Xarelto 10 mg film-coated tablets

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.

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 excessively
• if you have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or breast feedingDo not take Xareltoand tell your doctor if any of these apply to you.

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: - bleeding disorders - very high blood pressure, not controlled by medical treatment - active ulcer or a recent ulcer of your stomach or bowel - a problem with the blood vessels in the back of your eyes (retinopathy) - recent bleeding in your brain (intracranial or intracerebral bleeding) - problems with the blood vessels in your brain or spinal column - a recent operation on your brain, spinal column or eyeTell your doctor before you take Xarelto, if any of these apply to you. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
• Xarelto is not recommended after an operation of a hip fracture.
• in 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.
• if your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): - it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor - tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

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.

• If you are taking: - some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), unless they are only applied to the skin - some anti-viral medicines for HIV / AIDS (e.g. ritonavir) - other medicines to reduce blood clotting (e.g. enoxaparin or clopidogrel) - anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) Tell your doctor before taking Xarelto, because its effect may be increased. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation. If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.
• If you are taking: - some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) , - St Johns 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, if you should be treated with Xarelto and if you should be kept under closer observation.

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

Pregnancy and breast feedingIf 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 XareltoXarelto contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xarelto.

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 takeThe 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 XareltoTake 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 shouldContact 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.

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:

• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris. Your doctor may decide to keep you under closer observation or change how you should be treated.

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

• bleeding following your operation
• feeling sick, fever, swelling in your limbs
• blood tests may show an increase in some liver enzymes

Uncommon side effects

• bleeding in your stomach or bowel, urogenital bleeding, nose bleed
• bleeding into tissue or a cavity of your body (haematoma, bruising)
• oozing of blood or fluid from surgical wound
• raised heartbeat
• low blood pressure
• decreased general strength and energy (weakness, tiredness), headache, dizziness
• reduction in red blood cells which can make your skin pale and cause weakness or breathlessness
• stomach ache, indigestion, constipation, diarrhoea, being sick
• dry mouth
• localised swelling
• pain in your limbs
• rash, itchy skin
• impaired function of your kidneys
• blood tests may show an increase in bilirubin, some pancreatic enzymes or in the number of platelets

Rare side effects

• impaired function of your liver
• allergic skin reactions, hives
• fainting, feeling unwell

Side effects where frequency is not known

• bleeding into a critical organ (e.g. your brain)
• adrenal bleeding
• bleeding from the whites of your eyes
• collection of blood (haematoma) following complication in a cardiac procedure where a catheter is inserted to treat narrowed coronary arteries (pseudoaneurysm)
• coughing up blood
• increased pressure within muscles of your legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)
• kidney failure after a severe bleeding
• yellowing of the skin and eye (jaundice)
• hypersensitivity

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.

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.

What Xarelto contains

• 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 laurilsulfate, magnesium stearate. Film coat: macrogol 3350, hypromellose, titanium dioxide (E171), iron oxide red (E172).

What Xarelto looks like and contents of the pack
The film-coated tablets are light red, round and marked with the BAYER-cross on one side and "10" and a triangle on the other side. They come in blisters in cartons of 5, 10 or 30 tablets or unit dose blisters in cartons of 10 x 1 or 100 x 1 tablets.
Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Bayer Schering Pharma AG
13342 Berlin
Germany

Manufacturer

Bayer Schering Pharma AG
51368 Leverkusen
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Luxembourg Luxemburg Bayer SA-NV TélTel 32-02-535 63 11 Magyarország Bayer Hungária KFT Tel 36-1-487 4100 Malta Alfred Gera and Sons Ltd. Tel 356-21 44 62 05 Nederland Bayer B.V., Bayer Schering Pharma Tel 310297-28 06 66 Norge Bayer AS Tlf 47-24 11 18 00 Österreich Bayer Austria Ges. m. b. H. Tel 43-01-711 460 Polska Bayer Sp. z o.o. Tel 48-22-572 35 00 Portugal Bayer Portugal S.A Tel 351-21-416 42 00 România SC Bayer SRL Tel 40-021-528 59 00 Slovenija Bayer d. o. o. Tel 386-01-58 14 400 Slovenská republika Bayer, spol. s r.o. Tel 421-02-59 21 31 11 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel 358-020-78521 Sverige Bayer AB Tel 46-08-580 223 00 United Kingdom Bayer plc Tel 44-01635-563000 België Belgique Belgien Bayer SA-NV TélTel 32-02-535 63 11 359-02-81 401 01 eská republika Bayer s.r.o. Tel 420-266 101 111 Danmark Bayer AS Tlf 45-45 235 000 Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Eesti Bayer OÜ Tel 372-655 85 65 Bayer 30-210-618 75 00 España Bayer Hispania S.L. Tel 34-93-495 65 00 France Bayer Santé Tél 33-03-28 16 34 00 Ireland Bayer Limited Tel 353-01-2999 313 Ísland Icepharma hf. Sími 354-540 80 00 Italia Bayer S.p.A. Tel 39-02-3978 1 NOVAGEM Limited 357-22-747 747 Latvija SIA Bayer Tel 371-67 84 55 63 Lietuva UAB Bayer Tel 370-5-233 68 68

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