Rivaroxaban Aurobindo

Italy
Brand name Rivaroxaban Aurobindo
Form tablets, film-coated
Active substance / Dosage
RIVAROXABAN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AF01
Registration number 045562
Manufacturer AUROBINDO PHARMA (ITALIA) S.R.L.

Table of Contents

Patient Information Leaflet

Rivaroxaban Aurobindo 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms 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 Aurobindo is and what it is used for
  2. What you need to know before taking Rivaroxaban Aurobindo
  3. How to take Rivaroxaban Aurobindo
  4. Possible side effects
  5. How to store Rivaroxaban Aurobindo
  6. Contents of the pack and other information

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

Rivaroxaban Aurobindo contains the active substance rivaroxaban, which 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 the risk of developing blood clots increases after surgery;
  • treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Aurobindo 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 clot.

2. What you need to know before taking Rivaroxaban Aurobindo

Do not take Rivaroxaban Aurobindo

  • 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 a liver disease that increases the risk of bleeding;
  • during pregnancy or breastfeeding.

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

  • If you have an increased risk of bleeding, which may occur in situations such as:
    • moderate or severe kidney disease, because your kidney function may alter the amount of active medicine in your body
    • if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), 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 Aurobindo”)
    • coagulation disorders
    • very high blood pressure not controlled by medication
    • diseases of the stomach or intestine that could 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, intestine, genital tract or urinary tract
    • a blood vessel disorder in the back of the eye (retinopathy)
    • a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs.
  • If you have a prosthetic heart valve.
  • If you know you have a condition called antiphospholipid syndrome (an 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 Aurobindo. 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 Aurobindo 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 Aurobindo 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 intervention may be required.

Children and adolescents
Rivaroxaban Aurobindo is 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 Aurobindo
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 applied only to the skin
    • ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
    • certain antibiotics (e.g. clarithromycin, erythromycin)
    • certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
    • other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
    • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
    • dronedarone, a medicine used to treat atrial fibrillation
    • certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If any of the above conditions apply to you, inform your doctor before taking
Rivaroxaban Aurobindo, as the effect of Rivaroxaban Aurobindo may be
increased. Your doctor will decide whether you should be treated with this medicine and whether you should
be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may also prescribe preventive ulcer treatment.

  • 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 Aurobindo, as the effect of Rivaroxaban Aurobindo may be reduced.
Your doctor will decide whether you should be treated with Rivaroxaban Aurobindo and whether you should be
closely monitored.
Pregnancy, breastfeeding and fertility
Do not take Rivaroxaban Aurobindo during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Aurobindo. 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 Aurobindo may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4 “Possible side effects”). If
these symptoms occur, do not drive, ride a bicycle or operate tools or machinery.
Rivaroxaban Aurobindo 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 film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Rivaroxaban Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
How much Rivaroxaban Aurobindo to take

  • To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one Rivaroxaban Aurobindo tablet (10 mg) 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 Rivaroxaban Aurobindo 10 mg once daily.

Swallow the tablet preferably with water.
Rivaroxaban Aurobindo may be taken with or without food.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban Aurobindo in another way.
The tablet may be crushed and mixed with water or apple puree immediately before administration. If necessary, your doctor may administer the crushed Rivaroxaban Aurobindo tablet through a tube inserted into the stomach.
When to take Rivaroxaban Aurobindo
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 after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you had major hip surgery, you will usually need to take the tablets for 5 weeks.
If you had major knee surgery, you will usually need to take the tablets for 2 weeks.
If you take more Rivaroxaban Aurobindo than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Aurobindo tablets. If you take an excessive amount of Rivaroxaban Aurobindo, your risk of bleeding increases.
If you forget to take Rivaroxaban Aurobindo
If you forget a dose, take it as soon as you remember. Take the next tablet the following day and then continue as before with one tablet daily.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rivaroxaban Aurobindo
Do not stop taking Rivaroxaban Aurobindo without first talking to your doctor, because Rivaroxaban Aurobindo helps prevent serious conditions from occurring.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Aurobindo can cause bleeding which may potentially be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Tell your doctor immediately if you notice any of the following side effects:

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

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

  • Signs of severe skin reactions
    • widespread and severe rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis);
    • a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
  • Signs of severe allergic reactions
    • swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

  • reduction in red blood cells which may make the skin pale and cause weakness or breathlessness;
  • bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
  • bleeding in the eye (including bleeding in the white part of the eye);
  • bleeding into tissues or body cavities (haematoma, bruising);
  • coughing up blood;
  • bleeding from or under the skin;
  • bleeding after surgery;
  • blood or fluid leakage from the surgical wound;
  • swelling of limbs;
  • limb pain;
  • kidney problems (can be detected through tests performed by your doctor);
  • fever;
  • stomach ache, indigestion, feeling unwell, constipation, diarrhoea;
  • low blood pressure (symptoms include dizziness or fainting when standing);
  • lack of energy and strength (weakness, fatigue), headache, dizziness;
  • skin rash, itching;
  • increased levels of certain liver enzymes in blood tests.

