XARELTO. 20 mg. 28 tablets
XARELTO WHAT IS AND WHAT IT IS USED
Xarelto is used to prevent the formation of clots in the veins you after surgery for total
arthritic hip or knee you going . Your doctor has prescribed this
medicine , because after surgery have an increased risk of clots.
Xarelto belongs to a group of medicines called antiplatelet agents . Through its action
it blocks one clotting factor ( factor Xa) and thus reduces the ability of
blood to form clots.
2 . BEFORE YOU TAKE XARELTO
Do not take Xarelto
- If you are allergic ( hypersensitive) to rivaroxaban or any of the other
ingredients of Xarelto. The ingredients are listed at the end of this leaflet ;
- If you are bleeding ;
- 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
Take special care with Xarelto
- If you have moderate or severe kidney disease
- If you have moderate liver disease
- If you have an increased risk of bleeding , such as:
very high blood pressure , uncontrolled by medication
ulcer now or in the recent past ulcer of the stomach or intestines
problems with blood vessels in the fundus ( retinopathy )
bleeding in the brain in the recent past ( intracranial or intracerebral hemorrhage )
problems with the vessels of the brain or spinal cord
operations of the brain, spinal cord or eyes in the recent past
Tell your doctor before taking Xarelto, if any of these apply
for you. Your doctor will decide whether you should be treated with Xarelto and have to be monitored more
- Xarelto is not recommended after surgery on the occasion of hip fracture .
- Children and adolescents , Xarelto is not recommended for persons under 18.
There is insufficient information for use in children and adolescents.
- If the planned surgery suggests catheter or injection into the spinal canal (eg, epidural or spinal anesthesia or pain reduction ):
it is very 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 .
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- If you are taking :
drugs for fungal infections (e.g., ketoconazole , itraconazole, voriconazole and posaconazole , fluconazole ) , unless these are only for topical application
some antiviral medicines for HIV / AIDS (eg ritonavir)
other medicines to reduce blood clotting (eg enoxaparin or clopidogrel )
anti-inflammatory and pain relievers (eg, naproxen, or aspirin )
Tell your doctor before taking Xarelto, because its effect can be enhanced. Your doctor will decide whether you should be treated with Xarelto 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 epilepsy ( phenytoin , carbamazepine , phenobarbital )
John's wort ( a herbal product used for depression)
rifampicin ( an antibiotic).
Tell your doctor before taking Xarelto, because its effect may be reduced . Your doctor will decide whether you should be treated with Xarelto and have to be monitored more carefully.
Taking Xarelto with food and drink
Xarelto can be taken with or without food.
Pregnancy and lactation
If you are pregnant or breast-feeding , do not take Xarelto. If you could get pregnant , use a reliable contraceptive while taking Xarelto. If you become pregnant while taking Xarelto, tell your doctor about it, and he will decide how it should be treated.
Driving and using machines
Xarelto may cause side effects such as dizziness or fainting . Do not drive or use machines if you have these symptoms. These side effects are not common with Xarelto ( see section 4 " Possible side effects").
Important information about some of the ingredients of Xarelto
Xarelto contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Xarelto.
3 . HOW TO TAKE XARELTO
Always take Xarelto exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
How much to take
The usual dosage is one tablet (20 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 to
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
next day and then continue taking one tablet once daily 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 you
the development of a serious condition .
If you have any further questions on the use of this product, ask
Your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Xarelto can cause side effects, although not everybody gets them .
As similar medicines ( antithrombotic agents ), Xarelto can lead to bleeding which can be potentially life threatening. Very strong bleeding may also lead to a sharp drop in blood pressure ( shock) . In some cases this bleeding can not be visible .
Tell your doctor 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 , pain or angina ardite .
Your doctor may decide to monitor you more closely or adjust your treatment .
The following frequencies of the possible side effects are defined by the following rules:
common ( affects 1 to 10 in every 100 people taking the drug )
uncommon ( affects 1 to 10 out of every 1,000 people taking the drug )
rare (affects 1 to 10 users in 10,000 people taking the drug )
known ( from the available data can not be estimated ) .
Common side effects
- Bleeding after surgery
- Malaise , fever, swelling of the limbs
- Increase in some liver enzymes in blood tests
Uncommon side effects
- Bleeding in the stomach or intestines, bleeding from the genitourinary organs, bleeding from the nose
- Bleeding into the tissue or cavity of the body ( bruises , bruising )
- Oozing bleeding or leakage of fluid from the surgical site
- Rapid pulse
- Low blood pressure
- Reduced total power and energy (weakness , tiredness ), headache, dizziness
- A decrease in the number of red blood cells , resulting in the skin can become pale, cause weakness or breathlessness
- Stomach ache, indigestion, constipation , diarrhea, nausea
- Dry mouth
- Localized swelling
- Pain in the extremities
- Rash , itchy skin
- Renal dysfunction
- Blood tests may show raised levels of bilirubin , some enzymes
the pancreas or the number of platelets in the blood
Rare side effects
- Impaired liver function
- Allergic skin reactions , hives
- Fainting , malaise
Side effects of unknown frequency
- Especially bleeding in a critical organ (ie your brain )
- Bleeding into the adrenal glands
- Bleeding in the whites of the eyes
- Collection of the blood ( hematoma) , obtained as a result of complications of cardiac catheterization , in which the catheter is inserted in the treatment of narrowed coronary arteries ( pseudoaneurysm )
- Bloody sputum
- Increased pressure in the muscles of the legs or arms , after bleeding , which may lead to pain , swelling , abnormal sensations , tingling or paralysis ( compartment syndrome after bleeding )
- Renal failure after severe bleeding
- Yellowing of the skin and eyes ( jaundice)
If any of the side effects gets serious, or if you notice any
listed in this leaflet, please tell your doctor or pharmacist.
5 . HOW TO STORE XARELTO
Keep out of reach of children.
Do not use Xarelto after the expiry date stated on the carton after " EXP "
and 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.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
What does Xarelto
- The active substance is rivaroxaban. Each tablet contains 20 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