RIVAROXABAN 10 mg Film-Coated Tablets

Зміст інструкції

1. RIVAROXABAN IBSA 10 mg film-coated tablets
   1. What is RIVAROXABAN IBSA and what is it used for
   2. What you need to know before taking RIVAROXABAN IBSA
2. RIVAROXABAN IBSA, because the effect of RIVAROXABAN IBSA may be increased. The
   1. How to take RIVAROXABAN IBSA
   2. Possible side effects
   3. How to store RIVAROXABAN IBSA
   4. Contents of the pack and other information
3. RIVAROXABAN IBSA 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What is RIVAROXABAN IBSA and what it is used for
   2. What you need to know before taking RIVAROXABAN IBSA
   3. How to take RIVAROXABAN IBSA
   4. Possible side effects
   5. How to store RIVAROXABAN IBSA
   6. Contents of the pack and other information

RIVAROXABAN IBSA 10 mg film-coated tablets

rivaroxaban

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is RIVAROXABAN IBSA and what is it used for

RIVAROXABAN IBSA contains the active ingredient rivaroxaban and is used in adults for

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because, after surgery, the risk of blood clots forming in the blood increases.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

RIVAROXABAN IBSA belongs to the group of medicines called antithrombotic agents .Its action
is due to the blocking of the coagulation factor (factor Xa) and therefore to the reduction of the tendency of the
blood to form clots.

2. What you need to know before taking RIVAROXABAN IBSA

Do not take RIVAROXABAN IBSA

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding (haemorrhages)
• if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when changing anticoagulant therapy or when you are receiving heparins through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding

Do not take RIVAROXABAN IBSA and tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIVAROXABAN IBSA.

Pay particular attention with RIVAROXABAN IBSA
if you have a high risk of bleeding, which can occur in situations such as:

• moderate or severe kidney disease, because kidney function can change the amount of active medicine in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and RIVAROXABAN IBSA”)
• blood clotting disorders
• very high blood pressure, not controlled with medicines
• diseases of the stomach or intestine that can cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• a disorder of the blood vessels in the back of the eye (retinopathy)
• a lung disease with dilated and pus-filled bronchi (bronchiectasis), or a previous bleeding from your lungs
• if you have a prosthetic heart valve
• if you know you have a disease called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy
• if the doctor checks that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs. If any of the conditions described apply to you, tell your doctorbefore taking RIVAROXABAN IBSA. The doctor will decide if you should be treated with this medicine and if you should be kept under close observation.

If you are going to have surgery

• it is very important to take RIVAROXABAN IBSA before and after the surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia for pain relief):
• it is very important to take RIVAROXABAN IBSA exactly at the times indicated by your doctor
• immediately inform your doctor if you experience numbness or weakness in your legs or disorders of the bowel or bladder at the end of anesthesia, because in this case urgent intervention is necessary.

Children and adolescents
RIVAROXABAN IBSA 10 mg tablets are not recommended in patients under the age of 18 years.
There is not enough information available on its use in children and adolescents.

Other medicines and RIVAROXABAN IBSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.

If you are taking

• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against HIV / AIDS (e.g. ritonavir)
• other medicines used to inhibit 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 used in the treatment of atrial fibrillation
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described apply to you, tell your doctorbefore taking

RIVAROXABAN IBSA, because the effect of RIVAROXABAN IBSA may be increased. The

doctor will decide whether you need to be treated with this medicine and whether you need to be kept under close
observation.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment against ulcers.

If you are taking

• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort ( Hypericum perforatum), a herbal medicine for depression
• rifampicin, an antibiotic

If any of the conditions described apply to you, tell your doctorbefore taking
RIVAROXABAN IBSA, as the effect of RIVAROXABAN IBSA may be reduced. The doctor
will decide whether you need to be treated with RIVAROXABAN IBSA and whether you need to be kept under close
observation.

Pregnancy and breastfeeding
Do not take RIVAROXABAN IBSA during pregnancy or breastfeeding. If there is a possibility that you may become
pregnant, use a reliable method of contraception while taking RIVAROXABAN IBSA. If
you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to
continue the treatment.

Driving and using machines
RIVAROXABAN IBSA can cause dizziness (common undesirable effect) and fainting (uncommon
undesirable effect) (see section 4, “Possible undesirable effects”). If these symptoms occur,
do not drive vehicles, ride a bicycle or use tools or machinery.

RIVAROXABAN IBSA contains lactose and sodium
If your doctor has diagnosed you with an intolerance to some sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RIVAROXABAN IBSA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery, the recommended dose is one RIVAROXABAN IBSA 10 mg tablet once a day.
• To treat blood clots in the veins of the legs and in the blood vessels of the lungs and to prevent the recurrence of clots, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed RIVAROXABAN IBSA 10 mg once a day.

Swallow the tablet preferably with some water. RIVAROXABAN IBSA can be taken
independently of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take RIVAROXABAN IBSA
in another way. The tablet can be crushed and mixed with some water or applesauce
immediately before taking it.
If necessary, your doctor may administer the crushed RIVAROXABAN IBSA tablet
through a tube inserted into the stomach.

When to take RIVAROXABAN IBSA
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablets always at the same time of day, so you can remember more easily.
Your doctor will decide how long to continue your treatment.
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6 – 10 hours after the operation.
If you have had major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have had major knee surgery, you will generally need to take the tablets for 2 weeks.

If you take more RIVAROXABAN IBSA than you should
Contact your doctor immediately if you have taken too many RIVAROXABAN IBSA tablets. If you have taken
an excessive amount of RIVAROXABAN IBSA, the risk of bleeding increases.

If you forget to take RIVAROXABAN IBSA
If you have forgotten a dose, take it as soon as you remember. Take the next tablet the next
day and then continue with one tablet a day, as before.
Do not take a double dose to make up for a missed tablet.

If you stop taking RIVAROXABAN IBSA
Do not stop taking RIVAROXABAN IBSA without first talking to your doctor, because
RIVAROXABAN IBSA prevents
a serious condition from occurring.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVAROXABAN IBSA can cause side effects, although not everybody gets them.
Like other similar medicines to reduce blood clot formation, RIVAROXABAN IBSA can cause
bleeding which could potentially endanger the patient's life. Massive bleeding can cause a sudden drop
in blood pressure (shock). In some cases, the bleeding may not be visible.

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

• Signs of bleeding
• bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, convulsions, reduced level of consciousness, and stiff neck.
• A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
• Signs of severeskin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood counts, and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect 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 difficulty breathing; 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 edema; may affect up to 1 in 100 people).

Complete list of possible side effects
Common(may affect up to 1 in 10 people)

• decreased number of red blood cells, which can cause pale skin and weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after a surgical procedure
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected by tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itchy skin
• increased levels of certain liver enzymes in blood tests

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• joint bleeding causing pain and swelling
• thrombocytopenia (decreased number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• kidney malfunction (can be detected by tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1000 people)

• muscle bleeding
• cholestasis (decreased flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (inflammation of the liver including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a procedure at the level

cardiac involving the insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

Frequency not known(frequency cannot be estimated from available data)

• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)
• kidney impairment after severe bleeding

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system reported https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store RIVAROXABAN IBSA

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 after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIVAROXABAN IBSA contains

• The active ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (2910), sodium lauryl sulfate, magnesium stearate. See section 2 “RIVAROXABAN IBSA contains lactose and sodium”. Tablet film coating: macrogol 8000, hypromellose (2910), hydroxypropyl cellulose, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of RIVAROXABAN IBSA and contents of the pack
RIVAROXABAN IBSA 10 mg film-coated tablets are round, biconvex, light pink in colour
with the number “10” imprinted on one side.
The tablets are supplied in PVC/PVDC 90/Aluminum blisters in packs of 30 film-coated tablets

Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia n. 2 - 26900 Lodi

Manufacturer
ADAMED PHARMA S.A.
ul. Marszałka Józefa Piłsudskiego 5.
95-200 Pabianice, Poland

RIVAROXABAN IBSA 15 mg film-coated tablets, 20 mg film-coated tablets

rivaroxaban

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is RIVAROXABAN IBSA and what it is used for

RIVAROXABAN IBSA contains the active ingredient rivaroxaban and is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the leg veins (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the leg and/or lung blood vessels.

RIVAROXABAN IBSA is used in children and adolescents under 18 years of age and with a body weight
equal to or greater than 30 kg for:

• treating blood clots and preventing their recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots. RIVAROXABAN IBSA belongs to a group of medicines called antithrombotic agents.Its action is due to the blocking of a coagulation factor (factor Xa) followed by a reduced tendency of the blood to form clots.

2. What you need to know before taking RIVAROXABAN IBSA

Do not take RIVAROXABAN IBSA

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive (severe) bleeding
• if you have a disease or condition in a part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when changing anticoagulant therapy or when you are receiving heparin through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding Do not take RIVAROXABAN IBSA and tell your doctorif any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIVAROXABAN IBSA

Take special care with RIVAROXABAN IBSA

• if you have an increased risk of bleeding, such as may be the case with: o severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, because kidney function can change the amount of active medicine in the body o if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and RIVAROXABAN IBSA”) o disorders of blood clotting o very high blood pressure, not controlled with medicines o diseases of the stomach or intestine that can cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) o tumors located in the stomach or intestine or the genital tract or urinary tract o a disorder of the blood vessels in the back of the eye (retinopathy) or a lung disease with dilated and pus-filled bronchi (bronchiectasis), or previous bleeding from the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy
• if your doctor checks that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs

If any of the above conditions apply to you, tell your doctorbefore taking RIVAROXABAN
IBSA. The doctor will decide if you should be treated with this medicine and if you should be kept under
close observation.

If you are going to have surgery:

• it is very important to take RIVAROXABAN IBSA before and after the surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia to relieve pain):
• it is very important to take RIVAROXABAN IBSA before and after the injection or removal of the catheter exactly at the times indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia, because urgent intervention may be necessary.

Children and adolescents
RIVAROXABAN IBSA tablets are not recommended in children weighing less than 30 kg.
There is not enough information on use in children and adolescents in adult indications.

Other medicines and RIVAROXABAN IBSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.

If you are taking

• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against HIV / AIDS (e.g. ritonavir)
• other medicines used to inhibit 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 used to treat atrial fibrillation
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above conditions apply to you, tell your doctorbefore taking
RIVAROXABAN IBSA, because the effect of RIVAROXABAN IBSA may be increased. The
doctor will decide if you should be treated with this medicine and if you should be kept under close
observation.
If the doctor believes that you have an increased risk of developing stomach
or intestinal ulcers, they may prescribe preventive treatment against ulcers.

If you are taking

• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort ( Hypericum perforatum), a herbal medicine used for depression
• rifampicin, an antibiotic

If any of the above conditions apply to you, tell your doctorbefore taking
RIVAROXABAN IBSA, as the effect of RIVAROXABAN IBSA may be reduced. The doctor
will decide if you should be treated with RIVAROXABAN IBSA and if you should be kept under close
observation.

Pregnancy and breastfeeding
Do not take RIVAROXABAN IBSA during pregnancy or breastfeeding. If there is a possibility of becoming
pregnant, use a reliable method of contraception while taking RIVAROXABAN IBSA. If
you become pregnant while taking this medicine, tell your doctor immediately, who will decide how
to continue treatment.

Driving and using machines
RIVAROXABAN IBSA can cause dizziness (a common side effect) or lightheadedness (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms,
do not drive vehicles, ride a bicycle or use tools or machinery.

RIVAROXABAN IBSA contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RIVAROXABAN IBSA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

RIVAROXABAN IBSAmust be taken with a meal.
Swallow the tablet or tablets preferably with a little water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take RIVAROXABAN IBSA in another way. The tablet can be crushed and mixed with a little water or with applesauce immediately before taking it. Taking the mixture should be immediately followed by eating food. If necessary, your doctor may administer the crushed tablet of RIVAROXABAN IBSA through a tube inserted into the stomach.

What dose to take

• Adultsor To prevent blood clots in the brain (stroke) and in other blood vessels of the body The recommended dose is one RIVAROXABAN IBSA 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one RIVAROXABAN IBSA 15 mg tablet once a day. If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI - Percutaneous Coronary Intervention with stent placement), there is limited evidence to support reducing the dose to one RIVAROXABAN IBSA 15 mg tablet once a day (or to a 10 mg RIVAROXABAN IBSA tablet if your kidneys are not working properly), in addition to an antiplatelet medicine such as clopidogrel. o To treat blood clots in the veins of the legs and in the blood vessels of the lungs and to prevent the recurrence of clots The recommended dose is one RIVAROXABAN IBSA 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one RIVAROXABAN IBSA 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with a 10 mg tablet once a day or a 20 mg tablet once a day. If you have kidney problems and are taking a RIVAROXABAN IBSA 20 mg tablet once a day, your doctor may decide to reduce the dosage for treatment after 3 weeks to a RIVAROXABAN IBSA 15 mg tablet once a day if the risk of bleeding is greater than the risk of having a new blood clot.
• Children and adolescentsThe dose of RIVAROXABAN IBSA depends on body weight and will be calculated by your doctor. o The recommended dose for children and adolescents weighing between 30 kg and 50 kgis one RIVAROXABAN IBSA 15 mgtablet once a day. o The recommended dose for children and adolescents weighing 50 kg or moreis one RIVAROXABAN IBSA 20 mgtablet once a day. Take each dose of RIVAROXABAN IBSA 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 that the entire dose is taken. Because the dose of RIVAROXABAN IBSA is based on body weight, it is important to attend scheduled visits with the doctor because the dose may need to be adjusted as the weight changes. Never adjust the dose of RIVAROXABAN IBSA yourself.If necessary, the doctor will adjust the dose. Do not split the tablet in an attempt to fraction a dose. If you have difficulty swallowing the tablet whole, you can crush the RIVAROXABAN IBSA tablet and mix it with water or applesauce immediately before taking it. Eat some food after taking this mixture. If necessary, the doctor may also administer the crushed RIVAROXABAN IBSA tablet through a feeding tube.

If you spit out the dose or vomit

• less than 30 minutes after taking RIVAROXABAN IBSA, take a new dose.
• more than 30 minutes after taking RIVAROXABAN IBSA, do nottake a new dose. In this case, take the next dose of RIVAROXABAN IBSA at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking RIVAROXABAN IBSA.

When to take RIVAROXABAN IBSA
Take the tablet or tablets every day until your doctor tells you to stop taking them.
Try to take the tablet or tablets always at the same time of day, so you can remember it more easily.
Your doctor will decide how long to continue your treatment.
To prevent the formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat needs to be restored to normal through a procedure called cardioversion, take RIVAROXABAN IBSA exactly as your doctor has told you.

If you forget to take RIVAROXABAN IBSA

• Adults, children and adolescents :If you are taking a 20 mg or 15 mg tablet oncea day and have forgotten a dose, take it as soon as you remember. Do not take more than one tablet in the same day to make up for the missed dose. Take the next tablet the following day and then continue with one tablet once a day.
• Adults: If you are taking a 15 mg tablet twicea day and have forgotten a dose, take it as soon as you remember .Do not take more than two 15 mg tablets in the same day. If you forget a dose, you can take two 15 mg tablets at the same time to take a total of two tablets (30 mg) in one day. The next day, continue with one 15 mg tablet twice a day.

If you take more RIVAROXABAN IBSA than you should
Contact your doctor immediately if you have taken too many RIVAROXABAN IBSA tablets. If you have taken an excessive amount of RIVAROXABAN IBSA, the risk of bleeding increases.

If you stop taking RIVAROXABAN IBSA
Do not stop taking RIVAROXABAN IBSA without first talking to your doctor, because RIVAROXABAN IBSA treats serious conditions and prevents them from occurring.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVAROXABAN IBSA can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, RIVAROXABAN IBSA can cause
bleeding which can potentially endanger the patient's life. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the
bleeding may not be apparent.

Immediately inform your doctor if you notice the occurrence of any of the following side
effects:

• Signs of bleeding
• bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, convulsions, reduced level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown origin, shortness of breath, chest pain or angina pectoris. The doctor may decide to keep you under close observation or modify the treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may occur in 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 difficulty breathing; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100).

Complete list of possible side effects observed in adults, children and adolescents
Common(may affect up to 1 in 10 people)

• reduction in the number of red blood cells, which can cause pale skin, weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• blood with cough
• bleeding from the skin or under the skin
• bleeding after surgery
• blood or fluid leakage from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling or state of unwellness, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itchy skin
• increase in certain liver enzymes in blood tests

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• joint bleeding, causing pain and swelling
• thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 people)

• muscle bleeding
• cholestasis (decreased flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (inflammation of the liver including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving the insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia) Frequency not known(frequency cannot be estimated based on available data):
• renal failure after severe bleeding
• renal bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with RIVAROXABAN
IBSA have been similar to those observed in adults and have been mainly of mild to
moderate severity.
Side effects that have been observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (reduction of platelets, which are the cells that allow 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system reported https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store RIVAROXABAN IBSA

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 particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIVAROXABAN IBSA contains

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (2910), sodium lauryl sulfate, magnesium stearate. See section 2 “RIVAROXABAN IBSA contains lactose and sodium”. Tablet film coating: macrogol 8000, hypromellose (2910), hydroxypropyl cellulose, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of RIVAROXABAN IBSA and contents of the pack
The 15 mg film-coated tablets of RIVAROXABAN IBSA are round, biconvex, pink in color with the number “15” imprinted on one side.
The tablets are supplied in PVC/PVDC 90/Aluminum blisters in packs of 42 film-coated tablets.
The 20 mg film-coated tablets of RIVAROXABAN IBSA are round, biconvex, brown in color
with the number “20” imprinted on one side.
The tablets are supplied in PVC/PVDC 90/Aluminum blisters in packs of 28 film-coated tablets.

Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia n. 2 -26900 Lodi

Manufacturer
ADAMED PHARMA S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland