Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Xarelto 15 mg film-coated tablets
Xarelto 20 mg film-coated tablets
Treatment Initiation Pack
Not for use in children.
▼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.
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
Xarelto contains the active substance rivaroxaban and is used in adults to:
- treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.
Xarelto 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 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.
Talk to your doctor or pharmacist before taking 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)
- 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
- 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 your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned
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.
- 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 treatment initiation pack is not recommended for people under 18 years of age as it is specifically designed for initiation of treatment in adult patients and is not appropriate for 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
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.
- 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)
- 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
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.
- 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.
You must take Xarelto together with a meal.
Swallow the tablet(s) preferably with water.
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. This mixture should be immediately followed by food.
If necessary, your doctor may also give you the crushed Xarelto tablet through a stomach tube.
The recommended dose is one tablet Xarelto 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Xarelto 20 mg once a day.
This Xarelto 15 mg and 20 mg treatment initiation pack is only for the first 4 weeks of treatment.
Upon completion of this pack, treatment will continue on Xarelto 20 mg once daily as your doctor has told you.
If you have kidney problems, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Take the tablet(s) every day until your doctor tells you to stop.
Try to take the tablet(s) at the same time every day to help you to remember it.
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.
- If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day. On the following day you should carry on taking one 15 mg tablet twice a day.
- If you are taking one 20 mg tablet once a day and have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking one tablet once a day.
Do not stop taking Xarelto without talking to your doctor first, because Xarelto treats and prevents serious conditions.
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.
- Signs of bleeding
Your doctor may decide to keep you under closer observation or change the treatment.
- 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
- Signs of severe skin reactions
The frequency of these side effects is very rare (up to 1 in 10,000 people).
- 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).
- Signs of severe allergic reactions
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).
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.
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)
- 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
- feeling unwell
- faster heartbeat
- dry mouth
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)
Not known (frequency cannot be estimated from the available data)
- 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:
Yellow Card Scheme
or search for MHRA Yellow Card in the Google Play or Apple App Store.
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
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 wallet after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets are stable in water or apple puree for up to 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 15 mg or 20 mg of rivaroxaban, respectively.
- 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 red (E 172).
Xarelto 15 mg film-coated tablets are red, round, biconvex and marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Xarelto 20 mg film-coated tablets are brown-red, round, biconvex and marked with the BAYER-cross on one side and “20” and a triangle on the other.
First 4 weeks treatment initiation pack: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban in a wallet.
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
- If the first and second characters are IT, the manufacturer is
Bayer HealthCare Manufacturing Srl.
Via delle Groane, 126
20024 Garbagnate Milanese
- If the first and second characters are BT, the manufacturer is
Bayer Bitterfeld GmbH
Salegaster Chaussee 1
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tel: +44-(0) 118 206 3000
This leaflet was last revised in 01/2021
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.