2.5 mg film-coated tablets
rivaroxaban
What Xarelto is and what it is used for
You have received Xarelto since
- you have been diagnosed with the acute coronary syndrome (a group of conditions including heart attack and unstable angina pectoris, a severe type of chest pain) and you have been found to have an increase in certain blood tests that are important to the heart. Xarelto reduces the risk in adults of having another heart attack and reduces the risk of dying from the disease of the heart or blood vessels. You should not take Xarelto alone. The doctor will ask you to take Xarelto together with either:
- acetylsalicylic acid or
- aspirin and clopidogrel or ticlopidine
or
- you have been diagnosed with a high risk of a blood clot due to coronary artery disease or peripheral vascular disease that is causing symptoms.
Xarelto reduces the risk in adults of having blood clots (atherothrombotic events).
You should not take Xarelto alone. The doctor will ask you to take Xarelto together with aspirin. If you are given Xarelto after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, in some cases the doctor may also prescribe clopidogrel to be taken in addition to aspirin for a shorter period.
Xarelto contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa) and thus reduces the blood’s tendency to clot.
What you need to know before taking Xarelto
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 bleed a lot
- if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery )
- if you take medicines to prevent blood clotting (eg warfarin, dabigatran, apixaban, or heparin ), except when changing anti-clotting therapy or if you have a venous or arterial catheter that is flushed with heparin to keep the catheter open
- if you have the acute coronary syndrome and have had bleeding or blood clots in the brain ( stroke )
- if you have coronary artery disease or peripheral vascular disease and have previously had a brain hemorrhage ( stroke ) or a blockage of one of the small arteries that supply the deep tissue of the brain with blood (lacunar stroke ) or if you have had a blood clot in the brain (ischemic, nonlacunar stroke ) in the last month
- if you have a liver disease that leads to an increased risk of bleeding
- if you are pregnant or breastfeeding.
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 drugs that reduce the formation of blood clots such as prasugrel or ticagrelor other than aspirin and clopidogrel/ticlopidine.
Be especially careful with Xarelto
- if you have an increased risk of bleeding which may be the case if you have:
- severe kidney disease because kidney function can affect the amount of medicine that has an effect on the body
- if you are taking other medicines to prevent blood clots (eg warfarin, dabigatran, apixaban, or heparin ), when changing anti-clotting therapy or if you have a venous or arterial catheter that is flushed with heparin to keep the catheter open (see section “ Other medicines and Xarelto”)
- bleeding disorders
- very high blood pressure that is not controlled by drug therapy
- stomach or intestinal disease that can lead to bleeding, e.g. inflammation in the stomach or intestines, or inflammation in the esophagus, e.g. due to reflux disease (a condition in which stomach acid comes up into the esophagus) or tumors located in the stomach, intestines, genitals or urinary tract
- problems with the blood vessels in the fundus of the eye ( retinopathy )
- a lung disease where the airways widen and fill up (bronchiectasis), or previous bleeding from the lungs
- if you are over 75 years old
- if you weigh less than 60 kg
- if you have coronary artery disease with severe symptomatic heart failure
- if you have a prosthetic heart valve
- if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots). In such cases, inform your doctor, who will decide whether the treatment may need to be changed.
If any of the above apply to you, tell your doctor before taking Xarelto. The doctor will then decide whether you should be treated with this medicine and whether you need to be monitored more closely.
If you need to undergo an operation
- It is very important to take Xarelto before and after surgery, at exactly the times your doctor tells you.
- if your operation involves a catheter or injection into the spine (eg for epidural or spinal anesthesia or pain relief):
- it is very important to take Xarelto before and after the injection or the removal of the catheter exactly at the times the doctor told you
- tell the doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anesthesia has finished because prompt care is necessary.
Children and young people
Xarelto 2.5 mg tablets are not recommended for children or adolescents under 18 years of age. There is insufficient information on 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.
If you take
- certain medicines for fungal infections (eg, fluconazole, itraconazole, voriconazole, posaconazole) unless they are applied only to the skin
- ketoconazole tablets (used for Cushing’s syndrome – when the body produces too much cortisol )
- certain medicines for bacterial infections (eg clarithromycin, erythromycin)
- certain antiviral medicines for HIV/AIDS (eg ritonavir)
- other medicines that 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 drugs (eg naproxen or aspirin )
- dronedarone, a medicine to treat abnormal heartbeats
- certain medicines for depression (selective serotonin reuptake inhibitors ( SSRIs ) or serotonin and norepinephrine reuptake inhibitors ( SNRIs )).
If any of the above apply to you, tell your doctor before taking Xarelto, as the effect of Xarelto may be increased. The doctor will then decide whether you should be treated with this medicine and whether you need to be monitored more closely.
If your doctor thinks you are at increased risk of developing stomach or intestinal ulcers, you can receive preventive treatment against this.
If you take
- certain medicines for the treatment of epilepsy ( phenytoin, carbamazepine, phenobarbital)
- St. John’s wort (Hypericum perforatum), a traditional herbal medicine used for mild depression and mild anxiety
- rifampicin, an antibiotic .
If any of the above apply to you, tell your doctor before taking Xarelto, as the effectiveness of Xarelto may be reduced. The doctor will then decide whether you should be treated with Xarelto and whether you need to be monitored more closely.
Pregnancy and breastfeeding
Do not take Xarelto if you are pregnant or breastfeeding. If there is a possibility that you could become pregnant, you should use reliable contraception while taking Xarelto. If you become pregnant while taking this medicine, tell the doctor who will decide how to treat you immediately.
Driving ability and use of machinery
Xarelto can cause dizziness (a common side effect) and fainting (a less common side effect) (see section 4, Possible side effects ). You should not drive, cycle or use tools or machines if you have these symptoms.
Xarelto contains lactose and sodium
If you are intolerant to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Xarelto
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended dose is one 2.5 mg tablet twice daily. Take Xarelto at about the same time each day (eg one tablet in the morning and one in the evening). You can take this medicine with or without food.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Xarelto. The tablet can be crushed and mixed with water or applesauce just before taking it.
If necessary, the doctor may also give you the crushed Xarelto tablet through a stomach tube.
You should not take Xarelto alone.
The doctor will also ask you to take aspirin. If you receive Xarelto after an acute coronary syndrome, your doctor may ask you to also take clopidogrel or ticlopidine.
If you are given Xarelto after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, in some cases the doctor may also prescribe clopidogrel to be taken in addition to aspirin for a shorter period.
The doctor will tell you how much of these you should take (usually between 75 and 100 mg of aspirin daily or a daily dose of 75 to 100 mg of aspirin plus a daily dose of either 75 mg of clopidogrel or a regular daily dose of ticlopidine).
When should you start taking Xarelto?
Treatment with Xarelto after an acute coronary syndrome should be started as soon as possible after the acute coronary syndrome has stabilized, no earlier than 24 hours after admission to the hospital and at the time when parenteral (by injection ), anticoagulation therapy would normally be stopped.
The doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral vascular disease.
Your doctor will decide how long you should continue treatment.
If you have taken too much Xarelto
Contact your doctor immediately if you have taken too many Xarelto tablets. The risk of bleeding increases if you take too much Xarelto.
If you forget to take Xarelto
Do not take a double dose to make up for a missed dose. If you have forgotten a dose, take the next dose at the usual time.
If you stop taking Xarelto
Take Xarelto regularly as long as the doctor prescribes it.
Do not stop taking Xarelto without first talking to your doctor. If you stop taking the medicine, it may increase the risk of another heart attack or stroke, or an increased risk of dying from a disease related to the heart or blood vessels.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Xarelto can cause side effects, but not all users will experience them.
Like other similar drugs that reduce the formation of blood clots, Xarelto can cause bleeding that can sometimes be life-threatening. Heavy bleeding can 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 in the brain or inside the head (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness, and neck stiffness). A serious medical emergency. See a doctor immediately!
- prolonged or heavy bleeding
- unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris.
The doctor may decide that you should be monitored more closely or change the treatment
Signs of serious skin reaction
- severe skin rash that spreads, blisters, or sore mucous membranes, eg in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis ).
- a side effect that causes rash, fever, inflammation of internal organs, abnormal blood counts, and systemic illness (DRES’s syndrome).
The frequency of these side effects is very rare (may affect up to 1 in 10,000 users).
Signs of serious allergic reactions
- include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing, rash, difficulty breathing, and sudden drop in blood pressure.
The frequency of serious allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock may occur in up to 1 in 10,000 users) and less common ( angioedema and allergic edema occur in 1 in 100 users).
Complete list of possible side effects
Common side effects ( may affect up to 1 in 10 users)
- decrease in the number of red blood cells, which may make the skin pale and cause weakness or shortness of breath
- bleeding in the stomach or intestines, bleeding in the urinary tract or genitals (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
- bleeding in the eye (including bleeding from the whites of the eyes)
- bleeding into a tissue or cavity in your body (hemorrhage, bruising)
- bloody cough
- bleeding in the skin or under the skin
- bleeding after an operation
- oozing of blood or fluid from a surgical wound
- swelling of the arms or legs
- pain in arms or legs
- impaired kidney function (can be seen in samples taken by the doctor)
- fever
- stomach ache, upset stomach, nausea or vomiting, constipation, diarrhea
- low blood pressure (symptoms may be feeling dizzy or faint when you stand up)
- decreased general strength and energy (weakness, fatigue), headache, dizziness
- rash, itching of the skin
- blood tests may show an increase in certain liver enzymes.
Uncommon side effects ( may affect up to 1 in 100 users)
- bleeding in the brain or inside the head (see above, for signs of bleeding)
- bleeding in a joint which can cause pain and swelling
- thrombocytopenia (low number of platelets, which are cells that help the blood clot)
- allergic reactions, including allergic skin reactions
- impaired liver function (can be seen in samples taken by the doctor)
- blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or the number of platelets
- fainting
- malaise
- faster pulse
- dry mouth
- hives.
Rare side effects ( may affect up to 1 in 1,000 users)
- bleeding in a muscle
- cholestasis (reduced bile flow), hepatitis incl. hepatocellular damage (inflamed liver incl. liver damage)
- yellowing of the skin and eyes (jaundice)
- local swelling
- bleeding (hematoma) in the groin; a complication of a procedure in the heart, where a catheter is inserted to treat narrowed coronary arteries in the heart (pseudoaneurysm).
Has been reported (occurring in an unknown number of users)
- kidney failure after severe bleeding
- increased pressure in the muscles of the legs or arms after a bleed, which can lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after a bleed).
How to store Xarelto
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP and on each blister or can after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
- Other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, 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), yellow iron oxide (E 172).
Appearance and package sizes of the medicine
Xarelto 2.5 mg film-coated tablets are pale yellow, round, biconvex and marked with the BAYER cross on one side and “2.5” and a triangle on the other side. They are delivered
- in blisters in boxes of 14, 20, 28, 30, 56, 60, 98, 168, or 196 film-coated tablets or
- in single-dose blisters in cartons of 10 x 1 and 100 x 1 or
- in multiple packs of 10 cards, each of 10 x 1 film-coated tablet or
- in jars 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 of the carton and each blister or bottle:
- If the first two letters are BX, the manufacturer Bayer AGKaiser Wilhelm Allee51368 LeverkusenGermany
- If the first two letters are IT, the manufacturer Bayer HealthCare Manufacturing Srl.Via delle Groane, 12620024 Garbagnate MilaneseItaly
- If the first two letters are BT, the manufacturer isBayer Bitterfeld GmbHOrtsteil Greppin, Salegaster Chaussee 106803 Bitterfeld-WolfenGermany