Barsovi

Patient Information Leaflet: Information for the User

Barsovi 2.5 mg film-coated tablets

Rivaroxaban
Generic medicine
Please read this entire 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Barsovi is and what it is used for
2. What you need to know before taking Barsovi
3. How to take Barsovi
4. Possible side effects
5. How to store Barsovi
6. Contents of the pack and other information

1. What Barsovi is and what it is used for

Barsovi has been administered to you because

• you have been diagnosed with acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe form of chest pain) and an increase in certain cardiac markers has been detected in blood tests. In adults, Barsovi reduces the risk of another heart attack or the risk of dying from a disease related to the heart or blood vessels. Barsovi will not be administered to you alone. Your doctor will also prescribe:
  • acetylsalicylic acid, or
  • acetylsalicylic acid plus clopidogrel or ticlopidine. or
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. In adults, Barsovi reduces the risk of clot formation (atherothrombotic events). Barsovi will not be administered to you alone. Your doctor will also prescribe acetylsalicylic acid. Barsovi contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a coagulation factor (factor Xa), resulting in reduced tendency of the blood to form clots.

2. What you need to know before taking Barsovi

Do not take Barsovi

• 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 heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open
• if you have acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke), or if you have had a blockage of the small arteries supplying deep brain tissues (lacunar stroke) or 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 Barsovi 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 Barsovi.
Barsovi 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 Barsovi

• 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 Barsovi”)
  • coagulation disorders
  • very high blood pressure not controlled with medication
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example due to gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus)
  • a blood vessel disorder in the back of the eye (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous lung bleeding
  • if you are over 75 years old
  • if you weigh 60 kg or less
  • if you have coronary heart disease with severe symptomatic heart failure
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed. If any of the conditions described above apply to you, inform your doctor before taking Barsovi. 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 Barsovi exactly at the times indicated 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 Barsovi 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
Barsovi is not recommended for people under 18 years of age. There is insufficient information available on its use in children and adolescents.
Other medicines and Barsovi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

• If you are taking
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin
  • ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
  • certain antibacterial medicines (e.g. clarithromycin, erythromycin)
  • certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor (see section “Warnings and precautions”))
  • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
  • dronedarone, a medicine used to treat 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 Barsovi, because the effect of Barsovi may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive ulcer treatment.

• If you are taking
  • certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John’s wort ( Hypericum perforatum ), a herbal medicine used for depression
  • rifampicin, an antibiotic
    If any of the conditions described above apply to you, inform your doctor before taking Barsovi, as the effect of Barsovi may be reduced. Your doctor will decide whether you should be treated with Barsovi and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Barsovi during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Barsovi. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how to continue treatment.
Driving and use of machines
Barsovi 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 and do not operate machinery.
Barsovi 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 Barsovi

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 Barsovi 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 Barsovi in another way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before taking it.
If necessary, your doctor may administer crushed Barsovi tablets through a tube inserted into the stomach.
Barsovi will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you. If you need to take Barsovi after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
Your doctor will prescribe the correct dose of these medicines (usually 75 to 100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).
When to start taking Barsovi
Treatment with Barsovi after 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 tell you when to start treatment with Barsovi.
Your doctor will decide how long your treatment should continue.
If you take more Barsovi than you should
Contact your doctor immediately if you have taken too many Barsovi tablets. If you have taken an excessive amount of Barsovi, the risk of bleeding increases.
If you forget to take Barsovi
Do not take a double dose to make up for the forgotten dose. If you forget a dose, take the next dose at your usual time.
If you stop taking Barsovi
Take Barsovi regularly for the entire duration prescribed by your doctor.
Do not stop taking Barsovi without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from heart or blood vessel disease, may increase.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Like other similar medicines (antithrombotic agents), Barsovi can cause bleeding which may potentially be life-threatening. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Possible side effects that may indicate bleeding
Contact your doctor immediately if you notice any of the following side effects:

• prolonged or excessive bleeding
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris, which may be signs of bleeding. Your doctor may decide to monitor you closely or change your treatment.

Possible side effects that may indicate severe skin reactions
Contact your doctor immediately if you notice skin reactions such as:

• widespread and severe rash, blisters or mucosal lesions, for example 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 users).
• a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome). The frequency of this side effect is very rare (may affect up to 1 in 10,000 users).

Possible side effects that may indicate severe allergic reactions
Contact your doctor immediately if you experience any of the following side effects:

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

Complete list of possible side effects

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

• reduction in red blood cells, which may cause paleness, weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• blood or fluid leakage from surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (may 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)
• decreased strength and energy (weakness, fatigue), headache, dizziness
• skin rash, itching
• increased liver enzymes in blood tests

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

• bleeding in the brain or within the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduced platelets, which are the cells that help blood to clot)
• allergic reactions, including skin allergic reactions
• impaired liver function (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
• malaise
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
• yellowing of the skin and eyes (jaundice)
• localized swelling, formation of a blood collection (hematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• kidney impairment following severe bleeding
• 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 may also report side effects directly via the national reporting system at the following 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.

5. How to store Barsovi

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

6. Package contents and other information

What Barsovi contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 “Barsovi contains lactose and sodium”. Film coating of the tablet: hypromellose 2910, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

Description of the appearance of Barsovi and package contents
The 2.5 mg film-coated tablets of Barsovi are yellow, round, biconvex (6 mm in diameter), with “2.5” engraved on one side and smooth on the other side.
Transparent PVC/PVDC-aluminum blisters, packed in cartons.
Pack size: 45 film-coated tablets.

Marketing Authorization Holder
Sumar Pharma ehf.
Reynihvammur 3A
220 Hafnarfjörður, Iceland
+40746 103 100
[email protected]

Manufacturer
S.C. Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
Bucharest, code 032266
Romania

Aldavo Ltd
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann
SGN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Barsovi
[To be completed with national data]

Package leaflet: Information for the user

Barsovi 10 mg film-coated tablets

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

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

Contents of this leaflet:

1. What Barsovi is and what it is used for
2. What you need to know before taking Barsovi
3. How to take Barsovi
4. Possible side effects
5. How to store Barsovi
6. Contents of the pack and other information

1. What Barsovi is and what it is used for

Barsovi contains the active substance rivaroxaban and is used in adults for:

• preventing blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clots forming increases after surgery.
• 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 blood clots in the blood vessels of the legs and/or lungs. Barsovi belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a clotting factor (factor Xa), thereby reducing the blood's tendency to clot.

2. What you should know before taking Barsovi

Do not take Barsovi

• 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 heparins), 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 Barsovi 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 Barsovi.
Take special care with Barsovi

• if you have a high risk of bleeding, which may occur in situations such as:
  • 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 Barsovi”)
  • coagulation disorders
  • very high blood pressure, uncontrolled with medication
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the esophagus, for example caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus)
  • a blood vessel disorder at the back of the eye (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous history of bleeding from your lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
• if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Barsovi. 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 Barsovi exactly as directed by your doctor 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 anaesthesia for pain relief):
  • it is very important to take Barsovi 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 Barsovi is not recommended in patients under 18 years of age. There is insufficient information available on its use in children and adolescents.

Other medicines and Barsovi
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) (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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)) If any of the conditions described above apply to you, inform your doctor before taking Barsovi, as the effect of Barsovi may be enhanced. Your doctor will decide whether you should be treated with this medicine and whether you need to be closely monitored. If your doctor believes you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

  • If you are taking

• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)

• St John's wort (Hypericum perforatum), a herbal medicine for depression

• rifampicin, an antibiotic If any of the conditions described above apply to you, inform your doctor before taking Barsovi, as the effect of Barsovi may be reduced. Your doctor will decide whether you should be treated with Barsovi and whether you need to be closely monitored. Pregnancy and breastfeeding Do not take Barsovi during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Barsovi. 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
Barsovi 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 or operate machinery.
Barsovi 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 Barsovi

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

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

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

4. Possible side effects

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

Possible side effects that may be signs of bleeding
Tell 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 may be signs of bleeding. Your doctor may decide to monitor you closely or change your treatment.

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

• widespread and severe rash, blisters or mucosal lesions, for example 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 users).
• a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of this side effect is very rare (may affect up to 1 in 10,000 users).

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

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

Complete list of possible side effects

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

• reduction in red blood cells, which may cause paleness, weakness or shortness of breath
• bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• bleeding or fluid leakage from a surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (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)
• decreased strength and energy (weakness, fatigue), headache, dizziness
• skin rash, itching
• increased levels of certain liver enzymes in blood tests

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

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

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

• bleeding into a muscle
• cholestasis (reduced bile flow, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)
• kidney impairment following severe bleeding

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

5. How to store Barsovi

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

6. Package contents and other information

What Barsovi contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 “Barsovi contains lactose and sodium”. Film coating of the tablet: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

Description of the appearance of Barsovi and package contents

Barsovi 10 mg film-coated tablets are round, biconvex (6 mm in diameter), pink in colour, with “10” engraved on one side and smooth on the other side.
Transparent PVC/PVDC-aluminium blisters in boxes.
Pack size: 45 film-coated tablets.

