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Patient Info Service - information for patients

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1. What is Xarelto and what is it used for?

You get Xarelto,

  • because you have been diagnosed with acute coronary syndrome (a group of conditions including heart attack and unstable angina, a severe form of chest pain) and blood tests have shown an increase in certain heart-specific laboratory values.

    Xarelto reduces the risk of having another heart attack or death in adults from diseases of the heart or blood vessels.

    You are not only given Xarelto. Your doctor will also prescribe one of the following medicines for you:

    • Acetylsalicylic acid or

    • Acetylsalicylic acid plus clopidogrel or ticlopidine.

    or

  • because you have been established to be at high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms.

    Xarelto reduces the risk of blood clots (atherothrombotic events) in adults.

    You are not only given Xarelto. Your doctor will also prescribe acetylsalicylic acid for you.

Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. It works by inhibiting a blood clotting factor (factor Xa), which reduces the blood's tendency to form clots.

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2. What you need to know before you take Xarelto

Do not take Xarelto

  • if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed insection 6)

  • if you are bleeding profusely

  • if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g. a stomach ulcer, injury or bleeding in the brain, recent surgery on the brain or eyes)

  • if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin); Unless you change your anticoagulant treatment or if you are given heparin through venous or arterial access to keep it through

  • if you have acute coronary syndrome but have previously had bleeding or a blood clot in your brain (stroke)

  • if you have coronary artery disease or peripheral arterial disease and have previously had bleeding in the brain (stroke), or if there has been a blockage in the small arteries that carry blood to deeper brain regions (lacunar stroke), or if you have had a blood clot in the past month Brain (ischemic, non-lacunar stroke)

  • if you have liver disease which increases the risk of bleeding

  • during pregnancy and breastfeeding

Do not take Xarelto and tell your doctor if you have any of these factors.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Xarelto.

Xarelto should not be used in combination with certain other medicines that reduce blood clotting, such as prasugrel or ticagrelor. Exceptions are acetylsalicylic acid and clopidogrel / ticlopidine.

Take special care with Xarelto

    • if you are at increased risk of bleeding, as may be the case, for example:

      • severe kidney disease as your kidney function can affect the amount of medicine that works in your body

      • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), if you change your anticoagulant treatment, or if you are given heparin through a venous or arterial line to keep it through (see section 'Taking Xarelto together with other medicinal products ")

      • Bleeding disorders

      • very high blood pressure that is not controlled by medical treatment

      • Diseases of your stomach or intestines that can cause bleeding, such as inflammation of the intestines or stomach, or inflammation of the esophagus (gullet) such as gastro-oesophageal reflux disease (a condition in which stomach acid goes up the esophagus)

      • a problem with the blood vessels in the back of your eyes (retinopathy)

      • a lung disease in which your bronchi are enlarged and filled with pus (bronchiectasis) and if you have previously had bleeding from your lungs

      • if you are older than 75 years

      • if you weigh 60 kg or less

      • if you have problems with the blood supply to the heart muscle (coronary artery disease) with severe heart failure that affects you (severe symptomatic heart failure)

  • if you have an artificial 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 whether your treatment needs to be changed.

If any of these apply to you, tell your doctor before you take Xarelto. Your doctor will decide whether you will be treated with this medicine and whether you need closer monitoring.

If you need to have an operation

  • it is very important to take Xarelto before and after the operation at exactly the times your doctor has told you.

  • If a catheter or injection near the spinal cord is used during your operation (e.g. for epidural or spinal anesthesia or for pain relief):

    • It is very important to take Xarelto at exactly the time your doctor has told you before and after the injection or removal of the catheter

    • Tell your doctor straight away if you experience numbness or weakness in your legs, or problems with digestion or urination after the anesthesia, because immediate treatment is necessary.

Children and adolescents

Xarelto 2.5 mg tablets will be not recommended for people under 18 years of age. There is not enough information on its use in children and adolescents.

