Patient leaflet - RIVAROXABAN ACCORD 10 MG FILM-COATED TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rivaroxaban Accord is and what it is used for
2. What you need to know before you take Rivaroxaban Accord
3. How to take Rivaroxaban Accord
4. Possible side effects
5. How to store Rivaroxaban Accord
6. Contents of the pack and other information

1. what rivaroxaban accord is and what it is used for

You have been given Rivaroxaban Accord because

– you have been diagnosed with an acute coronary syndrome (a group of conditions that

includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests.

Rivaroxaban Accord reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels.

Rivaroxaban Accord will not be given to you on its own. Your doctor will also tell you to take either:

acetylsalicylic acid or
acetylsalicylic acid plus ticlopidine.

– you have been diagnosed with a high risk of getting a blood clot due to a coronary artery

disease or peripheral artery disease which causes symptoms. Rivaroxaban Accord reduces the risk in adults of getting blot clots (atherothrombotic events). Rivaroxaban Accord will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid.

Rivaroxaban Accord 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.

2. what you need to know before you take rivaroxaban accord- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

– 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 an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke)
– if you have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain’s deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, non-lacunar stroke) in the previous month
– if you have a liver disease which leads to an increased risk of bleeding
– if you are pregnant or breast feeding

Do not take Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Rivaroxaban Accord should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and ticlopidine.

Take special care with Rivaroxaban Accord

if you have an increased risk of bleeding, as could be the case in situations such as:
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 or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
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) or tumours located in the stomach or bowels or genital tract or urinary tract

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

you are older than 75 years
you weigh 60 kg or less
you have a coronary artery disease with severe symptomatic heart failure
if you have a prosthetic heart valve
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 any of the above apply to you, tell your doctor before you take Rivaroxaban Accord. 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:

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
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 Rivaroxaban Accord 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.

Children and adolescents

Rivaroxaban Accord 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 Rivaroxaban Accord

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

– If you are taking:

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
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 prasugrel and ticagrelor (see section “Warnings and Precautions”))
anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine to treat abnormal heart beat
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)).

If any of the above apply to you, tell your doctor before taking Rivaroxaban Accord, because the effect of Rivaroxaban Accord 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 apply to you, tell your doctor before taking Rivaroxaban Accord, because the effect of Rivaroxaban Accord may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban Accord and if you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take Rivaroxaban Accord 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 Rivaroxaban Accord. 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

Rivaroxaban Accord may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ‘Possible side effects’). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

Rivaroxaban Accord 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 rivaroxaban accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban Accord around the same time every day (for example, one tablet in the morning and one in the evening). This medicine can be taken with or without food.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Rivaroxaban Accord. 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 Rivaroxaban Accord tablet through a stomach tube.

In case of enteral feeding, your doctor may crush and suspend rivaroxaban tablets in 50 mL of water and administer via a nasogastric tube or gastric feeding tube. After the administration of a crushed rivaroxaban 15 mg or 20 tablet, enteral feeding is immediately followed.

Crushed rivaroxaban tablets are stable in water and in applesauce for up to 4 hours.

Rivaroxaban Accord will not be given to you on its own.

Your doctor will also tell you to take acetylsalicylic acid. If you get Rivaroxaban Accord after an acute coronary syndrome, your doctor may tell you to also take ticlopidine.

Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus standard daily dose of ticlopidine).

When to start Rivaroxaban Accord

Treatment with Rivaroxaban Accord after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.

Your doctor will tell you when to start treatment with Rivaroxaban Accord if you have been diagnosed with coronary artery disease or peripheral artery disease.

Your doctor will decide how long you must continue treatment.

If you take more Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

Do not take a double dose to make up for a missed dose. If you miss a dose, take your next dose at the usual time.

If you stop taking Rivaroxaban Accord

Take Rivaroxaban Accord on a regular basis and for as long as your doctor keeps prescribing it.

Do not stop taking Rivaroxaban Accord without talking to your doctor first. If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.

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

4. possible side effects

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
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
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 (see above, signs of bleeding)
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. You can also report side effects directly via

Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rivaroxaban accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on both the carton and on each blister or bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up tp 4 hours.

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 the active substance is rivaroxaban. each tablet contains 2.5 mg of rivaroxaban.

The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate (E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide yellow (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord 2.5 mg film-coated tablets are light yellow coloured, round, biconvex, approximately 6.00 mm in diameter, film coated tablets debossed with “IL4” on one side and plain on other side.

Rivaroxaban Accord film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 28, 56, 98, 100, 168 or 196 tablets, or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Rivaroxaban Accord film-coated tablets are also available in HDPE bottles containing 30, 90 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rivaroxaban Accord is and what it is used for
2. What you need to know before you take Rivaroxaban Accord
3. How to take Rivaroxaban Accord
4. Possible side effects
5. How to store Rivaroxaban Accord
6. Contents of the pack and other information

1. what rivaroxaban accord is and what it is used for

Rivaroxaban Accord contains the active substance rivaroxaban and 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.
treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Rivaroxaban Accord 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 rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

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 Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Take special care with Rivaroxaban Accord

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 or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
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) or tumours located in the stomach or bowels or genital tract or urinary tract
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 you have a prosthetic heart valve
if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.
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 need to have an operation

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

o it is very important to take Rivaroxaban Accord exactly at the times you have been told by your doctor

o 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

Rivaroxaban Accord 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 Rivaroxaban Accord

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

If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are only applied to the skin

ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
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
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin

norepinephrine reuptake inhibitors (SNRIs)).

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

Pregnancy and breast-feeding

Driving and using machines

Rivaroxaban Accord 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 rivaroxaban accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

To prevent blood clots in the veins after a hip or knee replacement operation

The recommended dose is one tablet Rivaroxaban Accord 10 mg once a day.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring

After at least 6 months blood clot treatment, the recommended dose is either one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed you Rivaroxaban Accord 10 mg once a day.

Swallow the tablet preferably with water.

Take Rivaroxaban Accord can be taken with or without food.

If necessary, your doctor may also give you the crushed Rivaroxaban Accord tablet through a stomach tube.

Crushed rivaroxaban tablets are stable in water and in apple sauce for up to 4 hours.

When to take Rivaroxaban Accord

Take the 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.

Your doctor will decide how long you must continue treatment.

To prevent blood clots in the veins after a hip or knee replacement operation:

Take the first tablet 6–10 hours after your operation.

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 Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

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 dose.

If you stop taking Rivaroxaban Accord

Do not stop taking Rivaroxaban Accord without talking to your doctor first, because Rivaroxaban Accord prevents the development of a serious condition.

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

4. possible side effects

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
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
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 (see above, signs of bleeding)
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. You can also report side effects directly via

Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rivaroxaban accord

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 blister or bottle after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

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 the active substance is rivaroxaban. each tablet contains 10 mg of rivaroxaban.

The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate(E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide red (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord 10 mg film-coated tablets are light pink to pink coloured, round, biconvex, approximately 6.00 mm in diameter, film coated tablets debossed with “IL1” on one side and plain on other side.

Rivaroxaban Accord film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 5, 10, 14, 28, 30, 98 or 100 tablets, or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Rivaroxaban Accord film-coated tablets are also available in HDPE bottles containing 30, 90 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rivaroxaban Accord is and what it is used for
2. What you need to know before you take Rivaroxaban Accord
3. How to take Rivaroxaban Accord
4. Possible side effects
5. How to store Rivaroxaban Accord
6. Contents of the pack and other information

1. what rivaroxaban accord is and what it is used for

Rivaroxaban Accord contains the active substance rivaroxaban and is used in adults to:

prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Rivaroxaban Accord is used in children and adolescents below 18 years and with a body weight of 30 kg or more to:

– treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Accord 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 rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

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 Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Take special care with Rivaroxaban Accord

if you have an increased risk of bleeding, as could be the case in situations such as:
severe kidney disease for adults, and moderate or severe kidney disease for children and adolescents, 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 or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
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) or tumours located in the stomach or bowels or genital tract or urinary tract
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 you have a prosthetic heart valve
if your doctor determines that your blood pressure is unstable or another treatment or surgical

procedure to remove the blood clot from your lungs is planned.

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 need to have an operation

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
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 Rivaroxaban Accord 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.

Children and adolescents

Rivaroxaban Accord is not recommended for children with a body weight below 30 kg. There is not enough information on the use of Rivaroxaban Accord in children and adolescents in the adult indications.

Other medicines and Rivaroxaban Accord

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

If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are only applied to the skin

ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
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
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin

norepinephrine reuptake inhibitors (SNRIs)).

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

Pregnancy and breast-feeding

Driving and using machines

Rivaroxaban Accord 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 rivaroxaban accord

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 Rivaroxaban Accord together with a meal.

Swallow the tablet(s) preferably with water.

If necessary, your doctor may also give you the crushed Rivaroxaban Accord tablet through a stomach tube.

Crushed rivaroxaban tablets are stable in water and in apple sauce for up to 4 hours.

How much to take

AdultsTo prevent blood clots in brain (stroke) and other blood vessels in your body The recommended dose is one tablet Rivaroxaban Accord 20 mg once a day.

If you have kidney problems, the dose may be reduced to one tablet Rivaroxaban Accord 15 mg once a day.

If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Rivaroxaban Accord 15 mg once a day (or to one tablet Rivaroxaban Accord 10 mg once a day in case your kidneys are not working properly) in addition to an antiplatelet medicinal product such as clopidogrel.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring.

The recommended dose is one tablet Rivaroxaban Accord 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Rivaroxaban Accord 20 mg once a day.

After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.

If you have kidney problems and take one tablet Rivaroxaban Accord 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Rivaroxaban Accord 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.

If you spit up the dose or vomit

less than 30 minutes after you have taken Rivaroxaban Accord, take a new dose.
more than 30 minutes after you have taken Rivaroxaban Accord, do not take a new dose. In this

case, take the next Rivaroxaban Accord dose at the usual time.

Contact the doctor if you repeatedly spit up the dose or vomit after taking Rivaroxaban Accord.

When to take Rivaroxaban Accord

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.

To prevent blood clots in the brain (stroke) and other blood vessels in your body:

If your heart beat needs to be restored to normal by a procedure called cardioversion, take Rivaroxaban Accord at the times your doctor tells you.

If you take more Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

- Adults, children and adolescents:

If you are taking one 20 mg tablet or one 15 mg tablet once a day and have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking one tablet once a day.

- Adults:

If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day. On the following day you should carry on taking one 15 mg tablet twice a day.

If you stop taking Rivaroxaban Accord

Do not stop taking Rivaroxaban Accord without talking to your doctor first, because Rivaroxaban Accord 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, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce the formation of blood clots, Rivaroxaban Accord 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.

Tell your doctor immediately if you or your child experience any of the following side effects:

Sign of bleeding
– bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness.

A serious medical emergency. Seek medical attention immediately!)

– 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 the treatment.

Signs of severe skin reactions

– spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
– a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effect is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions

– swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

The frequencies of severe allergic reactions 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 found in adults, children and adolescents

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
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
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 (see above, signs of bleeding)
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)

Side effects in children and adolescents

In general, the side effects observed in children and adolescents treated with Rivaroxaban Accord were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people)

■ ■ ■ ■

headache fever

nose bleeding vomiting

Common (may affect up to 1 in 10 people)

■ ■ ■ ■

raised heartbeat

blood tests may show an increase in bilirubin (bile pigment)

thrombocytopenia (low number of platelets which are cells that help blood to clot) heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

■ blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

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 Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rivaroxaban accord

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 blister or bottle after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

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 the active substance is rivaroxaban. each tablet contains 15 mg or 20 mg of rivaroxaban.

The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate (E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide red (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord 15 mg: Red coloured, round, biconvex, approximately 5.00 mm in diameter, film coated tablets debossed with ‘‘IL’’ on one side and ‘‘2’’ on other side.

Rivaroxaban Accord 15 mg film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 10, 14, 28, 30, 42, 48, 56, 90, 98 or 100 tablets, or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Rivaroxaban Accord 15 mg film-coated tablets are also available in HDPE bottles containing 30, 90 or 500 tablets.

Rivaroxaban Accord 20 mg: Dark red coloured, round, biconvex, approximately 6.00 mm in diameter, film coated tablets debossed with ‘‘IL3’’ on one side and plain on other side.

Rivaroxaban Accord 20 mg film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 10, 14, 28, 30, 42, 56, 90, 98 or 100 tablets or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50,

95–200 Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola PLA 3000, Malta

Laboratori Fundacio DAU

C/ C, 12–14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain

Accord Healthcare B.V

Winthontlaan 200, 3526KV Utrecht,

Netherland

This leaflet was last revised in 02/2022.

Package leaflet: Information for the user

Rivaroxaban Accord 10 mg film-coated tablets rivaroxaban

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rivaroxaban Accord is and what it is used for
2. What you need to know before you take Rivaroxaban Accord
3. How to take Rivaroxaban Accord
4. Possible side effects
5. How to store Rivaroxaban Accord
6. Contents of the pack and other information

1. what rivaroxaban accord is and what it is used for

Rivaroxaban Accord contains the active substance rivaroxaban and 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.
treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Rivaroxaban Accord 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 rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

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 Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Take special care with Rivaroxaban Accord

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 or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
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) or tumours located in the stomach or bowels or genital tract or urinary tract
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 you have a prosthetic heart valve
if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.
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 need to have an operation

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

o it is very important to take Rivaroxaban Accord exactly at the times you have been told by your doctor

o 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

Rivaroxaban Accord 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 Rivaroxaban Accord

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

If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are only applied to the skin

ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
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
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin

norepinephrine reuptake inhibitors (SNRIs)).

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

Pregnancy and breast-feeding

Driving and using machines

Rivaroxaban Accord 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 rivaroxaban accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

To prevent blood clots in the veins after a hip or knee replacement operation

The recommended dose is one tablet Rivaroxaban Accord 10 mg once a day.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring

Swallow the tablet preferably with water.

Take Rivaroxaban Accord can be taken with or without food.

If necessary, your doctor may also give you the crushed Rivaroxaban Accord tablet through a stomach tube.

Crushed rivaroxaban tablets are stable in water and in apple sauce for up to 4 hours.

When to take Rivaroxaban Accord

Take the 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.

Your doctor will decide how long you must continue treatment.

To prevent blood clots in the veins after a hip or knee replacement operation:

Take the first tablet 6–10 hours after your operation.

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 Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

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 dose.

If you stop taking Rivaroxaban Accord

Do not stop taking Rivaroxaban Accord without talking to your doctor first, because Rivaroxaban Accord prevents the development of a serious condition.

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

4. possible side effects

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

Tell your doctor immediately if you experience any of the following side effects:

Sign of bleeding
– bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek medical attention immediately!)
– 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 the treatment.

– spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
– a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effects is very rare (up to 1 in 10,000).

– swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and ncommon (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
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
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 (see above, signs of bleeding)
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. You can also report side effects directly via

Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rivaroxaban accord

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 blister or bottle after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

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 the active substance is rivaroxaban. each tablet contains 10 mg of rivaroxaban.

The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate(E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide red (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 5, 10, 14, 28, 30, 98 or 100 tablets, or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Rivaroxaban Accord film-coated tablets are also available in HDPE bottles containing 30, 90 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50,

95–200 Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Laboratori Fundacio DAU

C/ C, 12–14 Pol. Ind. Zona Franca,

08040 Barcelona, Spain

Accord Healthcare B.V

Winthontlaan 200, 3526KV Utrecht,

Netherland

This leaflet was last revised in 02/2022.

Package leaflet: Information for the user

Rivaroxaban Accord 15 mg film-coated tablets Rivaroxaban Accord 20 mg film-coated tablets rivaroxaban

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Rivaroxaban Accord is and what it is used for
2. What you need to know before you take Rivaroxaban Accord
3. How to take Rivaroxaban Accord
4. Possible side effects
5. How to store Rivaroxaban Accord
6. Contents of the pack and other information

1. what rivaroxaban accord is and what it is used for

Rivaroxaban Accord contains the active substance rivaroxaban and is used in adults to:

prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.

Rivaroxaban Accord is used in children and adolescents below 18 years and with a body weight of 30 kg or more to:

– treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Accord 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 rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

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 Rivaroxaban Accord and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Take special care with Rivaroxaban Accord

if you have an increased risk of bleeding, as could be the case in situations such as:
severe kidney disease for adults, and moderate or severe kidney disease for children and adolescents, 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 or arterial line to keep it open (see section ‘Other medicines and Rivaroxaban Accord’)
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) or tumours located in the stomach or bowels or genital tract or urinary tract
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 you have a prosthetic heart valve
if your doctor determines that your blood pressure is unstable or another treatment or surgical

procedure to remove the blood clot from your lungs is planned.

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 need to have an operation

it is very important to take Rivaroxaban Accord before and after the operation exactly at the times you have been told by your doctor.
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 Rivaroxaban Accord 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.

Children and adolescents

Other medicines and Rivaroxaban Accord

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

If you are taking

some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole,

posaconazole), unless they are only applied to the skin

ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol)
some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
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
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin

norepinephrine reuptake inhibitors (SNRIs)).

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

Pregnancy and breast-feeding

Driving and using machines

Rivaroxaban Accord 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 rivaroxaban accord

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 Rivaroxaban Accord together with a meal.

Swallow the tablet(s) preferably with water.

If necessary, your doctor may also give you the crushed Rivaroxaban Accord tablet through a stomach tube.

Crushed rivaroxaban tablets are stable in water and in apple sauce for up to 4 hours.

How much to take

AdultsTo prevent blood clots in brain (stroke) and other blood vessels in your body The recommended dose is one tablet Rivaroxaban Accord 20 mg once a day.

If you have kidney problems, the dose may be reduced to one tablet Rivaroxaban Accord 15 mg once a day.

To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring.

The recommended dose is one tablet Rivaroxaban Accord 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Rivaroxaban Accord 20 mg once a day.

After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.

The dose of Rivaroxaban Accord depends on the body weight, and will be calculated by the doctor.

■ The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one Rivaroxaban Accord 15 mg tablet once a day.
■ The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Accord 20 mg tablet once a day.

Take each Rivaroxaban Accord dose with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: please observe the child to ensure the full dose is taken.

As the Rivaroxaban Accord dose is based on body weight it is important to keep scheduled doctor’s visits because the dose may need to be adjusted as the weight changes.

Never adjust the dose of Rivaroxaban Accord by yourself. The doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to provide a fraction of a tablet dose. If a lower dose is required please use the alternative presentation of rivaroxaban granules for oral suspension available on the market.

For children and adolescents who are unable to swallow tablets whole, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you may crush the Rivaroxaban Accord tablet and mix with water or apple puree immediately before taking. Take some food after taking this mixture. If necessary, your doctor may also give the crushed Rivaroxaban Accord tablet through a stomach tube.

If you spit up the dose or vomit

less than 30 minutes after you have taken Rivaroxaban Accord, take a new dose.
more than 30 minutes after you have taken Rivaroxaban Accord, do not take a new dose. In this

case, take the next Rivaroxaban Accord dose at the usual time.

Contact the doctor if you repeatedly spit up the dose or vomit after taking Rivaroxaban Accord.

When to take Rivaroxaban Accord

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.

To prevent blood clots in the brain (stroke) and other blood vessels in your body:

If your heart beat needs to be restored to normal by a procedure called cardioversion, take Rivaroxaban Accord at the times your doctor tells you.

If you take more Rivaroxaban Accord than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Accord tablets. Taking too much Rivaroxaban Accord increases the risk of bleeding.

If you forget to take Rivaroxaban Accord

- Adults, children and adolescents:

- Adults:

If you stop taking Rivaroxaban Accord

Do not stop taking Rivaroxaban Accord without talking to your doctor first, because Rivaroxaban Accord 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, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you or your child experience any of the following side effects:

Sign of bleeding
– bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness.

A serious medical emergency. Seek medical attention immediately!)

– 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 the treatment.

Signs of severe skin reactions

– spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
– a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effect is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions

– swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

Overall list of possible side effects found in adults, children and adolescents

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
bleeding following an operation
oozing of blood or fluid from surgical wound
swelling in the limbs
pain in the limbs
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 (see above, signs of bleeding)
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)

Side effects in children and adolescents

In general, the side effects observed in children and adolescents treated with Rivaroxaban Accord were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people)

■ ■ ■ ■

headache fever

nose bleeding vomiting

Common (may affect up to 1 in 10 people)

■ ■ ■ ■

raised heartbeat

blood tests may show an increase in bilirubin (bile pigment)

thrombocytopenia (low number of platelets which are cells that help blood to clot) heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

■ blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects

5. how to store rivaroxaban accord

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 blister or bottle after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

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 the active substance is rivaroxaban. each tablet contains 15 mg or 20 mg of rivaroxaban.

The other ingredients are:

Tablet core

Lactose monohydrate

Croscarmellose sodium (E468)

Sodium laurilsulfate (E487)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Cellulose, microcrystalline (E460)

Silica, colloidal anhydrous (E551)

Magnesium stearate (E572)

Film-coating

Macrogol 4000 (E1521)

Hypromellose 2910 (nominal viscosity 5.1 mPa.S) (E464)

Titanium dioxide (E171)

Iron oxide red (E172)

What Rivaroxaban Accord looks like and contents of the pack

Rivaroxaban Accord 15 mg: Red coloured, round, biconvex, approximately 5.00 mm in diameter, film coated tablets debossed with ‘‘IL’’ on one side and ‘‘2’’ on other side.

Rivaroxaban Accord 15 mg film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 10, 14, 28, 30, 42, 48, 56, 90, 98 or 100 tablets, or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

Rivaroxaban Accord 15 mg film-coated tablets are also available in HDPE bottles containing 30, 90 or 500 tablets.

Rivaroxaban Accord 20 mg: Dark red coloured, round, biconvex, approximately 6.00 mm in diameter, film coated tablets debossed with ‘‘IL3’’ on one side and plain on other side.

Rivaroxaban Accord 20 mg film-coated tablets are packed in clear PVC/Aluminium blisters available in:

– blister of 10, 14, 28, 30, 42, 56, 90, 98 or 100 tablets or
– perforated unit dose blisters of 10 × 1 or 100 × 1 tablets.

RIVAROXABAN ACCORD 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - RIVAROXABAN ACCORD 10 MG FILM-COATED TABLETS

1. what rivaroxaban accord is and what it is used for

2. what you need to know before you take rivaroxaban accord- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

3. how to take rivaroxaban accord

4. possible side effects

5. how to store rivaroxaban accord

6. contents of the pack and other information the active substance is rivaroxaban. each tablet contains 2.5 mg of rivaroxaban.

1. what rivaroxaban accord is and what it is used for

2. what you need to know before you take rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

3. how to take rivaroxaban accord

4. possible side effects

5. how to store rivaroxaban accord

6. contents of the pack and other information the active substance is rivaroxaban. each tablet contains 10 mg of rivaroxaban.

1. what rivaroxaban accord is and what it is used for

2. what you need to know before you take rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

3. how to take rivaroxaban accord

4. possible side effects

5. how to store rivaroxaban accord

6. contents of the pack and other information the active substance is rivaroxaban. each tablet contains 15 mg or 20 mg of rivaroxaban.

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 rivaroxaban accord is and what it is used for

2. what you need to know before you take rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Take special care with Rivaroxaban Accord

If you need to have an operation

Children and adolescents

Other medicines and Rivaroxaban Accord

Pregnancy and breast-feeding

Driving and using machines

3. how to take rivaroxaban accord

How much to take

When to take Rivaroxaban Accord

If you take more Rivaroxaban Accord than you should

If you forget to take Rivaroxaban Accord

If you stop taking Rivaroxaban Accord

4. possible side effects

Overall list of possible side effects

Reporting of side effects

5. how to store rivaroxaban accord

6. contents of the pack and other information the active substance is rivaroxaban. each tablet contains 10 mg of rivaroxaban.

What Rivaroxaban Accord looks like and contents of the pack

Marketing Authorisation Holder

Manufacturer

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 rivaroxaban accord is and what it is used for

2. what you need to know before you take rivaroxaban accord if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Take special care with Rivaroxaban Accord

If you need to have an operation

Other medicines and Rivaroxaban Accord

Pregnancy and breast-feeding

Driving and using machines

Rivaroxaban Accord contains lactose and sodium

3. how to take rivaroxaban accord

How much to take

If you spit up the dose or vomit

When to take Rivaroxaban Accord

If you take more Rivaroxaban Accord than you should

If you forget to take Rivaroxaban Accord

If you stop taking Rivaroxaban Accord

4. possible side effects

Signs of severe skin reactions

Signs of severe allergic reactions

Overall list of possible side effects found in adults, children and adolescents

Side effects in children and adolescents

Reporting of side effects

5. how to store rivaroxaban accord

6. contents of the pack and other information the active substance is rivaroxaban. each tablet contains 15 mg or 20 mg of rivaroxaban.

What Rivaroxaban Accord looks like and contents of the pack