Marketing Authorisation Holder
Sumar Pharma ehf.
Reynihvammur 3A
220 Hafnarfjörður, Iceland
+40746 103 100
[email protected]

Manufacturer
S.C. Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
Bucharest cod 032266
Romania
Aldavo Ltd
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann
SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Barsovi
[To be completed with national data]

Instructions for the user: package leaflet

Barsovi 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 others, even if their symptoms are the same as yours, as it could 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:

1. What Barsovi is and what it is used for
2. What you need to know before taking Barsovi
3. How to take Barsovi
4. Possible side effects
5. How to store Barsovi
6. Contents of the pack and other information

1. What Barsovi is and what it is used for

Barsovi contains the active substance rivaroxaban and is used in adults for:

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

Do not take Barsovi

• 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 heparins), except when switching from one anticoagulant therapy to another 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 Barsovi 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 Barsovi.
Be especially careful with Barsovi

• if you have an increased risk of bleeding, such as in the following cases:
  • 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 Barsovi”)
  • coagulation disorders
  • very high blood pressure, uncontrolled with medication
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, or inflammation of the oesophagus, for example caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
  • a blood vessel disorder in the back of the eye (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary
• 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 Barsovi. 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 Barsovi exactly at the times indicated by your doctor, both before and after the procedure.
• If the surgical procedure involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
  • it is very important to take Barsovi exactly at the times indicated by your doctor, both before and after the injection or removal of the catheter
  • inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Barsovi is not recommended in individuals under 18 years of age. There is insufficient
information available on its use in children and adolescents.

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

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

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

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

Driving and using machines
Barsovi 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 or operate machinery.

Barsovi 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 Barsovi

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

What dose to take
To prevent blood clots in the brain (stroke) and in other blood vessels of the body, the recommended dose is one 20 mg Barsovi tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg Barsovi 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 Barsovi tablet once daily (or one 10 mg Barsovi 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 Barsovi tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Barsovi 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 Barsovi tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Barsovi tablet once daily, if the risk of bleeding is greater than the risk of developing a new blood clot.

Swallow the tablet(s) preferably with some water.
Take Barsovi with food.

If you have difficulty swallowing the tablet whole, ask your doctor how to take Barsovi in another way. The tablet can be crushed and mixed with a little water or apple puree immediately before taking. The mixture should be followed immediately by food.

If necessary, your doctor may administer the crushed Barsovi tablet through a tube inserted into the stomach.

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

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

If you forget to take Barsovi
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 the same day to make up for the missed dose. Take the next tablet the following day and continue with one tablet once daily.

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

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (antithrombotic agents), Barsovi may cause bleeding which could potentially be life-threatening. Massive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Possible side effects that may indicate bleeding
Contact your doctor immediately if you notice any of the following side effects:

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

Possible side effects that may indicate severe skin reactions
Contact your doctor immediately if you notice skin reactions such as:

• widespread and intense rash, blisters or mucosal lesions, for example 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 users).
• a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of this side effect is very rare (may affect up to 1 in 10,000 users).

Possible side effects that may indicate serious allergic reactions
Contact your doctor immediately if any of the following side effects occur:

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

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

• reduction in red blood cells, which may cause paleness, weakness or breathlessness
• bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissues or body cavities (haematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• loss of blood or fluid from surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (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)
• decreased strength and energy (weakness, fatigue), headache, dizziness
• rash, itching
• increased liver enzymes in blood tests

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

• bleeding in the brain or within the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduced platelets, which are cells that help blood to clot)
• allergic reactions, including skin allergic reactions
• impaired liver function (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
• malaise
• rapid heartbeat
• dry mouth
• hives

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

• 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, 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)

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

• kidney impairment 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Barsovi

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 or
bottle 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.

6. Package contents and other information

What Barsovi contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 “Barsovi contains lactose and sodium”. Film-coating of the tablet: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, red iron oxide (E 172).

Description of the appearance of Barsovi and contents of the pack
Barsovi 15 mg film-coated tablets are red, round, biconvex (diameter 5.6 mm), with “15” engraved on one side and smooth on the other side.
Transparent PVC/PDVC-aluminium blisters in boxes.
Pack size: 45 film-coated tablets.
Barsovi 20 mg film-coated tablets are dark red, round, biconvex (diameter 6.5 mm), with “20” engraved on one side and smooth on the other side.
Transparent PVC/PDVC-aluminium blisters in boxes.
Pack size: 45 film-coated tablets.
.
Marketing Authorization Holder
Sumar Pharma ehf.
Reynihvammur 3A
220 Hafnarfjörður, Iceland
+40746 103 100
[email protected]
Manufacturer
S.C. Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
Bucharest cod 032266
Romania
Aldavo Ltd
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann
SGN 3000, Malta
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Barsovi
[To be completed with national details]

Package leaflet: information for the user

Barsovi 15 mg film-coated tablets, 20 mg film-coated tablets

Initiation pack
Rivaroxaban
Generic medicine
Please read this entire 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, 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Barsovi is and what it is used for
2. What you need to know before taking Barsovi
3. How to take Barsovi
4. Possible side effects
5. How to store Barsovi
6. Contents of the pack and other information

1. What Barsovi is and what it is used for

Barsovi contains the active substance rivaroxaban and 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 blood vessels of the legs and/or lungs.

