Package leaflet: Information for the user

Rivaroxaban Alter 10 mg film-coated tablets

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

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

Contents of this leaflet:

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

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

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

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

Rivaroxaban Alter belongs to a group of medicines called antithrombotic agents. It works by inhibiting a blood clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before taking Rivaroxaban Alter

Do not take Rivaroxaban Alter

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 heparins), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding Do not take Rivaroxaban Alter 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 Alter.
Take special care with Rivaroxaban Alter

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); if you are switching anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Alter”); coagulation disorders; very high, uncontrolled blood pressure despite medication; stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract; a blood vessel disorder at the back of the eye (retinopathy); a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from your lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed. If your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Alter. 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 Alter exactly at the times indicated by your doctor, both before and after surgery.
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 Alter 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 intervention may be required.

Children and adolescents
Rivaroxaban Alter 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 Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
If you are taking:

certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat heart rhythm disorders
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 Alter, because the effect of Rivaroxaban Alter 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 Alter, as the effect of Rivaroxaban Alter may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Alter and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Alter during pregnancy or breastfeeding. If you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Alter. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban Alter 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 operate tools or machinery.
Rivaroxaban Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rivaroxaban Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Alter

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

What dose to take

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

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

When to take Rivaroxaban Alter
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day, so you are more likely to remember.
Your doctor will decide how long your treatment should last.
To prevent blood clots after hip or knee replacement surgery:
Take the first tablet 6 – 10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the tablets for 2 weeks.

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

If you forget to take Rivaroxaban Alter
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 Alter
Do not stop taking Rivaroxaban Alter without first talking to your doctor, because Rivaroxaban Alter helps prevent serious conditions.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Rivaroxaban Alter can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Alter 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.
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, decreased 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, breathlessness, 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 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).

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

reduction in 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 gums
bleeding in the eye (including bleeding in the white of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
bleeding or fluid leakage from the surgical wound
swelling of limbs
limb pain
kidney dysfunction (can be detected by 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
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 (reduced platelet count; platelets are the blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected by tests performed by your doctor)
blood tests showing increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
malaise
rapid heartbeat
dry mouth
hives

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

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

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

kidney impairment following severe bleeding
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 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or
bottle after Exp./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 Alter contains
The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
The other components are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate,
hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2
“Rivaroxaban Alter contains lactose and sodium”.
Tablet coating: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of Rivaroxaban Alter and contents of the pack
The 10 mg film-coated tablets of Rivaroxaban Alter are round, biconvex, pink in colour, with a diameter of 6.00 mm.
The Rivaroxaban Alter film-coated tablets are available in packs containing 10 or 30 film-coated tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan, Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
PORTUGAL: Rivaroxabano Biofarmoz
FRANCE: Rivaroxaban Alter, comprimé pelliculé
SPAIN: Rivaroxaban Alter, comprimidos recubiertos con película EFG
ITALY: Rivaroxaban Alter
April 2023

Package leaflet: Information for the user

Rivaroxaban Alter 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Rivaroxaban Alter contains the active substance rivaroxaban.
Rivaroxaban Alter 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 recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban Alter 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 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 Alter belongs to a group of medicines called antithrombotic agents. Its action
is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of
blood to form clots.

2. What you need to know before taking Rivaroxaban Alter

Do not take Rivaroxaban Alter

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rivaroxaban Alter and inform your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Rivaroxaban Alter.
Exercise special caution with Rivaroxaban Alter

if you have an increased risk of bleeding, such as in cases of: 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 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 Alter”) coagulation disorders very high blood pressure not controlled by medication stomach or intestinal disorders that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus) or tumors located in the stomach, intestine, genital tract, or urinary tract a blood vessel disorder in the back of the eye (retinopathy) a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs if you 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 Alter 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 Alter before and after the injection or catheter removal exactly as directed by your doctor
- inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

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

certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (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 heart rhythm abnormalities
certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Alter, because the effect of Rivaroxaban Alter may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor 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 Alter, as the effect of Rivaroxaban Alter may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Alter and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Alter during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Alter. 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 Alter 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 Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rivaroxaban Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Alter

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Rivaroxaban Alter should be taken with food. Swallow the tablet or tablets
preferably with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban Alter 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 Alter 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 Rivaroxaban Alter tablet once daily. If you have kidney problems,
the dose may be reduced to one 15 mg Rivaroxaban Alter 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 Alter tablet once daily (or one 10 mg Rivaroxaban Alter 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 Alter tablet twice daily for the first 3 weeks. After
3 weeks, the recommended dose is one 20 mg Rivaroxaban Alter 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 Alter tablet once daily, your doctor
may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Alter 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 Alter depends on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents with body weight between 30 kg and 50 kg is one 15 mg Rivaroxaban Alter tablet once daily.
The recommended dose for children and adolescents with body weight equal to or greater than 50 kg is one 20 mg Rivaroxaban Alter tablet once daily. Take each dose of Rivaroxaban Alter with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to remind you. For parents or caregivers: please observe the child to ensure the full dose is taken.

Since the dose of Rivaroxaban Alter is based on body weight, it is important to attend scheduled appointments
with your doctor, as the dose may need to be adjusted with changes in weight.
Never adjust the dose of Rivaroxaban Alter by yourself. If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide a dose.
You may crush the Rivaroxaban Alter tablet and mix it with water or apple puree immediately before
administration. Take food after taking this mixture.
If necessary, your doctor may also administer crushed Rivaroxaban Alter tablets via a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Alter
Take the tablet or tablets every day until your doctor tells you to stop.
Try to take the tablet or tablets at the same time each day to help you remember.
Your doctor will decide how long the treatment should last.
To prevent formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat is to be restored to normal through a procedure called cardioversion, take Rivaroxaban
Alter exactly as directed by your doctor.

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

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

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

If you stop taking Rivaroxaban Alter
Do not stop taking Rivaroxaban Alter without first discussing it with your doctor, as Rivaroxaban Alter
treats serious conditions and helps prevent their occurrence.

If you have any questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

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

bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased 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, inflammation of internal organs, blood abnormalities and systemic diseases (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 reported in adults, children and adolescents
Common (may affect up to 1 in 10 people):

reduction in red blood cell count, which may cause paleness, weakness or shortness of breath
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 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 through blood tests performed by your doctor)
fever
stomach pain, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing)
decreased 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 within the skull (see above, signs of bleeding)
bleeding into a joint, causing pain and swelling
thrombocytopenia (reduced platelet count; platelets are the cells that allow blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through blood tests performed by your doctor)
blood tests showing increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
malaise
rapid heartbeat
dry mouth
hives

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

bleeding into a muscle
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)

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

kidney impairment following severe bleeding
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 Alter have been similar in type 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; platelets are the cells that allow blood to clot)
heavy menstrual bleeding
Uncommon (may affect up to 1 in 100 people)
blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister or
bottle after Exp./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 Alter contains
The active substance is rivaroxaban.
Each film-coated tablet contains 15 mg of rivaroxaban.
Each film-coated tablet contains 20 mg of rivaroxaban.
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate,
hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2
“Rivaroxaban Alter contains lactose and sodium”.
Tablet coating: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E
171), red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E172).
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate,
hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2
“Rivaroxaban Alter contains lactose and sodium”.
Tablet coating: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E
171), red iron oxide (E 172).

Description of the appearance of Rivaroxaban Alter and package contents
Rivaroxaban Alter 15 mg film-coated tablets are dark pink, round and biconvex, with a diameter of 5.0 mm.
Rivaroxaban Alter 15 mg film-coated tablets are available in packs of 14, 28 or 42 film-coated tablets.
Rivaroxaban Alter 20 mg film-coated tablets are red-brown in colour, round and biconvex, with a diameter of 6.0 mm.
Rivaroxaban Alter 20 mg film-coated tablets are available in packs of 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
PORTUGAL: Rivaroxabano Biofarmoz
FRANCE: Rivaroxaban Alter, comprimé pelliculé
SPAIN: Rivaroxaban Alter, comprimidos recubiertos con película EFG
ITALY: Rivaroxaban Alter
April 2023