Xarelto 10 mg film-coated tablets Rivaroxaban - United Kingdom[英国药品]

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Xarelto 10 mg film-coated tablets Rivaroxaban

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For doctors

What is it and how is it used?

Xarelto is used to prevent blood clots in your veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.

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.

What do you have to consider before using it?

Do not take Xarelto

Take special care with Xarelto

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Xarelto with food and drink
Xarelto can be taken with or without food.

Pregnancy and breast feeding If you are pregnant or breast feeding do not take Xarelto. 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 Xarelto, immediately tell your doctor, who will decide how you should be treated.

Driving and using machines
Xarelto may cause side effects such as dizziness or fainting. You should not drive or use machines if you are affected by these symptoms. For Xarelto, these side effects are uncommon (see section 4 “Possible side effects”).

Important information about some of the ingredients of Xarelto Xarelto contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xarelto.

How is it used?

Always take Xarelto exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take The usual dose is one tablet (10 mg) once a day.

Swallow the tablet preferably with water.
Xarelto can be taken with or without food.

When to take Xarelto Take the first tablet 6 - 10 hours after your operation.
Then take a tablet every day until your doctor tells you to stop.
Try to take the tablet at the same time every day to help you to remember it.
If you have had a major hip operation you will usually take the tablets for 5 weeks. If you have had a major knee operation you will usually take the tablets for 2 weeks.

If you take more Xarelto than you should Contact your doctor immediately if you have taken too many Xarelto tablets. Taking too much Xarelto increases the risk of bleeding.

If you forget to take Xarelto
If you have missed a dose, take it as soon as you remember. Take the next tablet on the following day and then carry on taking a tablet once a day as normal.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Xarelto
Don’t stop taking Xarelto without talking to your doctor first, because Xarelto prevents the development of a serious condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Xarelto can cause side effects, although not everybody gets them.

Like other similar medicines (antithrombotic agents), Xarelto may cause bleedings which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases these bleedings may not be obvious.
Tell your doctor, if you experience any of the following side effects:

The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
not known (frequency cannot be estimated from the available data).

Common side effects

Uncommon side effects

Rare side effects

Side effects where frequency is not known

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Xarelto after the expiry date which is stated on the carton 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.

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For doctors

What is it?

Xarelto is a medicine that contains the active substance rivaroxaban. It is available as red, round tablets (10 mg).

What is it used for?

Xarelto is used to prevent venous thromboembolism (VTE, the formation of clots in the veins) in adults who are undergoing surgery to replace a hip or knee.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Xarelto should start six to 10 hours after surgery, provided that the patient is no longer bleeding from the site of surgery. Xarelto is taken as one tablet once a day, with or without food. Treatment should continue for five weeks in patients who have had hip replacement surgery, and for two weeks in patients who have had knee replacement surgery.

How does it work?

Patients undergoing hip or knee replacement surgery are at a high risk of forming blood clots in the veins. These clots can be dangerous if they move to another part of the body such as the lungs. The active substance in Xarelto, rivaroxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins.

How has it been studied?

Xarelto was compared with enoxaparin (another medicine that prevents the blood from clotting) in three main studies, two in patients undergoing hip replacement surgery and one in patients undergoing knee replacement surgery.

In hip replacement surgery, the first study compared five weeks of Xarelto with five weeks of enoxaparin in around 4,500 patients, and the second study compared five weeks of Xarelto with two weeks of enoxaparin in around 2,500 patients. The third study compared two weeks of Xarelto with two weeks of enoxaparin in around 2,500 patients undergoing knee replacement surgery. In all of the studies, the effectiveness was measured by looking at the number of patients who either had blood clots in the veins or in the lungs, or who died of any cause during the treatment period.

What benefits has it shown during the studies?

In all of the main studies, Xarelto was more effective than enoxaparin in preventing the formation of blood clots or death.

In the first study in hip replacement surgery, 1% of the patients who completed treatment with Xarelto either had blood clots or died (18 out of 1,595), compared with 4% of the patients receiving enoxaparin (58 out of 1,558). In the second study, 2% of the patients taking Xarelto had blood clots or died (17 out of 864), compared with 9% of the patients receiving enoxaparin (81 out of 869).

After knee replacement surgery, 10% of the patients receiving Xarelto had blood clots or died (79 out of 824), compared with 19% of the patients receiving enoxaparin (166 out of 878).

What is the risk associated?

The most common side effects with Xarelto (seen in between 1 and 10 patients in 100) are bleeding and anaemia (low red blood cell counts) following an operation, nausea (feeling sick), fever, peripheral oedema (swelling, especially of the ankles and feet) and increased levels of some liver enzymes in the blood. For the full list of all side effects reported with Xarelto, see the package leaflet.

Xarelto should not be used in people who may be hypersensitive (allergic) to rivaroxaban or any of the other ingredients. It must not be used in patients who are bleeding or in patients who have a liver disease that is associated with an increased risk of bleeding. Xarelto must not be used in women who are pregnant or breast-feeding.

Why has it been approved?

The CHMP decided that Xarelto’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Xarelto on 30 September 2008. The marketing authorisation holder is Bayer Schering Pharma AG. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Xarelto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2011.

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