Xarelto
rivaroxaban
rivaroxaban
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 Xarelto is and what it is used for
What you need to know before you take Xarelto
How to take Xarelto
Possible side effects
How to store Xarelto
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.
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
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.
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.
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.
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.
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 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
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.
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.
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.
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).
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.
Contact your doctor immediately if you have taken too many Xarelto tablets. Taking too much Xarelto increases the risk of bleeding.
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.
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.
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.
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).
- 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).
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
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
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)
kidney failure after a severe bleeding
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)
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.
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).
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
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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
UAB Bayer
Tel: +370-5-233 68 68
Байер България ЕООД Тел: +359-(0)2-424 72 80
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Bayer s.r.o.
Tel: +420-266 101 111
Bayer A/S
Tlf: +45-45 235 000
Alfred Gera and Sons Ltd. Tel: +356-21 44 62 05
Bayer Vital GmbH
Tel: +49-(0)214-30 513 48
Bayer B.V.
Tel: +31–(0)297-28 06 66
Bayer OÜ
Tel: +372-655 85 65
Bayer AS
Tlf: +47-23 13 05 00
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30-210-618 75 00
Bayer Austria Ges. m. b. H. Tel: +43-(0)1-711 460
Bayer Hispania S.L. Tel: +34-93-495 65 00
Bayer Sp. z o.o.
Tel: +48-22-572 35 00
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54
Bayer Portugal, Lda. Tel: +351-21-416 42 00
Bayer d.o.o.
Tel: + 385-(0)1-6599 900
SC Bayer SRL
Tel: +40-(0)21-528 59 00
Bayer Limited
Tel: +353 1 216 3300
Bayer d. o. o.
Tel: +386-(0)1-58 14 400
Icepharma hf.
Sími: +354-540 80 00
Bayer, spol. s r.o.
Tel: +421-(0)2-59 21 31 11
Bayer S.p.A.
Tel: +39-02-3978 1
Bayer Oy
Puh/Tel: +358-(0)20-78521
NOVAGEM Limited
Τηλ: +357-22-48 38 58
Bayer AB
Tel: +46-(0)8-580 223 00
SIA Bayer
Tel: +371-67 84 55 63
Bayer AG
Tel: +44-(0) 118 206 3000