Rivaroxaban HCS: detailed information

Package leaflet: Information for the user

Rivaroxaban HCS 2.5 mg film-coated tablets

rivaroxaban
Generic medicine
Please read all of 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 their symptoms are the same as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

You have been given Rivaroxaban HCS because

you have been diagnosed with acute coronary syndrome (a group of conditions that includes 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 HCS reduces the risk of another heart attack or the risk of dying from a heart- or blood vessel-related disease. Rivaroxaban HCS 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 arterial disease causing symptoms. In adults, Rivaroxaban HCS reduces the risk of clot formation (atherothrombotic events). Rivaroxaban HCS will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you need to take Rivaroxaban HCS following a procedure used to widen a narrowed or blocked leg artery in order to restore blood flow, your doctor may prescribe it in combination with acetylsalicylic acid for a short period.

Rivaroxaban HCS contains the active substance rivaroxaban and belongs to a group of medicines
called antithrombotic agents. It works by blocking a clotting factor (factor Xa), thereby
reducing the tendency of the blood to form clots.

2. What you need to know before taking Rivaroxaban HCS

Do not take Rivaroxaban HCS

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine
(listed in section 6)
if you are experiencing excessive bleeding
if you have a disease or condition in any part of your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent 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 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 deep brain tissues (lacunar stroke), or if you have had 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
during pregnancy or breastfeeding Do not take Rivaroxaban HCS 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 HCS.
Rivaroxaban HCS 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.
Be especially careful with Rivaroxaban HCS

if you have an increased risk of bleeding, such as in the following cases:
- severe kidney disease, as renal function may alter 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 HCS”)
- bleeding disorders
- very high blood pressure not controlled by medical treatment
- diseases of the stomach or intestine that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus (e.g. due to 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 in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
- if you are over 75 years old
- if you weigh less than 60 kg
- if you have 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 your treatment needs to be changed.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban HCS. 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 HCS exactly at the times indicated by your doctor, both before and after the procedure.
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 HCS exactly at the times indicated by your doctor, both before and after the injection or removal of the catheter
- 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 intervention may be required.

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

If you are taking
- certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
- ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
- certain 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, 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 abnormal heart rhythm
- certain medicines for 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 HCS, as the effect of Rivaroxaban HCS 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 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
  If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban HCS, as the effect of Rivaroxaban HCS may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban HCS and whether you need to be closely monitored.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Rivaroxaban HCS during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban HCS. 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 HCS 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 use tools or machines.
Rivaroxaban HCS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban HCS

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 taken twice daily. Take Rivaroxaban HCS 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 HCS 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 HCS tablets through a tube inserted into the stomach.

Rivaroxaban HCS will not be given to you as a single treatment.

Your doctor will also prescribe acetylsalicylic acid for you. If you are taking Rivaroxaban HCS after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.

If you are taking Rivaroxaban HCS following a procedure to widen a narrowed or blocked artery in the leg 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 dose of these medicines for you (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 HCS
Treatment with Rivaroxaban HCS after an acute coronary syndrome should be started 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 tell you when to start treatment with Rivaroxaban HCS.

Your doctor will decide how long you should continue treatment.

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

If you forget to take Rivaroxaban HCS
Do not take a double dose to make up for the forgotten dose. If you miss a dose, take the next dose at your usual time.

If you stop taking Rivaroxaban HCS
Take Rivaroxaban HCS regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban HCS without first discussing it with your doctor. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from heart or blood vessel disease, may increase.

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

4. Possible side effects

Like all medicines, Rivaroxaban HCS can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban HCS may cause bleeding, which can potentially be life-threatening. Severe bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you 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 bleeding
Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of severe skin reactions

Widespread and 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 (affecting 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 affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

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

Reduction in red blood cell count, which may cause paleness, weakness or shortness of breath
Bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
Bleeding in the eye (including bleeding in the white part of the eye)
Bleeding into tissues or body cavities (haematoma, bruising)
Coughing up blood
Bleeding from or under the skin
Bleeding after surgery
Loss of blood or fluid from surgical wound
Swelling in limbs
Limb pain
Impaired kidney function (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)
Decreased strength and energy (weakness, fatigue), headache, dizziness
Rash, itching
Blood tests may show increased levels of certain liver enzymes

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

Bleeding in the brain or within the skull (see above, signs of bleeding)
Bleeding into a joint, causing pain and swelling
Thrombocytopenia (reduced platelet count; platelets are the cells that help blood to clot)
Allergic reactions, including skin allergic reactions
Impaired liver function (can be detected through tests performed by your doctor)
Blood tests may show increased bilirubin levels, increased pancreatic or liver enzymes, or increased platelet count
Fainting
Malaise
Rapid heartbeat
Dry mouth
Hives

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

Bleeding into a muscle
Cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury)
Yellowing of the skin and eyes (jaundice)
Localised swelling
Formation of a 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 affect 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 (cannot be estimated from the available data):

Kidney impairment following severe bleeding
Renal 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, sensory changes, numbness or paralysis (compartment syndrome following bleeding)

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

5. How to store Rivaroxaban HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on each blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban HCS contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components (excipients) are mannitol, microcrystalline cellulose, polyethylene glycol, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, sodium stearoyl fumarate in the tablet core, and hypromellose, polyethylene glycol, titanium dioxide (E171) and yellow iron oxide (E172) in the film coating. See section 2 “Rivaroxaban HCS contains sodium”.

Description of the appearance of Rivaroxaban HCS and package contents
The film-coated tablets are light brownish-yellow to brownish-yellow, round, slightly biconvex, engraved with the mark "2.5" on one side of the tablet. Dimensions: diameter approximately 6.5 mm.
Rivaroxaban HCS is available in packages containing:

100 film-coated tablets in non-divisible blisters.
100 x 1 film-coated tablets in unit-dose divisible blisters.
calendar packs: 28 and 56 film-coated tablets in unit-dose divisible blisters.

The patient alert card is included in every medicine package.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State Name	Medicinal Product Name
Denmark, Spain	Rivaroxaban TAD
Austria, Italy	Rivaroxaban HCS

Instructions for the user

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

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

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

Contents of this leaflet

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

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

Rivaroxaban HCS contains the active substance rivaroxaban. Rivaroxaban HCS is used in adults to:

prevent 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.
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 HCS is used in children and adolescents under 18 years of age and with a body weight equal to or greater than 30 kg to:

treat blood clots and prevent their recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban HCS belongs to a group of medicines called antithrombotic agents. It works by
blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

2. What you should know before taking Rivaroxaban HCS

Do not take Rivaroxaban HCS

if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
if you have excessive bleeding
if you have a disease or condition in any part of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or 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
during pregnancy or breastfeeding

Do not take Rivaroxaban HCS 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 HCS.
Be especially careful with Rivaroxaban HCS

if you have an increased risk of bleeding, such as in the following cases:
- severe kidney disease in adults and moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban HCS”)
- bleeding disorders
- very high blood pressure that is not controlled by medical treatment
- diseases of the stomach or intestine 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 in the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an 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 that 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 HCS 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 HCS before and after the injection or catheter removal 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 HCS tablets are not recommended for children weighing less than 30 kg.
There is insufficient information available on the use of Rivaroxaban HCS in children and adolescents for adult indications.
Other medicines and Rivaroxaban HCS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

If you are taking
- certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
- ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces 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 abnormal heart rhythm
- certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

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 HCS, as the effect of Rivaroxaban HCS may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban HCS and whether you need to be closely monitored.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Rivaroxaban HCS during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking Rivaroxaban HCS. 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 HCS 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 use tools or machinery.
Rivaroxaban HCS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban HCS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban HCS should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban HCS in another way. The tablet can be crushed and mixed with a little water or apple puree immediately before taking it. The mixture should be followed immediately by food intake.
If necessary, your doctor may administer crushed Rivaroxaban HCS tablets through a tube inserted into the stomach.

What dose to take

Adults
- To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg Rivaroxaban HCS tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban HCS tablet once daily.
- If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI – Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting a dose reduction to one 15 mg Rivaroxaban HCS tablet once daily (or one 10 mg rivaroxaban 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 HCS tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban HCS 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 HCS tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban HCS 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 HCS depends on body weight and will be calculated by your doctor.
- The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one 15 mg Rivaroxaban HCS tablet once daily.
- The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban HCS tablet once daily. Take each dose of Rivaroxaban HCS with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time every 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 HCS is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted with changes in weight.
Never adjust the dose of Rivaroxaban HCS by yourself. If needed, your doctor will adjust the dose.
Do not split the tablet in an attempt to fractionate the dose. If a lower dose is required, use the alternative formulation, rivaroxaban granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, use rivaroxaban granules for oral suspension.
If the oral suspension is not available, the Rivaroxaban HCS tablet may be crushed and mixed with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer crushed Rivaroxaban HCS tablets via a gastric tube.

If you spit out the dose or vomit

If this happens less than 30 minutes after taking Rivaroxaban HCS, take a new dose.
If this happens more than 30 minutes after taking Rivaroxaban HCS, do not take another dose. In this case, take your next dose of Rivaroxaban HCS at the usual time.
Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban HCS.

When to take Rivaroxaban HCS
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 you should continue treatment.
To prevent the formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat needs to be restored to normal through a procedure called cardioversion, take Rivaroxaban HCS exactly as directed by your doctor.

If you forget to take Rivaroxaban HCS

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 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 daily dose of two tablets (30 mg). The following day, continue with one 15 mg tablet twice daily.

If you stop taking Rivaroxaban HCS
Do not stop taking Rivaroxaban HCS without first talking to your doctor, as Rivaroxaban HCS treats serious conditions and helps prevent their occurrence.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban HCS can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban HCS can cause
bleeding that could potentially be life-threatening. Massive bleeding can cause a sudden drop in
blood pressure (shock). In some cases, bleeding may not be obvious.
Contact your doctor immediately if you 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 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 bleeding
unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of severe skin reactions

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

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

reduction in red blood cells, which may cause paleness, 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 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 in limbs
limb pain
impaired kidney function (can be detected through blood tests performed by your doctor)
fever
stomach ache, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
decreased strength and energy (weakness, fatigue), headache, dizziness
rash, itching
blood tests may show increased levels of certain liver enzymes

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

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

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

bleeding into a muscle
cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver injury)
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 cell causing lung inflammation (eosinophilic pneumonia)

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

kidney impairment 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, sensory changes, 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 have been
similar to those seen in adults and have mainly been mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may affect more than 1 in 10 people):

headache
fever
nosebleeds
vomiting

Common (may affect up to 1 in 10 people):

increased heart rate
blood tests may show increased bilirubin (a bile pigment)
thrombocytopenia (reduction in platelets, the cells that help blood to clot)
heavy menstrual bleeding

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

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a 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 can 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.

5. How to store Rivaroxaban HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

6. Package contents and other information

What Rivaroxaban HCS contains

The active substance is rivaroxaban. 15 mg: Each tablet contains 15 mg of rivaroxaban. 20 mg: Each tablet contains 20 mg of rivaroxaban.
The other ingredients (excipients) are mannitol, microcrystalline cellulose, macrogol, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, sodium stearate fumarate in the tablet core and hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172) – for 15 mg tablets only in the film coating. See section 2 “Rivaroxaban HCS contains sodium”.

Description of the appearance of Rivaroxaban HCS and package contents
15 mg:
Film-coated tablets, reddish-orange to brownish-orange in colour, round, slightly biconvex, engraved with the mark 15 on one side of the tablet.
Size: diameter approximately 6.5 mm.
20 mg:
Film-coated tablets, pink to dark pink in colour, round, slightly biconvex, engraved with the mark 20 on one side of the tablet.
Size: diameter approximately 7 mm.
15 mg:
Rivaroxaban HCS is available in packages containing:

100 film-coated tablets in non-divisible blisters.
100 x 1 film-coated tablets in unit-dose divisible blisters.
calendar packs: 14, 28 and 42 film-coated tablets in unit-dose divisible blisters.

The patient alert card is included in every medicine package.
20 mg:
Rivaroxaban HCS is available in packages containing:

100 film-coated tablets in non-divisible blisters.
100 x 1 film-coated tablets in unit-dose divisible blisters.
calendar packs: 14 and 28 film-coated tablets in unit-dose divisible blisters.

The patient alert card is included in every medicine package.
Not all pack sizes may be marketed.
Marketing Authorization Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium
Local representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann - Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State Name	Medicinal Product Name
Denmark, Spain	Rivaroxaban TAD
Austria, Italy	Rivaroxaban HCS