Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xarelto

Document Subject

Generated Narrative: MedicinalProductDefinition mpfebe758b815af2dff26af1acacd31f32

identifier: http://ema.europa.eu/identifier/EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xarelto 2.5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-febe758b815af2dff26af1acacd31f32

identifier: http://ema.europa.eu/identifier/EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xarelto

Attesters

What is in this leaflet

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. How to store Xarelto
6. Contents of the pack and other information

You have been given Xarelto because

• you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests. Xarelto reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels. Xarelto will not be given to you on its own. Your doctor will also tell you to take either:

• acetylsalicylic acid or
• acetylsalicylic acid plus clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms.
  Xarelto reduces the risk in adults of getting blot clots (atherothrombotic events).
  Xarelto will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid.
  In some cases, if you get Xarelto after a procedure to open a narrowed or closed artery of your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short while.

Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

Do not take Xarelto

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
• if you have an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke)
• if you have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain s deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, non- lacunar stroke) in the previous month
• if you have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or breast-feeding Do not take Xarelto and tell your doctor if any of these apply to you.

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

Take special care with Xarelto

• if you have an increased risk of bleeding, as could be the case in situations such as:

severe kidney disease, since your kidney function may affect the amount of medicine that works in your body

if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section Other medicines and Xarelto )

bleeding disorders

very high blood pressure, not controlled by medical treatment

diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) or tumours located in the stomach or bowels or genital tract or urinary tract

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

a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung

you are older than 75 years

you weigh less than 60 kg

you have a coronary artery disease with severe symptomatic heart failure

• if you have a prosthetic heart valve
• if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

If any of the above apply to you, tell your doctor before you take Xarelto. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.

If you need to have an operation

• it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
• If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor

tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

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

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

• If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin

ketoconazole tablets (used to treat Cushing s syndrome - when the body produces an excess of cortisol)

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

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

other medicines 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 to treat abnormal heart beat

some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

• If you are taking

some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)

St John s Wort (Hypericum perforatum), a herbal product used for depression

rifampicin, an antibiotic If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be reduced. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.

Pregnancy and breast---feeding Do not take Xarelto if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, Possible side effects ). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

Xarelto contains lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

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

How much to take The recommended dose is one 2.5 mg tablet twice a day. Take Xarelto around the same time every day (for example, 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 to take Xarelto. The tablet may be crushed and mixed with water or apple puree immediately before you take it.
If necessary, your doctor may also give you the crushed Xarelto tablet through a stomach tube.

Xarelto will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid.
If you get Xarelto after an acute coronary syndrome, your doctor may tell you to also take clopidogrel or ticlopidine. If you get Xarelto after a procedure to open a narrowed or closed artery of your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short while.

Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).

When to start Xarelto Treatment with Xarelto after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped. Your doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral artery disease. Your doctor will decide how long you must 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 missed dose. If you miss a dose, take your next dose at the usual time.

If you stop taking Xarelto Take Xarelto on a regular basis and for as long as your doctor keeps prescribing it.

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 dying from a disease related to your heart or your blood vessels.

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

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

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

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

• Signs of bleeding

• bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek medical attention immediately!)
• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris

Your doctor may decide to keep you under closer observation or change the treatment.

• Signs of severe skin reactions

• spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (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 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 oedema; may affect up to 1 in 100 people).

Overall list of possible side effects

Common (may affect up to 1 in 10 people)

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum
• bleeding into the eye (including bleeding from the whites of the eyes)
• bleeding into tissue or a cavity of the body (haematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding following an operation
• oozing of blood or fluid from surgical wound
• swelling in the limbs
• pain in the limbs
• impaired function of the kidneys (may be seen in tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling or being sick, constipation, diarrhoea
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up)
• decreased general strength and energy (weakness, tiredness), headache, dizziness
• rash, itchy skin
• blood tests may show an increase in some liver enzymes

Uncommon (may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low number of platelets, which are cells that help blood to clot)
• allergic reactions, including allergic skin reactions
• impaired function of the liver (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
• fainting
• feeling unwell
• faster heartbeat
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)
• yellowing of the skin and eye (jaundice)
• localised swelling
• collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm)

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

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

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

• kidney failure after a severe bleeding
• bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy)
• increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)

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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 and on each blister or bottle after 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 or apple puree for up tp 4 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 laurilsulfate, magnesium stearate. See section 2 Xarelto contains lactose and sodium . Tablet film coat: macrogol (3350), hypromellose (2910), titanium dioxide (E 171), iron oxide yellow (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 come

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

in unit dose blisters in cartons of 10 x 1 or 100 x 1 or

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

in bottles of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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, 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi / Belgique / Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel: +370-5-233 68

: +359-(0)2-424 72 Luxembourg / Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420-266 101 Magyarorsz g Bayer Hung ria KFT Tel: +36-1-487 4Danmark Bayer A/S Tlf: +45-45 235 Malta Alfred Gera and Sons Ltd. Tel: +356-21 44 62 Deutschland Bayer Vital GmbH Tel: +49-(0)214-30 513 Nederland Bayer B.V. Tel: +31-23-799 1Eesti Bayer O
Tel: +372-655 85 Norge Bayer AS Tlf: +47-23 13 05
Bayer
: +30-210-618 75 sterreich Bayer Austria Ges. m. b. H. Tel: +43-(0)1-711 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48-22-572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351-21-416 42 Hrvatska Bayer d.o.o. Tel: + 385-(0)1-6599 Rom nia SC Bayer SRL
Tel: +40-(0)21-529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386-(0)1-58 14 sland Icepharma hf. S mi: +354-540 80 Slovensk republika Bayer, spol. s r.o. Tel: +421-(0)2-59 21 31 Italia Bayer S.p.A. Tel: +39-02-3978 1

Suomi/Finland Bayer Oy Puh/Tel: +358-(0)20-78
NOVAGEM Limited : +357-22-48 38 Sverige Bayer AB Tel: +46-(0)8-580 223 Latvija SIA Bayer Tel: +371-67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0) 118 206 3This leaflet was last revised in

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

Package leaflet: Information for the user

Xarelto 10 mg film-coated tablets rivaroxaban

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet