these situations before taking Xarelto. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If you need a surgical procedure

• It is very important to take Xarelto before and after surgery exactly at the times your doctor instructs.
• If your operation requires the placement of a catheter or injection into the spinal column (for example, for epidural or spinal anesthesia, or pain relief):
  • It is very important to take Xarelto exactly at the times your doctor instructs.
  • Inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anesthesia, as urgent medical attention is required.

Children and adolescents

Xarelto 10 mg tablets are not recommended for use in individuals under 18 years of age. There is insufficient information available on its use in children and adolescents.

Other medicines and Xarelto

Inform 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 a fungal infection (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 an excess of 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 situations apply to you, inform your doctor before taking Xarelto, as the effect of Xarelto could be increased. Your doctor will decide whether you should be treated with this medicine and whether you should be under closer monitoring.

If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they will recommend that you also use preventive ulcer treatment.

• If you are taking
  • any medicine used to treat 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 situations 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 should be under 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, who will decide how you should be treated.

Driving and operating machinery

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

Xarelto contains lactose and sodium

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

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

3. How to take Xarelto

Always follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose to take

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

The recommended dose is one 10 mg Xarelto 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 whole, 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 it.

If necessary, your doctor may also administer crushed Xarelto tablet 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 had major hip surgery, you will usually take tablets for 5 weeks.

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

If you take more Xarelto than you should

Contact 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 forgotten doses.

If you stop treatment with Xarelto

Do not stop treatment with Xarelto without first speaking to your doctor, because Xarelto prevents the development of a serious condition.

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

4. Possible adverse effects

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

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

Inform 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, difficulty breathing, chest pain, or angina

? Signs of serious skin reactions

• severe skin rashes that spread, blisters or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

The frequency of these adverse reactions 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; breathing difficulties; sudden drop in blood pressure.

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

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 body tissue or cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• impaired kidney function (may be observed in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or faintness 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 clot)
• allergic reaction, including skin allergic reactions
• impaired liver function (may be observed in tests performed by the doctor)
• blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• feeling of malaise
• 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 heart surgery involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of granulocytic white blood cells causing 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 the kidneys' inability to function properly (anticoagulant-related nephropathy)
• increased pressure within the muscles of the legs or arms following bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse reactions, 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 which is stated on the pack 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 purée 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".
Tablet film coating: macrogol (3350), hypromellose (2910), titanium dioxide (E 171), iron oxide red (E 172).

Appearance of the product and contents of the container

Xarelto 10 mg film-coated tablets are round, biconvex, light red in color, with the BAYER cross engraved on one side and a "10" and a triangle on the other. They are packaged

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

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, please contact 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.