Rivaroxaban TilloMed: detailed information

Package leaflet: Information for the user

Rivaroxaban Tillomed 2.5 mg film-coated tablets

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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rivaroxaban Tillomed has been prescribed to you because

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

In adults, Rivaroxaban Tillomed reduces the risk of another heart attack or reduces the risk of
dying due to heart- or blood vessel-related disease.
Rivaroxaban will not be given to you alone. Your doctor will also prescribe one of the following:

acetylsalicylic acid, or
acetylsalicylic acid plus clopidogrel or ticlopidine

you have been diagnosed with a high risk of developing blood clots due to coronary artery disease or peripheral artery disease causing symptoms.

Rivaroxaban Tillomed reduces, in adults, the risk of blood clots forming (atherothrombotic events).
Rivaroxaban Tillomed will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid.
In some cases, if you need to take Rivaroxaban Tillomed following a procedure used to widen a narrowed or blocked leg artery to restore blood flow, your doctor may also prescribe clopidogrel, which you will need 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. It works by blocking a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you need to know before taking Rivaroxaban Tillomed

Do not take Rivaroxaban Tillomed

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition affecting an organ in the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if you are receiving heparin through a venous or arterial catheter to keep it open
if you have 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 you have had a blockage of the small arteries supplying blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) within 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 inform your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Tillomed.
Rivaroxaban Tillomed must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except for acetylsalicylic acid and clopidogrel/ticlopidine.
Take special care with Rivaroxaban Tillomed

if you have an increased risk of bleeding, such as in cases of:
severe kidney disease, because kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or if you are receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Tillomed”)
coagulation disorders
very high blood pressure not controlled with medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
if you are over 75 years old
body weight below 60 kg
if you suffer from coronary artery disease with severe symptomatic heart failure
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tillomed. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If you are scheduled for surgery

it is very important to take Rivaroxaban Tillomed before and after surgery exactly as directed by your doctor.
If your surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Tillomed before and after the injection or removal of the catheter exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Rivaroxaban Tillomed 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient information available on its use in children and adolescents.
Other medicines and Rivaroxaban Tillomed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

If you are taking:
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”))
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tillomed, as the effect of rivaroxaban may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

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

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Tillomed, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Tillomed and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Tillomed during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Tillomed. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide how to proceed with your treatment.
Driving and using machines
Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or operate 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, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Tillomed

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban Tillomed at the same time each 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 tablet whole, ask your doctor how to take Rivaroxaban Tillomed in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer the crushed Rivaroxaban Tillomed tablet through a tube inserted into the stomach.
Rivaroxaban Tillomed will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.
If you are taking Rivaroxaban Tillomed after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rivaroxaban Tillomed following a procedure used to widen a narrowed or blocked leg artery to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or a standard daily dose of ticlopidine).
When to start Rivaroxaban Tillomed
Treatment with Rivaroxaban Tillomed after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, but not earlier than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will advise you when to start treatment with Rivaroxaban Tillomed.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Tillomed than you should
Contact your doctor immediately if you have taken too many rivaroxaban tablets. If you take an excessive amount of rivaroxaban, your risk of bleeding increases.
If you forget to take Rivaroxaban Tillomed
Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at your usual time.
If you stop taking Rivaroxaban Tillomed
Take Rivaroxaban Tillomed regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Tillomed without first discussing it with your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or of dying from heart or blood vessel disease increases.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

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

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

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding causing pain and swelling
thrombocytopenia (low platelet count; platelets are cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced bile flow), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of blood collection (haematoma) in the groin as a complication of a cardiac procedure involving 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 granulocyte white blood cells causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding sometimes with blood in urine leading to kidney dysfunction (anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs following bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Tillomed

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

6. Package contents and other information

What Rivaroxaban Tillomed contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica. See section 2 “Rivaroxaban Tillomed contains lactose and sodium”.
Film coating: macrogol E1521, hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172).

Description of the appearance of Rivaroxaban Tillomed and pack contents
Rivaroxaban Tillomed 2.5 mg film-coated tablets are light yellow, round, biconvex tablets, marked with “2.5” 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

Manufacturers
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 names:
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

Package leaflet: Information for the user

Rivaroxaban Tillomed 10 mg film-coated tablets

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

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

Contents of this leaflet

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

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

Rivaroxaban Tillomed contains the active substance rivaroxaban and is used in adults to

prevent the formation of blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots increases after surgery.
treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent 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. It works by blocking a clotting factor (factor Xa), thereby reducing 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 to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition affecting an organ in your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have liver disease that increases the risk of bleeding
if you are pregnant or breastfeeding Do not take Rivaroxaban Tillomed and inform your doctor if any of the conditions listed above apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Tillomed.
Be especially careful with Rivaroxaban Tillomed

if you have an increased risk of bleeding, such as in cases of:
moderate or severe kidney disease, because kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Tillomed”)
coagulation disorders
very high blood pressure not controlled by medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or oesophagitis, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, intestine, genital tract or urinary tract
a blood vessel disorder at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous lung bleeding
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If you are scheduled for surgery

it is very important to take Rivaroxaban Tillomed before and after surgery exactly as directed by your doctor.
if the surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Tillomed exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

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

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

If you are taking:
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibacterial medicines (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions listed above apply to you, inform your doctor before taking Rivaroxaban Tillomed, because the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor believes you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

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

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

Driving and using machines
Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle or operate 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, i.e. essentially “sodium-free”.

9. How to take Rivaroxaban Tillomed

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

What dose to take

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

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 may be crushed and mixed with a small amount of water or apple puree immediately before administration.
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.
Try to take the tablet at the same time each day to help you remember.
Your doctor will decide how long treatment should continue.

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

If you take more 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, your risk of bleeding increases.

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

If you stop taking Rivaroxaban Tillomed
Do not stop taking Rivaroxaban Tillomed without first talking to your doctor, as Rivaroxaban Tillomed helps prevent a serious condition from occurring.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

10. Possible side effects

Like all medicines, Rivaroxaban Tillomed can cause side effects, although not everybody will experience them.
Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you notice any of the following side effects:

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

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

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

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding causing pain and swelling
thrombocytopenia (low platelet count; platelets are blood cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected by blood tests performed by your doctor)
blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced 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 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 granulocyte white blood cells causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding, sometimes with blood in the urine, leading to kidney dysfunction (anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

12. Package contents and other information

What Rivaroxaban Tillomed contains

The active substance 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 silica. See section 2
“Rivaroxaban Tillomed contains lactose and sodium”.
Film coating: macrogol E1521, hypromellose, titanium dioxide (E 171), iron oxide red (E 172)
Description of the appearance of Rivaroxaban Tillomed and contents of the pack
Rivaroxaban Tillomed 10 mg film-coated tablets are light pink to pink in colour, round, biconvex,
with “10” engraved 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 Milano (MI), Italy
Manufacturers
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 European Economic Area Member States under the
following names
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

Package leaflet: Information for the user

Rivaroxaban Tillomed 15 mg film-coated tablets, 20 mg film-coated tablets

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

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

Contents of this leaflet

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

13. What Rivaroxaban Tillomed is 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
at least 30 kg for:

treating blood clots and preventing their recurrence in veins or 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 inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to form clots.

14. What you need to know before taking Rivaroxaban Tillomed

Do not take Rivaroxaban Tillomed

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

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

if you have an increased risk of bleeding, such as:
severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when 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 medication
stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestines, or inflammation of the oesophagus (e.g. due to gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)) or tumours in the stomach, intestines, genital tract or urinary tract
a blood vessel disorder at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

it is very important to take Rivaroxaban Tillomed before and after surgery exactly as directed by your doctor.
if the surgical procedure involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Tillomed before and after the injection or removal of the catheter exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

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

If you are taking:
certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
certain antibiotics (e.g. clarithromycin, erythromycin)
certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the conditions listed above apply to you, inform your doctor before taking Rivaroxaban Tillomed, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers you to be at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

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

If any of the conditions listed above apply to you, inform your doctor before taking Rivaroxaban Tillomed, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Tillomed and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Tillomed during pregnancy or while breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Tillomed. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or operate 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, i.e. essentially “sodium-free”.

15. How to take Rivaroxaban Tillomed

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must take Rivaroxaban Tillomed with food.
Swallow the tablet or tablets preferably with water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban Tillomed in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban Tillomed tablets 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 20 mg Rivaroxaban Tillomed tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Tillomed tablet once daily.
If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI – Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Tillomed tablet once daily (or one 10 mg Rivaroxaban Tillomed tablet if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of clots: The recommended dose is one 15 mg Rivaroxaban Tillomed tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Tillomed tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Rivaroxaban Tillomed tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Tillomed tablet once daily if the risk of bleeding is greater than the risk of developing a new blood clot.
- Children and adolescents: The dose of Rivaroxaban Tillomed depends on body weight and will be calculated by your doctor.
  - The recommended dose for children and adolescents weighing between 30 kg and less than 50 kg is one 15 mg Rivaroxaban Tillomed tablet once daily.
  - The recommended dose for children and adolescents weighing 50 kg or more is one 20 mg Rivaroxaban Tillomed tablet once daily. Take each dose of Rivaroxaban Tillomed with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to help you remember.
For parents or caregivers: Please observe the child to ensure the full dose is taken.
Since the dose of Rivaroxaban Tillomed is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted as weight changes. Never adjust the dose of Rivaroxaban Tillomed by yourself. If adjustment is needed, your doctor will do so.
Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use alternative formulations of rivaroxaban. For children and adolescents who cannot swallow whole tablets, use other available formulations of rivaroxaban.
If no other formulation is available, the Rivaroxaban Tillomed tablet may be crushed and mixed with water or apple puree immediately before administration. Take food after administering this mixture. If necessary, your doctor may also administer crushed Rivaroxaban Tillomed tablets 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 not take 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.
Try to take the tablet or tablets at the same time each day to help you remember.
Your doctor will decide how long treatment should continue.
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 at the time instructed by your doctor.

If you forget to take Rivaroxaban Tillomed

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

If you take more Rivaroxaban 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 helps prevent serious conditions.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

16. Possible side effects

Like all medicines, Rivaroxaban Tillomed can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may potentially be life-threatening. Excessive bleeding can lead to a sudden drop in arterial pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you or the 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 of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
- prolonged or excessive blood loss
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.
Signs of severe skin reactions
- widespread and intense rash, blisters, or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illnesses (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 breathing difficulties; sudden drop in blood pressure. The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

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

Uncommon (may occur in 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 platelet count; platelets are the cells that help blood to clot)
allergic reactions, including skin allergic reactions
liver dysfunction (can be detected through blood tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

muscle bleeding
cholestasis (reduced 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 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 granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney bleeding, sometimes with blood in urine, leading to kidney dysfunction (anticoagulant-related nephropathy)
increased pressure in the muscles of arms or legs after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Side effects in children and adolescents
In general, side effects observed in children and adolescents treated with Rivaroxaban Tillomed have been similar in type to those observed in adults and have mainly been mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)

headache
fever
nosebleeds
vomiting

Common (may occur in up to 1 in 10 people)

increased heart rate
blood tests may show increased bilirubin (bile pigment)
thrombocytopenia (reduced platelet count; platelets are the cells that help blood to clot)
heavy menstrual periods

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

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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 stated on the carton. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

18. Package contents and other information

What Rivaroxaban Tillomed contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, croscarmellose sodium, monohydrate lactose, 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 pack contents
Rivaroxaban Tillomed 15 mg film-coated tablets are red, round, biconvex, with “15” engraved on one side and “R” on the other side.
They are supplied in blisters in boxes containing 10, 14, 28, 42, 98 or 100 film-coated tablets.
Rivaroxaban Tillomed 20 mg film-coated tablets are red-brown, round, biconvex, with “20” engraved on one side and “R” on the other side.
They are supplied in blisters in boxes containing 10, 14, 28, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturers
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 authorized in the European Economic Area countries under the following names:
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