INDIFAXA 10 mg Film-Coated Tablets

Зміст інструкції

1. INDIFAXA 10 mg film-coated tablets
   1. Possible side effects
   2. How to store INDIFAXA
   3. Contents of the pack and other information
2. INDIFAXA 15 mg film-coated tablets
3. INDIFAXA tablets are not recommended in children with a body weight less than 30 kg. Do not
   1. How to take INDIFAXA
   2. Possible side effects
   3. Contents of the pack and other information

INDIFAXA 10 mg film-coated tablets

Rivaroxaban
“Generic medicine”

Read this leaflet carefully before you start 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

INDIFAXA contains the active ingredient rivaroxaban and is used in adults for:

• Preventing 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.

INDIFAXA belongs to a group of medicines called antithrombotic agents. Its action is due to
blocking the coagulation factor (factor Xa) and therefore reducing the tendency of the blood to
form clots.

• 2.What you need to know before you takeINDIFAXA

Do not takeINDIFAXA

• If you are allergic to rivaroxaban or 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 a 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 heparin), 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 INDIFAXA and tell your doctorif one of the conditions described applies to you.

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

Take special care with INDIFAXA

• 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 receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and INDIFAXA”)
• Disorders of blood coagulation
• Very high blood pressure, not controlled with medicines
• Diseases of the stomach or intestines that can 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 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 a previous bleeding from your 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), tell your doctor, who will decide whether it is necessary to change the therapy
• If the doctor checks that the 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 INDIFAXA. The
doctor will decide whether you should be treated with this medicine and whether you should be kept under close
observation.

If you are going to have surgery

• It is very important to take INDIFAXA before and after 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 INDIFAXA exactly at the times indicated by your doctor
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your bowels or bladder at the end of anesthesia, because urgent intervention is necessary in such cases.

Children and adolescents
INDIFAXA is not recommended in patients under the age of 18 years.
There is not enough information on its use in children and adolescents.

Other medicines andINDIFAXA
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 too much 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 INDIFAXA,
because the effect of INDIFAXA may be increased. The doctor will decide whether you should be treated with
this medicine and whether 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 for depression
• Rifampicin, an antibiotic

If any of the conditions described apply to you, tell your doctorbefore taking INDIFAXA,
because the effect of INDIFAXA may be reduced. The doctor will decide whether you should be treated with
INDIFAXA and whether you should be kept under close observation.

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

Driving and using machines
INDIFAXA 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 and do not use machines.
INDIFAXA contains: lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
‘sodium-free’.

• 3.How to takeINDIFAXA Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

What dose to take:

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one INDIFAXA 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 of 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 INDIFAXA 10 mg once a day.

Swallow the tablet with a little water, preferably.
INDIFAXA 10 mg can be taken independently of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take INDIFAXA in another
way. The tablet can be crushed and mixed with a little water or applesauce
immediately before taking it.
If necessary, your doctor may administer the crushed tablet of INDIFAXA through a
tube inserted into the stomach.

When to takeINDIFAXA
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablets at the same time each day, to help you remember.
Your doctor will decide how long to continue your treatment.
To prevent blood clots in the veins after hip or
knee replacement, take the first tablet 6 – 10 hours after the operation.
If you have had major hip surgery, you will usually need to take the tablets for 5 weeks.
If you have had major knee surgery, you will usually need to take the tablets for 2
weeks.

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

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

If you stop takingINDIFAXA
Do not stop taking INDIFAXA without first talking to your doctor, because
INDIFAXA prevents a serious condition from occurring.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, INDIFAXA 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 immediatelyif 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, which may be signs of bleeding. 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, blood abnormalities and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 user in 10,000).

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 these side effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 user in 10,000) and uncommon (angioedema and allergic edema; may affect up to 1 user in 100).

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

• reduction in the number of red blood cells, which can cause paleness and weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• 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
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the 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, itching
• increase in certain liver enzymes in blood tests

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

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or the number of platelets
• fainting
• feeling unwell, rapid heartbeat
• dry mouth
• hives

Rare (may affect up to 1 in 1000 people):

• bleeding into a muscle
• cholestasis (decreased flow of bile, a substance produced by the liver), hepatitis including hepatocellular damage (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)
• Very rare(may occur in up to 1 person in 10,000)
• - accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

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

• increased pressure of the muscles of the legs or arms after bleeding, causing pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)
• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• kidney impairment after severe bleeding

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store INDIFAXA

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 package and on each blister after
Exp. The expiry date refers to the last day of that month.
No special storage precautions.
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. Contents of the pack and other information

What INDIFAXA contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “INDIFAXA contains lactose and sodium”. Tablet film coating: hypromellose, hydroxypropyl cellulose, macrogol 8000, titanium dioxide (E171), red iron oxide (E172). Description of the appearance of INDIFAXA and contents of the packThe 10 mg film-coated tablets of INDIFAXA are round, biconvex, light pink in colour, with “10” imprinted on one side.

The tablets are supplied in PVC/PVDC 90/Aluminum blisters in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer
ERREKAPPA EUROTERAPICI S.P.A
Via Ciro Menotti, 1/A
20129 Milano

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland

INDIFAXA 15 mg film-coated tablets

INDIFAXA 20 mg film-coated tablets
Rivaroxaban
“Generic medicine”

Read this leaflet carefully before you start 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 INDIFAXA is and what it is used for
• 2. What you need to know before you take INDIFAXA
• 3. How to take INDIFAXA
• 4. Possible side effects
• 5. How to store INDIFAXA
• 6. Contents of the pack and other information
• 1.What INDIFAXA is and what it is used forINDIFAXA contains the active substance rivaroxaban and 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. INDIFAXA 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 at least 5 days of initial treatment with injectable medicines used to treat blood clots.

INDIFAXA belongs to a group of medicines called antithrombotic agents. Its action is due to
blocking the coagulation factor (factor Xa) and therefore reducing the blood's tendency to
form clots.

• 2.What you need to know before you takeINDIFAXA

Do not takeINDIFAXA

• If you are allergic to rivaroxaban or 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 your 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 heparin), 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 takeINDIFAXA and tell your doctorif any of the conditions described apply to you.

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

Pay particular attention withINDIFAXA

• If you have an increased risk of bleeding, such as may be the case if:
• You have severe kidney disease, because kidney function can change the amount of active medicine in the body
• 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 INDIFAXA”)
• You have blood clotting disorders
• You have very high blood pressure that is not controlled with medicines
• You have diseases of the stomach or intestines that can 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 rises into the esophagus) or tumors located in the stomach or intestine or the genital tract or urinary tract
• You have a disorder of the blood vessels in the back of the eye (retinopathy)
• You have a lung disease with dilated and pus-filled bronchi (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 (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide whether it is necessary to change your therapy
• If your doctor finds 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 conditions described apply to you, tell your doctorbefore taking INDIFAXA. Your
doctor will decide whether you should be treated with this medicine and whether you should be kept under close
observation.

If you are going to have surgery

• It is very important to take INDIFAXA 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 INDIFAXA before and after the injection or removal of the catheter exactly as indicated by your doctor
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anesthesia, as urgent action may be needed.

Children and adolescents

INDIFAXA tablets are not recommended in children with a body weight less than 30 kg. Do not

have
sufficient information is available on the use of INDIFAXA in children and adolescents for the
adult indications.

Other medicines andINDIFAXA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, 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 coagulation (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
• 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 INDIFAXA,
because the effect of INDIFAXA may be enhanced. The doctor will decide whether you need to be treated with
this medicine and whether you need to be kept under close observation.
If the doctor believes that you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe you 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 conditions described apply to you, tell your doctorbefore taking INDIFAXA,
because the effect of INDIFAXA may be reduced. The doctor will decide whether you need to be treated with
INDIFAXA and whether you need to be kept under close observation.

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

Driving and using machines
INDIFAXA can cause dizziness (a common undesirable effect) and fainting (an uncommon undesirable
effect) see section 4, “Possible undesirable effects”). If these symptoms occur, do not
drive vehicles, ride a bicycle or use tools or machinery.
INDIFAXA contains: lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take INDIFAXA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablet or tablets preferably with a little water.
Take INDIFAXA in conjunction with a meal.
If you have difficulty swallowing the tablet whole, ask your doctor how to take INDIFAXA 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 eating food.
If necessary, your doctor may administer the crushed tablet of INDIFAXA 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 in the body, the recommended dose is one INDIFAXA 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one INDIFAXA 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 INDIFAXA 15
mg tablet once a day (or one 10 mg INDIFAXA 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 INDIFAXA 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one INDIFAXA 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with a 10 mg tablet once a day or a 20 mg tablet once a day.

If you have kidney problems and are taking one INDIFAXA 20 mg tablet once a day, your
doctor may decide to reduce the dosage after 3 weeks to one INDIFAXA 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 INDIFAXA depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and 50 kgis one INDIFAXA 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one INDIFAXA 20 mgtablet once a day.

Take each dose of INDIFAXA 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 you.
For parents or caregivers:please observe the child to ensure that the entire dose is
taken.
Since the dose of INDIFAXA is based on body weight, it is important to attend scheduled visits
with your doctor because the dose may need to be adjusted as the weight changes.

Never adjust the dose ofINDIFAXA on your own.If necessary, your doctor will adjust the
dose.
Do not split the tablet in an attempt to fraction a dose. If a lower dose is needed,
use an alternative formulation of rivaroxaban in granules for oral suspension.
If the oral suspension is not available, you can crush the INDIFAXA tablet and mix it
with water or applesauce immediately before taking it. Eat food after
taking this mixture. If necessary, your doctor may also administer the crushed INDIFAXA
tablet via a feeding tube.
For children and adolescents who cannot swallow whole tablets, use an
alternative formulation of rivaroxaban in granules for oral suspension.

If you spit out the dose or vomit

• less than 30 minutes after taking INDIFAXA, take a new dose.
• more than 30 minutes after taking INDIFAXA, do nottake a new dose. In this case, take the next dose of INDIFAXA at the usual time.

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

When to takeINDIFAXA
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablet or tablets at the same time each day, so you can
remember it more easily.
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 of the body, if your
heartbeat needs to be restored to normal through a procedure called
cardioversion, take INDIFAXA exactly as your doctor has told you.

If you forget to takeINDIFAXA
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 the same 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 the same 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 INDIFAXA than you should
Contact your doctor immediately if you have taken too many INDIFAXA tablets. If you have taken a
excessive amount of INDIFAXA, the risk of bleeding increases.

If you stop taking INDIFAXA
Do not stop taking INDIFAXA without first talking to your doctor, because
INDIFAXA treats serious conditions and prevents their occurrence.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, INDIFAXA 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 the appearance of 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, swelling of unknown origin, shortness of breath, chest pain or angina pectoris. The doctor may decide to keep you under close observation or change the type of 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 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 users).

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 users) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 users).

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

• reduction in the number of red blood cells, which may be the cause of paleness and weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or a cavity in the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• loss of blood or fluid from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling or state of unwellness, constipation, diarrhea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching
• increase in certain liver enzymes in blood tests

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

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including skin allergic reactions
• liver malfunction (can be ascertained with tests performed by the doctor)
• blood tests may show an increase in bilirubin, certain pancreas or liver enzymes, or the number of platelets
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives

Rare (may affect up to 1 in 1000 people):

• bleeding into a muscle
• cholestasis (decreased flow of bile, a substance produced by the liver), hepatitis including hepatocellular damage (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 procedure at the cardiac level involving the insertion of a catheter into the leg artery (pseudoaneurysm)
• Very rare(may occur in up to 1 in 10,000 people)
• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

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

• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding)
• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (Anticoagulant-associated nephropathy)
• renal failure after severe bleeding

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with INDIFAXA
were similar to those observed in adults and were mainly of mild to
moderate severity.
Side effects that have been observed more often 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 an increase in bilirubin (bile pigment)
• thrombocytopenia (reduction of 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/en/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on
the safety of this medicine.

5How to store INDIFAXA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on each blister after
Scad. The expiry date refers to the last day of that month.
No special storage precautions.
Crushed tablets
Crushed tablets are stable in water or applesauce for up to 4 hours.
Do not dispose of any medicine in water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What INDIFAXA contains

• The active ingredient is rivaroxaban. Each tablet contains 15 mg and 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 “INDIFAXA contains lactose and sodium”.

Tablet film coating: hypromellose, hydroxypropylcellulose, macrogol 8000,
titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of INDIFAXA and contents of the pack
The film-coated tablets of INDIFAXA15 mg are round, biconvex, pink in color, with
“15” imprinted on one side.
The film-coated tablets of INDIFAXA20 mg are round, biconvex, brown in color,
with “20” imprinted on one side.
The film-coated tablets are supplied in PVC/PVDC 90/Aluminum blisters in boxes of 28
tablets.

Marketing authorisation holder and manufacturer
ERREKAPPA EUROTERAPICI S.P.A
Via Ciro Menotti, 1/A
20129 Milano

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland