Rivaroxaban Doc Generici: detailed information

Package leaflet: Information for the user

RIVAROXABAN DOC 2.5 mg film-coated tablets

Equivalent 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

RIVAROXABAN DOC has been prescribed for you because
you have been diagnosed with acute coronary syndrome (a group of conditions that includes 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 DOC reduces the risk of another heart attack or the risk of dying due to
a heart- or blood vessel-related disease.
RIVAROXABAN DOC will not be given to you alone. Your doctor will also prescribe one of the following:

acetylsalicylic acid, or
acetylsacetic 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 DOC reduces, in adults, the risk of clot formation (atherothrombotic events).
RIVAROXABAN DOC will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you need to take RIVAROXABAN DOC following a procedure 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.
RIVAROXABAN DOC contains the active substance rivaroxaban and 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 form clots.

2. What you should know before taking RIVAROXABAN DOC

Do not take RIVAROXABAN DOC 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 DOC.
RIVAROXABAN DOC must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except for acetylsalicylic acid and clopidogrel/ticlopidine.

Be especially careful with RIVAROXABAN DOC
if you have an increased risk of bleeding, such as in the following cases:
severe kidney disease, because kidney function may alter 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 DOC”)
coagulation disorders
very high blood pressure, uncontrolled with medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach or intestine or in the genital or urinary tract
a blood vessel disorder at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous history of bleeding from the lungs
if you are over 75 years old
if you weigh less than 60 kg
if you have coronary artery 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 a change in therapy is needed.

If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN DOC. 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 DOC 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 anesthesia for pain relief):
it is very important to take RIVAROXABAN DOC before and after the injection or catheter removal exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anesthesia wears off, as urgent intervention may be required.

2/21

Children and adolescents
RIVAROXABAN DOC 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 DOC
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
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics for bacterial infections (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”))
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
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 DOC, because the effect of RIVAROXABAN DOC may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking
certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St. John’s wort (Hypericum perforatum), a herbal medicine used for depression
rifampicin, an antibiotic

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

Pregnancy and breastfeeding
Do not take RIVAROXABAN DOC during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking RIVAROXABAN DOC. 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 DOC 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 DOC contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RIVAROXABAN DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
What dose to take
3/21
The recommended dose is one 2.5 mg tablet twice daily. Take RIVAROXABAN DOC 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 DOC 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 RIVAROXABAN DOC tablet through a tube inserted into the stomach.
RIVAROXABAN DOC will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.
If you are taking RIVAROXABAN DOC following an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking RIVAROXABAN DOC after a procedure used to widen a narrowed or blocked artery in the leg 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 acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or a standard daily dose of ticlopidine).
When to start RIVAROXABAN DOC
Treatment with RIVAROXABAN DOC after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, no sooner than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) 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 DOC.
Your doctor will decide how long your treatment should continue.
If you take more RIVAROXABAN DOC than you should
Contact your doctor immediately if you have taken too many RIVAROXABAN DOC tablets. If you have taken an excessive amount of RIVAROXABAN DOC, your risk of bleeding increases.
If you forget to take RIVAROXABAN DOC
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 DOC
Take RIVAROXABAN DOC regularly for the entire duration prescribed by your doctor.
Do not stop taking RIVAROXABAN DOC 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, RIVAROXABAN DOC may cause side effects, although not everybody experiences them.
Like other similar medicines used to reduce clot formation, RIVAROXABAN DOC can cause bleeding that may potentially be life-threatening. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Inform your doctor immediately if you notice any of the following side effects:
4/21

Signs of bleeding – bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. A 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 occur in 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 occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

Complete list of possible side effects
Common (may affect up to 1 in 10 people)
reduction in red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
bleeding or fluid leakage from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through 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)
general decrease in strength and energy (weakness, fatigue), headache, dizziness, rash, itchy skin
increase in certain liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)
bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
5/21
hives

Rare (may affect up to 1 in 1,000 people)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling

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

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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after Exp./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 DOC contains
The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are:
Tablet core: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose (E460),
sodium croscarmellose, magnesium stearate (E470b), anhydrous colloidal silica (E551). See section 2
“RIVAROXABAN DOC contains lactose and sodium”
Film coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521),
iron oxide yellow (E172)
Description of the appearance of RIVAROXABAN DOC and pack sizes
The 2.5 mg film-coated tablets of RIVAROXABAN DOC are light yellow, round, biconvex, with “2.5” engraved on one side and smooth on the other side. The tablet diameter is approximately 8.6 mm ± 0.2 mm.
The tablets are supplied in blisters in packs containing 56 film-coated tablets.
Marketing Authorization Holder:
6/21
DOC Generici Srl - Via Turati 40, 20121 Milano – Italy
Manufacturers:
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004, Greece
PharOS MT Ltd., HF62X, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta
7/21

Package leaflet: Information for the user

RIVAROXABAN DOC 10 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, because it could 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 DOC is and what it is used for
What you need to know before taking RIVAROXABAN DOC
How to take RIVAROXABAN DOC
Possible side effects
How to store RIVAROXABAN DOC
Contents of the pack and other information

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

RIVAROXABAN DOC contains the active substance rivaroxaban and is used in adults to
prevent the formation of blood clots 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 recurrence of blood clots in the blood vessels of the legs
and/or lungs.
RIVAROXABAN DOC belongs to a group of medicines called antithrombotic agents. It works by
inhibiting a clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

2. What you should know before taking RIVAROXABAN DOC

Do not take RIVAROXABAN DOC
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 DOC 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 DOC.
8/21
Exercise particular caution with RIVAROXABAN DOC
if you have an increased risk of bleeding, such as in the following cases:
moderate or severe kidney disease, as 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 DOC”)
coagulation disorders
very high blood pressure not controlled with medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours located in the stomach or intestine or in the genital or urinary tract
a blood vessel disorder at 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 therapy 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 DOC. 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 DOC 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):
it is very important to take RIVAROXABAN DOC exactly at the times indicated by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent medical intervention may be required.
Children and adolescents
RIVAROXABAN DOC 10 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 DOC
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
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, a condition in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))
9/21
If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN DOC, as the effect of RIVAROXABAN DOC may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.
If you are taking
certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St. John’s wort (Hypericum perforatum), a herbal medicine used for depression
rifampicin, an antibiotic
If any of the conditions described above apply to you, inform your doctor before taking RIVAROXABAN DOC, as the effect of RIVAROXABAN DOC may be reduced. Your doctor will decide whether you should be treated with RIVAROXABAN DOC and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take RIVAROXABAN DOC during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking RIVAROXABAN DOC. 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 DOC may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If these symptoms occur, do not drive, ride a bicycle, or use tools or machinery.
RIVAROXABAN DOC contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RIVAROXABAN DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or
pharmacist.
What dose to take
To prevent blood clots in veins after hip or knee replacement surgery
The recommended dose is one 10 mg RIVAROXABAN DOC tablet once daily.
To treat blood clots in the leg veins and in the blood vessels of the lungs, and to prevent recurrence of clots
After at least 6 months of treatment for blood clots, the recommended dose is either one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you
RIVAROXABAN DOC 10 mg once daily.
Swallow the tablet preferably with some water.
RIVAROXABAN DOC may be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take RIVAROXABAN DOC 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 RIVAROXABAN DOC tablet via a tube inserted into the stomach.
When to take RIVAROXABAN DOC
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.
10/21
To prevent blood clots in veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the tablets for 2 weeks.
If you take more RIVAROXABAN DOC than you should
Contact your doctor immediately if you have taken too many RIVAROXABAN DOC tablets. If you have taken an excessive amount of RIVAROXABAN DOC, your risk of bleeding increases.
If you forget to take RIVAROXABAN DOC
If you forget a dose, take it as soon as you remember. Take the next tablet the following day, and then continue taking one tablet daily as before.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking RIVAROXABAN DOC
Do not stop taking RIVAROXABAN DOC without first talking to your doctor, as RIVAROXABAN DOC prevents the development of a serious condition.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIVAROXABAN DOC can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce the formation of blood clots, RIVAROXABAN DOC can cause bleeding that may potentially be life-threatening. Massive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you notice any of the following side effects:

Signs of bleeding: bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness – a 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 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 diseases (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
Signs of severe allergic reactions: swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

Complete list of possible side effects
Common (may occur in up to 1 in 10 people)
reduction in red blood cell count, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding 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
pain in limbs
kidney dysfunction (can be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in strength and energy (weakness, fatigue), headache, dizziness, rash, itchy skin
increase in certain liver enzymes in blood tests
Uncommon (may occur in up to 1 in 100 people)
bleeding in the brain or inside the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduction in the number of platelets, the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives
Rare (may occur in up to 1 in 1,000 people)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare (may occur in up to 1 in 10,000 people)
accumulation of eosinophils, a type of granulocytic white blood cells causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from the available data)
renal failure following severe bleeding
renal bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

5. How to store RIVAROXABAN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on each blister after Exp./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. Contents of the pack and other information

What RIVAROXABAN DOC contains
The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other components are:
Tablet core: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose (E460),
sodium croscarmellose, magnesium stearate (E470b), anhydrous colloidal silica (E551). See section 2
“RIVAROXABAN DOC contains lactose and sodium”
Tablet film coating: hypromellose (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide red (E172)
Description of the appearance of RIVAROXABAN DOC and pack contents
The 10 mg film-coated tablets of RIVAROXABAN DOC are light red, round, biconvex, with “10” engraved on one side and smooth on the other. The tablet diameter is approximately 8.6 mm ± 0.2 mm.
The tablets are supplied in blisters in packs of 10 or 30 film-coated tablets.
Marketing Authorization Holder:
DOC Generici Srl - Via Turati 40, 20121 Milano – Italy
Manufacturers:
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004, Greece
PharOS MT Ltd., HF62X, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta
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Package leaflet: Information for the user

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

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

RIVAROXABAN DOC contains the active substance rivaroxaban.
RIVAROXABAN DOC is used in adults to:
prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

RIVAROXABAN DOC is used in children and adolescents under 18 years of age and weighing at least 30 kg to:
treat blood clots and prevent their recurrence in 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 DOC belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you should know before taking RIVAROXABAN DOC

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

Take special care with RIVAROXABAN DOC
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 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 DOC”)
coagulation disorders
very high blood pressure that is not controlled with medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours located in the stomach or intestine or in the genital 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 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 you are scheduled for surgery
it is very important to take RIVAROXABAN DOC before and after surgery exactly as directed by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take RIVAROXABAN DOC before and after the injection or catheter removal exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent intervention may be required.

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

Other medicines and RIVAROXABAN DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.

If you are taking
some antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
some antibiotics (e.g. clarithromycin, erythromycin)
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some antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
some medicines for the treatment of 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 DOC, because the effect of RIVAROXABAN DOC 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
some medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St. John’s wort (Hypericum perforatum), a herbal medicine used for depression
rifampicin, an antibiotic

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

3. How to take RIVAROXABAN DOC

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
RIVAROXABAN DOC should be taken with a meal.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take RIVAROXABAN DOC in another
way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
The mixture should be taken immediately followed by food.
If necessary, your doctor may administer crushed RIVAROXABAN DOC tablets 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 RIVAROXABAN DOC tablet once daily.
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If you have kidney problems, the dose may be reduced to one 15 mg RIVAROXABAN DOC tablet 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 DOC tablet once daily (or one 10 mg RIVAROXABAN DOC tablet 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 RIVAROXABAN DOC tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg RIVAROXABAN DOC tablet 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 RIVAROXABAN DOC tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg RIVAROXABAN DOC 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 DOC 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 DOC tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg RIVAROXABAN DOC tablet once daily.
Take each dose of RIVAROXABAN DOC 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 remind you.
For parents or caregivers: please observe the child to ensure the full dose is taken.
Since the dose of RIVAROXABAN DOC is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted as weight changes.
Never adjust the dose of RIVAROXABAN DOC by yourself. If needed, 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 the alternative formulation of rivaroxaban granules for oral suspension.
For children and adolescents unable to swallow whole tablets, use rivaroxaban granules for oral suspension.
If the oral suspension is not available, the RIVAROXABAN DOC tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken after administration of this mixture. If necessary, your doctor may also administer crushed RIVAROXABAN DOC tablets via a gastric tube.

If you spit out the dose or vomit

Less than 30 minutes after taking RIVAROXABAN DOC, take a new dose.
More than 30 minutes after taking RIVAROXABAN DOC, do not take a new dose. In this case, take the next dose of RIVAROXABAN DOC at the usual time.
Contact your doctor if you spit out the dose or vomit repeatedly after taking RIVAROXABAN DOC.

When to take RIVAROXABAN DOC
Take the tablet or tablets every day until your doctor tells you to stop.
Try to take the tablet or tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
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To prevent 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 DOC exactly as directed by your doctor.

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

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

If you stop taking RIVAROXABAN DOC
Do not stop taking RIVAROXABAN DOC without first talking to your doctor, because RIVAROXABAN DOC 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, RIVAROXABAN DOC may cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, RIVAROXABAN DOC may cause bleeding that could potentially be life-threatening. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
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 of the body, vomiting, seizures, reduced 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 severe skin reactions widespread and intense skin rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis). A drug reaction causing skin rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
Signs of severe allergic reactions

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swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties;
sudden drop in blood pressure.
The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock;
may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).
Complete list of possible side effects reported in adults, children and adolescents
Common (may affect up to 1 in 10 people)
reduction in red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
bleeding or fluid leakage from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through blood tests performed by the doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general loss of strength and energy (weakness, fatigue), headache, dizziness,
skin rash, itchy skin
increase in certain liver enzymes in blood tests
Uncommon (may affect up to 1 in 100 people)
bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through blood tests performed by the 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)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling

formation of a blood collection (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 cells causing lung inflammation (eosinophilic pneumonia) Frequency not known (frequency cannot be estimated from the available data) kidney failure following severe bleeding renal bleeding sometimes with blood in urine leading to kidney dysfunction

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(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, 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 platelets, which are the cells that allow blood to clot)
heavy menstrual bleeding
Uncommon (may affect up to 1 in 100 people)
blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, bile pigment)
Reporting of side effects
If you experience any side effects, 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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after Exp./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 DOC contains
The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other components are:
Tablet core: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose (E460),
sodium croscarmellose, magnesium stearate (E470b), anhydrous colloidal silica (E551). See section 2
“RIVAROXABAN DOC contains lactose and sodium”
Tablet film coating: hypromellose (E464), titanium dioxide (E171), macrogol 3350 (E1521), iron oxide red (E172)

7. Description of the appearance of RIVAROXABAN DOC and contents of the pack

RIVAROXABAN DOC 15 mg film-coated tablets: red, round, biconvex tablets with “15” engraved on one side and smooth on the other side. The tablet diameter is approximately 5.6 mm ± 0.2 mm.
The tablets are supplied in blisters in packs of 42 film-coated tablets.
RIVAROXABAN DOC 20 mg film-coated tablets: red-brown, round, biconvex tablets with “20” engraved on one side and smooth on the other side. The tablet diameter is approximately 6.6 mm ± 0.2 mm.
The tablets are supplied in blisters in packs of 28 film-coated tablets.
Marketing Authorization Holder:
DOC Generici Srl - Via Turati 40, 20121 Milano – Italy
Manufacturers:
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004, Greece
PharOS MT Ltd.,
HF62X, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta
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