Active ingredient
- rivaroxaban
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/08/472/040.
Xarelto 15mg & 20mg Film-Coated Tablets Treatment Initiation Pack
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.
Package leaflet: Information for the user
Xarelto 15 mg film-coated tablets
Xarelto 20 mg film-coated tablets
Treatment Initiation Pack
rivaroxaban
▼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.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1. What Xarelto is and what it is used for
Xarelto contains the active substance rivaroxaban and is used in adults to:
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.
2. What you need to know before you take Xarelto
Do not take Xarelto
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 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.
If you need to have an operation
Children and adolescents
Xarelto is not recommended for people under 18 years of age. There is not enough 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 might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
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.
Driving and using machines
Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ”Possible side effects”). You should not drive or use machines if you are affected by these symptoms.
Xarelto contains lactose and sodium
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”.
3. How to take Xarelto
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.
How much to take
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.
When to take Xarelto
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.
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 stop taking Xarelto
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.
4. 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 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.
Possible side effects which may be a sign of bleeding
Tell your doctor immediately if you experience any of the following side effects:
Your doctor may decide to keep you under closer observation or change how you should be treated.
Possible side effects which may be a sign of severe skin reaction
Tell your doctor immediately if you experience skin reactions such as:
Possible side effects which may be a sign of severe allergic reactions
Tell your doctor immediately if you experience any of the following side effects:
Overall list of possible side effects
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
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:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
Malta
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Xarelto
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.
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.
6. Contents of the pack and other information
What Xarelto contains
What Xarelto looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister or bottle:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 07/2019
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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