Rivaroxaban Zentiva: detailed information

Patient Information Leaflet

Rivaroxaban Zentiva 10 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rivaroxaban Zentiva contains the active substance rivaroxaban and is used in adults for

preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because, after surgery, there is an increased risk of blood clots forming.
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 belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

2. What you need to know before taking Rivaroxaban Zentiva

Do not take Rivaroxaban Zentiva

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 clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rivaroxaban Zentiva 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.
Be especially careful with Rivaroxaban Zentiva

if you have an increased risk of bleeding, such as in cases of:
o moderate or severe kidney disease, because kidney function can affect the amount of active medicine in your body
o if you are taking other medicines to prevent clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Zentiva”)
o coagulation disorders
o very high, uncontrolled blood pressure despite medication
o stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus, for example caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
o tumours in the stomach, intestine, genital tract or urinary tract
o a blood vessel disorder at the back of the eye (retinopathy)
o 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 determines that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Zentiva. 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 before and after surgery exactly at the times indicated by your doctor.
If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
o it is very important to take Rivaroxaban Zentiva exactly at the times indicated 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 intervention may be required.

Children and adolescents
Rivaroxaban Zentiva 10 mg capsules 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
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:
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 inhibit blood clotting (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, as the effect of Rivaroxaban Zentiva 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 considers you to be at 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, as the effect of Rivaroxaban Zentiva may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Zentiva and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking Rivaroxaban Zentiva. 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 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 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 capsule, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Zentiva

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 a hip or knee replacement surgery: The recommended dose is one 10 mg Rivaroxaban Zentiva capsule 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 either one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed you Rivaroxaban Zentiva 10 mg once daily.

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

To prevent blood clots in the veins after hip or knee replacement surgery:
Take the first capsule 6–10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the capsules for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the capsules for 2 weeks.

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

If you forget to take Rivaroxaban Zentiva
If you forget a dose, take it as soon as you remember. Take the next capsule the following day, then continue as before with one capsule per day.
Do not take a double dose to make up for the forgotten capsule.

If you stop taking Rivaroxaban Zentiva
Do not stop taking Rivaroxaban Zentiva without first talking to your doctor, as Rivaroxaban Zentiva helps prevent serious conditions from occurring.

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 everyone gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Zentiva 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.
Tell your doctor immediately if you notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side 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 blood loss
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of serious 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 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 not common (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 breathlessness
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 (haematoma, 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 problems (can be detected by tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms 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 within 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 problems (can be detected by 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 cardiac 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 available data):

kidney impairment following severe bleeding
bleeding in the kidneys, sometimes with blood in the urine, leading to inability of the kidneys to function properly (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 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after Exp. The expiry date refers to the last day of that month.
PVC / PVdC / Alu blisters: store below 30 °C. Keep in the original packaging to protect from moisture.
Alu / Alu blisters: 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 contains

The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate and magnesium stearate in the capsule core; gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E 172) in the capsule shell.

Description of the appearance of Rivaroxaban Zentiva and contents of the pack
Rivaroxaban Zentiva 10 mg capsules are filled with white to off-white powder in a size “3” capsule (approximately 16 mm in length) with a beige opaque cap and body.
The hard capsules are packed in PVC/PVdC/Alu or Alu/Alu blisters.
Rivaroxaban Zentiva 10 mg is available in packs of 5, 10, 15, 20, 30 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

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

Manufacturers
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 300, Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Denmark, Germany, Hungary, Iceland, Italy, Netherlands, Norway, Spain and Sweden:
Rivaroxaban Zentiva
Croatia: Rivaroxaban Zentiva
France: Rivaroxaban ZENTIVA
Portugal: Rivaroxabano Zentiva.

Package leaflet: information for the patient

Rivaroxaban Zentiva 15 mg hard capsules, 20 mg hard capsules

Generic medicine
Please read all of this leaflet carefully before you take 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 may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rivaroxaban Zentiva 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 is used in children and adolescents under 18 years of age and weighing at least 30 kg for:

treating blood clots and preventing the recurrence of blood clots in the veins or in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

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

2. What you need to know before taking Rivaroxaban Zentiva

Do not take Rivaroxaban Zentiva

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 severe bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery);
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open;
if you have a liver disease that increases the risk of bleeding;
during pregnancy or breastfeeding.

Do not take Rivaroxaban Zentiva 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.
Take special care with Rivaroxaban Zentiva

if you have an increased risk of bleeding, such as:
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 clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Zentiva”);
blood clotting disorders;
very high blood pressure that is not controlled with medication;
diseases of the stomach or intestines that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus, for example caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours 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 the 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 therapy needs to be changed;
if your doctor determines that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban
Zentiva. Your doctor will decide whether you should be treated with this medicine and whether you should be
closely monitored.
If you are scheduled for surgery:

it is very important to take Rivaroxaban Zentiva before and after the procedure exactly as directed by your doctor.
if the 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 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 disturbances in bowel or bladder function after the anaesthesia, as urgent medical intervention may be required.
Children and adolescents
Rivaroxaban Zentiva 15 mg is not recommended in children weighing less than 30 kg.
Rivaroxaban Zentiva 20 mg is not recommended in children weighing less than 50 kg.
There is insufficient information on the use of rivaroxaban in children and adolescents for the adult indications.
Other medicines and Rivaroxaban Zentiva
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 applied only to the skin; o 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 inhibit blood clotting (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, as the effect of Rivaroxaban Zentiva may be increased. The
doctor will decide whether you should be treated with this medicine and whether you should be closely
monitored.
If your doctor considers you to be at increased risk of developing ulcers in the
stomach or intestines, 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, as the effect of Rivaroxaban Zentiva may be reduced. The doctor
will decide whether you should be treated with Rivaroxaban Zentiva and whether you should be closely
monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Zentiva during pregnancy or breastfeeding. If there is a possibility of
becoming pregnant, use a reliable method of contraception while taking
Rivaroxaban Zentiva. 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 Zentiva 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 Zentiva 15 mg and 20 mg contain lactose monohydrate (a type of sugar) and
sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
“sodium-free”.

3. How to take Rivaroxaban Zentiva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban Zentiva must be taken with food.
Swallow the capsule preferably with water.
If you have difficulty swallowing the capsule whole, ask your doctor how to take Rivaroxaban Zentiva in another way. The contents of the capsule may be mixed with water or apple puree immediately before taking. The mixture should be followed immediately by eating food.
If necessary, your doctor may administer the dispersed contents of the Rivaroxaban Zentiva capsule 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 Rivaroxaban Zentiva capsule once daily.
If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Zentiva capsule 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), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Zentiva capsule once daily (or one 10 mg Rivaroxaban Zentiva capsule 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 Rivaroxaban Zentiva capsule twice daily for the first 3 weeks.
After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Zentiva capsule once daily.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily.
If you have kidney problems and are taking one 20 mg Rivaroxaban Zentiva capsule once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Zentiva capsule 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 depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg Rivaroxaban Zentiva capsule once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban Zentiva capsule once daily. Take each dose of Rivaroxaban Zentiva with a drink (e.g. water or juice) during a meal. Take the capsules at approximately the same time each day. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban Zentiva is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted with changes in weight.
Never adjust the dose of Rivaroxaban Zentiva on your own. If necessary, your doctor will adjust the dose.
Do not split the capsule contents 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 the capsules whole, use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, the contents of the Rivaroxaban Zentiva capsule may be dispersed and mixed with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer the dispersed contents of the Rivaroxaban Zentiva capsule via a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Zentiva
Take the capsule every day until your doctor tells you to stop.
Try to take the capsules at the same time each day to help you remember. Your doctor will decide how long your treatment should continue.
To prevent formation of clots in the brain (stroke) and in other blood vessels of the body:
If your heartbeat needs to be restored to normal through a procedure called cardioversion, take Rivaroxaban Zentiva exactly as directed by your doctor.

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

If you forget to take Rivaroxaban Zentiva
Adults, children and adolescents:
If you are taking one 20 mg capsule or one 15 mg capsule once daily and have missed a dose, take it as soon as you remember. Do not take more than one capsule in a single day to make up for the missed dose. Take the next capsule the following day and continue with one capsule once daily.

Adults:
If you are taking one 15 mg capsule twice daily and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in a single day. If you miss a dose, you may take two 15 mg capsules together to achieve a total of two capsules (30 mg) in one day. The following day, continue with one 15 mg capsule twice daily.

If you stop taking Rivaroxaban Zentiva
Do not stop taking Rivaroxaban Zentiva without first talking to your doctor, because Rivaroxaban Zentiva helps prevent serious conditions.
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 gets them.
As with other similar medicines used to reduce the formation of blood clots, Rivaroxaban Zentiva 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, or your child, 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 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 illnesses (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

Complete list of possible side effects 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 the skin or under the skin
bleeding after surgery
blood or fluid discharge from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected by tests performed by your doctor)
fever
stomach ache, indigestion, feeling or state of malaise, constipation, diarrhoea
low blood pressure (symptoms 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
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected by 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 cardiac 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 cells causing lung inflammation (eosinophilic pneumonia)

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

kidney impairment following severe bleeding
bleeding in the kidneys, sometimes with blood in urine leading to inability of the kidneys to function properly (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 following bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with rivaroxaban
were similar to those observed in adults and were mainly 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 (low platelet count; platelets are cells that help blood clotting)
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

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 blister after Exp. The expiry date refers to the last day of that month.
PVC / PVdC / Alu blisters: store below 30 °C. Keep in the original packaging to protect from moisture.
Alu / Alu blisters: 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 contains

The active substance is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, and magnesium stearate in the capsule core.
Gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172) in the capsule coating.

Description of the appearance of Rivaroxaban Zentiva and contents of the pack
Rivaroxaban Zentiva 15 mg capsules contain white to off-white powder in a size “1” capsule (approximately 19 mm in length) with a light brown opaque cap and body.
Rivaroxaban Zentiva 20 mg capsules contain white to off-white powder in a size “0” capsule (approximately 22 mm in length) with a dark brown opaque cap and body.
The hard capsules are packaged in PVC/PVdC/Alu or Alu/Alu blisters.
Rivaroxaban Zentiva 15 mg is available in packs of 14, 28, 30, 42, 98 or 100 hard capsules.
Rivaroxaban Zentiva 20 mg is available in packs of 14, 28, 30, 98 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

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

Manufacturers
S.C. Zentiva S.A.
Bulevardul Pallady Theodor nr. 50, Sector 3
322 66 Bucharest, Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 300, Malta

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic, Denmark, Germany, Hungary, Iceland, Italy, Netherlands, Norway, Spain and Sweden: Rivaroxaban Zentiva
Croatia: Rivaroxaban ZENTIVA
France: Rivaroxaban ZENTIVA
Portugal: Rivaroxabano Zentiva