Package leaflet: Information for the user

Ellebax 10 mg film-coated tablets

rivaroxaban
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 others, even if they have the same symptoms as you, because it could 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 Ellebax is and what it is used for
What you need to know before taking Ellebax
How to take Ellebax
Possible side effects
How to store Ellebax
Contents of the pack and other information

1. What Ellebax is and what it is used for

Ellebax 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 the risk of blood clots forming increases after surgery.
treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

2. What you should know before taking Ellebax Do not take Ellebax

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding Do not take Ellebax 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 Ellebax.
Pay special attention to Ellebax

if you have a high risk of bleeding, which may occur in situations such as:
- moderate or severe kidney disease, because kidney function can 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 Ellebax”)
- disorders of blood coagulation
- very high blood pressure, uncontrolled with medication
- stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, 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 previous 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 you need to change your treatment
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 Ellebax. 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 Ellebax before and after surgery exactly as scheduled by your doctor.
If the surgical procedure involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Ellebax exactly as scheduled 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
Ellebax 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient information available on its use in children and adolescents.
Other medicines and Ellebax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are taking:

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

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

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

3. How to take Ellebax

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

What dose to take

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

Swallow the tablet preferably with some water.
Ellebax can be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Ellebax in another way. The tablet can be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Ellebax tablets through a tube inserted into the stomach.

When to take Ellebax
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 the formation of blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the tablets for 2 weeks.

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

If you forget to take Ellebax
If you forget a dose, take it as soon as you remember. Take the next tablet the following day and then continue taking one tablet daily as before.
Do not take a double dose to make up for the missed tablet.

If you stop taking Ellebax
Do not stop taking Ellebax without first talking to your doctor, because Ellebax helps prevent serious conditions from occurring.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ellebax may cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Ellebax 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 notice any of the following side effects:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive blood loss
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
Signs of severe skin reactions
- widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
a drug reaction causing rash, fever, 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; breathing difficulties; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

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

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

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (may 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 occur in up to 1 in 1,000 people)

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a 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 legs or arms following 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 Ellebax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after Exp.
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 Ellebax contains

The active substance is rivaroxaban. Each 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 “Ellebax contains lactose and sodium”
Film coating of the tablet: macrogol, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of Ellebax and contents of the pack
The 10 mg film-coated tablets of Ellebax are round, biconvex, pink in colour, with a diameter of 6.0 mm.
The 10 mg film-coated tablets of Ellebax are available in packs containing 10 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ELLEVA PHARMA S.r.l.
Via San Francesco n. 5
80034 Marigliano (NA)
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 member states under the following names:
Italy: Ellebax

Package leaflet: Information for the user

Ellebax 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 others, even if their symptoms are the same as yours, as it could 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 Ellebax is and what it is used for
What you need to know before taking Ellebax
How to take Ellebax
Possible side effects
How to store Ellebax
Contents of the pack and other information

1. What Ellebax is and what it is used for

Ellebax contains the active substance rivaroxaban.
Ellebax 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. Ellebax is used in children and adolescents under 18 years of age and with body weight equal to or greater than 30 kg for:
treating blood clots and preventing their recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Ellebax belongs to a group of medicines called antithrombotic agents. Its effect is due to
inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to
form clots.

2. What you need to know before taking Ellebax

Do not take Ellebax

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 (haemorrhage)
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 surgery on the brain or eyes)
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 Ellebax 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 Ellebax.
Be especially careful with Ellebax

if you have an increased risk of bleeding, such as in the following cases:
§ severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
§ if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), 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 Ellebax”)
§ disorders of blood coagulation
§ very high blood pressure not controlled by medication
§ diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the oesophagus, such as caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, 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 autoimmune 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 Ellebax. 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 Ellebax 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 for pain relief):
§ it is very important to take Ellebax 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 the legs or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

Children and adolescents
Ellebax tablets are not recommended for children weighing less than 30 kg. There is
insufficient information available on the use of Ellebax in children and adolescents for the indications approved in
adults.
Other medicines and Ellebax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, including those not requiring a prescription.

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

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

If any of the conditions described above apply to you, inform your doctor before taking Ellebax, as
the effect of Ellebax may be reduced. Your doctor will decide whether you should be treated with Ellebax and whether you need
to be closely monitored.
Pregnancy and breastfeeding
Do not take Ellebax during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a
reliable method of contraception while taking Ellebax. 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
Ellebax may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If these symptoms occur, do not drive, ride a bicycle, or use tools or machinery.
Ellebax contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Ellebax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ellebax

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Ellebax 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 Ellebax in another way. The
tablet may be crushed and mixed with a small amount of water or apple puree immediately before taking it.
The mixture should be followed immediately by food intake.
If necessary, your doctor may administer the crushed Ellebax 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 Ellebax tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Ellebax tablet once daily.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI – Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting a dose reduction to one 15 mg Ellebax tablet once daily (or one 10 mg Ellebax 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 Ellebax tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Ellebax tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Ellebax tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Ellebax 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 Ellebax 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 Ellebax tablet once daily.
The recommended dose for children and adolescents with a body weight equal to or greater than 50 kg is one 20 mg Ellebax tablet once daily. Take each dose of Ellebax 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 entire dose is taken.

Since the dose of Ellebax 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 Ellebax on your own. If needed, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide the dose.
You may crush the Ellebax tablet and mix it with water or apple puree immediately before administration. Take food after consuming this mixture. If necessary, your doctor may also administer the crushed Ellebax tablet via a gastric tube.

If you spit out the dose or vomit

less than 30 minutes after taking Ellebax, take a new dose.
more than 30 minutes after taking Ellebax, do not take another dose. In this case, take the next dose of Ellebax at your usual time.

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

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

If you forget to take Ellebax
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 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 following day, continue with one 15 mg tablet twice daily.

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

If you stop taking Ellebax
Do not stop taking Ellebax without first talking to your doctor, as Ellebax 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, Ellebax can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce the formation of blood clots, Ellebax can cause bleeding that
may potentially be life-threatening. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you notice any of the following side effects:

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

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

reduced number of red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual flow), 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 dysfunction (may be detected through tests performed by your doctor)
fever
stomach pain, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general lack of energy and strength (weakness, fatigue), headache, dizziness
rash, itchy skin
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)
joint bleeding causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that help blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (may be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

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

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

kidney failure 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 Ellebax have been similar to those observed 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, which are the cells that help blood to clot)
heavy menstrual periods
Uncommon (may affect up to 1 in 100 people)
blood tests may show increased levels of a specific bilirubin subtype (direct bilirubin, bile pigment)

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 .
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ellebax

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

6. Package contents and other information

What Ellebax 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 components are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2 “Ellebax contains lactose and sodium”. Film coating of the tablet: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172). The other components are Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch. See section 2 “Ellebax contains lactose and sodium”. Film coating of the tablet: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172).

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

Marketing Authorization Holder
ELLEVA PHARMA S.r.l.
Via San Francesco n. 5
80034 Marigliano (NA)
Italy

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

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: Ellebax