RIVAROXABAN 10 mg Hard Capsule

Зміст інструкції

1. Rivaroxaban Zentiva 10 mg hard capsules
   1. What is Rivaroxaban Zentiva and what is it used for
   2. What you need to know before taking Rivaroxaban Zentiva
   3. How to take Rivaroxaban Zentiva
   4. Possible side effects
   5. How to store Rivaroxaban Zentiva
   6. Contents of the pack and other information
2. Rivaroxaban Zentiva 15 mg hard capsules, 20 mg hard capsules
   1. What is Rivaroxaban Zentiva and what it is used for
   2. What you need to know before taking Rivaroxaban Zentiva
   3. How to take Rivaroxaban Zentiva
   4. Possible side effects
   5. How to store Rivaroxaban Zentiva
   6. Contents of the pack and other information

Rivaroxaban Zentiva 10 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

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

Rivaroxaban Zentiva belongs to a group of medicines called antithrombotic agents
.Its action is due to the blocking of the coagulation factor (factor
Xa) and therefore to the reduction of the blood's tendency 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 any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding
• if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when changing anticoagulant therapy or when you are receiving heparins through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding

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

If any of the conditions described apply to you, tellyour doctor before taking Rivaroxaban
Zentiva. The doctor will decide if you should be treated with this medicine and if you should be
closely monitored.

If you are going to have 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 anesthesia for pain relief): o it is very important to take Rivaroxaban Zentiva exactly at the times indicated by your doctor o immediately inform your doctor if you experience numbness or weakness in your legs or disturbances in the bowel or bladder at the end of the anesthesia, because in this case urgent intervention is necessary.

Children and adolescents
Rivaroxaban Zentiva 10 mg capsules are not recommended in people under
18 years of age.There is not enough information available on its use in children and
adolescents.

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 available without a prescription.

• If you are taking:o some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin or ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol) o some medicines against bacterial infections (e.g. clarithromycin, erythromycin) o some antiviral medicines against 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 some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)) If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban Zentiva, because the effect of Rivaroxaban Zentiva may be increased. The doctor will decide if you should be treated with this medicine and if you should be closely monitored. If the 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 some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) o St. John's Wort ( Hypericum perforatum), a herbal medicine used for depression o rifampicin, an antibiotic If any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban Zentiva, because the effect of Rivaroxaban Zentiva may be reduced. The doctor will decide if you should be treated with Rivaroxaban Zentiva and if 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, tell
your doctor immediately, who will decide how to continue treatment.

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

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

What dose to take

• To prevent the formation of blood clots in the veins after hip or kneereplacement surgeryThe recommended dose is one Rivaroxaban Zentiva 10 mg capsule once a day.
• To treat blood clots in the veins of the legs and in the blood vessels of thelungs and to prevent the recurrence of clotsAfter at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed Rivaroxaban Zentiva 10 mg once a day.

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

When to take Rivaroxaban Zentiva
Take the capsule every day until your doctor tells you to stop taking it.
Try to take the capsules at the same time each day, so you can
remember more easily. Your doctor will decide how long to continue your
treatment.
To prevent the formation of blood clots in the veins after hip or knee replacement:
Take the first capsule 6 – 10 hours after surgery.
If you have had major hip surgery, you will generally need to take the capsules for 5 weeks.
If you have had 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. If you
have taken an excessive amount of Rivaroxaban Zentiva, the risk of bleeding increases.

If you forget to take Rivaroxaban Zentiva
If you have forgotten a dose, take it as soon as you remember. Take the next capsule
the next day and then continue with one capsule a day, as before.
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, because Rivaroxaban Zentiva prevents a serious condition from occurring.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like other medicines with similar effects to reduce blood clot formation, Rivaroxaban Zentiva can
cause bleeding which could potentially endanger the patient's life.
Massive bleeding can cause a sudden drop in blood pressure (shock).
In some cases, bleeding may not be apparent.

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

• Signs of bleeding
• bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, convulsions, decreased level of consciousness and neck stiffness. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of severe skin reactions

• widespread and severe rash, blisters or mucous membrane 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 diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in
• 10,000).

Signs of severe allergic reactions:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

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

• reduction in the number of red blood cells, which can cause paleness and weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding into the white of the eye)
• bleeding into tissues or a body cavity (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after a surgical procedure
• blood or fluid leakage from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected by tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• 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 platelets, which are the cells that allow blood to clot)
• allergic reactions, including skin allergic reactions
• liver malfunction (can be detected by tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (decreased 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 cardiac procedure involving the insertion of a catheter into the leg artery

(pseudoaneurysm)

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

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

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• kidney impairment after severe bleeding
• bleeding in the kidneys, sometimes with blood in the urine leading to the inability of the kidneys to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system 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 blister
after Exp. The expiry date refers to the last day of that month.
PVC / PVdC / Alu blisters: store at a temperature below 30 ° C. Store in the original
package to protect from moisture.
Alu / Alu blisters: this medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Zentiva contains

• The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are lactose monohydrate, 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 powder ranging in color from white to off-white in
a size “3” capsule (approximately 16 mm in length) with an opaque beige cap and body.
The hard capsules are packaged 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 Member States of the European Economic Area with the
following denominations:
Czech Republic, Denmark, Germany, Hungary, Iceland Italy, Netherlands, Norway, Spain and Sweden:
Rivaroxaban Zentiva
Croatia: Rivaroxaban Zentiva
France: Rivaroxaban ZENTIVA
Portugal: Rivaroxabano Zentiva.

Rivaroxaban Zentiva 15 mg hard capsules, 20 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Rivaroxaban Zentiva 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 leg veins (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the leg and/or lung blood vessels.

Rivaroxaban Zentiva is used in children and adolescents under 18 years of age and with a body weight
of 30 kg or more for:

• treating blood clots and preventing the recurrence of blood clots 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 belongs to a group of medicines called antithrombotic agents.Its action is due to the blocking of the coagulation factor (factor
Xa) and therefore to the reduction of the blood's tendency 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 any of the other ingredients of this medicine

(listed in section 6);

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

Do not take Rivaroxaban Zentiva and tell your doctor if any of the above conditions 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 may be the case in case of:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, because kidney function can change the amount of active medicine in the body;
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant therapy or when you are 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, not controlled with medicines;
• diseases of the stomach or intestine that can cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract;
• a disorder of the blood vessels in the back of the eye (retinopathy);
• a lung disease with dilated and pus-filled bronchi (bronchiectasis), or 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), tell your doctor, who will decide if it is necessary to change the therapy
• if your doctor determines that blood pressure is unstable or another treatment or surgical procedure is planned to remove the blood clot from the lungs.

If any of the above conditions apply to you, tellyour doctor before taking Rivaroxaban
Zentiva. The doctor will decide whether you should be treated with this medicine and whether you should
be kept under close observation.

If you are going to have 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

vertebral (e.g. for epidural or spinal anesthesia for pain relief):
or it is very important to take Rivaroxaban Zentiva before and after the injection or the
removal of the catheter exactly at the times indicated by your doctor
or immediately inform your doctor if you experience numbness or weakness in the legs or
problems with the intestines or bladder at the end of anesthesia, because in this case
urgent intervention is necessary.

Children and adolescents
Rivaroxaban Zentiva 15 mg is not recommended in children with a body weight below
30 kg.
Rivaroxaban Zentiva 20 mg is not recommended in children with a body weight below
50 kg.
There is not enough information available on the use of rivaroxaban in children and
adolescents in the adult indications.

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

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

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

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

If any of the above conditions apply to you, tell your doctorbefore 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 kept under
close observation.

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, tell
your doctor immediately, who will decide how to continue treatment.

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

Rivaroxaban 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, 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 following exactly the instructions of your doctor. If you have
any doubts, ask your doctor or pharmacist.
Rivaroxaban Zentiva must be taken with a meal.
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 can be mixed with water or applesauce
immediately before taking it. Taking the mixture should be immediately followed
by taking food.
If necessary, your doctor may administer the dispersed contents of the Rivaroxaban
Zentiva capsule through a tube inserted into your 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 Rivaroxaban Zentiva 20 mg capsule once
a day.
If you have kidney problems, the dose may be reduced to one Rivaroxaban
Zentiva 15 mg capsule once a day.
If you need to undergo a procedure to treat blocked blood vessels
in your heart (called PCI - Percutaneous Coronary Intervention with
stent placement), there is limited evidence to support reducing
the dose to one Rivaroxaban Zentiva 15 mg capsule once a day (or to
one Rivaroxaban Zentiva 10 mg capsule 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 the recurrence of clots
The recommended dose is one Rivaroxaban Zentiva 15 mg capsule twice a day
for the first 3 weeks.
After 3 weeks, the recommended dose is one Rivaroxaban Zentiva 20 mg
capsule once a day.
After at least 6 months of treatment for blood clots, your doctor may decide to
continue treatment with one 10 mg capsule once a day or one
20 mg capsule once a day.
If you have kidney problems and are taking one Rivaroxaban Zentiva 20 mg capsule once a day,
your doctor may decide to reduce the dosage for treatment after 3 weeks to one
Rivaroxaban Zentiva 15 mg capsule once a day if the risk of bleeding is greater than the
risk of having a new blood clot.

• Children and adolescentsThe dose of Rivaroxaban Zentiva depends on body weight and will be calculated by your doctor.
• The recommended dose for children and adolescents weighing between 30 kgand 50 kgis one Rivaroxaban Zentiva 15 mgcapsule once a day.
• The recommended dose for children and adolescents weighing 50 kg or moreis one Rivaroxaban Zentiva20 mgcapsule once a day. Take each dose of Rivaroxaban Zentiva with a drink (e.g. water or juice) during a meal. Take the capsules each day at approximately the same time. Consider setting an alarm to remind yourself. For parents or caregivers: observe the child to make sure the entire dose is taken.

Because the dose of Rivaroxaban Zentiva is based on body weight, it is important to attend
scheduled visits with your doctor because the dose may need to be adjusted as
your weight changes.
Never adjust the dose of Rivaroxaban Zentiva yourself. If necessary, your doctor will
adjust the dose.
Do not divide the contents of the capsule in an attempt to fractionate the capsule dose. If a
lower dose is needed, use an alternative medicine containing rivaroxaban in the
form of granules for oral suspension.
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, you can disperse the contents of the
Rivaroxaban Zentiva capsule and mix it with water or applesauce immediately before
taking it. Take food after taking this mixture. If necessary, your doctor
may also administer the dispersed contents of the Rivaroxaban Zentiva capsule through
a gastric tube.

If you spit out the dose or vomit

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

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

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

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, the risk of bleeding increases.

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

Adults:
If you are taking a 15 mg capsule twice a day and have forgotten
a dose, take it as soon as you remember .Do not take more than two 15 mg capsules in the same day. If you forget a dose, you can
take two 15 mg capsules at the same time to take a total of two
capsules (30 mg) in one day. The next day, continue with one
15 mg capsule twice a day.

If you stop taking Rivaroxaban Zentiva
Do not stop taking Rivaroxaban Zentiva without first talking to
your doctor, because Rivaroxaban Zentiva prevents a serious condition from occurring.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like other medicines similar to reduce blood clot formation, Rivaroxaban Zentiva can
cause bleeding which may potentially endanger the patient's life.
Massive bleeding can cause a sudden drop in blood pressure (shock).
In some cases, bleeding may not be apparent.

Immediately inform your doctor 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, vomiting, convulsions, decreased level of consciousness and neck stiffness. A serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 in 100).

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

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

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull
• 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 malfunction (can be detected by tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or the number of platelets
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (decreased 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 cardiac procedure involving the insertion of a catheter into the leg artery (pseudoaneurysm)

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

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

Frequency not known(frequency cannot be estimated based on available data):

• kidney impairment after severe bleeding
• bleeding in the kidneys, sometimes with blood in the urine leading to the inability of the kidneys to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with rivaroxaban
were similar to those observed in adults and mainly of mild to moderate severity.

Side effects that have been observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low number of platelets that are cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system 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 blister
after Exp. The expiry date refers to the last day of that month.
PVC / PVdC / Alu blisters: store at a temperature below 30 ° C. Store in the original
packaging to protect from moisture.
Alu / Alu blisters: this medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Zentiva contains

• The active ingredient is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are lactose monohydrate, 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 15 mg capsules are filled with powder of colour from white to off-white in
size “1” capsule (approximately 19 mm in length) with cap and body of light brown
opaque colour.
Rivaroxaban Zentiva 20 mg capsules are filled with powder of colour from white to off-white in
size “0” capsule (approximately 22 mm in length) with cap and body of dark brown
opaque colour.
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 Member States of the European Economic Area with the
following denominations:
Czech Republic, Denmark, Germany, Hungary, Iceland, Italy, Netherlands, Norway, Spain and
Sweden: Rivaroxaban Zentiva
Croatia: Rivaroxaban ZENTIVA
France: Rivaroxaban ZENTIVA
Portugal: Rivaroxabano Zentiva