Rivaroxaban Polpharma

Package leaflet: Information for the user

Rivaroxaban Polpharma 2.5 mg film-coated tablets

rivaroxaban
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 effects, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
What Rivaroxaban Polpharma is and what it is used for
What you need to know before taking Rivaroxaban Polpharma
How to take Rivaroxaban Polpharma
Possible side effects
How to store Rivaroxaban Polpharma
Contents of the pack and other information

What Rivaroxaban Polpharma is and what it is used for
Rivaroxaban Polpharma has been prescribed for you because:

• You have been diagnosed with acute coronary syndrome (a group of conditions including heart attack and unstable angina, a severe form of chest pain) and blood tests have shown an increase in certain cardiac markers. In adults, Rivaroxaban Polpharma reduces the risk of another heart attack or the risk of death due to heart or circulatory disease. Rivaroxaban Polpharma will not be given to you alone. Your doctor will also prescribe: acetylsalicylic acid (also known as aspirin), or acetylsalicylic acid plus clopidogrel or ticlopidine. alternatively
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban Polpharma reduces, in adults, the risk of clot formation (atherothrombotic events). Rivaroxaban Polpharma will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. Rivaroxaban Polpharma contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. The medicine works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency of blood to clot.

What you need to know before taking Rivaroxaban Polpharma
Do not take Rivaroxaban Polpharma
if you are allergic to rivaroxaban or to any of the other ingredients of this
medicine (listed in section 6)
if you experience excessive bleeding
if you suffer from a disease or condition that increases your risk of
serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain,
recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have acute coronary syndrome and previously had bleeding or
a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and previously had bleeding in the brain (stroke) or a blockage of the small arteries supplying blood to deep brain tissues (lacunar stroke) or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rivaroxaban Polpharma and inform your doctor if any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Polpharma.
Rivaroxaban Polpharma must not be used in combination with medicines that reduce blood clotting such as prasugrel or ticagrelor, except for acetylsalicylic acid and clopidogrel/ticlopidine.
Take special care with Rivaroxaban Polpharma

• if you are at increased risk of bleeding, which may occur in situations such as: severe kidney disease, as kidney function may affect the amount of active medicine in your body if you are taking other medicines to prevent clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Polpharma") coagulation disorders very high blood pressure, uncontrolled by medication diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the esophagus caused, for example, by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus) a condition affecting the blood vessels at the back of the eye (retinopathy) a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous pulmonary bleeding you are over 75 years old you weigh 60 kg or less 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 your treatment needs to be changed.

If any of the above conditions apply to you, inform your doctor before taking
Rivaroxaban Polpharma. Your doctor will decide whether you can 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 Polpharma before and after the operation

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 Polpharma before and after the injection or removal of the catheter exactly as directed by your doctor
• inform your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.

Children and adolescents
Rivaroxaban Polpharma is not recommended for people under 18 years of age. There is
insufficient information available on the use of this medicine in children and adolescents.

Other medicines and Rivaroxaban Polpharma
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 applied locally to the skin ketoconazole tablets (used to treat Cushing's syndrome, which causes excessive cortisol production); certain antibiotics (e.g. clarithromycin, erythromycin) certain antiviral medicines for HIV/AIDS (e.g. ritonavir) other medicines used to inhibit clotting, e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”) anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine used to treat atrial fibrillation certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs), or serotonin-norepinephrine reuptake inhibitors (SNRIs))

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

• 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 above conditions apply to you, inform your doctor before taking
Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your
doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.

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

Driving and using machines
Rivaroxaban Polpharma may cause dizziness (a common side effect) or fainting (an uncommon side effect): see section 4, "Possible side effects". If these symptoms occur, do not drive or operate machinery.

Rivaroxaban Polpharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

How to take Rivaroxaban Polpharma
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is one 2.5 mg tablet twice daily. Take Rivaroxaban
Polpharma every day, preferably at the same time each day (e.g. 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 for advice on alternative ways to take Rivaroxaban Polpharma. 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 crushed Rivaroxaban Polpharma tablets via a tube inserted into the stomach.
Rivaroxaban Polpharma will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid. If you are taking Rivaroxaban Polpharma after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
Your doctor will prescribe the dose of these medicines (generally 75 to 100 mg of acetylsalicylic acid daily or a daily dose of 75–100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start treatment with Rivaroxaban Polpharma
Treatment with Rivaroxaban Polpharma following an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome: not earlier than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will advise you when to start treatment with Rivaroxaban Polpharma.
Your doctor will decide how long you should continue treatment.

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

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

If you stop taking Rivaroxaban Polpharma
Take Rivaroxaban Polpharma regularly and for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Polpharma without first discussing it with your doctor. If you stop taking this medicine, your risk of a new heart attack, stroke, or death from cardiovascular disease may increase.
For any questions about the use of this medicine, contact your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Like other similar medicines (antithrombotic agents), Rivaroxaban Polpharma can cause bleeding that could potentially be life-threatening. Excessive bleeding may cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Possible side effects that could indicate bleeding
Inform your doctor immediately if you notice any of the following side effects:
prolonged or excessive bleeding;
unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling,
shortness of breath, chest pain or angina pectoris, which could be signs of ongoing bleeding.
Your doctor may decide to monitor you closely or change your treatment.

Possible side effects that could indicate a severe skin reaction
Inform your doctor immediately if you notice skin reactions such as:

• widespread and severe rashes, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis). This side effect is very rare (may affect up to 1 in 10,000 people).
• a drug reaction causing rashes, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).

Possible side effects that may indicate serious allergic reactions
Inform your doctor immediately if you notice any of the following side effects:

• swelling of the face, lips, mouth or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. These side effects 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, gum bleeding
bleeding in the eye (including bleeding in the white of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood;
skin and subcutaneous bleeding
bleeding after surgery
bleeding or fluid leakage from the surgical wound
swelling of limbs
pain in limbs
reduced kidney function (can be confirmed by blood tests prescribed by your doctor)
fever
stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing);
decrease in strength and energy (weakness, fatigue), headache, dizziness
skin rash or 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
bleeding into a joint, causing pain and swelling
thrombocytopenia (decrease in platelet count, the cells involved in blood clotting)
allergic reactions, including skin allergic reactions
impaired liver function (can be confirmed by blood tests prescribed by your doctor)
blood tests may show increased bilirubin, certain pancreatic or liver enzymes, or platelet count
fainting
malaise
tachycardia
dry mouth
urticaria

Rare (may affect up to 1 in 1,000 people):
bleeding into a muscle
cholestasis (reduced bile flow, a substance produced by the liver), hepatitis, including hepatocellular damage (liver inflammation including liver damage), yellowing of the skin and eyes (jaundice)
localized swelling
accumulation of blood (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

Frequency not known (frequency cannot be estimated from available data):
kidney failure following severe bleeding
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, sensory changes, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the website: 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.

How to store Rivaroxaban Polpharma
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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Contents of the pack and other information
What Rivaroxaban Polpharma contains
The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other ingredients are:
Tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose,
sodium croscarmellose, hypromellose, magnesium stearate.
Film coating (Opadry Yellow 03F12967): hypromellose, titanium dioxide (E171), talc, macrogol 8000, yellow iron oxide (E172).

Description of the appearance of Rivaroxaban Polpharma and contents of the pack
The 2.5 mg film-coated tablets of Rivaroxaban Polpharma are light yellow,
round, biconvex, with the number "2.5" engraved on one side.
They are supplied in blisters, in packs of 28, 30, 56 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
For any information about this medicine, contact the local representative of the marketing authorisation holder.
Marketing Authorisation Holder
Zaklady Farmaceutyczne Polpharma SA
ul. Pelplinska 19
83-200 Starogard Gdanski
Poland
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
83-200 Starogard Gdański, Poland

Package leaflet: Information for the user

Rivaroxaban Polpharma 10 mg film-coated tablets

rivaroxaban
Please read this entire 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may 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 Rivaroxaban Polpharma is and what it is used for
What you need to know before taking Rivaroxaban Polpharma
How to take Rivaroxaban Polpharma
Possible side effects
How to store Rivaroxaban Polpharma
Contents of the pack and other information

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What Rivaroxaban Polpharma is and what it is used for

Rivaroxaban Polpharma contains the active substance rivaroxaban, which is used to prevent the formation of blood clots in adult patients undergoing hip or knee replacement surgery. Your doctor has prescribed this medicine because there is an increased risk of blood clots after surgery.