Uncommon (may affect up to 1 in 100 people):

  • bleeding in the brain or inside the skull (see above, signs of bleeding);
  • bleeding into a joint, causing pain and swelling;
  • thrombocytopenia (reduction in platelets, which are the cells that help blood to clot);
  • allergic reactions, including skin allergic reactions;
  • liver problems (can be detected through 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):

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

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

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

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

  • kidney impairment following severe bleeding;
  • kidney bleeding sometimes with blood in 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 after bleeding).

Reporting of side effects
If you get 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 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 Aurobindo

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 blister and the carton 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Aurobindo contains

  • The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
  • The other components are:
    Tablet core: microcrystalline cellulose (grade 101 and grade 102), lactose monohydrate, croscarmellose sodium, hypromellose type 2910 (3 cPs), sodium lauryl sulfate, magnesium stearate
    Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), red iron oxide (E172)

Description of the appearance of Rivaroxaban Aurobindo and contents of the pack
Film-coated tablet.
Light red, round (diameter 6.1 mm), biconvex film-coated tablets, marked with "M" on one side and "10" on the other.
Film-coated tablets of Rivaroxaban Aurobindo are available in blister packs containing 5, 10, 30 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Rivaroxaban Aurobindo 10 mg Filmtabletten
Italy: Rivaroxaban Aurobindo
Portugal: Rivaroxabano Generis

Patient Information Leaflet: Information for the User

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

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

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

Contents of this leaflet:

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

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

Rivaroxaban Aurobindo contains the active substance rivaroxaban, which 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 Aurobindo is used in children and adolescents under 18 years of age and with body weight equal to or above 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 Aurobindo belongs to a group of medicines called antithrombotic agents.
Its action is due to the inhibition of clotting factor (factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you should know before taking Rivaroxaban Aurobindo

Do not take Rivaroxaban Aurobindo:

  • 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 your 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 from one anticoagulant therapy to another 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 Aurobindo 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 Aurobindo.

Take special care with Rivaroxaban Aurobindo

  • 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 Aurobindo”);
    • coagulation disorders;
    • very high blood pressure not controlled by medicines;
    • stomach or intestinal diseases that could cause bleeding, e.g. inflammation of the intestine or stomach, or oesophagitis, e.g. caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours in the stomach, intestine, genital tract or urinary tract;
    • a blood vessel disorder in the back of the eye (retinopathy);
    • a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs.
  • If you have a prosthetic heart valve.
  • If you know you have a condition called antiphospholipid syndrome (an 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 Aurobindo. 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 Aurobindo exactly at the times indicated by your doctor.
  • If your 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 Aurobindo before and after the injection or catheter removal exactly at the times indicated by your doctor;
    • inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent action may be required.

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

Other medicines and Rivaroxaban Aurobindo
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 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 atrial fibrillation;
    • 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 Aurobindo, as the effect of Rivaroxaban Aurobindo 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 also 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 above conditions apply to you, inform your doctor before taking Rivaroxaban Aurobindo, as the effect of Rivaroxaban Aurobindo may be reduced.
Your doctor will decide whether you should be treated with Rivaroxaban Aurobindo and whether you need to be closely monitored.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Rivaroxaban Aurobindo during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Aurobindo. 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 Aurobindo may cause dizziness (a common side effect) and 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 Aurobindo 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 film-coated tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Rivaroxaban Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Rivaroxaban Aurobindo 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 Aurobindo in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. The mixture should be followed immediately by food intake. If necessary, your doctor may administer crushed Rivaroxaban Aurobindo tablets through a tube inserted into the stomach.

