Package leaflet: Information for the patient

Rixacam 2.5 mg film-coated tablets

Rivaroxaban
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rixacam is and what it is used for

You have been given Rixacam because:

you have been diagnosed with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and an increase in certain cardiac markers has been detected in blood tests. Rixacam reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to the heart or blood vessels. Rixacam will not be given to you alone. Your doctor will instruct you to also take:
- acetylsalicylic acid or
- acetylsalicylic acid plus clopidogrel or ticlopidine.

you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Rixacam reduces the risk in adults of developing blood clots (atherothrombotic events). Rixacam will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you need to take Rixacam 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 in combination with acetylsalicylic acid.

Rixacam 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 Rixacam

Do not take Rixacam

if you are allergic to rivaroxaban or 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 blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (ischaemic stroke, non-lacunar) within the previous month
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding Do not take Rixacam 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 Rixacam.
Rixacam 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 Rixacam

if you have an increased risk of bleeding, such as in the following cases:
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 when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rixacam”)
disorders of blood clotting
very high blood pressure not controlled with medicines
stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the oesophagus, 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 bleeding from the lungs
if you are over 75 years old
if you weigh less than 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 Rixacam. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If you are undergoing surgery

it is very important to take Rixacam before and after surgery exactly as scheduled 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 Rixacam before and after the injection or removal of the catheter exactly as scheduled 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
Rixacam 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 Rixacam
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 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 for depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)).

If any of the conditions described above apply to you, inform your doctor before taking Rixacam, as the effect of Rixacam 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 product used for depression
rifampicin, an antibiotic

If any of the conditions described above apply to you, inform your doctor before taking Rixacam, as the effect of Rixacam may be reduced. Your doctor will decide whether you should be treated with Rixacam and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rixacam during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rixacam. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rixacam 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.
Rixacam 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 Rixacam

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet twice daily. Take Rixacam 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 Rixacam in another way. The tablet can be crushed and mixed with a small amount of water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed Rixacam tablet through a tube inserted into the stomach.
Rixacam will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.
If you are taking Rixacam after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rixacam following a procedure used to dilate 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 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 Rixacam
Treatment with Rixacam 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 (injection) anticoagulant therapy would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will tell you when to start treatment with Rixacam.
Your doctor will decide how long treatment should continue.
If you take more Rixacam than you should
Contact your doctor immediately if you have taken too many Rixacam tablets. If you have taken an excessive amount of Rixacam, the risk of bleeding increases.
If you forget to take Rixacam
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 Rixacam
Take Rixacam regularly for the entire duration prescribed by your doctor.
Do not stop taking Rixacam without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or dying from heart or blood vessel disease may increase.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rixacam can cause side effects, although not everybody gets them.
Like other similar medicines used to reduce blood clot formation, Rixacam can cause bleeding which
may potentially be life-threatening. Severe bleeding can cause a sudden drop in
arterial 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 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 serious skin reactions
- widespread and severe 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 (may occur in up to 1 in 10,000 people).
Signs of serious 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 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)

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 pain, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in 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 (reduced number of platelets, which are blood cells involved in clotting)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through 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 affect up to 1 in 1,000 people)

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized 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 cells, causing lung inflammation (eosinophilic pneumonia)

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

kidney failure following severe bleeding
kidney haemorrhage, sometimes with blood in the urine, leading to inability of the kidneys to function properly (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 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: 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 Rixacam

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 packaging and on each blister after
Exp. 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 mash for up to 4 hours.
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 Rixacam contains

The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Tablet film coating: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E171).

Description of the appearance of Rixacam and pack contents
Rixacam 2.5 mg film-coated tablets are white, round, biconvex, with the number "2.5" engraved on one side.
The tablets are available in blisters in packs of 56, 60, 98, 100 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milan
Italy

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

Patient information leaflet

Rixacam 10 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rixacam is and what it is used for

Rixacam contains the active substance rivaroxaban and is used in adults to

prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots in the bloodstream 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rixacam belongs to a group of medicines called antithrombotic agents. It works by inhibiting
the blood clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you should know before taking Rixacam

Do not take Rixacam

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 a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rixacam 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 Rixacam.
Be especially careful with Rixacam

if you have a high risk of bleeding, which may occur in situations such as:
moderate or severe kidney disease, because kidney function can 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 Rixacam”)
coagulation disorders
uncontrolled high blood pressure
stomach or intestinal diseases 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 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 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

If any of the conditions described above apply to you, inform your doctor before taking Rixacam. 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 Rixacam at exactly the times prescribed by your doctor, both before and after surgery.
if your surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anesthesia for pain relief):
- it is very important to take Rixacam 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 anesthesia, as urgent medical intervention may be required.

Children and adolescents
Rixacam 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 Rixacam
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-relief 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 Rixacam, because
the effect of Rixacam 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 remedy for depression
rifampicin, an antibiotic

If any of the conditions described above apply to you, inform your doctor before taking Rixacam, as
the effect of Rixacam may be reduced. Your doctor will decide whether you should be treated with Rixacam and whether you
need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rixacam during pregnancy or breastfeeding. If there is a possibility you could become pregnant,
use a reliable method of contraception while taking Rixacam. If you become pregnant
while taking this medicine, inform your doctor immediately. Your doctor will decide how to proceed with
treatment.
Driving and using machines
Rixacam may cause dizziness (a common side effect) and 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.
Rixacam 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 Rixacam

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
What dose to take

To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg Rixacam 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 Rixacam 10 mg once daily.

Swallow the tablet preferably with some water.
Rixacam can be taken regardless of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rixacam in another way.
The tablet may be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer crushed Rixacam tablets through a tube inserted into the stomach.
When to take Rixacam
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent blood clots in the 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 Rixacam than you should
Contact your doctor immediately if you have taken too many Rixacam tablets. If you have taken an excessive amount of Rixacam, your risk of bleeding increases.
If you forget to take Rixacam
If you forget a dose, take it as soon as you remember. Take the next tablet the following day and then continue with one tablet per day as before.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rixacam
Do not stop taking Rixacam without first talking to your doctor, because Rixacam helps prevent serious conditions from occurring.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rixacam can cause side effects, although not everyone experiences them.
Like other similar medicines used to reduce the formation of blood clots, Rixacam can cause bleeding that
may potentially endanger the patient's life. Massive bleeding can cause a sudden drop
in blood pressure (shock). In some cases, bleeding may not be obvious.
Inform 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. 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 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 illnesses (DRESS syndrome). The frequency of these side effects is very rare (may occur in 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 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 flow), 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 surgical wound
swelling of limbs
limb pain
kidney dysfunction (may be detected through tests performed by your doctor)
fever
stomach ache, indigestion, feeling or state of malaise, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in 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 (reduction in the number of platelets, which are cells that help blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (may be detected through 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 affect up to 1 in 1,000 people)

muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), 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 cell causing inflammation in the lung (eosinophilic pneumonia)

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

kidney impairment following severe bleeding
renal hemorrhage, sometimes with presence of blood in urine, leading to the kidneys' inability to function properly (anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you 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: 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 Rixacam

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on each blister after
Exp. 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 you no longer use. This will help protect the environment.

6. Pack contents and other information

What Rixacam contains

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate. Film coating of the tablet: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E 171), iron oxide red (E 172).

Description of the appearance of Rixacam and pack contents
Rixacam 10 mg film-coated tablets are light pink, round, biconvex, with the number "10" engraved on one side.
The tablets are available in blisters in packs of 10, 30, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milan
Italy

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

Patient information leaflet

Rixacam 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, because it may be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rixacam is and what it is used for

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

preventing 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.

Rixacam is used in children and adolescents under 18 years of age and with body weight equal to or above 30 kg for:

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

Rixacam 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 clot.

2. What you should know before taking Rixacam

Do not take Rixacam

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 Rixacam 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 Rixacam.
Be especially careful with Rixacam

if you have an increased risk of bleeding, such as in the following cases:
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), 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 Rixacam”)
coagulation disorders
very high blood pressure not controlled with medicines
stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the oesophagus, e.g. caused by gastro-oesophageal 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 a history of 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 that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned

If any of the conditions described above apply to you, inform your doctor before taking Rixacam. 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 Rixacam exactly at the times indicated by your doctor, both before and after surgery.
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 Rixacam exactly at the times indicated by your doctor, both before and after the injection or catheter removal
inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Rixacam tablets are not recommended for children weighing less than 30 kg. There is insufficient information available on the use of Rixacam in children and adolescents for adult indications.
Other medicines and Rixacam
Tell 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 for 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 Rixacam, as the effect of Rixacam 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 product used for depression
rifampicin, an antibiotic

If any of the conditions listed above apply to you, inform your doctor before taking Rixacam, as the effect of Rixacam may be reduced. Your doctor will decide whether you should be treated with Rixacam and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rixacam during pregnancy or breastfeeding. If there is a possibility of becoming pregnant, use a reliable method of contraception while taking Rixacam. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rixacam may cause dizziness (a common side effect) or fainting (a non-common side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rixacam contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor 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 Rixacam

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Rixacam should be taken with food.
Swallow the tablet(s) preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rixacam in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration. The mixture should be followed immediately by food intake.
If necessary, your doctor may administer crushed Rixacam 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 Rixacam tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rixacam 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 Rixacam tablet once daily (or one 10 mg Rixacam 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 Rixacam tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rixacam 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 Rixacam tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rixacam tablet once daily if your risk of bleeding is greater than the risk of developing a new blood clot.
Children and adolescents The dose of Rixacam depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg Rixacam tablet once daily.
The recommended dose for children and adolescents with a body weight equal to or above 50 kg is one 20 mg Rixacam tablet once daily.

Take each dose of Rixacam 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 remind yourself. For parents or caregivers: Monitor the child to ensure the entire dose is taken.
Since the dose of Rixacam is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted with changes in weight.
Never adjust the dose of Rixacam on your own. If needed, your doctor will adjust the dose.
Do not split the tablet in an attempt to divide the dose. If a lower dose is required, use the alternative formulation of Rixacam granules for oral suspension. For children and adolescents unable to swallow whole tablets, use other rivaroxaban-containing medicines formulated as granules for oral suspension. If the oral suspension is not available, you may crush the Rixacam tablet and mix it with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer crushed Rixacam tablets via a gastric tube.

If you spit out the dose or vomit

If this occurs less than 30 minutes after taking Rixacam, take a new dose.
If this occurs more than 30 minutes after taking Rixacam, do not take a new dose. In this case, take your next dose at the usual time.

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

When to take Rixacam
Take the tablet(s) every day until your doctor tells you to stop.
Try to take the tablet(s) at the same time each day to help you remember. Your doctor will decide how long your treatment should continue.
To prevent the formation of clots in the brain (stroke) and in other blood vessels in the body:
If your heartbeat is to be restored to normal through a procedure called cardioversion, take Rixacam exactly as instructed by your doctor.

If you forget to take Rixacam

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 one 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 Rixacam than you should
Contact your doctor immediately if you have taken too many Rixacam tablets. If you have taken an excessive amount of Rixacam, your risk of bleeding increases.

If you stop taking Rixacam
Do not stop taking Rixacam without first talking to your doctor, as Rixacam 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, Rixacam can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce blood clot formation, Rixacam can cause bleeding
that may potentially endanger the patient's life. Major bleeding can cause 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.
- A 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 serious skin reactions
- widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
Signs of serious 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 observed in adults, children and adolescents
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 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 surgical wound
swelling of limbs
limb pain
kidney problems (may 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 decrease in 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 inside the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are blood cells that help blood to clot)
allergic reactions, including allergic skin reactions
liver problems (may be detected through 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 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 (haematoma) in the groin as a complication of a heart 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 haemorrhage, sometimes with blood in the urine, leading to inability of the kidneys to function properly (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)

Side effects in children and adolescents
In general, the side effects observed in children and adolescents treated with Rixacam have been
similar to those seen in adults and were mainly 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 (bile pigment)
thrombocytopenia (reduced platelets, which are blood cells that help blood to clot)
heavy menstrual periods

Uncommon (may affect 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 can also report side effects directly via the national reporting system at: 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 Rixacam

6. Package contents and other information

What Rixacam contains

The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are: Tablet core: microcrystalline cellulose, monohydrate lactose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate. Film coating: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of Rixacam and pack contents
Rixacam 15 mg film-coated tablets are round, biconvex, pink tablets, with the number “15” engraved on one side.
They are available in blister packs containing 14, 28, 30, 42, 98 or 100 film-coated tablets.
Rixacam 20 mg film-coated tablets are round, biconvex, pink tablets, with the number “20” engraved on one side.
They are available in blister packs containing 14, 28, 30, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milano
Italy

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