Barsovi belongs to a group of medicines called antithrombotic agents. Its action is due to
inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to
form clots.

2. What you should know before taking Barsovi

Do not take Barsovi

• 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 heparins), 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 Barsovi 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 Barsovi.
Be especially careful with Barsovi

• 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), 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 Barsovi”)
  • coagulation disorders
  • very high blood pressure, uncontrolled with medication
  • stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as that caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
  • a blood vessel disorder in the back of the eye (retinopathy)
  • a lung disease with dilated bronchi filled with pus (bronchiectasis), or previous bleeding from the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether you need to change your treatment
• 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 Barsovi. 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 Barsovi exactly at the times indicated by your doctor, both before and after surgery.
• If the surgery involves using a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
  • it is very important to take Barsovi exactly at the times indicated by your doctor, both before and after the injection or removal of the catheter
  • inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Barsovi is not recommended for individuals under 18 years of age. There is insufficient
information available on its use in children and adolescents.
Other medicines and Barsovi
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 on 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 described above apply to you, inform your doctor before taking Barsovi, because
the effect of Barsovi may be enhanced. Your doctor will decide whether you should be treated with this
medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

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

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

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 15 mg Barsovi tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Barsovi tablet once daily.
This starter pack containing 15 mg and 20 mg Barsovi tablets is intended for use only during the first 4 weeks of treatment.
Once this pack is finished, treatment will continue with one 20 mg Barsovi tablet once daily, as instructed by your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Barsovi tablet once daily, if the risk of bleeding is greater than the risk of developing a new blood clot.
Barsovi should be taken with a meal.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Barsovi in another way. The tablet may be crushed and mixed with water or apple puree immediately before taking. The mixture should be followed immediately by food intake.
If necessary, your doctor may administer crushed Barsovi tablets through a tube inserted into the stomach.
When to take Barsovi
Take the tablet or tablets every day until your doctor tells you to stop.
Try to take the tablet or tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.
If you take more Barsovi than you should
Contact your doctor immediately if you have taken too many Barsovi tablets. If you have taken an excessive amount of Barsovi, your risk of bleeding increases.
If you forget to take Barsovi
If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. On the following day, continue with one 15 mg tablet twice daily.
If you are taking one 20 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in the same day to make up for the missed dose. Take the next tablet the following day and then continue with one tablet once daily.
If you stop taking Barsovi
Do not stop taking Barsovi without first talking to your doctor, because Barsovi prevents the development of a serious condition.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Possible side effects that may indicate bleeding
Contact 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 may be signs of bleeding. Your doctor may decide to monitor you closely or change your treatment.

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

• widespread and severe rash, blisters or mucosal lesions, for example 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 users).
• a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome). The frequency of this side effect is very rare (may affect up to 1 in 10,000 users).

Possible side effects that may indicate severe allergic reactions
Contact your doctor immediately if any of the following side effects occur:

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

Comprehensive list of possible side effects:

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

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

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

• bleeding in the brain or within the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduced platelet count; platelets are cells that help blood to clot)
• allergic reactions, including skin allergic reactions
• impaired liver function (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
• malaise
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (reduced bile flow, a substance produced by the liver), hepatitis including hepatocellular damage (liver inflammation including liver injury)
• yellowing of the skin and eyes (jaundice)
• localized swelling, formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)

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

• kidney impairment 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 following bleeding)

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

5. How to store Barsovi

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 or wallet container 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.

6. Package contents and other information

What Barsovi contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 “Barsovi contains lactose and sodium”.
  Tablet film coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, red iron oxide (E 172).

Description of the appearance of Barsovi and contents of the pack

Film-coated Barsovi 15 mg tablets are red, round, biconvex (diameter 5.6 mm), with “15” engraved on one side and smooth on the other side.
Film-coated Barsovi 20 mg tablets are dark red, round, biconvex (diameter 6.5 mm), with “20” engraved on one side and smooth on the other side.

Starting treatment pack for the first 4 weeks: Each pack containing 49 film-coated tablets for the first 4 weeks of treatment includes:
42 film-coated tablets containing 15 mg of rivaroxaban and 7 film-coated tablets containing 20 mg of rivaroxaban, in a blister pack.

Marketing Authorization Holder
Sumar Pharma ehf.
Reynihvammur 3A
220 Hafnarfjörður, Iceland
+40746 103 100
[email protected]

Manufacturer
S.C. Labormed-Pharma S.A.
Bd. Theodor Pallady nr. 44B, sector 3
Bucharest cod 032266
Romania

Aldavo Ltd
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann
SGN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Barsovi
[To be completed with national information]