ELLEBAX 10 mg Film-Coated Tablets

Зміст інструкції

1. Ellebax 10 mg film-coated tablets
   1. What is Ellebax and what is it used for
   2. What you need to know before taking Ellebax Do not take Ellebax
   3. How to take Ellebax
   4. Possible side effects
   5. How to store Ellebax
   6. Package contents and other information What Ellebax contains
2. Ellebax 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Ellebax and what is it used for
   2. What you need to know before you take Ellebax
   3. How to take Ellebax
   4. Possible side effects
   5. How to store Ellebax
   6. Contents of the pack and other information

Ellebax 10 mg film-coated tablets

rivaroxaban
Generic Medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ellebax and what is it 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, after surgery, the risk of blood clots forming in the blood increases.
• 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 blocking
of the coagulation factor (factor Xa) and therefore to the reduction of the blood's tendency to form
clots.

2. What you need to know before taking Ellebax Do not take Ellebax

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding (haemorrhages)
• 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 to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when changing anticoagulant therapy or when you are 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 tell your doctorif any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ellebax.

Take special care with Ellebax

• if you have a high risk of bleeding, which can occur in situations such as:
• moderate or severe kidney disease, because kidney function can change the amount of active medicine in the body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Ellebax”)
• blood clotting disorders
• very high blood pressure, not controlled with medicines
• stomach or intestinal diseases that can cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• a disorder of the blood vessels in the back of the eye (retinopathy)
• a lung disease with dilated and pus-filled bronchi (bronchiectasis), or previous bleeding from your lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy
• if the doctor checks that your blood pressure is unstable or if another treatment or surgery is planned to remove blood clots from the lungs.

If any of the above conditions apply to you, tell your doctorbefore taking Ellebax. The doctor
will decide if you should be treated with this medicine and if you should be closely monitored.

If you are going to have surgery

• it is very important to take Ellebax before and after surgery exactly as indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia for pain relief):
• it is very important to take Ellebax exactly as indicated by your doctor
• immediately inform your doctor if you experience numbness or weakness in your legs or disturbances in your bowel or bladder function at the end of the anesthesia, because urgent intervention is necessary in such cases.

Children and adolescents
Ellebax 10 mg tablets are not recommended in patients under the age of 18 years. Sufficient information is not
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 available without a prescription.
If you are taking:

• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against 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
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above conditions apply to you, tell your doctorbefore taking Ellebax, because
the effect of Ellebax may be increased. The doctor will decide if you should be treated with this
medicine and if you should be closely monitored.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment against ulcers .

• If you are taking
• some medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum) ,a herbal medicine for depression
• rifampicin ,an antibiotic

If any of the above conditions apply to you, tell your doctorbefore taking Ellebax, as
the effect of Ellebax may be reduced. The doctor will decide if you should be treated with Ellebax and if you should
be closely monitored.

Pregnancy and breastfeeding
Do not take Ellebax during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use
a reliable method of contraception while taking Ellebax. If you become pregnant while taking this
medicine, tell your doctor immediately, who will decide how to continue treatment.

Driving and using machines
Ellebax can cause dizziness (a common side effect) and lightheadedness (an uncommon side effect)
(see section 4, “Possible side effects”). If you experience these symptoms, do not drive vehicles, ride a
bicycle or use tools or machinery.

Ellebax contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have any doubts, ask 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 Ellebax 10 mg tablet once a day.
• To treat blood clots in the veins of the legs and in the blood vessels of the lungs and to prevent the recurrence of clots. After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Ellebax 10 mg once a day.

Swallow the tablet preferably with some water.
Ellebax can be taken independently 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 some water or applesauce immediately
before taking it.
If necessary, your doctor may administer the crushed Ellebax tablet through a tube inserted
into the stomach.

When to take Ellebax
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablets always at the same time of day, so you can remember more easily. The
doctor will decide how long to continue your treatment.
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6 - 10 hours after the operation.
If you have had major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have had 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, the risk of bleeding increases.

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

If you stop taking Ellebax
Do not stop taking Ellebax without first talking to your doctor, because Ellebax prevents
a serious condition from occurring.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ellebax can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Ellebax can cause bleeding which
could potentially endanger the patient's life. Massive bleeding can cause a sudden
drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

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, vomiting, convulsions, reduced level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• 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 mucous membrane lesions, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood counts and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in
• 10,000).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden decrease 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) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100).

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

• decreased number of red blood cells, which can cause pale skin and weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual flow), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a body cavity (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after a surgical procedure
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected by tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• 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 inside the skull (see above, signs of bleeding)
• joint bleeding, causing pain and swelling
• thrombocytopenia (decreased number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be detected by tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1000 people)

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

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

• kidney impairment after severe bleeding
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the carton and on each blister after Scad.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in 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 ingredient is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, corn starch. See section 2 “Ellebax contains lactose and sodium” Tablet film coating: macrogol, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of Ellebax and package contents
Ellebax 10 mg film-coated tablets are round, biconvex, pink in color, with a
diameter of 6.0 mm.
Ellebax 10 mg film-coated tablets are available in packs of 10 or 30 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 authorised in the Member States of the European Economic Area with the following
names:
Italy: Ellebax

Ellebax 15 mg film-coated tablets, 20 mg film-coated tablets

Rivaroxaban
Generic Equivalent Medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ellebax and what is it 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 weighing 30 kg or more 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 action is due to the
blockage of a coagulation factor (factor Xa) followed by a reduced tendency of the blood to
form clots.

2. What you need to know before you take Ellebax

Do not take Ellebax

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding (haemorrhages)
• 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 to the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparins), except when changing anticoagulant therapy or when you are 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 tell your doctorif any of the conditions described apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ellebax

Pay particular attention with Ellebax

• if you have an increased risk of bleeding, such as may be the case in: § severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, because kidney function can change the amount of active medicine in the body § if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are changing anticoagulant treatment or while you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Ellebax”) § blood clotting disorders § very high blood pressure, not controlled with medicines § diseases of the stomach or intestines that can cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (disease in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract § a disorder of the blood vessels in the back of the eye (retinopathy) § a lung disease with dilated bronchi full of pus (bronchiectasis), or a previous bleeding from the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change the therapy
• if the doctor checks that your blood pressure is unstable or if another treatment or surgery to remove blood clots from the lungs is planned

If any of the conditions described apply to you, tell your doctorbefore taking Ellebax. The doctor
will decide if you should be treated with this medicine and if you should be kept under close observation.

If you are going to have surgery:

• it is very important to take Ellebax before and after the surgery exactly at the times indicated by your doctor.
• If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia for pain relief): § it is very important to take Ellebax before and after the injection or removal of the catheter exactly at the times indicated by your doctor § immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder at the end of the anesthesia, because in this case urgent intervention is necessary.

Children and adolescents
Ellebax tablets are not recommended in children with a body weight less than 30 kg.There is not
sufficient information available on the use of Ellebax in children and adolescents in adult indications.

Other medicines and Ellebax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.

• If you are taking
• some medicines against fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• some medicines against bacterial infections (e.g. clarithromycin, erythromycin)
• some antiviral medicines against 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
• some medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described apply to you, tell your doctorbefore taking Ellebax, because
the effect of Ellebax may be enhanced. The doctor will decide if you should be treated with this
medicine and if you should be kept under close observation.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment against ulcers.

• If you are taking
• some medicines for the treatment of 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 apply to you, tell your doctorbefore taking Ellebax, because
the effect of Ellebax may be reduced. The doctor will decide if you should be treated with Ellebax and if you
should be kept under close observation.

Pregnancy and breastfeeding
Do not take Ellebax during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a
reliable method of contraception while taking Ellebax. If you become pregnant while taking this
medicine, tell your doctor immediately, who will decide how to continue treatment.

Driving and using machines
Ellebax can cause dizziness (a common side effect) or lightheadedness (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive
vehicles, ride a bicycle or use tools or machines.

