RIVAROXABAN SUN

Package leaflet: Information for the user

Rivaroxaban Sun 2.5 mg film-coated tablets

Rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rivaroxaban Sun has been prescribed to 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 your blood tests. In adults, Rivaroxaban Sun reduces the risk of another heart attack or the risk of dying due to heart- or blood vessel-related disease. Rivaroxaban Sun will not be given to you alone. Your doctor will also prescribe one of the following:
  • acetylsalicylic acid, or
  • acetylsalicylic acid plus clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of developing blood clots due to coronary artery disease or peripheral artery disease causing symptoms. In adults, Rivaroxaban Sun reduces the risk of clot formation (atherothrombotic events). Rivaroxaban Sun will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you are taking Rivaroxaban Sun following a procedure 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.

Rivaroxaban Sun contains the active substance rivaroxaban and belongs to a group of medicines called
antithrombotic agents . It works by blocking a clotting factor (factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you should know before taking Rivaroxaban Sun

Do not take Rivaroxaban Sun

• 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 heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
• if you have acute coronary syndrome and previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and previously had bleeding in the brain (stroke), or a blockage of the small arteries supplying deep brain tissues (lacunar stroke), or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding

Do not take Rivaroxaban Sun 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 Sun.
Rivaroxaban Sun must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except acetylsalicylic acid and clopidogrel/ticlopidine.
Take special care with Rivaroxaban Sun
if you have an increased risk of bleeding, such as in the following cases:

• severe kidney disease, because kidney function may affect the amount of active medicine in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Sun”)
• coagulation disorders
• very high blood pressure not controlled with medicines
• 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, intestine, genital tract or urinary tract
• a blood vessel disorder in the back of the eye (retinopathy)
• a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
• if you are over 75 years old
• if you weigh less than 60 kg
• if you suffer from 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 therapy needs to be changed.

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

Children and adolescents
Rivaroxaban Sun 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 Sun
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, 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, 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 abnormal heart rhythm
  • certain 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 Sun,
because the effect of Rivaroxaban Sun may be enhanced. The doctor will decide whether you should be treated with
this medicine and whether you need to be closely monitored.
If your doctor considers you to be at increased risk of developing stomach or intestinal ulcers,
they may prescribe preventive treatment for ulcers.

• If you are taking
  • 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 Sun,
as the effect of Rivaroxaban Sun may be reduced. The doctor will decide whether you should be treated with
Rivaroxaban Sun and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Sun during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Sun. 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 Sun may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machines.
Rivaroxaban Sun 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 Sun

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban Sun at the same times every
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 whole tablet, ask your doctor how to take Rivaroxaban Sun in another
way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before
taking.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Sun through a tube inserted into
the stomach.
Rivaroxaban Sun will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.
If you are taking Rivaroxaban Sun after an acute coronary syndrome, your doctor may also prescribe
clopidogrel or ticlopidine.
If you are taking Rivaroxaban Sun following a procedure used to dilate a narrowed or blocked leg artery to
restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in
combination with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetylsalicylic acid per
day, or a daily dose of 75–100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel, or a
standard daily dose of ticlopidine).
When to start Rivaroxaban Sun
Treatment with Rivaroxaban Sun 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 Sun.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Sun than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Sun tablets. If you have taken an
excessive amount of Rivaroxaban Sun, your risk of bleeding increases.
If you forget to take Rivaroxaban Sun
Do not take a double dose to make up for the forgotten dose. If you forget a dose, take the next dose at your
regular scheduled time.
If you stop taking Rivaroxaban Sun
Take Rivaroxaban Sun regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Sun 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 adverse effects

Like all medicines, Rivaroxaban Sun can cause adverse effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Sun 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.
Inform your doctor immediately if you notice any of the following adverse effects:

• Signs of bleeding
  • bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
  • prolonged or excessive blood loss
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris.

Your doctor may decide to monitor you closely or modify your treatment.

• Signs of severe skin reactions
  • widespread and intense 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 adverse 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; 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 adverse effects
Common (may affect up to 1 in 10 people)

• reduction in red blood cell count, which may cause pale skin, weakness, or shortness of breath
• gastrointestinal or intestinal bleeding, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• eye bleeding (including bleeding in the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• blood or fluid discharge from a surgical wound
• swelling in limbs
• limb pain
• impaired kidney function (can be detected through blood tests performed by a doctor)
• fever
• stomach ache, indigestion, feeling unwell, constipation, diarrhea
• 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
• increased 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 cells that help blood to clot)
• allergic reactions, including allergic skin reactions
• impaired liver function (can be detected through blood tests performed by a 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 bile flow), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving catheter insertion into the leg artery (pseudoaneurysm)

Very rare (may affect up to 1 in 10,000 people)
accumulation of eosinophils, a type of granulocytic white blood cell causing lung inflammation (eosinophilic pneumonia)
Frequency not known (frequency cannot be estimated from the available data)

• kidney failure following severe bleeding
• bleeding in the kidney with possible presence of blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy)
• increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Sun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or bottle
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Sun contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are: Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, low-substituted hydroxypropylcellulose (E463), croscarmellose sodium (E486), sodium lauryl sulfate (E487), magnesium stearate (E572). Film coating: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172). See also section 2 “Rivaroxaban Sun contains Lactose and Sodium”.

Description of the appearance of Rivaroxaban Sun and pack sizes
Rivaroxaban Sun 2.5 mg film-coated tablets are light yellow, round, biconvex, with " " imprinted on one side and “2.5” on the other side.
Rivaroxaban Sun 2.5 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters with an aluminium foil, in boxes containing: 10, 20, 21, 28, 30, 56, 60, 98, 100, 196 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, Hoofddorp,
Noord-Holland,
2132 JH,
The Netherlands
Terapia S.A.
Strada Fabricii Nr. 124,
Cluj-Napoca, Jud. Cluj,
400632, Romania

Package leaflet: information for the user

Rivaroxaban Sun 10 mg film-coated tablets

Rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• preventing the formation of blood clots in the veins after a hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots increases after surgery.
• 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 Sun belongs to a group of medicines called antithrombotic agents. It works by
inhibiting a clotting factor (Factor Xa), thereby reducing the blood's tendency to form clots.

2. What you should know before taking Rivaroxaban Sun

Do not take Rivaroxaban Sun

• 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 heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
• if you have liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding Do not take Rivaroxaban Sun and inform your doctor if any of the conditions listed above apply to you.

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

• if you have a high risk of bleeding, which may occur in situations such as:
  • moderate or severe kidney disease, because kidney function may affect the amount of active medicine in your body
  • if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Sun”)
  • blood clotting disorders
  • very high blood pressure, not controlled with medication
  • diseases of the stomach or intestines that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as 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 in the back of the eye (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from your lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
• if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

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

Children and adolescents
Rivaroxaban Sun 10 mg film-coated tablets are not recommended for patients under 18 years of age.
There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Sun
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, in which the body produces excess cortisol)
• certain antibacterial medicines (e.g. clarithromycin, erythromycin)
• certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
• other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• 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 Sun,
as the effect of Rivaroxaban Sun 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 you to be at increased risk of developing stomach or intestinal ulcers,
they may prescribe preventive treatment for ulcers.

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

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Sun,
as the effect of Rivaroxaban Sun may be reduced. Your doctor will decide whether you should be treated with
Rivaroxaban Sun and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Sun during pregnancy or breastfeeding. If you could become pregnant,
use a reliable method of contraception while taking Rivaroxaban Sun. 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 Sun 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 Sun 10 mg film-coated tablets contain 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 Sun

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
What dose to take

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Rivaroxaban Sun tablet once daily.
• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Sun 10 mg once daily. Swallow the tablet preferably with some water.

Rivaroxaban Sun can be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Sun in another way. The tablet can be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed Rivaroxaban Sun tablet through a tube inserted into the stomach.
When to take Rivaroxaban Sun
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day, to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have 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 Sun than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Sun tablets. If you have taken an excessive amount of Rivaroxaban Sun, the risk of bleeding increases.
If you forget to take Rivaroxaban Sun
If you have missed a dose, take it as soon as you remember. Take the next tablet the following day and then continue taking one tablet a day as before.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Rivaroxaban Sun
Do not stop taking Rivaroxaban Sun without first talking to your doctor, because Rivaroxaban Sun prevents the occurrence of a serious condition.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Signs of bleeding
  • bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
  • prolonged or excessive blood loss
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change 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, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).

• Signs of 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 occur in 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 (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• • bleeding after surgery
• • loss of blood or fluid from the surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (can be detected through blood tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• skin rash, itchy skin
• increased levels of certain liver enzymes in blood tests

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

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

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

• muscle bleeding
• cholestasis (reduced bile flow), hepatitis including hepatocellular injury (liver inflammation including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Sun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or bottle after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Sun contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose
monohydrate, low-substituted hydroxypropylcellulose (E463), sodium croscarmellose (E486), sodium
lauryl sulfate (E487), magnesium stearate (E572).
Film coating of the tablet: hypromellose 2910 (E464), lactose monohydrate, macrogol
4000 (E1521), titanium dioxide (E 171), iron oxide yellow (E172), carmine (E120).
See also section 2, "Rivaroxaban Sun 10 mg film-coated tablets contain lactose and
sodium".

Description of the appearance of Rivaroxaban Sun and package contents

Rivaroxaban Sun 10 mg are pink, round, film-coated tablets with a diameter of 6 mm, marked with a " " on one side and “10” on the other side.

Rivaroxaban Sun 10 mg film-coated tablets are packed in transparent PVC/PVDC/Al blisters, sealed with an aluminium foil, in boxes containing: 5, 10, 28, 30, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, Hoofddorp,
Noord-Holland,
2132 JH,
The Netherlands

Terapia S.A.
Strada Fabricii Nr. 124,
Cluj-Napoca, Jud. Cluj,
400632, Romania

Package leaflet: Information for the user

Rivaroxaban Sun 15 mg film-coated tablets, 20 mg film-coated tablets

Rivaroxaban
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rivaroxaban Sun contains the active substance rivaroxaban.
Rivaroxaban Sun is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban Sun is used in children and adolescents under 18 years of age and with body weight equal to or greater than 30 kg for:
• treating blood clots and preventing their recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Sun belongs to a group of medicines called antithrombotic agents. Its action is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you should know before taking Rivaroxaban Sun

Do not take Rivaroxaban Sun

• 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 heparin through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding

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

• if you have an increased risk of bleeding, such as:
• severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Sun”)
• 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, intestine, genital tract 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 a change in therapy is needed
• if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned

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

Children and adolescents
Rivaroxaban Sun tablets are not recommended for children weighing less than 30 kg. There is insufficient information on the use of Rivaroxaban Sun in children and adolescents for adult indications.
Other medicines and Rivaroxaban Sun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

• If you are taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain antibiotics 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)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• 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 Sun, because the effect of Rivaroxaban Sun 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 Sun, as the effect of Rivaroxaban Sun may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Sun and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Sun during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Sun. 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 Sun may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Sun 15 mg film-coated tablets contain 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”.
Rivaroxaban Sun 20 mg film-coated tablets contain 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 Sun

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Rivaroxaban Sun should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban Sun in another
way. The tablet may be crushed and mixed with a little water or apple puree immediately before taking.
The mixture should be taken immediately followed by food. If necessary, your doctor may administer the
crushed Rivaroxaban Sun tablet through a tube inserted into the stomach.

What dose to take

• Adults
  • To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg Rivaroxaban Sun tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Sun 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 a reduced dose of one 15 mg Rivaroxaban Sun tablet once daily (or one 10 mg Rivaroxaban Sun 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 Sun tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Sun 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 Sun tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Sun 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 Sun 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 Sun tablet once daily.
  • The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban Sun tablet once daily. Take each dose of Rivaroxaban Sun with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to help you remember. For parents or caregivers: please observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban Sun is based on body weight, it is important to attend scheduled
appointments with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Sun on your own. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to fractionate a dose. If a lower dose is required, use a rivaroxaban
product formulated as granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, use rivaroxaban granules for oral suspension.
If the oral suspension is not available, the Rivaroxaban Sun tablet may be crushed and mixed with water or
apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor
may also administer the crushed Rivaroxaban Sun tablet via a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Sun
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.
To prevent 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 Sun exactly as directed by your doctor.

If you forget to take Rivaroxaban Sun

• Adults, children and adolescents: If you are taking one 20 mg 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 Sun than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Sun tablets. If you have taken an excessive amount of Rivaroxaban Sun, your risk of bleeding increases.

If you stop taking Rivaroxaban Sun
Do not stop taking Rivaroxaban Sun without first talking to your doctor, because Rivaroxaban Sun 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 Sun may cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Sun may cause bleeding, which could potentially be life-threatening. Massive bleeding may cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you experience any of the following side effects:

• Signs of bleeding
  • bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
  • prolonged or excessive bleeding
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris.

Your doctor may decide to monitor you closely or change your treatment.

• Signs of 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 (up to 1 in 10,000 people may be affected).
• 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; up to 1 in 10,000 people may be affected) and uncommon (angioedema and allergic edema; up to 1 in 100 people may be affected).

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 part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• blood or fluid leakage from surgical wound
• swelling in limbs
• limb pain
• impaired kidney function (can be detected by blood tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general loss of strength and energy (weakness, fatigue), headache, dizziness
• skin rash, itchy skin
• increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

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

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

• muscle bleeding
• cholestasis (reduced bile flow), hepatitis including hepatocellular injury (liver inflammation including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of white granulocyte causing lung inflammation (eosinophilic pneumonia)
• Frequency not known (frequency cannot be estimated from the available data):
• kidney failure following severe bleeding
• kidney bleeding, possibly with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy)
• increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with Rivaroxaban Sun have been similar to those seen in adults and have mainly been mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show increased bilirubin (bile pigment)
• thrombocytopenia (reduced platelet count; platelets are blood cells that help blood to clot)
• heavy menstrual periods

Uncommon (may affect up to 1 in 100 people)

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

Reporting of side effects
If you experience any side 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Sun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or bottle
after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Sun contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, low-substituted hydroxypropylcellulose (E463), croscarmellose sodium (E486), sodium lauryl sulfate (E487), magnesium stearate (E572).
Tablet film coating:
Rivaroxaban Sun 15 mg: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), iron oxide red (E172), carmine (E120).
See also section 2, "Rivaroxaban Sun 15 mg film-coated tablets contain lactose and sodium".
Rivaroxaban Sun 20 mg: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), iron oxide red (E172).
See also section 2, "Rivaroxaban Sun 20 mg film-coated tablets contain lactose and sodium".

Description of the appearance of Rivaroxaban Sun and contents of the pack
Rivaroxaban Sun 15 mg are film-coated tablets, red in colour, round, 6 mm in diameter, imprinted with a " " on one side and “15” on the other side.
Rivaroxaban Sun 20 mg are film-coated tablets, dark red in colour, round, 6 mm in diameter, imprinted with a " " on one side and “20” on the other side.
Rivaroxaban Sun 15 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters, sealed with an aluminium foil, in cartons containing: 14, 28, 30, 42, 98 and 100 tablets.
Rivaroxaban Sun 20 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters, sealed with an aluminium foil, in cartons containing: 7, 10, 14, 28, 30, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, Hoofddorp,
Noord-Holland,
2132 JH,
The Netherlands
Terapia S.A.
Strada Fabricii Nr. 124,
Cluj-Napoca, Jud. Cluj,
400632, Romania