XARELTO. 10 mg. 5 tablets
Xarelto belongs to a group of medicines called antiplatelet agents.
XARELTO. 10 mg. 5 tablets
What Xarelto and what it is used?
Xarelto contains the active ingredient rivaroxaban is used in adults for the prevention of blood clots in the veins after surgery for total joint replacement surgery of the hip or knee. Your doctor has prescribed this medication because after surgery have an increased risk of clots.
Xarelto belongs to a group of medicines called antiplatelet agents . By its action , it blocks one of the coagulation factor ( Factor Xa) and thus reduces the ability of blood to form clots.
2 . What you should 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 are bleeding
- If you have a disease or condition of the body in the body , increasing the risk of serious bleeding (eg gastric ulcer , injury or bleeding in the brain , recent surgery of the brain or eyes)
- If you are taking medicines to prevent blood clots (eg warfarin , dabigatran , apixaban or heparin ), except when changing anticoagulant treatment or while receiving heparin in venous or arterial catheter to keep it open
- If you suffer from liver disease , leading to 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. Take special care with Xarelto
- If you have an increased risk of bleeding , as the case may be , for example, in :
- Moderate or severe renal disease
- If you take other medicines to prevent blood clots (eg warfarin , dabigatran , apixaban or heparin) when changing anticoagulant treatment or while receiving heparin in venous or arterial catheter to keep it open (see section " Other medicines and Xarelto ")
- Bleeding disorders
- Very high blood pressure , uncontrolled by medication
- Ulcer of stomach or intestines
- Problems with the blood vessels of the fundus ( retinopathy )
- Pulmonary disease in which you are dilated bronchi and filled with pus ( bronchiectasis ) or bleeding out of the lungs in the past
Tell your doctor before taking Xarelto, if any of these apply to you. Your doctor will decide whether to treat you with this medication and have to be monitored more carefully.
- Xarelto is not recommended after surgery on the occasion of hip fracture .
- If you are planning surgery suggests catheter or injection into the spinal canal (eg, epidural or spinal anesthesia or pain reduction ):
- It is important to take Xarelto before and after the injection or removal of the catheter exactly at the time prescribed by your doctor
- Tell your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder after anesthesia for urgent measures are needed .
Children and adolescents
Xarelto is not recommended for persons under the age of 18 years . There is little 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 take any other medicines , including medicines obtained without a prescription.
- If you are taking :
? some medicines for fungal infections ( eg ketoconazole , itraconazole , voriconazole, posaconazole ) , unless only for topical application
? some antiviral medicines for HIV / AIDS (eg ritonavir)
? other medicines to reduce blood clotting (eg enoxaparin , clopidogrel and vitamin K antagonists such as warfarin and acenocoumarol )
? anti-inflammatory and pain relievers (eg, naproxen, or aspirin )
? dronedarone , a drug to treat irregular heartbeat. Tell your doctor before taking Xarelto, because the effect of Xarelto may be enhanced. Your doctor will decide whether to treat you with this medication and have to be monitored more carefully.
If your doctor thinks that you have an increased risk of stomach or intestinal ulcers, it may appoint a prophylactic treatment for ulcers.
- If you are taking :
? certain drugs for treatment of epilepsy ( phenytoin , carbamazepine, phenobarbital)
? St. John's wort (Hypericum perforatum), ( a herbal product used for depression)
? rifampicin ( antibiotic)
Tell your doctor before taking Xarelto, because the effect of Xarelto may be reduced . Your doctor will decide whether you should be treated with Xarelto and have to be monitored more carefully.
Pregnancy and lactation
Do not take Xarelto, if you are pregnant or breast-feeding . If you could get pregnant , use a reliable contraceptive while taking Xarelto. If you become pregnant while taking this drug , tell your doctor who will decide how it should be treated.
Driving and using machines
Xarelto may cause side effects such as dizziness or fainting (see section 4 " Possible side effects"). These side effects are common. Do not drive or use machines if you have these symptoms.
Xarelto contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 . How to take Xarelto?
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
How much to take ?
The recommended dose is one tablet (10 mg) once daily. Swallow , preferably with water. Xarelto can be taken with or without food.