What dose to take

  • Adults
    • To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg tablet of Rivaroxaban Aurobindo once daily. If you have kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban Aurobindo 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 dose reduction to one 15 mg tablet of Rivaroxaban Aurobindo once daily (or one 10 mg tablet of Rivaroxaban Aurobindo 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 tablet of Rivaroxaban Aurobindo twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Aurobindo 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 tablet of Rivaroxaban Aurobindo once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg tablet of Rivaroxaban Aurobindo 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 Aurobindo depends on body weight and will be calculated by the doctor.
    • The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg tablet of Rivaroxaban Aurobindo once daily.
    • The recommended dose for children and adolescents with a body weight equal to or above 50 kg is one 20 mg tablet of Rivaroxaban Aurobindo once daily. Take each dose of Rivaroxaban Aurobindo with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to help you remember. For parents or caregivers: please observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban Aurobindo 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 Aurobindo by yourself. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide a dose. If a lower dose is required, use the alternative formulation, rivaroxaban granules for oral suspension.
For children and adolescents who cannot swallow tablets whole, use rivaroxaban granules for oral suspension.
If the oral suspension is not available, the Rivaroxaban Aurobindo 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 crushed Rivaroxaban Aurobindo tablets via a gastric tube.

If you spit out the dose or vomit

  • If this happens less than 30 minutes after taking Rivaroxaban Aurobindo, take a new dose.
  • If this happens more than 30 minutes after taking Rivaroxaban Aurobindo, do not take a new dose. In this case, take your next dose of Rivaroxaban Aurobindo at the usual time.

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

When to take Rivaroxaban Aurobindo
Take the tablet(s) every day until your doctor tells you to stop.
Try to take the tablet(s) at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent the formation of blood 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 Aurobindo exactly as your doctor instructed.

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

If you forget to take Rivaroxaban Aurobindo

  • Adults, children and adolescents: If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in a single 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 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 Aurobindo
Do not stop taking Rivaroxaban Aurobindo without first talking to your doctor, as Rivaroxaban Aurobindo 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, this medicine can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Aurobindo can cause bleeding that may potentially be life-threatening.
Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you or your child experience any of the following side effects:

  • Signs of bleeding
    • bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. 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, e.g. 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 observed in adults, children and adolescents
Common (may affect up to 1 in 10 people):

  • reduced number of red blood cells, which may cause paleness, weakness or breathlessness;
  • bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums;
  • bleeding in the eye (including bleeding in the white of the eye);
  • bleeding into tissues or body cavities (haematoma, bruising);
  • coughing up blood;
  • bleeding from or under the skin;
  • bleeding after surgery;
  • blood or fluid leakage from surgical wound;
  • swelling in limbs;
  • limb pain;
  • kidney dysfunction (can be detected through tests performed by your doctor);
  • fever;
  • stomach ache, indigestion, feeling unwell, constipation, diarrhoea;
  • low blood pressure (symptoms include dizziness or fainting when standing);
  • decreased 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 within the skull (see above, signs of bleeding);
  • bleeding into a joint, causing pain and swelling;
  • thrombocytopenia (reduced platelet count; platelets are cells that help blood to clot);
  • allergic reactions, including skin allergic reactions;
  • liver dysfunction (can be detected through tests performed by your doctor);
  • blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count;
  • fainting;
  • feeling unwell;
  • dry mouth;
  • rapid heartbeat;
  • hives.

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

  • bleeding into a muscle;
  • cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury);
  • yellowing of the skin and eyes (jaundice);
  • localized swelling.

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

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

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

  • kidney impairment 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).

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with Rivaroxaban Aurobindo 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 cells that help blood to clot);
  • heavy menstrual bleeding.

Uncommon (may affect up to 1 in 100 people):

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

Reporting of side effects
If you experience any side 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 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 Aurobindo

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 blister and the carton
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 used. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Aurobindo contains

  • The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
  • The other components are:
    Tablet core: microcrystalline cellulose (type 101 and type 102), monohydrate lactose, croscarmellose sodium, hypromellose type 2910 (3 cPs), sodium lauryl sulfate, magnesium stearate.
    Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Rivaroxaban Aurobindo and package contents
Film-coated tablet.
Rivaroxaban Aurobindo 15 mg:
Film-coated tablets, red in colour, round, biconvex, marked with “M” on one side and “15” on the other side.
Rivaroxaban Aurobindo 20 mg:
Film-coated tablets, dark red to reddish-brown in colour, oval, biconvex, marked with “M” on one side and “20” on the other side.
Film-coated tablets of Rivaroxaban Aurobindo are available in blister packs.
Pack sizes:
For 15 mg: 14, 28, 42 and 98 film-coated tablets.
For 20 mg: 14, 28 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Rivaroxaban Aurobindo 15 mg/20 mg Filmtabletten
Italy: Rivaroxaban Aurobindo
Portugal: Rivaroxabano Generis