Package leaflet: Information for the user

Rivaroxaban Cipla 2.5 mg film-coated tablets

rivaroxaban
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 they have the same symptoms as you, because it could 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

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

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

Rivaroxaban Cipla has been prescribed to you because

you have been diagnosed with acute coronary syndrome (a group of conditions including heart attack and unstable angina, a severe form of chest pain) and blood tests have shown elevated levels of certain cardiac markers. In adults, Rivaroxaban Cipla reduces the risk of another heart attack or the risk of death due to heart- or blood vessel-related disease. Rivaroxaban Cipla will not be given to you alone. Your doctor will also prescribe:
- acetylsalicylic acid, or
- acetylsalicylic acid plus clopidogrel or ticlopidine.

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 Cipla reduces the risk of clot formation (atherothrombotic events). Rivaroxaban Cipla will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you need to take Rivaroxaban Cipla following 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.

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

2. What you need to know before taking Rivaroxaban Cipla

Do not take Rivaroxaban Cipla

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 ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
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 have previously had bleeding or a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke), or if there has been a blockage of the small arteries carrying blood to the deep tissues of the brain (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 Cipla 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 Cipla.
Rivaroxaban Cipla 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 Cipla

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 heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Cipla”)
- coagulation disorders
- very high blood pressure, uncontrolled with medicines
- diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the esophagus, e.g., 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 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 a change in therapy is necessary.

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

Children and adolescents
Rivaroxaban Cipla 2.5 mg tablets are not recommended for people under 18 years of age. There is insufficient information on its use in children and adolescents.
Other medicines and Rivaroxaban Cipla
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 excess cortisol)
certain antibacterial medicines (e.g., clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g., ritonavir)
other medicines used to reduce 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 depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Cipla,
because the effect of Rivaroxaban Cipla may be increased. Your doctor will decide whether you should be treated with
this medicine and whether you need to be closely monitored.
If your doctor considers 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
Cipla, as the effect of Rivaroxaban Cipla may be reduced. Your doctor will decide whether you should be
treated with Rivaroxaban Cipla and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Cipla during pregnancy or breastfeeding. If there is a possibility you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Cipla.
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 Cipla 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 Cipla 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 Cipla

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban Cipla 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 Cipla in another way. The tablet may be crushed and mixed with a small amount of water or apple puree, immediately before taking it.
If necessary, your doctor may administer the crushed Rivaroxaban Cipla tablet through a tube inserted into the stomach.
Rivaroxaban Cipla will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you. If you are taking Rivaroxaban Cipla after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rivaroxaban Cipla following 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 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 Cipla
After an acute coronary syndrome, treatment with Rivaroxaban Cipla should be started 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 Cipla.
Your doctor will decide how long your treatment should continue.
Remember to always carry your patient alert card with you. Inform any doctor or dentist treating you that you are taking Rivaroxaban Cipla.
If you take more Rivaroxaban Cipla than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Cipla tablets. If you have taken an excessive amount of Rivaroxaban Cipla, your risk of bleeding increases.
If you forget to take Rivaroxaban Cipla
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 Cipla
Take Rivaroxaban Cipla regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Cipla without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or 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 Cipla can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Cipla can cause bleeding which may potentially be life-threatening. Severe bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Immediately inform your doctor if you experience any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, 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 rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including

anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).
Complete list of possible side effects
Common (may affect up to 1 in 10 people)

reduced number of red blood cells, which may cause paleness and lead to 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 the skin or under the skin
bleeding after surgery
loss of blood or fluid from surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected by blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing)
general decrease in strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

accumulation of eosinophils, a type of granulocyte white blood cells causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding, sometimes with blood in 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)

Reporting of side effects
If you get any side effects, including ones 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 Cipla

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 packaging and on each blister
or bottle after Exp./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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Cipla contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other ingredients are: Tablet core: croscarmellose sodium, hypromellose, monohydrate lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. See section 2 “Rivaroxaban Cipla contains lactose and sodium”. Film coating: hypromellose 2910 (E464), yellow iron oxide (E172), macrogol (E1521), titanium dioxide (E171).

Description of the appearance of Rivaroxaban Cipla and contents of the pack
Rivaroxaban Cipla 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated, with a diameter of 6.0 ± 0.20 mm, imprinted with “2.5” on one side and smooth on the other. They are supplied in PVC/PVDC/Aluminium blisters in packs of 14, 56, 98, 168 and 196 film-coated tablets.
Not all pack sizes may be marketed.
Inside the Rivaroxaban Cipla package, together with the package leaflet, you will find a Patient Card containing useful information for you and alerting other physicians that you are taking Rivaroxaban Cipla. Always carry this card with you.

Marketing Authorisation Holder

Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer

Alterno AD d.o.o.,
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia

Package leaflet: Information for the user

Rivaroxaban Cipla 10 mg film-coated tablets

rivaroxaban
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 they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rivaroxaban Cipla contains the active substance rivaroxaban and is used in adults to

prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because, after surgery, there is an increased risk of blood clots forming.
treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking Rivaroxaban Cipla

Do not take Rivaroxaban Cipla

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of severe bleeding (e.g., stomach ulcer, 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 a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding.

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

if you have an increased risk of bleeding, such as in the following cases:
- 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 when receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Cipla”)
- coagulation disorders
- very high blood pressure not controlled with medication
- stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours 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 previous bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor 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 listed above apply to you, inform your doctor before taking Rivaroxaban Cipla.
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 Cipla 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 or for pain relief):
- it is very important to take Rivaroxaban Cipla 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 Cipla 10 mg tablets are not recommended for individuals under 18 years of age.
There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Cipla
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 antibacterial medicines (e.g., clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g., ritonavir)
other medicines used to reduce 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 the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions listed above apply to you, inform your doctor before taking Rivaroxaban Cipla,
as the effect of Rivaroxaban Cipla may be increased. Your doctor will decide whether you should be treated with
this medicine and whether you need to be closely monitored.
If your doctor considers 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 listed above apply to you, inform your doctor before taking Rivaroxaban
Cipla, as the effect of Rivaroxaban Cipla may be reduced. Your doctor will decide whether you should be
treated with Rivaroxaban Cipla and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Cipla during pregnancy or breastfeeding. If there is a possibility you may become pregnant, use a reliable method of contraception while taking Rivaroxaban Cipla.
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 Cipla 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 Cipla 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 Cipla

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 Cipla 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 either one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you rivaroxaban 10 mg once daily.

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

Remember to always carry your patient alert card with you. Inform any doctor or dentist treating you that you are taking Rivaroxaban Cipla.

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

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

If you forget to take Rivaroxaban Cipla
If you forget a dose, take it as soon as you remember. Take the next dose the following day at your usual time, and then continue as before with one tablet daily.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Rivaroxaban Cipla
Do not stop taking Rivaroxaban Cipla without first talking to your doctor, as Rivaroxaban Cipla helps prevent a serious condition.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, 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 rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

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

reduction in red blood cell count, which may cause paleness and lead to 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
limb pain
kidney dysfunction (can be detected by blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general loss of strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or inside the skull (see above, signs of bleeding)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (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, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia)

Frequency not known (cannot be estimated from available data)

kidney failure following severe bleeding
kidney bleeding, sometimes with blood in the 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, please inform 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 Cipla

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 packaging 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.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Cipla contains

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
Other components are:
Tablet core: croscarmellose sodium, hypromellose, monohydrate lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. See section 2 “Rivaroxaban Cipla contains lactose and sodium”.
Film coating: hypromellose 2910 (E464), iron oxide red (E172), macrogol (E1521), titanium dioxide (E171).

Description of the appearance of Rivaroxaban Cipla and package contents
The 10 mg film-coated tablets of Rivaroxaban Cipla are pink, round, biconvex, film-coated, with a diameter of 6.0 ± 0.20 mm, imprinted with “10” on one side and smooth on the other.
They are supplied in PVC/PVDC/Aluminum blisters in pack sizes of 10, 14, 30, 56, 98, and 168 film-coated tablets.
Not all pack sizes may be marketed.
Inside the Rivaroxaban Cipla packaging, together with the package leaflet, you will find a Patient Card containing useful information for you and informing other healthcare professionals that you are taking Rivaroxaban Cipla. Always carry this card with you.

Marketing Authorization Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer
Alterno AD d.o.o.,
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia

Package leaflet: information for the user

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

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

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

Contents of this leaflet

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

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

Rivaroxaban Cipla contains the active substance rivaroxaban.
Rivaroxaban Cipla 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 Cipla is used in children and adolescents under 18 years of age and with body weight equal to or greater than 30 kg for:

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

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

2. What you need to know before taking Rivaroxaban Cipla

Do not take Rivaroxaban Cipla

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 ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
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 a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding.

if you have an increased risk of bleeding, such as:
- severe kidney disease in adults, and moderate or 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 heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Cipla”)
- coagulation disorders
- very high blood pressure not controlled with medicines
- diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus) or tumours 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 previous 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 Cipla.
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 Cipla 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 or for pain relief):
- it is very important to take Rivaroxaban Cipla before and after the injection or removal of the catheter 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 treatment may be required.

Children and adolescents
Rivaroxaban Cipla tablets are not recommended for children weighing less than 30 kg.
There is insufficient information on the use of Rivaroxaban Cipla in children and adolescents for the adult indications.
Other medicines and Rivaroxaban Cipla
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
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 reduce 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 used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Cipla,
because the effect of Rivaroxaban Cipla may be increased. Your doctor will decide whether you should be treated with
this medicine and whether you need to be closely monitored.
If your doctor considers 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 remedy used for depression
rifampicin, an antibiotic.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Cipla,
because the effect of Rivaroxaban Cipla may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Cipla and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Cipla during pregnancy or breastfeeding. If you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Cipla.
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 Cipla 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 Cipla contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor 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 Cipla

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Rivaroxaban Cipla should be taken with a meal.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Cipla in
another way. The tablet may be crushed and mixed with water or apple puree immediately before
taking. The mixture should be followed immediately by food intake.
If necessary, your doctor may administer the crushed Rivaroxaban Cipla 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 Cipla tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Cipla 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 Cipla tablet once daily (or one 10 mg Rivaroxaban Cipla 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 Cipla tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Cipla 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 Cipla tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Cipla 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 Cipla 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 Cipla tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban Cipla tablet once daily.

Take each dose of Rivaroxaban Cipla 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 Cipla is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Cipla by yourself. If adjustment is needed, your doctor will do it.
Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use an alternative formulation of rivaroxaban.
For children and adolescents who cannot swallow whole tablets, use an alternative formulation of rivaroxaban.
If an alternative formulation is not available, the Rivaroxaban Cipla tablet may be crushed and mixed with water or apple puree immediately before administration. Food should be taken after taking this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Cipla tablet via a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Cipla
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 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 Cipla exactly as your doctor has instructed.
Remember to always carry your patient alert card with you. Inform any doctor or dentist treating you that you are taking Rivaroxaban Cipla.

If you forget to take Rivaroxaban Cipla

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

If you stop taking Rivaroxaban Cipla
Do not stop taking Rivaroxaban Cipla without first talking to your doctor, as Rivaroxaban Cipla treats serious conditions and helps prevent their occurrence.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Cipla can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Cipla can cause bleeding, which 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 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. 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 rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
Signs of serious allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives; breathing difficulties; sudden drop in blood pressure. The frequencies of these serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

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

reduced number of red blood cells, which may cause paleness and lead to 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
kidney dysfunction (may be detected through blood tests performed by the doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing up)
general lack of strength and energy (weakness, fatigue), headache, dizziness
skin rash, itching
increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or inside the skull (see above, signs of bleeding)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (may 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 bile flow, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (hematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

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

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

kidney failure following severe bleeding
kidney 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)

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 (a bile pigment)
thrombocytopenia (reduced platelet count, 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 specific bilirubin subtype (direct bilirubin, a bile pigment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on each blister
or bottle after Exp./EXP. The expiry date refers to the last day of that month.
This medicine requires no 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 Cipla contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, monohydrate lactose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Cipla contains lactose and sodium”.
Film coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172). Yellow iron oxide (E172) is also present in the 15 mg strength.

Description of the appearance of Rivaroxaban Cipla and pack sizes

The 15 mg film-coated tablets of Rivaroxaban Cipla are beige, round, biconvex, film-coated tablets with a diameter of 5.5 ± 0.20 mm, marked with “15” on one side and smooth on the other side. They are supplied in PVC/PVDC/Aluminium blisters in packs containing 10, 14, 28, 42 and 98 film-coated tablets.

The 20 mg film-coated tablets of Rivaroxaban Cipla are brown, round, biconvex, film-coated tablets with a diameter of 6.0 ± 0.20 mm, marked with “20” on one side and smooth on the other side. They are supplied in PVC/PVDC/Aluminium blisters in packs containing 14, 28 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Inside the Rivaroxaban Cipla packaging, together with the package leaflet, you will find a Patient Card containing useful information for you and alerting other physicians that you are taking Rivaroxaban Cipla. Always carry this card with you.

Marketing Authorisation Holder and Manufacturer

Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer

Alterno AD d.o.o.,
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia

Package leaflet: information for the user

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

Treatment initiation pack
Not for use in children
rivaroxaban
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

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

Contents of this leaflet

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

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

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

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 Cipla 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 need to know before taking Rivaroxaban Cipla

Do not take Rivaroxaban Cipla

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 ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
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 a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding.

