Rivaroxaban Zentiva Italia: detailed information

Patient Information Leaflet

Rivaroxaban Zentiva Italia 2.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rivaroxaban Zentiva Italia is and what it is used for

You have been given Rivaroxaban Zentiva Italia because:

You have been diagnosed with acute coronary syndrome (a group of conditions including heart attack and unstable angina, a severe form of chest pain) and an increase in certain cardiac markers has been detected in blood tests. In adults, Rivaroxaban Zentiva Italia reduces the risk of another heart attack or the risk of dying from a disease related to the heart or blood vessels. Rivaroxaban Zentiva Italia will not be given to you alone. Your doctor will also prescribe one of the following:
acetylsalicylic acid, or
acetylsalicylic acid plus clopidogrel or ticlopidine. or
You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban Zentiva Italia reduces, in adults, the risk of clot formation (arterothrombotic events). Rivaroxaban Zentiva Italia will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you need to take Rivaroxaban Zentiva Italia following a

procedure used to widen a narrowed or blocked artery in the leg
in order to restore blood flow, your doctor may also prescribe clopidogrel, which
you will have to take for a short period in combination with acetylsalicylic acid.
Rivaroxaban Zentiva Italia contains the active substance rivaroxaban and belongs to a group of
medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you need to know before taking Rivaroxaban Zentiva Italia

Do not take Rivaroxaban Zentiva Italia

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 your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and have previously had a stroke or a blockage of the small arteries supplying deep brain tissue (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
if you have a liver disease that increases the risk of bleeding
if you are pregnant or breastfeeding Do not take Rivaroxaban Zentiva Italia 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 Zentiva Italia.
Rivaroxaban Zentiva Italia must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except acetylsalicylic acid and clopidogrel/ticlopidine.
Be especially careful with Rivaroxaban Zentiva Italia

if you have an increased risk of bleeding, such as in the following cases:
o severe kidney disease, because kidney function may affect the amount of active medicine in your body
o if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), in case of switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Zentiva Italia”)
o coagulation disorders
o very high blood pressure not controlled with medication
o stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus (gullet), for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus)
o tumors in the stomach, intestine, genital tract, or urinary tract
o a blood vessel disorder in the back of the eye (retinopathy)
o a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous lung bleeding
o if you are over 75 years old
o if you weigh less than 60 kg
o if you suffer from coronary heart disease with severe symptomatic heart failure
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 your treatment needs to be changed.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia. 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 Zentiva Italia before and after surgery exactly as directed by your doctor.
If your surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia for pain relief):
o it is very important to take Rivaroxaban Zentiva Italia before and after the injection or removal of the catheter exactly as directed by your doctor
o inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after anesthesia, as urgent intervention may be required.

Children and adolescents
Rivaroxaban Zentiva Italia 2.5 mg tablets are not recommended for
people under 18 years of age. There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Zentiva Italia
Tell 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:
o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
o ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
o certain antibacterial medicines (e.g. clarithromycin, erythromycin)
o certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
o other medicines used to prevent blood clots (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”))
o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
o dronedarone, a medicine used to treat atrial fibrillation
o certain medicines for 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 Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia 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 ulcer treatment.
If you are taking:
o certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
o St. John’s wort (Hypericum perforatum), a herbal remedy used for depression
o rifampicin, an antibiotic
If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Zentiva Italia and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva Italia if you are pregnant or breastfeeding. If there is a possibility you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Zentiva Italia. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban Zentiva Italia 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 use tools or machines.
Rivaroxaban Zentiva Italia contains lactose monohydrate (a type of sugar) 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 Zentiva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban Zentiva Italia at the same time each 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, ask your doctor how to take Rivaroxaban Zentiva Italia in another way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Zentiva Italia through a tube inserted into the stomach.
Rivaroxaban Zentiva Italia will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you. If you are taking Rivaroxaban Zentiva Italia after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rivaroxaban Zentiva Italia following a procedure used to widen a narrowed or blocked leg artery to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetylsalicylic acid daily, or a daily dose of 75–100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).
When to start Rivaroxaban Zentiva Italia
Treatment with Rivaroxaban Zentiva Italia after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, but not earlier than 24 hours after hospital admission and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will tell you when to start treatment with Rivaroxaban Zentiva Italia.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Zentiva Italia than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Zentiva Italia tablets. If you have taken an excessive amount of Rivaroxaban Zentiva Italia, your risk of bleeding increases.
If you forget to take Rivaroxaban Zentiva Italia
Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at your usual time.
If you stop taking Rivaroxaban Zentiva Italia
Take Rivaroxaban Zentiva Italia regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Zentiva Italia without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from heart or blood vessel disease, may increase.
If you have any doubts about how to use this medicine, consult 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 used to reduce the formation of blood clots, Rivaroxaban Zentiva Italia
can cause bleeding which may potentially be life-threatening.
Major bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you experience 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, decreased level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
prolonged or excessive bleeding
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 serious skin reactions
widespread and severe 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 illnesses (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
- Signs of serious 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 these serious 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)

reduction in red blood cells, which may cause paleness, 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 (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
loss of blood or fluid from surgical wound
swelling of limbs
limb pain
kidney dysfunction (may be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms may include dizziness or fainting when standing)
decreased strength and energy (weakness, fatigue), headache, dizziness
skin rash, itching
increased 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)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduction in platelets, which are the cells that allow blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (may be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
malaise
rapid heartbeat
dry mouth
hives

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

bleeding into a muscle
cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney impairment following severe bleeding
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, sensory changes, numbness or paralysis (compartment syndrome following 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 Zentiva Italia

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 blister and carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Zentiva Italia contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate.
Tablet coating (OPADRY YELLOW 03F520307): hypromellose, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172).

Description of the appearance of Rivaroxaban Zentiva Italia and the contents of the pack
Rivaroxaban Zentiva Italia 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated tablets (approximately 5 mm in diameter), marked with “2.5” on one side and smooth on the other side.
Rivaroxaban Zentiva Italia 2.5 mg is available in packs containing 20, 28, 56, 100, 168 and 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milan, Italy

Manufacturer
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic and Germany: Rivaroxaban Zentiva
France: RIVAROXABAN ZENTIVA
Italy: Rivaroxaban Zentiva Italia
Portugal: Rivaroxabano Zentiva

Patient Information Leaflet

Rivaroxaban Zentiva Italia 10 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rivaroxaban Zentiva Italia is and what it is used for

Rivaroxaban Zentiva Italia 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, after surgery, there is an increased risk of blood clots forming.
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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Zentiva Italia belongs to a group of medicines called antithrombotic agents.
Its action is due to inhibition of clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

2. What you should know before taking Rivaroxaban Zentiva Italia

Do not take Rivaroxaban Zentiva Italia

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 brain or eye surgery)

if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), 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
if you are pregnant or breastfeeding Do not take Rivaroxaban Zentiva Italia and inform your doctor if any of the conditions listed above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Zentiva Italia.
Take special care with Rivaroxaban Zentiva Italia

if you have a high risk of bleeding, which may occur in situations such as: o moderate or severe kidney disease, because kidney function can affect the amount of active medicine in your body or if you are taking other medicines to prevent blood clots (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 Zentiva Italia”) or coagulation disorders or very high blood pressure not controlled by medicines or diseases of the stomach or intestine that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus (gullet), for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours in the stomach or intestine or genital or urinary tract or a blood vessel disorder at the back of the eye (retinopathy) or a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous history of bleeding from your 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 your treatment needs to be changed
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 above apply to you, inform your doctor before taking
Rivaroxaban Zentiva Italia. 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 Zentiva Italia exactly at the times indicated by your doctor, both before and after surgery.
If your surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief): o it is very important to take Rivaroxaban Zentiva Italia exactly at the times indicated by your doctor

o 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 action may be needed.
Children and adolescents
Rivaroxaban Zentiva Italia 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient information on the use of this medicine in children and adolescents.
Other medicines and Rivaroxaban Zentiva Italia
Inform 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: o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin or ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol) o certain antibiotics (e.g. clarithromycin, erythromycin) o certain antiviral medicines for HIV/AIDS (e.g. ritonavir) o other medicines used to prevent blood clots (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol) o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid) o dronedarone, a medicine used to treat atrial fibrillation o certain medicines for 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 Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia 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: o certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital) o St John's wort (Hypericum perforatum), a herbal remedy for depression o rifampicin, an antibiotic If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Zentiva Italia and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva Italia during pregnancy or breastfeeding. If there is a possibility that you could become pregnant, use a reliable method of contraception while taking
Rivaroxaban Zentiva Italia. If you become pregnant while taking this medicine, inform your
doctor immediately. Your doctor will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban Zentiva Italia 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 Zentiva Italia contains lactose monohydrate (a type of sugar) 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 Zentiva Italia

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 the veins after hip or knee replacement surgery
The recommended dose is one 10 mg tablet of Rivaroxaban Zentiva Italia once daily.
To treat blood clots in the veins of the legs 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 one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you Rivaroxaban Zentiva Italia 10 mg once daily.

Swallow the tablet preferably with some water.
Rivaroxaban Zentiva Italia may be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Zentiva Italia in another way. The tablet may be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Zentiva Italia through a tube inserted into the stomach.

When to take Rivaroxaban Zentiva Italia
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 the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have had major hip surgery, you will usually need to take the tablets for 5 weeks.
If you have had major knee surgery, you will usually need to take the tablets for 2 weeks.

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

If you forget to take Rivaroxaban Zentiva Italia
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 per day as before.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rivaroxaban Zentiva Italia
Do not stop taking Rivaroxaban Zentiva Italia without first talking to your doctor, because Rivaroxaban Zentiva Italia helps prevent a serious condition from occurring.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with other similar medicines used to reduce blood clot formation, Rivaroxaban Zentiva Italia
can cause bleeding that could 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, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
prolonged or excessive bleeding
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 serious skin reactions

widespread and severe 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 affect up to 1 in 10,000 people).

Signs of serious 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 serious 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)

reduction in red blood cells, which may cause paleness, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual periods), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
loss of blood or fluid from the surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms may include dizziness or fainting when standing)
decreased strength and energy (weakness, fatigue), headache, dizziness
rash, itching
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)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduction in platelets, the cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain pancreatic or liver enzymes, or increased platelet count
fainting
malaise
rapid heartbeat
dry mouth
hives

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

bleeding into a muscle
cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney impairment following severe bleeding
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following 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 Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Zentiva Italia contains

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate.
Tablet coating (OPADRY ROSA 03F540128): hypromellose, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

Description of the appearance of Rivaroxaban Zentiva Italia and contents of the pack
Rivaroxaban Zentiva Italia 10 mg film-coated tablets are pink, round, biconvex, film-coated tablets (approximately 8.4 mm in diameter), marked with "10" on one side and smooth on the other.
Rivaroxaban Zentiva Italia 10 mg is available in packs containing 5, 10, 15, 20, 30, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milan, Italy

Manufacturer
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania

Patient information leaflet: information for the patient

Rivaroxaban Zentiva Italia 15 mg film-coated tablets

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, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rivaroxaban Zentiva Italia is and what it is used for

Rivaroxaban Zentiva Italia contains the active substance 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 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 Zentiva Italia is used in children and adolescents under 18 years of age and with 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 Zentiva Italia 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 need to know before taking Rivaroxaban Zentiva Italia

Do not take Rivaroxaban Zentiva Italia:

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 brain or eye surgery);
if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), 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;
if you are pregnant or breastfeeding. Do not take Rivaroxaban Zentiva Italia and inform your doctor if any of the conditions listed above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Zentiva Italia.
Be especially careful with Rivaroxaban Zentiva Italia

if you have an increased risk of bleeding, such as in the following cases:
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;
if you are taking other medicines to prevent blood clots (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 Zentiva Italia”);
coagulation disorders;
very high blood pressure that is not controlled with medication;
stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus (e.g. due to gastroesophageal reflux disease (a condition where stomach acid flows back into the oesophagus)) or tumours 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 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 your treatment needs to be changed;
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 above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia. 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 Zentiva Italia 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 spine (e.g. for epidural or spinal anaesthesia for pain relief):
o it is very important to take Rivaroxaban Zentiva Italia before and after the injection or removal of the catheter exactly as directed by your doctor;
o 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 Zentiva Italia tablets are not recommended for children weighing less than 30 kg. There is insufficient information on the use of rivaroxaban in children and adolescents for the adult indications.
Other medicines and Rivaroxaban Zentiva Italia
Inform 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:
o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin;
o ketoconazole tablets (used to treat Cushing's syndrome, a condition in which the body produces too much cortisol);
o certain antibiotics (e.g. clarithromycin, erythromycin);
o certain antiviral medicines for HIV/AIDS (e.g. ritonavir);
o other medicines used to prevent blood clots (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol);
o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
o dronedarone, a medicine used to treat atrial fibrillation;
o certain antidepressants (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 Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia 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:
o certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);
o St John's Wort (Hypericum perforatum), a herbal remedy used for depression;
o rifampicin, an antibiotic.
If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Zentiva Italia and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva Italia during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Zentiva Italia. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban Zentiva Italia 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 use tools or machinery.
Rivaroxaban Zentiva Italia contains lactose monohydrate (a type of sugar) 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 Zentiva Italia

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Zentiva Italia should be taken with food. Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Zentiva Italia in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken immediately after taking the mixture.
If necessary, your doctor may also administer the crushed tablet of Rivaroxaban Zentiva Italia through a tube inserted into the stomach.

What dose to take

Adults
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 Zentiva Italia once daily.
If you have kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban Zentiva Italia once daily.
If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg tablet of Rivaroxaban Zentiva Italia once daily (or one 10 mg tablet of Rivaroxaban Zentiva Italia if your kidneys do not function properly), in addition to an antiplatelet medicine such as clopidogrel.

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 Zentiva Italia twice daily for the first 3 weeks.
After 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Zentiva Italia 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 Zentiva Italia once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg tablet of Rivaroxaban Zentiva Italia 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 Zentiva Italia depends on body weight and will be calculated by your doctor.
- The recommended dose for children and adolescents weighing between 30 kg and 50 kg is one 15 mg tablet of Rivaroxaban Zentiva Italia once daily.
- The recommended dose for children and adolescents weighing 50 kg or more is one 20 mg tablet of Rivaroxaban Zentiva Italia once daily.
  Take each dose of Rivaroxaban Zentiva Italia 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: observe the child to ensure the full dose is taken.
  Since the dose of Rivaroxaban Zentiva Italia is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as weight changes. Never adjust the dose of Rivaroxaban Zentiva Italia on your own. If necessary, your doctor will adjust the dose.

Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use an alternative medicine containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, the tablet of Rivaroxaban Zentiva Italia may be crushed and mixed with water or apple puree immediately before administration.
Take food after taking this mixture. If necessary, your doctor may also administer the crushed tablet of Rivaroxaban Zentiva Italia via a gastric tube.

If you spit out the dose or vomit

If this happens less than 30 minutes after taking Rivaroxaban Zentiva Italia, take a new dose.
If this happens more than 30 minutes after taking Rivaroxaban Zentiva Italia, do not take a new dose. In this case, take your next dose of Rivaroxaban Zentiva Italia at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Zentiva Italia.

When to take Rivaroxaban Zentiva Italia
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 blood clots in the brain (stroke) and in other blood vessels in the body:
If your heart rhythm is to be restored to normal through a procedure called cardioversion, take Rivaroxaban Zentiva Italia exactly as instructed by your doctor.

If you take more Rivaroxaban Zentiva Italia than you should
Contact your doctor immediately if you have taken too many tablets of Rivaroxaban Zentiva Italia. Taking an excessive amount of Rivaroxaban Zentiva Italia increases the risk of bleeding.

If you forget to take Rivaroxaban Zentiva Italia
Adults, children and adolescents:
If you are taking 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 the same day to make up for the missed dose. Take the next tablet the following day and 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 stop taking Rivaroxaban Zentiva Italia
Do not stop taking Rivaroxaban Zentiva Italia without first talking to your doctor, as Rivaroxaban Zentiva Italia treats serious conditions and helps prevent their occurrence.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Zentiva Italia
may cause bleeding that could potentially be life-threatening.
Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact the child's doctor or 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, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding;
- 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 serious skin reactions

widespread and severe 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 illnesses (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).

Signs of serious 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 serious 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 reported in adults, children and adolescents
Common (may affect up to 1 in 10 people)

reduction in red blood cell count, which may cause paleness, 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
bleeding or fluid leakage 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, diarrhoea
low blood pressure (symptoms may include dizziness or fainting when standing)
decreased strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased 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)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are the cells that help blood to clot)
allergic reactions, including skin allergic 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 affect up to 1 in 1,000 people)

bleeding into a muscle
cholestasis (reduced bile flow), hepatitis including hepatocellular damage (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 affect 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 the available data)

kidney impairment following severe bleeding
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Side effects in children and adolescents
In general, side effects observed in children and adolescents treated with rivaroxaban
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 help blood to clot)
heavy menstrual bleeding

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, 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Zentiva Italia contains

The active substance is rivaroxaban. Each tablet contains 15 mg of rivaroxaban.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate.
Film coating (OPADRY RED 03F650001): hypromellose, titanium dioxide (E 171), macrogol 3350, red iron oxide (E 172).

Description of the appearance of Rivaroxaban Zentiva Italia and the contents of the pack

Rivaroxaban Zentiva Italia 15 mg film-coated tablets are red, round, biconvex, film-coated tablets (approximately 9.5 mm in diameter), marked with "15" on one side and smooth on the other side.

Rivaroxaban Zentiva Italia 15 mg is available in packs containing 10, 14, 28, 30, 42, 50, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano, Italy

Manufacturer
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania

Patient information leaflet

Rivaroxaban Zentiva Italia 20 mg film-coated tablets

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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rivaroxaban Zentiva Italia is and what it is used for

Rivaroxaban Zentiva Italia contains the active substance 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 when you have a type of irregular heartbeat called non-valvular atrial fibrillation.
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 Zentiva Italia is used in children and adolescents under 18 years of age and with 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, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

2. What you should know before taking Rivaroxaban Zentiva Italia

Do not take Rivaroxaban Zentiva Italia:

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 your body that increases the risk of serious bleeding (e.g. stomach ulcers, injuries or bleeding in the brain, recent brain or eye surgery);
if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), 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;
if you are pregnant or breastfeeding. Do not take Rivaroxaban Zentiva Italia 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 Zentiva Italia.
Be especially careful with Rivaroxaban Zentiva Italia

if you have an increased risk of bleeding, such as in the following cases:
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;
if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Zentiva Italia”);
blood clotting disorders;
very high blood pressure that is not controlled with medication;
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 gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)) or tumours 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 lung bleeding;
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 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 above apply to you, inform your doctor before taking Rivaroxaban Zentiva Italia. 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 Zentiva Italia exactly at the times indicated by your doctor, both before and after surgery.
If your surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
o it is very important to take Rivaroxaban Zentiva Italia exactly at the times indicated by your doctor, both before and after the injection or catheter removal;
o 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 treatment may be required.

Other medicines and Rivaroxaban Zentiva Italia
Tell 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:
o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin;
o ketoconazole tablets (used to treat Cushing's syndrome, a condition in which the body produces too much cortisol);
o certain antibacterial medicines (e.g. clarithromycin, erythromycin);
o certain antiviral medicines for HIV/AIDS (e.g. ritonavir);
o other medicines used to prevent blood clots (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol);
o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
o dronedarone, a medicine used to treat atrial fibrillation;
o 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 Zentiva Italia, as the effect of Rivaroxaban Zentiva Italia may be increased. 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:
o certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);
o St John's wort (Hypericum perforatum), a herbal remedy used for depression;
o rifampicin, an antibiotic.

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

Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva Italia during pregnancy or breastfeeding. If you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Zentiva Italia. 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 Zentiva Italia 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 use tools or machinery.

Rivaroxaban Zentiva Italia contains lactose monohydrate (a type of sugar) 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 Zentiva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Rivaroxaban Zentiva Italia should be taken with food. Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Zentiva Italia in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken immediately after taking the mixture.
If necessary, your doctor may also administer the crushed Rivaroxaban Zentiva Italia tablet through a tube inserted into the stomach.

What dose to take

Adults
To prevent blood clots in the brain (stroke) and in other blood vessels in the body
The recommended dose is one 20 mg tablet of Rivaroxaban Zentiva Italia once daily.
If you have kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban Zentiva Italia once daily.
If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg tablet of Rivaroxaban Zentiva Italia once daily (or to one 10 mg tablet of Rivaroxaban Zentiva Italia if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.

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 Zentiva Italia twice daily for the first 3 weeks.
After 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Zentiva Italia 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 Zentiva Italia once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg tablet 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 Zentiva Italia depends on body weight and will be calculated by your doctor.
- The recommended dose for children and adolescents with body weight between 30 kg and 50 kg is one 15 mg tablet of Rivaroxaban Zentiva Italia once daily.
- The recommended dose for children and adolescents with body weight equal to or above 50 kg is one 20 mg tablet of Rivaroxaban Zentiva Italia once daily.
  Take each dose of Rivaroxaban Zentiva Italia with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time every day. Consider setting an alarm to help you remember.
  For parents or caregivers: observe the child to ensure the entire dose is taken. Since the dose of Rivaroxaban Zentiva Italia is based on body weight, it is important to attend scheduled doctor visits so that the dose can be adjusted if the child's weight changes. Never adjust the dose of Rivaroxaban Zentiva Italia on your own. If adjustment is needed, your doctor will do it.

Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use an alternative medicine containing rivaroxaban in the form of oral suspension granules.
For children and adolescents who cannot swallow whole tablets, use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, the Rivaroxaban Zentiva Italia tablet may be crushed and mixed with water or apple puree immediately before administration.
Eat food after taking this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Zentiva Italia tablet via a gastric tube.

If you spit out the dose or vomit

If this happens less than 30 minutes after taking Rivaroxaban Zentiva Italia, take a new dose.
If this happens more than 30 minutes after taking Rivaroxaban Zentiva Italia, do not take a new dose. In this case, take your next dose of Rivaroxaban Zentiva Italia at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Zentiva Italia.

When to take Rivaroxaban Zentiva Italia
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 blood 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 Zentiva Italia exactly as your doctor has instructed.

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

If you forget to take Rivaroxaban Zentiva Italia
Adults, children and adolescents:
If you are taking one 20 mg tablet once daily and have missed 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 continue with one tablet once daily.

Adults:
If you are taking one 15 mg tablet twice daily and have missed 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 stop taking Rivaroxaban Zentiva Italia
Do not stop taking Rivaroxaban Zentiva Italia without first talking to your doctor, because Rivaroxaban Zentiva Italia treats serious conditions and helps prevent their occurrence.
If you have any questions about using this medicine, consult 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 used to reduce blood clot formation, Rivaroxaban Zentiva Italia
can cause bleeding, which 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 the child's doctor or 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, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive bleeding;
- 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 serious skin reactions

widespread and severe 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 affect up to 1 in 10,000 people).

Signs of serious allergic reactions

swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; breathing difficulties; sudden drop in blood pressure.
The frequencies of serious 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 reported in adults, children, and adolescents
Common (may affect up to 1 in 10 people)

reduced number of red blood cells, which may cause paleness, 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 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 a surgical wound
swelling in limbs
limb pain
kidney dysfunction (may be detected through blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhea
low blood pressure (symptoms may include dizziness or fainting when standing)
decreased strength and energy (weakness, fatigue), headache, dizziness
rash, itching
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)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (may 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
malaise
rapid heartbeat
dry mouth
hives

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

bleeding into a muscle
cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury)
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 affect 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 (cannot be estimated from available data)

kidney impairment following severe bleeding
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, 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
have been similar to those observed 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 (a bile pigment)
thrombocytopenia (reduced platelet count; platelets are blood cells that help blood to clot)
heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

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

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 the website
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 Zentiva Italia

6. Package contents and other information

What Rivaroxaban Zentiva Italia contains

The active substance is rivaroxaban. Each tablet contains 20 mg of rivaroxaban.
The other components are:
- Tablet core: monohydrate lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate.
- Film-coating OPADRY BROWN 03F565080: hypromellose, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

Description of the appearance of Rivaroxaban Zentiva Italia and pack sizes
Rivaroxaban Zentiva Italia 20 mg film-coated tablets are reddish-brown, round, biconvex, film-coated tablets (approximately 10.5 mm in diameter), marked with "20" on one side and smooth on the other.
Rivaroxaban Zentiva Italia 20 mg is available in packs of 10, 14, 28, 30, 50, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milan, Italy

Manufacturer
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic and Germany: Rivaroxaban Zentiva
France: RIVAROXABAN ZENTIVA
Italy: Rivaroxaban Zentiva Italia
Portugal: Rivaroxabano Zentiva