Other medicines and Xarelto

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

  • When taking

    • certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only used on the skin

    • Ketoconazole tablets (used to treat Cushing's syndrome, where the body makes too much cortisol)

    • certain medicines for bacterial infections (e.g. clarithromycin, erythromycin)

    • some anti-viral medicines for HIV / AIDS (e.g. ritonavir)

    • other medicines to prevent 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 relievers (e.g. naproxen or acetylsalicylic acid)

    • Dronedarone, a medicine used to treat irregular heartbeat

    • certain drugs used to treat depression (selective serotonin reuptake inhibitors [SSRI] or serotonin-norepinephrine reuptake inhibitors [SNRI])

    If any of these apply to you, tell your doctor Before taking Xarelto, because it can make Xarelto more effective. Your doctor will decide whether you will be treated with this medicine and whether you need closer monitoring.

    If your doctor thinks you are at increased risk of developing stomach or intestinal ulcers, they may also start preventive ulcer treatment.

  • When taking

    • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)

    • Johannis herbs (Hypericum perforatum), a herbal remedy for depression

    • Rifampicin, an antibiotic

    If any of these apply to you, tell your doctor before taking Xarelto, as it may make Xarelto less effective. Your doctor will decide whether you are treated with Xarelto and whether you need closer monitoring.

pregnancy and breast feeding period

You should not take Xarelto if you are pregnant or breastfeeding. If there is a possibility that you could become pregnant, effective contraception should be used while you are being treated with Xarelto. If you become pregnant while taking this medicine, tell your doctor straight away, who will decide on your further treatment.

Driving and using machines

Xarelto may make you feel dizzy (common side effect) or fainting (uncommon side effect) (see section 4, “Possible side 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

Please only take Xarelto after consulting your doctor if you know that you are intolerant to sugar.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

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3. How to take Xarelto

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much is to be taken

The recommended dose is one 2.5 mg tablet twice a day. Take Xarelto at the same time each 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, talk to your doctor about other ways of taking Xarelto. The tablet can be crushed just before ingestion and mixed with water or applesauce.

If necessary, your doctor may give you the crushed Xarelto tablet through a feeding tube.

You are not only given Xarelto.

Your doctor will also prescribe acetylsalicylic acid for you. If you are receiving Xarelto after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you.

Your doctor will tell you how much to take at a time (usually between 75 to 100 mg acetylsalicylic acid per day, or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a usual daily dose of ticlopidine).

When to start with Xarelto

Treatment with Xarelto after acute coronary syndrome should be started as soon as possible after the acute coronary syndrome has stabilized, but no earlier than 24 hours after hospitalization and at the time when parenteral (injection) anticoagulant therapy is usually discontinued becomes.

If you have been diagnosed with coronary artery disease or peripheral arterial disease, your doctor will tell you when to start treatment with Xarelto.

Your doctor will decide how long you should continue treatment.

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

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take the next dose at the normal time.

If you stop taking Xarelto

Take Xarelto regularly and for as long as your doctor prescribes it for you.

Do not stop taking Xarelto without talking to your doctor first. If you stop taking this medicine it may increase your risk of having another heart attack or stroke, or it may increase your risk of dying from disease of the heart or blood vessels.

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

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4. What side effects are possible?

Like all medicines, Xarelto can cause side effects, although not everybody gets them.

Like other medicines in this group, which reduce the formation of blood clots, Xarelto can cause bleeding that can be life-threatening. Very heavy bleeding can lead to a sudden drop in blood pressure (shock). In some cases the bleeding may not be visible.

Tell your doctor straight away if you notice any of the following side effects:

  • Signs of bleeding

    • Bleeding into the brain or within the skull (symptoms may include headache, unilateral weakness, vomiting, seizures, decreased consciousness, and neck stiffness. This is a serious medical emergency. See a doctor immediately!)

    • bleeding that goes on for a long time or is very heavy

    • unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina.

Your doctor will decide if you need to be monitored more closely or if your treatment needs to be changed.

  • Signs of a severe skin reaction

    • spreading, severe skin rash, blistering or mucous membrane wounds, e.g. in the mouth or eyes (Stevens-Johnson syndrome / toxic epidermal necrolysis).

    • a drug reaction causing a rash, fever, inflammation of the internal organs, blood count abnormalities and a general feeling of illness (DRESS syndrome). These side effects are very rare (may affect up to 1 in 10,000 people).

  • Signs of a severe allergic reaction

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

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

Complete overview of the possible side effects

Often (may affect up to 1 in 10 people)

  • Reduction in the number of red blood cells which can cause pale skin and feeling weak or breathless

  • Bleeding from the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums

  • Bleeding in one eye (including conjunctival bleeding)

  • Bleeding into a tissue or body cavity (bruises, bruises)

  • Coughing up blood

  • Bleeding from or under the skin

  • Bleeding after an operation

  • Oozing blood or secretions from the surgical wound

  • Swelling of limbs

  • Pain in the limbs

  • Impairment of kidney function (may show up in laboratory tests done by your doctor)

  • fever

  • Stomach pain, indigestion, nausea or vomiting, constipation, diarrhea

  • low blood pressure (symptoms may include dizziness or fainting when standing up)

  • decreased performance (weakness, tiredness), headache, dizziness

  • Rash, itchy skin

  • Blood tests may show high levels of some liver enzymes

Occasionally (may affect up to 1 in 100 people)

  • Bleeding into the brain or within the skull (see above, signs of bleeding)

  • Bleeding into a joint causing pain and swelling

  • Thrombocytopenia (low number of blood platelets; platelets are cells that help blood to clot)

  • allergic reactions, including allergic skin reactions

  • Impairment of liver function (may show up in laboratory tests carried out by your doctor)

  • Blood tests may show increased levels of bilirubin, some pancreatic or liver enzymes, and platelet counts

  • Fainting

  • malaise

  • increased heart rate

  • Dry mouth

  • Hives

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

  • Bleeding into a muscle

  • Cholestasis (decreased bile flow), hepatitis including hepatocellular damage (inflammation of the liver including liver damage)

  • Yellowing of the skin and eyes (jaundice)

  • localized swelling

  • as a complication of a cardiac exam where a catheter has been inserted into your leg artery, blood (hematoma) may build up in the groin area (pseudoaneurysm)

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

  • Kidney failure after severe bleeding

  • increased pressure in the muscles of the legs or arms after a bleeding, causing pain, swelling, abnormal sensation, numbness or paralysis (post-bleeding compartment syndrome)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: http://www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store 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 carton or bottle after "EXP" and on each blister pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicinal product does not require special storage conditions.

Crushed tablets

Crushed tablets can be stored in water and applesauce for up to 4 hours.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

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6. Contents of the pack and other information

What Xarelto contains

  • The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.

  • The other ingredients are:

    Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose (2910), sodium dodecyl sulfate, magnesium stearate (Ph.Eur.). See section 2 “Xarelto contains lactose and sodium”.

    Film-coated tablet coating: macrogol (3350), hypromellose (2910), titanium dioxide (E 171), iron (III) hydroxide oxide x H2O (E 172).

What Xarelto looks like and contents of the pack

Xarelto 2.5 mg film-coated tablets are light yellow, round, biconvex and marked with the BAYER cross on one side and "2.5" and a triangle on the other side.

They are in blister packs

  • in cartons with 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or

  • in blister packs for dispensing single doses in cartons with 10 x 1 or 100 x 1 film-coated tablets or

  • in multipacks of 10 cartons, each containing 10 x 1 film-coated tablets, or

  • available in bottles of 100 film-coated tablets.

Not all pack sizes may be marketed.

Pharmaceutic entrepreneur

Bayer AG

51368 Leverkusen

Germany

Manufacturer

The manufacturer can be determined using the batch number that is printed on the side flap of the folding box and on each blister or bottle:

  • If the first two letters BX the manufacturer is:

    Bayer AG

    Kaiser-Wilhelm-Allee

    51368 Leverkusen

    Germany

  • If the first two letters IT the manufacturer is:

    Bayer HealthCare Manufacturing Srl.

    Via delle Groane, 126

    20024 Garbagnate Milanese

    Italy

  • If the first two letters BT the manufacturer is:

    Bayer Bitterfeld GmbH

    Greppin district, Salegaster Chaussee 1

    06803 Bitterfeld-Wolfen

    Germany

For more information about the medicine, please contact the local representative of the Marketing Authorization Holder.

Germany

Bayer Vital GmbH

Tel: + 49- (0) 214-30 513 48

This leaflet was last revised in January 2021

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