It is also used to 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 clots in the veins of the legs and/or lungs.

Rivaroxaban Polpharma belongs to a group of medicines called antithrombotic agents. The medicine works by blocking a blood clotting factor (Factor Xa), thereby reducing the blood’s tendency to clot.

---

What you need to know before taking Rivaroxaban Polpharma

Do not take Rivaroxaban Polpharma

• 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 that increases your risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
• if you are taking other 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 Polpharma and inform your doctor if any of the above conditions apply to you.

---

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Polpharma.

Exercise particular caution with Rivaroxaban Polpharma if you are at increased risk of bleeding, which may occur in situations such as:

• moderate or severe kidney disease, as kidney function may affect the amount of active medicine in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Polpharma")
• coagulation disorders
• uncontrolled high blood pressure
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine or stomach, or oesophagitis caused, for example, by gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
• a condition affecting the blood vessels at the back of the eye (retinopathy)
• a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of pulmonary bleeding
• 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 your treatment needs to be adjusted
• if your doctor determines 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 above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma. Your doctor will decide whether you can 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 Polpharma exactly as directed by your doctor, both before and after surgery.

If your surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):

• It is very important to take Rivaroxaban Polpharma exactly as directed by your doctor.
• Inform your doctor immediately if, after anaesthesia, you experience numbness or weakness in your legs, or problems with your bowel or bladder, as urgent intervention may be required.

---

Children and adolescents

Rivaroxaban Polpharma is not recommended for people under 18 years of age. There is insufficient information available on the use of this medicine in children and adolescents.

---

Other medicines and Rivaroxaban Polpharma

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: antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied locally to the skin; ketoconazole tablets (used to treat Cushing's syndrome, which causes excessive cortisol production); certain antibiotics (e.g. clarithromycin, erythromycin); antiviral medicines for HIV/AIDS (e.g. ritonavir); other anticoagulant medicines (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); or certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

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

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

If any of the above apply to you, inform your doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.

---

Pregnancy and breastfeeding

Do not take Rivaroxaban Polpharma during pregnancy or breastfeeding. If you could become pregnant, use a reliable contraceptive method while taking Rivaroxaban Polpharma. 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 Polpharma may cause dizziness (a common side effect) or fainting (a less common side effect) – see section 4, "Possible side effects". If you experience these symptoms, do not drive or operate machinery.

---

Rivaroxaban Polpharma contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

---

How to take Rivaroxaban Polpharma

Always take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Dosage

• To prevent blood clots after hip or knee replacement surgery:
  The recommended dose is one 10 mg Rivaroxaban Polpharma tablet once daily.

• To prevent blood clots in the legs or lungs and to prevent their recurrence:
  The recommended dose, after at least 6 months of anticoagulant treatment, is one tablet of 10 mg or 20 mg once daily. Your doctor has prescribed Rivaroxaban Polpharma 10 mg once daily.

Swallow the tablet, preferably with water.

Rivaroxaban Polpharma can be taken with or without food.

If you have difficulty swallowing the tablet whole, ask your doctor for advice on alternative ways to take Rivaroxaban Polpharma. The tablet can be crushed and mixed with a small amount of water or apple puree immediately before administration.

If necessary, your doctor may administer crushed Rivaroxaban Polpharma tablets via a tube inserted into the stomach.

---

When to take Rivaroxaban Polpharma

Take the tablet every day until your doctor tells you to stop.

Try to take the tablet at the same time each day – this will help you remember to take it. Your doctor will decide how long you should continue treatment.

• After hip or knee replacement surgery: Take the first tablet 6–10 hours after surgery.
• For major hip surgery, treatment usually lasts 5 weeks.
• For major knee surgery, treatment usually lasts 2 weeks.

---

If you take more Rivaroxaban Polpharma than you should

Contact your doctor immediately if you have taken too many Rivaroxaban Polpharma tablets.

Taking an excessive dose increases the risk of bleeding.

---

If you forget to take Rivaroxaban Polpharma

Take the missed dose as soon as you remember. The next day, take your tablet as usual and continue taking one tablet daily.

Do not take a double dose to make up for a forgotten tablet.

---

If you stop taking Rivaroxaban Polpharma

Do not stop taking Rivaroxaban Polpharma without first discussing it with your doctor, as it helps prevent serious conditions.

For any questions about the use of this medicine, consult your doctor or pharmacist.

---

Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Like other similar medicines (antithrombotic agents), Rivaroxaban Polpharma can cause bleeding that may potentially be life-threatening. Excessive bleeding may cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Possible side effects that may be signs of bleeding:

Inform your doctor immediately if you notice any of the following:

• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina – these may be signs of ongoing bleeding.

Your doctor may decide to monitor you closely or change your treatment.

Possible side effects that may indicate a severe skin reaction:

Inform your doctor immediately if you notice skin reactions such as:

• widespread and intense rashes, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis). This side effect is very rare (may affect up to 1 in 10,000 people).
• a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).

Possible side effects that may indicate serious allergic reactions:

Inform your doctor immediately if you notice any of the following:

• swelling of the face, lips, mouth or throat; difficulty swallowing; hives; breathing difficulties; sudden drop in blood pressure. These side effects are very rare (anaphylactic reactions, including anaphylactic shock, may affect up to 1 in 10,000 people) and not common (angioedema and allergic oedema; may affect 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 paleness, weakness or breathlessness
• bleeding in the stomach or intestine, urogenital bleeding (including blood in urine and heavy menstruation), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or body cavities (haematoma, bruising)
• coughing up blood
• skin and subcutaneous bleeding
• bleeding after surgery
• blood or fluid leakage from the surgical wound
• swelling of limbs
• limb pain
• reduced kidney function (can be confirmed by blood tests prescribed by your doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea
• low blood pressure (symptoms include dizziness or fainting when standing)
• decreased strength and energy (weakness, fatigue), headache, dizziness
• skin rash or itching
• blood tests may show increased liver enzymes

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

• bleeding in the brain or within the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduced number of platelets, the blood cells involved in clotting)
• allergic reactions, including skin allergies
• impaired liver function (can be confirmed by blood tests prescribed by your doctor)
• blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
• fainting
• malaise
• tachycardia
• 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
• blood accumulation (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• kidney failure after severe bleeding
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, sensory changes, numbness or paralysis (compartment syndrome after bleeding)

---

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Reporting side effects helps provide more information on the safety of this medicine.

---

How to store Rivaroxaban Polpharma

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 pack after "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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

---

Contents of the pack and other information

What Rivaroxaban Polpharma contains

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.

Other ingredients:

• Tablet core: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate.
• Film coating (Opadry II Pink 33G34170): hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin, yellow iron oxide (E172), black iron oxide (E172).

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Description of the appearance of Rivaroxaban Polpharma and contents of the pack

Rivaroxaban Polpharma 10 mg film-coated tablets are pink, round, biconvex, with the number "10" engraved on one side.

They are supplied in blisters, in cartons containing 5, 10 or 30 film-coated tablets.

Not all pack sizes may be marketed.

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Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zaklady Farmaceutyczne Polpharma SA
ul. Pelplinska 19
83-200 Starogard Gdanski
Poland

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
83-200 Starogard Gdański, Poland

Package leaflet: Information for the user

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

rivaroxaban
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,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet
What Rivaroxaban Polpharma is and what it is used for
What you need to know before taking Rivaroxaban Polpharma
How to take Rivaroxaban Polpharma
Possible side effects
How to store Rivaroxaban Polpharma
Contents of the pack and other information
What Rivaroxaban Polpharma is and what it is used for
Rivaroxaban Polpharma contains the active substance rivaroxaban, which 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 recurrence of clots in the blood vessels of the legs and/or lungs.
Rivaroxaban Polpharma belongs to a group of medicines called antithrombotic agents. The medicine works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency of blood to clot.
What you need to know before taking Rivaroxaban Polpharma
Do not take Rivaroxaban Polpharma
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 that increases your risk of serious bleeding (e.g. stomach ulcer, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding
Do not take Rivaroxaban Polpharma and inform your doctor if any of the above conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Polpharma.
Be especially careful with Rivaroxaban Polpharma
if you are at increased risk of bleeding, which may occur in situations such as:
severe kidney disease, since kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Polpharma")
bleeding disorders
very high, uncontrolled blood pressure
stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine or stomach, or inflammation of the oesophagus caused, for example, by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
a condition affecting the blood vessels at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous pulmonary 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 therapy adjustment is needed
if your doctor determines 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 above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma. Your doctor will decide whether you can be treated with this medicine and whether you need to be closely monitored.
If you are undergoing surgery:
it is very important to take Rivaroxaban Polpharma before and after the operation exactly as directed by your doctor.
If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Polpharma 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 Polpharma is not recommended for people under 18 years of age. There is insufficient information available on the use of this medicine in children and adolescents.
Other medicines and Rivaroxaban Polpharma
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.

• If you are taking: certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied locally to the skin; ketoconazole tablets (used to treat Cushing's syndrome, which causes excessive cortisol production); certain antibacterial medicines (e.g. clarithromycin, erythromycin); certain antiviral medicines for HIV/AIDS (e.g. ritonavir); other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol); anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid); dronedarone, a medicine used to treat atrial fibrillation; certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs), or serotonin-norepinephrine reuptake inhibitors (SNRIs)) If any of the above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be enhanced. Your doctor will decide whether you can be treated with this medicine and whether you need to be closely monitored. If your doctor believes you have a higher risk of developing stomach or intestinal ulcers, they may decide to 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 above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Polpharma during pregnancy or breastfeeding. If there is a possibility that you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Polpharma. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Polpharma may cause dizziness (a common side effect) or fainting (an uncommon side effect): see section 4, "Possible side effects". If these symptoms occur, do not drive or operate machinery.
Rivaroxaban Polpharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rivaroxaban Polpharma 20 mg contains Allura Red AC. Rivaroxaban Polpharma 15 mg contains Allura Red AC and Sunset Yellow FCF.
It may cause allergic reactions.
How to use Rivaroxaban Polpharma
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Take the tablet(s), swallowing them preferably with water.
Take Rivaroxaban Polpharma with food.
If you have difficulty swallowing the tablet whole, ask your doctor for advice on alternative ways to take Rivaroxaban Polpharma. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before taking. After swallowing the mixture, eat food immediately.
If necessary, your doctor may administer the crushed Rivaroxaban Polpharma tablet via a tube inserted into the stomach.
Dosage

• To prevent blood clots in the brain (stroke) or in other blood vessels of the body, the recommended dose is one 20 mg Rivaroxaban Polpharma tablet once daily. In case of kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Polpharma tablet once daily. If you need to undergo a procedure to treat blockage of heart blood vessels (called PCI - Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Polpharma tablet once daily (or one 10 mg Rivaroxaban Polpharma tablet, if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel. To prevent blood clots in the leg veins or lung vessels and to prevent their recurrence: The recommended dose is one 15 mg Rivaroxaban Polpharma tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Polpharma tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with 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 Polpharma tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Polpharma tablet once daily, if the risk of bleeding is greater than the risk of developing a new clot.

When to take Rivaroxaban Polpharma
Take the tablet(s) every day until your doctor tells you to stop treatment.
Try to take the tablet(s) at the same time each day: this will help you remember to take it. Your doctor will decide how long you should continue treatment.
To prevent blood clots in the brain (stroke) and in other blood vessels of the body:
If your heartbeat needs to be restored to normal through a procedure called cardioversion, take Rivaroxaban Polpharma exactly as your doctor has instructed.
If you take more Rivaroxaban Polpharma than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Polpharma tablets.
Taking an excessive dose of Rivaroxaban Polpharma increases the risk of bleeding.
If you forget to take Rivaroxaban Polpharma

• If you are taking one 20 mg tablet 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 one day to make up for a missed dose. The next day, take the tablet as usual and continue with one tablet per day.
• 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 stop taking Rivaroxaban Polpharma
Do not stop taking Rivaroxaban Polpharma without first talking to your doctor, as Rivaroxaban Polpharma treats and prevents serious conditions.
For any questions about the use of this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Like other similar medicines (antithrombotic agents), Rivaroxaban Polpharma can cause bleeding that could potentially be life-threatening. Excessive bleeding could cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Possible side effects that could indicate bleeding
Inform your doctor immediately if you notice any of the following side effects:
prolonged or excessive blood loss;
unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris, which could be signs of ongoing bleeding.
Your doctor may decide to monitor you closely or change your treatment.
Possible side effects that could indicate a severe skin reaction
Inform your doctor immediately if you notice skin reactions such as:
widespread and intense rashes, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis). The frequency of this side effect is very rare (may affect up to 1 in 10,000 people); a drug reaction causing rashes, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
Possible side effects that may indicate serious allergic reactions
Inform your doctor immediately if you notice any of the following side effects:
swelling of the face, lips, mouth or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. These side effects are very rare (anaphylactic reactions, including anaphylactic shock, may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).
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 intestine, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
bleeding in the eye (including bleeding in the white of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood;
skin and subcutaneous bleeding
bleeding after surgery
blood or fluid leakage from the surgical wound
swelling of limbs
pain in limbs
reduced kidney function (may be confirmed by tests prescribed by your doctor)
fever
stomach ache, indigestion, nausea or vomiting, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing);
decreased strength and energy (weakness, fatigue), headache, dizziness
rash or skin 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 inside the skull
bleeding into a joint, causing pain and swelling
thrombocytopenia (decrease in platelet count, cells that contribute to blood clotting)
allergic reactions, including skin allergic reactions
impaired liver function (may be confirmed by tests prescribed by your doctor)
blood tests may show increased bilirubin, certain pancreatic or liver enzymes, or platelet count
fainting
malaise
tachycardia
dry mouth
urticaria
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 damage)
yellowing of the skin and eyes (jaundice)
localized swelling
accumulation of blood (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)
Frequency not known (frequency cannot be estimated from available data):
kidney failure following severe bleeding
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, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the website: 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.
How to store Rivaroxaban Polpharma
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." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What Rivaroxaban Polpharma contains
The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:
Tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate.
Film coating of Rivaroxaban Polpharma 15 mg (Opadry II Pink 33G240016): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3000, triacetin, aluminium lake of Allura Red AC (E129), aluminium lake of Sunset Yellow FCF (E110), aluminium lake of indigo carmine (E132).
Film coating of Rivaroxaban Polpharma 20 mg (Opadry II Red 33G250002): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3000, triacetin, aluminium lake of Allura Red AC (E129), yellow iron oxide (E172).
Description of the appearance of Rivaroxaban Polpharma and contents of the pack
Rivaroxaban Polpharma 15 mg film-coated tablets are pink, round, biconvex, with the number "15" engraved on one side.
They are supplied in blisters, packed in cartons of 10, 14, 28, 42, 98 or 100 film-coated tablets.
Rivaroxaban Polpharma 20 mg film-coated tablets are red, round, biconvex, with the number "20" engraved on one side.
They are supplied in blisters, packed in cartons of 10, 14, 28, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zaklady Farmaceutyczne Polpharma SA
ul. Pelplinska 19
83-200 Starogard Gdanski
Poland
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
83-200 Starogard Gdański, Poland
Patient Information Leaflet

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

Initial treatment pack
rivaroxaban
Please read this entire 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 adverse reaction, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
What Rivaroxaban Polpharma is and what it is used for
What you need to know before taking Rivaroxaban Polpharma
How to take Rivaroxaban Polpharma
Possible side effects
How to store Rivaroxaban Polpharma
Contents of the pack and other information
What Rivaroxaban Polpharma is and what it is used for
Rivaroxaban Polpharma contains the active substance rivaroxaban, which is used in adults to:

• 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 veins of the legs and/or lungs.

Rivaroxaban Polpharma belongs to a group of medicines called antithrombotic agents. The
medicine works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency of blood to clot.
What you need to know before taking Rivaroxaban Polpharma
Do not take Rivaroxaban Polpharma
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 that puts you at higher risk of serious
bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
if you have liver disease that increases the risk of bleeding
during pregnancy or breastfeeding
Do not take Rivaroxaban Polpharma and inform your doctor if any of the above conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Polpharma.
Exercise particular caution with Rivaroxaban Polpharma
if you are at increased risk of bleeding, which may occur in situations such as:
severe kidney disease, as kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin,
dabigatran, apixaban or heparin), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section "Other medicines and Rivaroxaban Polpharma")
coagulation disorders
very high blood pressure not controlled by medication
stomach or intestinal diseases that may cause bleeding, e.g.
inflammation of the intestine or stomach, or inflammation of the oesophagus caused, for example,
by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
a condition affecting the blood vessels at the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous pulmonary bleed
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 adjusted
if your doctor determines 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 above conditions apply to you, inform your doctor before taking Rivaroxaban
Polpharma. Your doctor will decide whether you can 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 Polpharma before and after the operation
exactly as directed by your doctor.
If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Polpharma before and after the injection or removal of the catheter exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs, or bowel or bladder problems after the anaesthesia, as urgent intervention may be required.
Children and adolescents
Rivaroxaban Polpharma is not recommended for people under 18 years of age. There is insufficient information available on the use of this medicine in children and adolescents.
Other medicines and Rivaroxaban Polpharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

• If you are taking: certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin; ketoconazole tablets (used to treat Cushing's syndrome, which causes excessive cortisol production); certain antibacterial medicines (e.g. clarithromycin, erythromycin); certain antiviral medicines for HIV/AIDS (e.g. ritonavir); other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol); anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid); dronedarone, a medicine used to treat atrial fibrillation; certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs), or serotonin-norepinephrine reuptake inhibitors (SNRIs)) If any of the above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be enhanced. Your doctor will decide whether you can be treated with this medicine and whether you need to be closely monitored. If your doctor believes you are at higher risk of developing stomach or intestinal ulcers, they may decide to prescribe preventive treatment for ulcers.
• If you are taking: certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital); St John's wort (Hypericum perforatum), a herbal remedy used for depression; rifampicin, an antibiotic If any of the above conditions apply to you, inform your doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether you need to be treated with this medicine and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Polpharma during pregnancy or breastfeeding. If there is a possibility
that you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Polpharma. If you become pregnant while taking this medicine,
inform your doctor immediately, who will decide how to proceed with treatment.
Driving and using machines
Rivaroxaban Polpharma may cause dizziness (a common side effect) or fainting (an uncommon side effect): see section 4, "Possible side effects". If these symptoms occur, do not drive or operate machinery.
Rivaroxaban Polpharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Rivaroxaban Polpharma 20 mg contains Allura Red AC.
Rivaroxaban Polpharma 15 mg contains Allura Red AC and Sunset Yellow FCF.
These may cause allergic reactions.
How to use Rivaroxaban Polpharma
Always take this medicine exactly as your doctor has instructed. If you have any doubts,
consult your doctor or pharmacist.
Take the tablet(s), swallowing them preferably with water. Take Rivaroxaban
Polpharma with food.
If you have difficulty swallowing the tablet whole, ask your doctor for advice on how to take Rivaroxaban Polpharma in another way. The tablet may be crushed and mixed with a
small amount of water or apple puree immediately before taking. After swallowing the mixture, eat food immediately.
If necessary, your doctor may administer crushed Rivaroxaban Polpharma tablets via a tube inserted into the stomach.
Dosage
The recommended dose is one 15 mg Rivaroxaban Polpharma tablet twice daily for the
first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban
Polpharma tablet once daily.
This initial treatment pack of 15 mg and 20 mg Rivaroxaban Polpharma tablets is intended
only for the first 4 weeks of treatment. After this pack is finished, treatment will continue with
Rivaroxaban Polpharma 20 mg once daily, as prescribed by your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks of
treatment to one 15 mg Rivaroxaban Polpharma tablet once daily, if the risk of bleeding is greater than the risk of developing a new clot.
When to take Rivaroxaban Polpharma
Take the tablet(s) every day until your doctor tells you to stop treatment.
Try to take the tablet(s) at the same time each day: this will help you remember to take it. Your doctor will decide how long you should continue treatment.
If you take more Rivaroxaban Polpharma than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Polpharma tablets.
Taking an excessive dose of Rivaroxaban Polpharma increases the risk of bleeding.
If you forget to take Rivaroxaban Polpharma
If you are taking one 15 mg tablet twice daily and have missed a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same
day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The following day, continue with one 15 mg tablet twice daily.
If you are taking one 20 mg tablet once daily and have missed 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. The next day, take the tablet as usual and continue with one tablet daily.
If you stop taking Rivaroxaban Polpharma
Do not stop taking Rivaroxaban Polpharma without first talking to your doctor,
because Rivaroxaban Polpharma treats and prevents serious conditions.
For any questions about the use of this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Like other similar medicines (antithrombotic agents), Rivaroxaban Polpharma can cause
bleeding that could potentially be life-threatening. Excessive
bleeding could cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Possible side effects that may be signs of bleeding:
Inform your doctor immediately if you notice any of the following
side effects:

• prolonged or excessive blood loss;
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris, which could be signs of ongoing bleeding. Your doctor may decide to monitor you closely or change your treatment.

Possible side effects that may indicate a serious skin reaction
Inform your doctor immediately if you notice skin reactions such as:
widespread and severe skin rashes, blisters or mucosal lesions, e.g. in the mouth or
eyes (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis). This side effect is very rare (affects fewer than 1 in 10,000 people).
a drug reaction causing skin rash, fever, internal organ inflammation, haematological changes and systemic symptoms (DRESS syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
Possible side effects that may indicate serious allergic reactions
Inform your doctor immediately if you notice any of the following side effects:

• swelling of the face, lips, mouth or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. These side effects are very rare (anaphylactic reactions, including anaphylactic shock, may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).

Possible side effects
Common (may affect up to 1 in 10 people):
reduction in red blood cells, which may cause paleness, weakness or breathlessness;
bleeding in the stomach or intestine, urogenital bleeding (including blood in urine and particularly heavy menstrual periods), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood;
skin and subcutaneous bleeding
bleeding after surgery
bleeding or fluid leakage from the surgical wound
swelling of limbs
limb pain
reduced kidney function (can be confirmed by tests prescribed by your doctor)
fever
stomach ache, indigestion, nausea or vomiting, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing);
decreased strength and energy (weakness, fatigue), headache, dizziness
skin rash or 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
bleeding into a joint, causing pain and swelling
thrombocytopenia (decrease in platelet count, cells that contribute to blood clotting)
allergic reactions, including skin allergic reactions
impaired liver function (can be confirmed by tests prescribed by your doctor)
blood tests may show increased bilirubin, certain pancreatic or liver enzymes, or platelet count
fainting
malaise
tachycardia
dry mouth
urticaria
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 damage)
yellowing of the skin and eyes (jaundice)
localized swelling
accumulation of blood (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery
(pseudoaneurysm)
Frequency not known (frequency cannot be estimated from available data):
kidney failure following severe bleeding
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, sensory changes, numbness or paralysis
(compartment syndrome after bleeding)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your
doctor, pharmacist, or nurse. You can also report side effects directly via the website: 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.
How to store Rivaroxaban Polpharma
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 medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What Rivaroxaban Polpharma contains
The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
The other excipients are:
Tablet core: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose,
sodium croscarmellose, hypromellose, magnesium stearate.
Film coating of Rivaroxaban Polpharma 15 mg (Opadry II Pink 33G240016):
hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3000, triacetin, aluminium lake of Allura Red AC (E129), aluminium lake of Sunset Yellow FCF (E110), aluminium lake of Indigo Carmine (E132).
Film coating of Rivaroxaban Polpharma 20 mg (Opadry II Red 33G250002):
hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3000, triacetin, aluminium lake of Allura Red AC (E129), yellow iron oxide (E172).
Description of the appearance of Rivaroxaban Polpharma and contents of the pack
Rivaroxaban Polpharma 15 mg film-coated tablets are pink, round, biconvex, with the number "15" engraved on one side.
Rivaroxaban Polpharma 20 mg film-coated tablets are red, round, biconvex, with the number "20" engraved on one side.
Initial treatment pack for the first 4 weeks; each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
42 film-coated tablets of rivaroxaban 15 mg and 7 film-coated tablets of
rivaroxaban 20 mg.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zaklady Farmaceutyczne Polpharma SA
ul. Pelplinska 19
83-200 Starogard Gdanski
Poland
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
83-200 Starogard Gdański, Poland