When to take Xarelto?
Take the first tablet of 6-10 hours after surgery.
Then take one tablet a day until your doctor tells you to stop. Try to take the tablet at the same time each day - this will help you remember .
If you have been undergoing major hip surgery will usually take the tablets for 5 weeks.
If you have been undergoing major knee surgery will usually take the tablets for 2 weeks.
If you take more dose Xarelto
Immediately contact your doctor if you take more tablets Xarelto than necessary. Taking more tablets Xarelto than necessary increases the risk of bleeding.
If you forget to take Xarelto
If you miss a dose, take it as soon as you remember. Take the next tablet the next day and then continue taking one tablet once a day as usual.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Xarelto
Do not stop taking Xarelto, without first talking to your doctor , because Xarelto prevents the development of a serious illness.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
As similar medicines ( antithrombotic agents ), Xarelto can lead to bleeding which is potentially life-threatening . Very strong bleeding may also lead to a sharp drop in blood pressure ( shock) . In some cases, bleeding may not be visible .
Possible side effects that could be a sign of bleeding : Tell your doctor immediately if you experience any of the following side effects:
- Prolonged or very heavy bleeding
- Severe weakness, fatigue , pallor , dizziness , headache, unexplained swelling , shortness of breath , chest pain or angina, which may be signs of bleeding.
Your doctor may decide to monitor you more closely or adjust your treatment .
A summary list of possible side effects : Common ( may affect up to 1 in 10 people):
- Bleeding in the stomach or intestines, bleeding from the genitourinary organs (including blood in the urine and excessive menstrual bleeding) , nosebleeds , bleeding gums
- Bleeding in the eye (including bleeding from the whites of the eyes )
- Bleeding into the tissue or body cavity ( hematoma , bruising )
- Bleeding after surgery
- Oozing bleeding or leakage of fluid from the surgical site
- Swelling of the limbs
- Pain in extremity
- High temperature
- A decrease in the number of red blood cells , resulting in the skin may become pale and can lead to weakness and dyspnea
- Stomach pain , indigestion, nausea and vomiting , constipation, diarrhea
- Rapid heartbeat
- Low blood pressure ( with symptoms such as feeling dizzy or fainting upon standing )
- Reduced overall strength and energy (weakness , tiredness ), headache, dizziness , seizures
- Rash , itchy skin
- Blood tests may show raised levels of some liver enzymes
Uncommon ( may affect up to 1 in 100 people):
- Bleeding in the brain or skull
- Bleeding into joints, which causes pain or swelling
- Bloody sputum
- Bleeding from the skin or under the skin
- Dry mouth
- Localized swelling
- Allergic reactions including allergic skin reactions
- Impaired renal or hepatic function (can be found if the doctor do some tests )
- Blood tests may show increased bilirubin, some pancreatic or liver enzymes in platelets
Rare (may affect up to 1 in 1000 people):
- Bleeding into muscle
- Yellowing of the skin and eyes ( jaundice)
Not known ( data can not be estimated frequency )
- Collection of the blood ( hematoma) after cardiac complication of procedure in which a catheter for the treatment of narrowed coronary arteries ( pseudoaneurysm )
- Increased tension in the muscles of the legs or arms , after bleeding , which results in pain , swelling , abnormal sensations , tingling or paralysis ( compartment syndrome after bleeding )
- Renal failure after severe bleeding
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Xarelto?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after " EXP" on each blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Xarelto?
- The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
- The other ingredients are:
Tablet core : microcrystalline cellulose , croscarmellose sodium, lactose monohydrate , hypromellose , sodium lauryl sulfate , magnesium stearate. Film coat : macrogol 3350, hypromellose , titanium dioxide (E171), iron oxide red (E172).
Xarelto looks like and contents of the pack ?
The film-coated tablets are light red, round, biconvex and marked on one side with the cross of BAYER, on the other hand - with "10" and a triangle. They are packed in blister and carton 5, 10 or 30 tablets or unit dose blisters in cartons of 10 x 1 or 100 x 1 or multipack comprising 10 cartons , each containing 10 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder