Patient Information Leaflet

RIVAROXABAN IBSA 10 mg film-coated tablets

rivaroxaban
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What RIVAROXABAN IBSA is and what it is used for
What you need to know before taking RIVAROXABAN IBSA
How to take RIVAROXABAN IBSA
Possible side effects
How to store RIVAROXABAN IBSA
Contents of the pack and other information

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

RIVAROXABAN IBSA contains the active substance rivaroxaban and is used in adults to

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

RIVAROXABAN IBSA belongs to a group of medicines called antithrombotic agents. Its action
is due to inhibition of a blood clotting factor (factor Xa), thereby reducing the blood's tendency 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 to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
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 on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparins), except when switching anticoagulant therapy or when 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 inform your doctor if any of the conditions described above 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 a high risk of bleeding, which may occur in situations such as:

moderate or severe kidney disease, because kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and RIVAROXABAN IBSA”)
coagulation disorders
very high blood pressure not controlled with medication
diseases of the stomach or intestine that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition where stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder in the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from your lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned. If any of the conditions described apply to you, inform your doctor before taking RIVAROXABAN IBSA. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.

If you are undergoing surgery

it is very important to take RIVAROXABAN IBSA before and after surgery exactly as directed by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take RIVAROXABAN IBSA exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent intervention may be required.

Children and adolescents
RIVAROXABAN IBSA 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient information available on its use in children and adolescents.
Other medicines and RIVAROXABAN IBSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
If you are taking

certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for 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
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI))

If any of the conditions described apply to you, inform your doctor before taking RIVAROXABAN IBSA, because the effect of RIVAROXABAN IBSA may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.
If you are taking

certain medicines for 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, inform your doctor before taking RIVAROXABAN IBSA, as the effect of RIVAROXABAN IBSA may be reduced. Your doctor will decide whether you should be treated with RIVAROXABAN IBSA and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take RIVAROXABAN IBSA during pregnancy or breastfeeding. If there is a possibility you could 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 proceed with treatment.
Driving and using machines
RIVAROXABAN IBSA may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, 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, please consult 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

What dose to take

To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one 10 mg RIVAROXABAN IBSA tablet once daily.
To treat blood clots in the leg veins and in the blood vessels of the lungs, and to prevent recurrence of clots: After at least 6 months of treatment for blood clots, the recommended dose is either one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed RIVAROXABAN IBSA 10 mg once daily.

Swallow the tablet preferably with some water. RIVAROXABAN IBSA can be taken regardless of meals.

If you have difficulty swallowing the tablet whole, ask your doctor how to take RIVAROXABAN IBSA in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.

If necessary, your doctor may administer crushed RIVAROXABAN IBSA through a tube inserted into the stomach.

When to take RIVAROXABAN IBSA

Take the tablet every day until your doctor tells you to stop. Try to take the tablets at the same time each day to help you remember.

Your doctor will decide how long your treatment should continue.

To prevent blood clots in veins after hip or knee replacement surgery:

Take the first tablet 6–10 hours after surgery.

If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.

If you have undergone 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, your risk of bleeding increases.

If you forget to take RIVAROXABAN IBSA

If you forget a dose, take it as soon as you remember. Take the next tablet the following day, and then continue taking one tablet daily as before.

Do not take a double dose to make up for the forgotten tablet.

If you stop taking RIVAROXABAN IBSA

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVAROXABAN IBSA can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, RIVAROXABAN IBSA can cause bleeding, which may potentially be life-threatening. Massive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact 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 of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness.
A medical emergency. Seek immediate medical help!)
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 severe skin reactions
widespread and intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic illness (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 breathing difficulties; 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 people) and not common (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

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

Uncommon (may occur in up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding causing pain and swelling
thrombocytopenia (reduced number of platelets, the cells responsible for blood clotting)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through blood tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation 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 heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

accumulation of eosinophils, a type of granulocytic white blood cells causing lung inflammation (eosinophilic pneumonia)

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What RIVAROXABAN IBSA contains

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

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

Package leaflet: Information for the user

RIVAROXABAN IBSA 15 mg film-coated tablets
RIVAROXABAN IBSA 20 mg film-coated tablets
rivaroxaban
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What RIVAROXABAN IBSA is and what it is used for
What you need to know before taking RIVAROXABAN IBSA
How to take RIVAROXABAN IBSA
Possible side effects
How to store RIVAROXABAN IBSA
Contents of the pack and other information

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

RIVAROXABAN IBSA contains the active substance rivaroxaban and is used in adults to:

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

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

treat blood clots and prevent their recurrence in the veins or in the blood vessels of the lungs, following 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 inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you should know before taking RIVAROXABAN IBSA

Do not take RIVAROXABAN IBSA

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding (haemorrhage)
if you have a disease or condition in any part of your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when switching anticoagulant therapy or when 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 inform your doctor if any of the conditions described above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIVAROXABAN IBSA.
Be especially careful with RIVAROXABAN IBSA

if you have an increased risk of bleeding, such as in cases of:
o severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
or if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and RIVAROXABAN IBSA”)
or if you have coagulation disorders
or very high blood pressure not controlled by medication
or stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus (e.g. caused by gastroesophageal reflux disease – a condition in which stomach acid flows back into the oesophagus)
or tumours in the stomach, intestine, genital tract, or urinary tract
or a blood vessel disorder in the back of the eye (retinopathy)
or a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds your blood pressure to be unstable, or if another treatment or surgical procedure to remove blood clots from the lungs is planned

If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN IBSA. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.

If you are scheduled for surgery:

it is very important to take RIVAROXABAN IBSA before and after surgery exactly as directed by your doctor.
If the surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
- it is very important to take RIVAROXABAN IBSA before and after the injection or catheter removal exactly as directed by your doctor
- inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
RIVAROXABAN IBSA tablets are not recommended for children weighing less than 30 kg.
There is insufficient information on the use of this medicine in children and adolescents for the indications approved in adults.

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 not requiring a prescription.

If you are taking

certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
certain antibacterial medicines (e.g. clarithromycin, erythromycin)
certain antiviral medicines for 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
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN IBSA, as the effect of RIVAROXABAN IBSA may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor believes you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking

certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St John's wort (Hypericum perforatum), a herbal remedy used for depression
rifampicin, an antibiotic

If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN IBSA, as the effect of RIVAROXABAN IBSA may be reduced. Your doctor will decide whether you should be treated with RIVAROXABAN IBSA and whether you need to be closely monitored.

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

Driving and using machines
RIVAROXABAN IBSA may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). If you experience these symptoms, do not drive, ride a bicycle, or operate 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
RIVAROXABAN IBSA must be taken with food.
Swallow the tablet or tablets with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take RIVAROXABAN IBSA in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. The mixture should be taken immediately followed by food. If necessary, your doctor may administer crushed RIVAROXABAN IBSA tablets through a tube inserted into the stomach.

What dose to take

Adults
o To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg tablet of RIVAROXABAN IBSA once daily. If you have kidney problems, the dose may be reduced to one 15 mg tablet of RIVAROXABAN IBSA once daily. If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI - Percutaneous Coronary Intervention with stent placement), limited evidence supports reducing the dose to one 15 mg tablet of RIVAROXABAN IBSA once daily (or one 10 mg tablet of RIVAROXABAN IBSA if your kidneys do not function 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 recurrence of clots: The recommended dose is one 15 mg tablet of RIVAROXABAN IBSA twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet of RIVAROXABAN IBSA once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg tablet of RIVAROXABAN IBSA once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg tablet of RIVAROXABAN IBSA once daily if the risk of bleeding is greater than the risk of developing a new blood clot.
Children and adolescents
The dose of RIVAROXABAN IBSA depends on body weight and will be calculated by your doctor.
o The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg tablet of RIVAROXABAN IBSA once daily.
o The recommended dose for children and adolescents with a body weight equal to or greater than 50 kg is one 20 mg tablet of RIVAROXABAN IBSA once daily.
Take each dose of RIVAROXABAN IBSA with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to help you remember.
For parents or caregivers: please observe the child to ensure the full dose is taken. Since the dose of RIVAROXABAN IBSA is based on body weight, it is important to attend scheduled doctor appointments, as the dose may need to be adjusted with changes in weight. Never adjust the dose of RIVAROXABAN IBSA by yourself. If an adjustment is needed, your doctor will do it. Do not split the tablet in an attempt to divide the dose. If you have difficulty swallowing the whole tablet, you may crush the RIVAROXABAN IBSA tablet and mix it with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer the crushed RIVAROXABAN IBSA tablet via a gastric tube.

If you spit out the dose or vomit

If this happens less than 30 minutes after taking RIVAROXABAN IBSA, take a new dose.
If this happens more than 30 minutes after taking RIVAROXABAN IBSA, do not take a new dose. In this case, take your next dose 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(s) every day until your doctor tells you to stop.
Try to take the tablet(s) at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent the formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat is to be restored to normal through a procedure called cardioversion, take RIVAROXABAN IBSA exactly as your doctor instructed.

If you forget to take RIVAROXABAN IBSA

Adults, children and adolescents: If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day and then continue with one tablet once daily.
Adults: If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The next day, continue with one 15 mg tablet twice daily.

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

If you stop taking RIVAROXABAN IBSA
Do not stop taking RIVAROXABAN IBSA without first talking to your doctor, as RIVAROXABAN IBSA treats serious conditions and helps prevent their occurrence.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVAROXABAN IBSA can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, RIVAROXABAN IBSA can cause bleeding that may potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact 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 of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
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 modify your treatment.
Signs of severe skin reactions
widespread and intense rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (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 breathing difficulties; 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 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

reduction in red blood cell count, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (hematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
blood or fluid discharge from a surgical wound
swelling in limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing up)
general lack of energy and strength (weakness, fatigue), headache, dizziness
rash, itchy skin
increased liver enzymes in blood tests

Uncommon (may occur in up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation 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 insertion of a catheter into the leg artery (pseudoaneurysm)

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

accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)
Frequency not known (frequency cannot be estimated from available data):
kidney failure following severe bleeding
kidney bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensitivity, numbness or paralysis (compartment syndrome following 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 seen in adults and have mainly been mild to moderate in severity.
Side effects 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 increased bilirubin (bile pigment)
thrombocytopenia (reduced platelet count; platelets are the cells that allow blood to clot)
heavy menstrual periods

Uncommon (may affect up to 1 in 100 people)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps 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 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 dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RIVAROXABAN IBSA contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other components 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), hydroxypropylcellulose, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of RIVAROXABAN IBSA and package contents
The 15 mg film-coated tablets of RIVAROXABAN IBSA are round, biconvex, pink in colour, with the number “15” engraved on one side.
The tablets are supplied in PVC/PVDC 90/Aluminium blisters, in boxes containing 42 film-coated tablets.
The 20 mg film-coated tablets of RIVAROXABAN IBSA are round, biconvex, brown in colour, with the number “20” engraved on one side.
The tablets are supplied in PVC/PVDC 90/Aluminium blisters, in boxes containing 28 film-coated tablets.

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

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

Rivaroxaban Ibsa

Patient Information Leaflet