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 heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Cipla”)
- bleeding disorders
- very high blood pressure not controlled with medicines
- diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g., caused by gastro-oesophageal reflux disease (a condition in which stomach acid rises into the oesophagus) or tumours located in the stomach, intestines, 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 previous bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether 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.

it is very important to take Rivaroxaban Cipla before and after surgery exactly as directed by your doctor.
If the surgery involves the use of a catheter or an injection into the spinal column (e.g., for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Rivaroxaban Cipla 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 the legs or bowel or bladder problems after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
The starter pack of Rivaroxaban Cipla is not recommended for individuals under 18 years of age, as it is specifically designed for initiating treatment in adult patients and is not suitable for use in children and adolescents.
Other medicines and Rivaroxaban Cipla
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 antibacterial medicines (e.g., clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g., ritonavir)
other medicines used to reduce 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 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 Cipla,
because the effect of Rivaroxaban Cipla 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
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
Cipla, as the effect of Rivaroxaban Cipla may be reduced. Your doctor will decide whether you should be
treated with Rivaroxaban Cipla and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Cipla during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Cipla.
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 Cipla 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 Cipla contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor 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 Cipla

Take this medicine exactly as your doctor has told you. If you are not sure, consult your
doctor or pharmacist.
Rivaroxaban Cipla should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Cipla in
another way. The tablet may be crushed and mixed with water or apple puree immediately before
taking. The mixture should be followed immediately by food.
If necessary, your doctor may administer the crushed Rivaroxaban Cipla tablet through a tube inserted
into the stomach.

What dose to take
The recommended dose is one 15 mg Rivaroxaban Cipla tablet twice daily for the first 3 weeks. After
3 weeks, the recommended dose is one 20 mg Rivaroxaban Cipla tablet once daily.
This starter pack containing 15 mg and 20 mg Rivaroxaban Cipla tablets should only be used for the
first 4 weeks of treatment.
After completing this pack, treatment will continue with Rivaroxaban Cipla 20 mg once daily, as
instructed by your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks to one
15 mg Rivaroxaban Cipla tablet once daily, if the risk of bleeding is greater than the risk of developing
a new blood clot.
Remember to always carry your patient alert card with you. Inform any doctor or dentist treating you
that you are taking Rivaroxaban Cipla.

When to take Rivaroxaban Cipla
Take the tablet or tablets 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.

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

If you forget to take Rivaroxaban Cipla
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 following day, resume
taking one 15 mg tablet twice daily.
If you are taking one 20 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 then continue taking one tablet once daily.

If you stop taking Rivaroxaban Cipla
Do not stop taking Rivaroxaban Cipla without first talking to your doctor, because Rivaroxaban Cipla
treats serious conditions and helps prevent their occurrence.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Cipla can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Cipla can cause bleeding that may potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Inform 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 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, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of these severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

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

reduction in red blood cell count, which may cause paleness and lead to 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 surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected through blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell or malaise, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing up)
general loss of strength and energy (weakness, fatigue), headache, dizziness
rash, itching
increased levels of certain liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduction in platelet count; platelets are blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through blood tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain 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, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

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

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

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

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

5. How to store Rivaroxaban Cipla

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 pack, the wallet container,
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.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Cipla contains

The active substance is rivaroxaban. Each tablet contains either 15 mg or 20 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Cipla contains lactose and sodium”. Film coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172). The 15 mg tablet additionally contains iron oxide yellow (E172).

Description of the appearance of Rivaroxaban Cipla and package contents
Rivaroxaban Cipla 15 mg film-coated tablets are beige, round, biconvex, film-coated, with a diameter of 5.5 ± 0.20 mm, marked with “15” on one side and smooth on the other side.
Rivaroxaban Cipla 20 mg film-coated tablets are brown, round, biconvex, film-coated, with a diameter of 6.0 ± 0.20 mm, marked with “20” on one side and smooth on the other side.
Treatment initiation pack for the first 4 weeks: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
42 film-coated tablets containing 15 mg rivaroxaban and 7 film-coated tablets containing 20 mg rivaroxaban in a blister pack.
Inside the Rivaroxaban Cipla package, together with the package leaflet, you will find a Patient Alert Card containing useful information for you and warning other healthcare professionals that you are taking Rivaroxaban Cipla. Always carry this card with you.

Marketing Authorisation Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Manufacturer
Alterno AD d.o.o.,
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia