1. What Extaq® is and what it is used for:

Pharmacotherapeutic group:

Extaq® contains the active substance

rivaroxaban and 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.

Therapeutic indications:

Extaq® is used in adults to prevent blood clots

in the 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.

2. Before you take Extaq®

Do not take Extaq®:

• If you are allergic to rivaroxaban or any of the

other ingredients of this medicine.

• If you are bleeding excessively.

• If you have a disease or condition in an organ

of the body that increases the risk of serious

bleeding (e.g. stomach ulcer, injury or bleeding

in the brain, recent surgery of the brain or eyes).

• If you are taking medicines to prevent blood

clotting (e.g. warfarin, dabigatran, apixaban or

heparin), except when changing anticoagulant

treatment or while getting heparin through a

venous or arterial line to keep it open.

• If you have a liver disease which leads to an

increased risk of bleeding.

• If you are pregnant or breast feeding.

Do not take Extaq® and tell your

doctor if any of these apply to you.

Take special care with Extaq®:

Talk to your doctor or pharmacist before taking

Extaq®

- If you know that you have a disease called

antiphospholipid syndrome (a disorder of the

immune system that causes an increased risk of

blood clots) tell your doctor who will decide if

the treatment may need to be changed.

- If you have an increased risk of bleeding, as

could be the case in situations such as:

• Moderate or severe kidney disease, since your

kidney function may affect the amount of

medicine that works in your body.

• If you are taking other medicines to prevent

blood clotting (e.g. warfarin, dabigatran,

apixaban or heparin), when changing anticoagulant

treatment or while getting heparin through

a venous arterial line to keep it open.

• Bleeding disorders.

• very high blood pressure, not controlled by

medical treatment

• Diseases of your stomach or bowel that might

result in bleeding, e.g. inflammation of the

bowels or stomach, or inflammation of the

oesophagus (gullet) e.g. due to gastroesophageal

reflux disease (disease where stomach acid

goes upwards into the oesophagus)

• A problem with the blood vessels in the back

of your eyes (retinopathy)

• A lung disease where your bronchi are

widened and filled with pus (bronchiectasis) or

previous bleeding from your lung.

If any of the above applies to you, tell your

doctor before you take Extaq®. Your doctor

will decide, if you should be treated with this

medicine and if you should be kept under closer

observation.

- 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 Extaq® 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.

Children and adolescents:

Extaq® is not recommended for people under

18 years of age. There is not enough

information on its use in children and

adolescents.

Taking other medicines:

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines. This includes medicines that you can

buy without a prescription, including herbal

medicines. The effects of these medicines could

be changed by Extaq® or they could change

the effects of Extaq®.

If you are taking:

• Some medicines for fungal infections (e.g.

ketoconazole, itraconazole, voriconazole,

posaconazole), 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, clopidogrel or vitamin K

antagonists such as warfarin and acenocoumarol).

• anti-inflammatory and pain relieving

medicines (e.g. naproxen

or acetylsalicylic acid).

• Dronedarone, a medicine to treat abnormal

heart beat.

If any of the above applies to you, tell your

doctor before taking Extaq®, because the

effect of Extaq® may be increased.

Your doctor will decide, if you should be treated

with this medicine 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 John’s Wort (Hypericum perforatum), a

herbal product used for depression.

• Rifampicin, an antibiotic.

If any of the above applies to you, tell your

doctor before taking Extaq®, because the

effect of Extaq® may be reduced. Your doctor

will decide, if you should be treated with

Extaq® and if you should be kept under closer

observation.

Pregnancy and breast-feeding:

Do not take Extaq® 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 Extaq®. 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:

Extaq® may cause dizziness (common side

effect) or fainting (uncommon side effect). You

should not drive or use machines if you are

affected by these symptoms.

Important information about some

of the ingredients of Extaq®:

Extaq® contains lactose; If you have been told

by your doctor that you have intolerance to

some sugars, contact your doctor before taking

this medicine.

3. How to take Extaq®:

Always take Extaq® 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 recommended dose is one tablet (10 mg)

once a day.

Swallow the tablet preferably with water.

Extaq® can be taken with or without food.

If you have difficulty swallowing the tablet

whole, talk to your doctor about other ways to

take Extaq®.

The tablet may be crushed and mixed with

water or apple puree immediately before you

take it.

