RIVAROXABAN 2.5 mg Film-coated tablets

Зміст інструкції

1. Rivaroxaban Tillomed 2,5 mg film-coated tablets
   1. What is Rivaroxaban Tillomed and what it is used for
   2. What you need to know before taking Rivaroxaban Tillomed
   3. How to take Rivaroxaban Tillomed
   4. Possible side effects
   5. How to store Rivaroxaban Tillomed
   6. Contents of the pack and other information
2. Rivaroxaban Tillomed 10 mg film-coated tablets
   1. What is Rivaroxaban Tillomed and what it is used for
   2. What you need to know before taking Rivaroxaban Tillomed
   3. How to take Rivaroxaban Tillomed
   4. Possible side effects
   5. How to store Rivaroxaban Tillomed
   6. Package contents and other information
3. Rivaroxaban Tillomed 15 mg film-coated tablets
   1. What is Rivaroxaban Tillomed and what it is used for
   2. What you need to know before you take Rivaroxaban Tillomed
   3. How to take Rivaroxaban Tillomed
   4. Possible side effects
   5. How to store Rivaroxaban Tillomed
   6. Package Contents and Other Information

Rivaroxaban Tillomed 2,5 mg film-coated tablets

Generic medicine
Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, 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 Rivaroxaban Tillomed is and what it is used for
• 2.What you need to know before you take Rivaroxaban Tillomed
• 3.How to take Rivaroxaban Tillomed
• 4.Possible side effects
• 5.How to store Rivaroxaban Tillomed
• 6.Contents of the pack and other information

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

Rivaroxaban Tillomed has been given to you because

• you have been diagnosed with an acute coronary syndrome (a set of conditions that includes heart attack and unstable angina, a severe form of chest pain) and an increase in certain cardiac markers has been found in blood tests.

In adults, Rivaroxaban Tillomed reduces the risk of another heart attack or reduces the risk of
dying from a heart or blood vessel related illness.
Rivaroxaban will not be given to you alone. Your doctor will also prescribe:

• acetylsalicylic acid or
• acetylsalicylic acid plus clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral artery disease that causes symptoms.

Rivaroxaban Tillomed reduces the risk in adults of forming blood clots (atherothrombotic
events).
Rivaroxaban Tillomed will not be given to you alone. Your doctor will also prescribe acetyl
salicylic acid.
In some cases, if you are to take Rivaroxaban Tillomed following a procedure used to
widen a narrowed or blocked artery in your leg in order to restore blood flow, your
doctor may also prescribe clopidogrel, which you will have to take for a short period together
with acetylsalicylic acid.
Rivaroxaban Tillomed contains the active substance rivaroxaban and belongs to a group of medicines
called antithrombotic agents. Its action is due to the blocking of a coagulation factor
(factor Xa) followed by a reduced tendency of the blood to form clots.

2. What you need to know before taking Rivaroxaban Tillomed

Do not take Rivaroxaban Tillomed

• if you are allergic to rivaroxaban or 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 an organ 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 if you are receiving heparin through a venous or arterial catheter to keep it open.
• if you have an acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke) or if there has been a blockage of the small arteries that carry blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) in the previous month
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Tillomed and tell your doctorif any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Tillomed.
Rivaroxaban Tillomed should not be used in combination with certain medicines that reduce blood
clotting such as prasugrel or ticagrelor except acetylsalicylic acid and
clopidogrel/ticlopidine.

Take special care with Rivaroxaban Tillomed

• if you have an increased risk of bleeding, such as in case of:
• 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), when changing anticoagulant therapy or if you are receiving heparin through a venous or arterial catheter to keep it open (see sections “Other medicines and Rivaroxaban Tillomed”)
• 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 (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 the lungs
• you are over 75 years old
• weight less than 60 kg
• you suffer from coronary artery disease with symptomatic severe heart failure
• 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 any of the conditions described apply to you, tell your doctorbefore taking Rivaroxaban
Tillomed. The doctor will decide whether you should be treated with this medicine and whether you should be
closely monitored

If you are going to have surgery

• it is very important to take Rivaroxaban Tillomed 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 Rivaroxaban Tillomed 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 bowel or bladder problems at the end of anesthesia, because urgent intervention is necessary in this case.

Children and adolescents
Rivaroxaban Tillomed 2.5 mg tablets are not recommended in patients under 18 years of age.
There is not enough information on its use in children and adolescents.

Other medicines and Rivaroxaban Tillomed
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, prasugrel and ticagrelor (see section “Warnings and precautions”))
• 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 Rivaroxaban
Tillomed, because the effect of rivaroxaban may be enhanced. The doctor will decide whether you should be
treated with this medicine and whether 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 for 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 Rivaroxaban
Tillomed, as the effect of rivaroxaban may be reduced. The doctor will decide whether you should be treated
with Rivaroxaban Tillomed and whether you should be closely monitored.

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

Driving and using machines
Rivaroxaban 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 machinery.

Rivaroxaban Tillomed 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 take Rivaroxaban Tillomed

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

What dose to take
The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban Tillomed
always at the same time of day (for example, one tablet in the morning and one in the evening). This
medicine can be taken with or without food.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban
Tillomed in another way. The tablet can be crushed and mixed with a little water or with
applesauce immediately before taking it.
If necessary, your doctor may administer the crushed Rivaroxaban Tillomed
tablet through a tube inserted into the stomach.
Rivaroxaban Tillomed will not be administered to you alone.
Your doctor will also prescribe acetylsalicylic acid.
If you need to take Rivaroxaban Tillomed after an acute coronary syndrome, your doctor may
also prescribe clopidogrel or ticlopidine.
If you need to take Rivaroxaban Tillomed following a procedure used to widen a narrowed or blocked
artery in the leg in order to restore blood flow, your doctor may also prescribe
clopidogrel, which you will have to take for a short period in association with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetyl
salicylic acid per day or a daily dose of 75 - 100 mg of acetylsalicylic acid plus a
daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start with Rivaroxaban Tillomed
Treatment with Rivaroxaban Tillomed after an acute coronary syndrome should begin as
soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after
hospitalization and at the time when parenteral (injection) anticoagulant therapy would normally be
discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease,
your doctor will tell you when to start treatment with Rivaroxaban Tillomed.
Your doctor will decide how long to continue your treatment.

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

If you forget to take Rivaroxaban Tillomed
Do not take a double dose to make up for a missed dose. If you forget a dose,
take the next dose at the usual time.

If you stop taking Rivaroxaban Tillomed
Take Rivaroxaban Tillomed regularly for the entire time prescribed by your doctor.
Do not stop taking Rivaroxaban Tillomed without first talking to your doctor. If
you stop taking this medicine, you may increase the risk of a new heart attack or
stroke or death from heart or blood vessel disease.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Tillomed can cause side effects, although not everybody gets them.
Like other medicines similar to reduce the formation of blood clots, rivaroxaban can cause
bleeding which can 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.

Immediately inform your doctor 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, unexplained swelling, shortness of breath, chest pain or angina pectoris. The doctor may decide to keep you under close observation or modify the 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 (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 decrease in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; can occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; can 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, gum bleeding
• bleeding in the eye (including bleeding in 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 or state of unwellness, constipation, diarrhea
• low blood pressure (symptoms include feeling dizzy or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itchy skin
• 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)
• joint bleeding causing pain and swelling thrombocytopenia (low 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, certain enzymes of the pancreas or liver, 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 bile flow), hepatitis, including hepatocellular injury (liver inflammation 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 artery of the leg (pseudoaneurysm)

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

• accumulation of eosinophils, a type of white blood cells granulocytes that cause inflammation in the lung (eosinophilic pneumonia)

Frequency not known(the frequency cannot be estimated on the basis of the available data)

• kidney failure after severe bleeding
• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (anticoagulant-related nephropathy)
• 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 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 Rivaroxaban Tillomed

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. 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. Contents of the pack and other information

What Rivaroxaban Tillomed contains

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica. See section 2 “Rivaroxaban Tillomed contains lactose and sodium”.

Tablet film coating: macrogol E1521, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172)

Description of the appearance of Rivaroxaban Tillomed and contents of the pack
The film-coated tablets of Rivaroxaban Tillomed 2.5 mg are light yellow in colour, round,
biconvex, with “2.5” imprinted on one side and “R” on the other side.
They are supplied in blisters in packs of 20, 28, 56, 100 and 196 film-coated tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milano (MI), Italy

Manufacturer
MIAS Pharma Limited
Suite 1, First floor, Stafford House,
Strand Road, Portmarnock, Co. Dublin,
D13 WC83, Ireland

Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Germany Rivaroxaban Tillomed 2.5 mg filmtabletten
Denmark Rivaroxaban Tillomed
Finland Rivaroxaban Tillomed
Sweden Rivaroxaban Tillomed
Ireland Rivaroxaban Tillomed 2.5 mg Film Coated Tablets
Norway Rivaroxaban Tillomed
Malta Rivaroxaban Tillomed 2.5 mg Film Coated Tablets
Italy Rivaroxaban Tillomed

Rivaroxaban Tillomed 10 mg film-coated tablets

Generic medicine
Read 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 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

• 7.What Rivaroxaban Tillomed is and what it is used for
• 8.What you need to know before you take Rivaroxaban Tillomed
• 9.How to take Rivaroxaban Tillomed
• 10.Possible side effects
• 11.How to store Rivaroxaban Tillomed
• 12.Contents of the pack and other information

7. What is Rivaroxaban Tillomed and what it is used for

Rivaroxaban Tillomed 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.

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

8. What you need to know before taking Rivaroxaban Tillomed

Do not take Rivaroxaban Tillomed

• if you are allergic to rivaroxaban or 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 an organ 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
• if you are pregnant or breastfeeding Do not take Rivaroxaban Tillomed and tell your doctorif any of the conditions described apply to you.

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

Be particularly careful with Rivaroxaban Tillomed

• if you have an increased risk of bleeding, such as in case of:
• moderate or severe kidney disease, because kidney function may 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), when changing anticoagulant therapy or while taking heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Tillomed”)
• 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 (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 the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), 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 Rivaroxaban
Tillomed. 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 Rivaroxaban Tillomed before and after the 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 Rivaroxaban Tillomed exactly as indicated by your doctor
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia, because urgent intervention may be necessary.

Children and adolescents
Rivaroxaban Tillomed 10 mg tablets are not recommended in patients under 18 years of age.There is not enough information about its use in children and adolescents.

Other medicines and Rivaroxaban Tillomed
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 in 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 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 Rivaroxaban
Tillomed, because the effect of rivaroxaban 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 you have an increased risk of developing stomach or
intestinal ulcers, they may prescribe preventive treatment for 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 Rivaroxaban
Tillomed, because the effect of rivaroxaban may be reduced. The doctor will decide if you should be treated
with Rivaroxaban Tillomed and if you should be closely monitored.

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

Driving and using machines
Rivaroxaban 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.

Rivaroxaban Tillomed 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”

9. How to take Rivaroxaban Tillomed

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 from forming in the veins after hip or knee replacement surgery. The recommended dose is one 10 mg Rivaroxaban Tillomed 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 Rivaroxaban Tillomed 10 mg once a day.

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

When to take Rivaroxaban Tillomed
Take the tablet every day until your doctor tells you to stop taking it.
Try to take the tablet at the same time each day to make it easier to remember.
Your doctor will decide how long to continue treatment.
To prevent blood clots from forming 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 Rivaroxaban Tillomed than you should
Contact your doctor immediately if you have taken too many rivaroxaban tablets. If you have taken an
excessive amount of Rivaroxaban Tillomed, the risk of bleeding increases.

If you forget to take Rivaroxaban Tillomed
If you forget 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 a missed tablet.

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

10. Possible side effects

Like all medicines, Rivaroxaban Tillomed can cause side effects, although not everybody gets them.
Like other medicines similar to it used to reduce the formation of blood clots, rivaroxaban can
cause bleeding which could potentially endanger the patient’s life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some
cases, the bleeding may not be apparent.

Immediately inform your doctor if you notice any of the following side effects:

• Signs of bleedingor 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!) or prolonged or excessive blood loss or unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. The doctor may decide to keep you under close observation or change the treatment.
• Signs of severe skin reactionsor widespread and severe rash, blisters or lesions of the mucous membranes, for example in the mouth or eyes (Stevens-Johnson Syndrome/toxic epidermal necrolysis). or 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 (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 decrease in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; can occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; can occur in up to 1 in 100 people).

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 bleeding), 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 ascertained with tests performed by the doctor)
• fever
• stomach pain, indigestion, feeling or state of unwellness, constipation, diarrhea
• low blood pressure (symptoms include feeling dizzy 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)
• bleeding into a joint causing pain and swelling thrombocytopenia (low 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, 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 1,000 people)

• muscle bleeding
• cholestasis (decreased flow of bile), hepatitis, including hepatocellular injury (liver inflammation 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 heart level involving the insertion of a catheter into the artery of the leg (pseudoaneurysm)

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

• accumulation of eosinophils, a type of white blood cells granulocytes causing inflammation of the lung (eosinophilic pneumonia)

Frequency not known(the frequency cannot be estimated on the basis of the available data)

• kidney failure after severe bleeding
• renal bleeding sometimes with blood in the urine leading to kidney malfunction (anticoagulant-associated nephropathy)
• 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, 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.

11. How to store Rivaroxaban Tillomed

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. 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.

12. Package contents and other information

What Rivaroxaban Tillomed 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, anhydrous colloidal silicon dioxide. See section 2
“Rivaroxaban Tillomed contains lactose and sodium”.
Tablet film coating: macrogol E1521, hypromellose, titanium dioxide (E 171), iron oxide red (E 172)

Description of the appearance of Rivaroxaban Tillomed and package contents
The film-coated tablets of Rivaroxaban Tillomed 10 mg are light pink to pink in colour,
round, biconvex, with “10” imprinted on one side and “R” on the other side.
They are supplied

• in blisters in packs of 10, 14, 30, 98 or 100 film-coated tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milan (MI), Italy

Manufacturer
MIAS Pharma Limited
Suite 1, First floor, Stafford House,
Strand Road, Portmarnock, Co. Dublin,
D13 WC83, Ireland

Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Germany Rivaroxaban Tillomed 10 mg filmtabletten
Denmark Rivaroxaban Tillomed
Finland Rivaroxaban Tillomed
Sweden Rivaroxaban Tillomed
Ireland Rivaroxaban Tillomed 10 mg Film Coated Tablets
Norway Rivaroxaban Tillomed
Malta Rivaroxaban Tillomed 10 mg Film Coated Tablets
Italy Rivaroxaban Tillomed

Rivaroxaban Tillomed 15 mg film-coated tablets

Rivaroxaban Tillomed 20 mg film-coated tablets
Generic medicine
Read 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 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

• 13.What Rivaroxaban Tillomed is and what it is used for
• 14.What you need to know before you take Rivaroxaban Tillomed
• 15.How to take Rivaroxaban Tillomed
• 16.Possible side effects
• 17.How to store Rivaroxaban Tillomed
• 18.Contents of the pack and other information

13. What is Rivaroxaban Tillomed and what it is used for

Rivaroxaban Tillomed contains the active substance rivaroxaban.
Rivaroxaban Tillomed is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Tillomed 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 in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Tillomed belongs to a group of medicines called antithrombotic agents. Its
action is due to the blocking of a coagulation factor (factor Xa) followed by a reduced
tendency of the blood to form clots.

14. What you need to know before you take Rivaroxaban Tillomed

Do not take Rivaroxaban Tillomed

• if you are allergic to rivaroxaban or 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 an organ 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 in the case of 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
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Tillomed and tell your doctorif any of the conditions described apply to you.

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

Take special care with Rivaroxaban Tillomed

• if you have an increased risk of bleeding, as may be the case in case of:
• 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), in the case of changing anticoagulant therapy or when you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Tillomed”)
• bleeding 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 (a condition in which stomach acid rises into the esophagus) or tumors located in the stomach or intestine or 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 the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy
• if your 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 Rivaroxaban
Tillomed. 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 Rivaroxaban Tillomed 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 Rivaroxaban Tillomed 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 after the anesthesia has worn off, because urgent intervention may be necessary.

Children and adolescents
Rivaroxaban Tillomed tablets are not recommended in children weighing less than
30 kg.There is not enough information on the use of rivaroxaban in children and adolescents
in the adult indications.

Other medicines and Rivaroxaban Tillomed
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 in 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 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 Rivaroxaban
Tillomed, because the effect of rivaroxaban 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 for 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 Rivaroxaban
Tillomed, as the effect of rivaroxaban may be reduced. The doctor will decide if you should be treated
with Rivaroxaban Tillomed and if you should be closely monitored.

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

Driving and using machines
Rivaroxaban 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.

Rivaroxaban Tillomed 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”

15. How to take Rivaroxaban Tillomed

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your doctor or pharmacist.
You must take Rivaroxaban Tillomed with a meal.
Swallow the tablet or tablets preferably with water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban
Tillomed in another way. The tablet can be crushed and mixed with a little water or with
applesauce immediately before taking it.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Tillomed
through a gastric tube.

What dose to take

• Adults
• To prevent blood clots in the brain (stroke) or in other blood vessels in the body. The recommended dose is one Rivaroxaban Tillomed 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Rivaroxaban Tillomed 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 Rivaroxaban Tillomed
15 mg tablet once a day (or to a 10 mg Rivaroxaban Tillomed tablet in the case
where 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 the recurrence of clots. The recommended dose is one Rivaroxaban Tillomed 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one Rivaroxaban Tillomed 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 a Rivaroxaban Tillomed 20 mg tablet once a day, your doctor may decide to reduce the dosage for treatment after 3 weeks to a Rivaroxaban Tillomed 15 mg tablet once a day if the risk of bleeding is greater than the risk of having a new blood clot
• Children and adolescentsThe dose of Rivaroxaban Tillomed 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 andless than 50 kgis one Rivaroxaban Tillomed 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban Tillomed 20 mgtablet once a day. Take each dose of Rivaroxaban Tillomed with a drink (e.g. water or juice) during a meal. Take the tablets each 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 Rivaroxaban Tillomed is based on body weight, it is important to attend scheduled visits
with the doctor because the dose may need to be adjusted as the weight changes. Never
adjust the dose of Rivaroxaban Tillomed on your own. If necessary, the doctor will adjust
the dose.
Do not split the tablet in an attempt to fraction a dose. If a lower dose is needed,
use alternative formulations of rivaroxaban. For children and adolescents who cannot swallow
whole tablets, use other available formulations of rivaroxaban.
If another formulation is not available, you can crush the Rivaroxaban Tillomed tablet and
mix it with water or applesauce immediately before taking it. Take food after
taking this mixture. If necessary, the doctor may also administer the crushed Rivaroxaban
Tillomed tablet via a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Tillomed, take a new dose.
• more than 30 minutes after taking Rivaroxaban Tillomed, do nottake a new dose. In this case, take the next dose of Rivaroxaban Tillomed at the usual time. Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Tillomed.

When to take Rivaroxaban Tillomed
Take the tablet or tablets every day until your doctor tells you to stop
taking them.
Try to take the tablet or tablets always at the same time of day to make it easier to
remember.
Your doctor will decide how long to continue treatment.
To prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body:
If your heart rhythm needs to be restored to normal through a procedure called
cardioversion, take Rivaroxaban Tillomed when your doctor has told you to.

If you forget to take Rivaroxaban Tillomed

• Adults, children and adolescents: If you are taking a 20 mg or 15 mg tablet oncea 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 following day and then continue with one tablet a day.
• Adults: If you are taking a 15 mg tablet twicea 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 Rivaroxaban Tillomed than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Tillomed tablets. If you
have taken an excessive amount of Rivaroxaban Tillomed, the risk of bleeding increases.

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

16. Possible side effects

Like all medicines, Rivaroxaban Tillomed can cause side effects, although not everybody gets them.
Like other medicines similar to reduce blood clot formation, rivaroxaban can cause bleeding which can potentially endanger the patient's life. Excessive 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 or your child experience any of the following
side effects:

• Signs of bleeding
• bleeding in the brain or skull (symptoms may include headache, weakness on one side, 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 lesions of the mucous membranes, 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 (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 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 in adults, children and adolescents
Common(may affect up to 1 in 10 people)

• reduction in the 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 bleeding), nosebleeds, bleeding gums
• 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 a surgical procedure
• blood or fluid leakage from the surgical wound
• swelling of the limbs
• pain in the limbs
• kidney malfunction (can be detected with tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling unwell, constipation, diarrhea
• low blood pressure (symptoms include feeling dizzy or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itchy skin
• 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 (low number of platelets, which are the cells that allow blood to clot)
• allergic reactions, including allergic skin reactions
• liver malfunction (can be detected with tests performed by your doctor)
• blood tests may show an increase in 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 bile flow), hepatitis, including hepatocellular injury (liver inflammation 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 affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white blood cells granulocytes that cause inflammation in the lung (eosinophilic pneumonia)

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

• kidney failure after severe bleeding
• kidney bleeding sometimes with blood in the urine leading to kidney malfunction (anticoagulant-associated nephropathy)
• 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 Rivaroxaban
Tillomed have been similar 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 an increase in bilirubin (bile pigment)
• thrombocytopenia (reduced number 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 subclass 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.

17. How to store Rivaroxaban Tillomed

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. 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 waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

18. Package Contents and Other Information

What Rivaroxaban Tillomed Contains

• The active ingredient is rivaroxaban. Each tablet contains 15mg or 20mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica. See section 2 “Rivaroxaban Tillomed contains lactose and sodium”. Tablet film coating: macrogol E1521, hypromellose, titanium dioxide (E 171), red iron oxide (E172)

Description of the appearance of Rivaroxaban Tillomed and package contents
Rivaroxaban Tillomed 15 mg film-coated tablets are red, round,
biconvex, with “15” imprinted on one side and “R” on the other side.
They are supplied in blisters in packs of 10, 14, 28, 42, 98 or 100 film-coated tablets.
Rivaroxaban Tillomed 20 mg film-coated tablets are reddish-brown, round,
biconvex, with “20” imprinted on one side and “R” on the other side.
They are supplied in blisters in packs of 10, 14, 28, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milan (MI), Italy

Manufacturer
MIAS Pharma Limited
Suite 1, First floor, Stafford House,
Strand Road, Portmarnock, Co. Dublin,
D13 WC83, Ireland

Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations
Germany Rivaroxaban Tillomed 15 mg filmtabletten
Rivaroxaban Tillomed 20 mg filmtabletten
Denmark Rivaroxaban Tillomed
Finland Rivaroxaban Tillomed
Sweden Rivaroxaban Tillomed
Ireland Rivaroxaban Tillomed 15 mg Film Coated Tablets
Rivaroxaban Tillomed 20 mg Film Coated Tablets
Norway Rivaroxaban Tillomed
Malta Rivaroxaban Tillomed 15 mg Film Coated Tablets
Rivaroxaban Tillomed 20 mg Film Coated Tablets
Italy Rivaroxaban Tillomed