Ellebax contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Ellebax must be taken with a meal.
Swallow the tablet or tablets preferably with a little water.
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 a little water or with applesauce immediately
before taking it. Taking the mixture should be immediately followed by taking
food.
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 Ellebax 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Ellebax 15 mg tablet once a day.

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 to support reducing the dose to one Ellebax 15 mg tablet
once a day (or one 10 mg Ellebax tablet in case your kidneys do not
function properly), in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the legs and in the blood vessels of the lungs and to prevent the recurrence of clots, the recommended dose is one Ellebax 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Ellebax 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one Ellebax 20 mg tablet once a day, your doctor may decide to reduce the dosage for treatment after 3 weeks to one Ellebax 15 mg tablet once a day if the risk of bleeding is greater than the risk of having a new blood clot.

Children and adolescents
The dose of Ellebax depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and50 kgis one Ellebax 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of50kg or moreis one Ellebax 20 mgtablet once a day. 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 remind yourself. For parents or caregivers:please observe the child to ensure that the entire dose is taken.

Because the dose of Ellebax is based on body weight, it is important to go to scheduled visits with
your doctor because the dose may need to be adjusted as the weight changes.

Never adjust the dose of Ellebax on your own.If necessary, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide a dose.
You can crush the Ellebax tablet and mix it with water or applesauce immediately
before taking it. Take food after taking this mixture. If necessary, your
doctor may also administer the crushed Ellebax tablet through a feeding 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 nottake a new dose. In this case, take the next dose of Ellebax at the 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
taking them.
Try to take the tablet or tablets at the same time each day, to make it easier to remember.
Your doctor will decide how long to continue your treatment.
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 your doctor has told you.

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

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, because Ellebax treats
serious conditions and prevents them from occurring.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ellebax can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, Ellebax can cause bleeding which
could potentially endanger the patient's life. Massive bleeding can cause a sudden
drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

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, vomiting, convulsions, reduced level of consciousness, and stiff neck. A serious medical emergency. Seek immediate medical attention!)
• 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 closely monitor you or change your treatment.
• Signs of severe skin reactions
• widespread and severe rash, blisters or mucous membrane lesions, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, changes in blood counts and diseases affecting the whole body (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 difficulty breathing; sudden drop in blood pressure. The frequencies of 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 observed in adults, children and adolescents
Common(may affect up to 1 in 10 people)

• decreased number of red blood cells, which can cause pale skin, weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual flow), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding into the white of the eye)
• bleeding into tissues or a cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• blood or fluid leakage from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected by tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• 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 inside the skull (see above, signs of bleeding)
• joint bleeding, causing pain and swelling
• thrombocytopenia (decreased number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be detected by tests performed by your doctor)
• blood tests may show increased bilirubin, certain pancreatic or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• fast heartbeat
• dry mouth
• hives

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

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

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

• kidney failure after severe bleeding
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with Ellebax have been of
similar type to those observed in adults and have been mainly of mild to moderate severity.
Side effects that have been 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 (decreased platelets, which are the cells that allow blood to clot)
• heavy menstrual bleeding Uncommon(may affect up to 1 in 100 people)
• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is 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 particular storage conditions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ellebax contains

• The active ingredient 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, corn starch. See paragraph 2 “Ellebax contains lactose and sodium”. Tablet film coating: 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 ingredients are Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, corn starch. See paragraph 2 “Ellebax contains lactose and sodium”. Tablet film coating: macrogol, lactose monohydrate, hypromellose (E464), titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of Ellebax and contents of the pack
Ellebax 15 mg film-coated tablets are round, biconvex, dark pink in colour, with a
diameter of 5.0 mm.
Ellebax 15 mg film-coated tablets are available in packs of 42 film-coated
tablets.
Ellebax 20 mg film-coated tablets are reddish-brown in colour, round, biconvex, with a
diameter of 6.0 mm.
Ellebax 20 mg film-coated tablets are available in packs of 28 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 Member States of the European Economic Area under the following
names:
Italy: Ellebax