If necessary, your doctor may also give you the

crushed Extaq® tablet through a stomach

tube.

When to take Extaq®:

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 Extaq® than you

should:

Contact your doctor immediately if you have

taken too many Extaq® tablets. Taking too

much Extaq® increases the risk of bleeding.

If you forget to take Extaq® :

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 Extaq®:

Do not stop taking Extaq® without talking to

your doctor first, because Extaq® prevents the

development of a serious condition.

If you have any further questions on the use of

this medicine, ask your doctor or pharmacist.

v

4. Possible side effects:

Like all medicines, Extaq® can cause side

effects, although not everybody gets them.

Like other similar medicines (antithrombotic

agents),Extaq® 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:

- Long or excessive bleeding.

- Exceptional weakness, tiredness, paleness,

dizziness, headache, unexplained swelling,

breathlessness, chest pain or angina pectoris,

which may be signs of bleeding.

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:

- spreading intense skin rash, blisters or

mucosal lesions, e.g. in the mouth or eyes

(Stevens-Johnson syndrome/toxic epidermal

necrolysis). The frequency of this side effect is

very rare (up to 1 in 10,000).

- a drug reaction that causes rash, fever,

inflammation of internal organs, hematologic

abnormalities and systemic illness (DRESS

syndrome). The frequency of this side effect is

very rare (up to 1 in 10,000).

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:

- swelling of the face, lips, mouth, tongue or

throat; difficulty swallowing; hives and

breathing difficulties; sudden drop in blood

pressure. The frequencies of these side effects

are very rare (anaphylactic reactions, including

anaphylactic shock; may affect up to 1 in

10,000 people) and uncommon (angioedema

and allergic oedema; may affect up to 1 in 100

people).

Overall list of possible side effects:

Common (may affect up to 1 in 10

people):

- reduction in red blood cells which can make

the skin pale and cause weakness or breathlessness.

- bleeding in the stomach or bowel, urogenital

bleeding (including blood in the urine and heavy

menstrual bleeding), nose bleed, bleeding in the

gum.

- bleeding into the eye (including bleeding from

the whites of the eyes).

- bleeding into tissue or a cavity of the body

(haematoma, bruising).

- coughing up blood.

- bleeding from the skin or under the skin.

- impaired function of the kidneys (may be seen

in tests performed by your doctor).

- fever.

- stomach ache, indigestion, feeling or being

sick, constipation, diarrhoea.

- low blood pressure (symptoms may be feeling

dizzy or fainting when standing up).

- decreased general strength and energy

(weakness, tiredness), headache, dizziness.

- rash, itchy skin.

- blood tests may show an increase in some liver

enzymes.

Uncommon (may affect up to 1 in

100 people):

- bleeding into the brain or inside the skull.

- bleeding into a joint causing pain and

swelling.

- thrombocytopenia (low number of platelets,

which are cells that help blood to clot).

- allergic reactions, including allergic skin

reactions.

- impaired function of the liver (may be seen in

tests performed by your doctor).

- blood tests may show an increase in bilirubin,

some pancreatic or liver enzymes or in the

number of platelets.

- fainting.

- feeling unwell.

- faster heartbeat.

- dry mouth.

- hives.

Rare (may affect up to 1 in 1,000

people):

- bleeding into a muscle.

- cholestasis (decreased bile flow), hepatitis incl.

hepatocellular injury (inflamed liver incl. liver

injury).

- yellowing of the skin and eye (jaundice).

- localised swelling.

- collection of blood (haematoma) in the groin

as a complication of the cardiac procedure

where a catheter is inserted in your leg artery

(pseudoaneurysm).

Not known (frequency cannot be

estimated from the available data):

- kidney failure after a severe bleeding.

- increased pressure within muscles of the legs

or arms after a bleeding, which leads to pain,

swelling, altered sensation, numbness or

paralysis (compartment syndrome after a

bleeding).

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. By reporting side

effects, you can help provide more information

on the safety of this medicine.

To report any side effect(s):

Saudi Arabia:

National Pharmacovigilance and

Drug Safety Center (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222,

Exts: 317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

Email: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Other GCC States:

Please contact the relevant competent

authority.

5. How to store Extaq®:

- Keep out of the reach and sight of children.

- Store below 30°C.

- Do not use Extaq® after the expiry date

which is stated on the carton after Exp. The

expiry date refers to the last day of that month.

- 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.