RIVAROXABAN TEVA

Package leaflet: Information for the user

Rivaroxaban Teva 2.5 mg film-coated tablets

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

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

Contents of this leaflet

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

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

You have been given Rivaroxaban Teva because

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

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

• acetylsalicylic acid, or
• acetylsalicylic acid plus clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or symptomatic peripheral arterial disease. Rivaroxaban Teva reduces, in adults, the risk of clot formation (atherothrombotic events). Rivaroxaban Teva will not be given to you alone. Your doctor will also prescribe acetylsalicylic acid.

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

2. What you need to know before taking Rivaroxaban Teva

DO NOT take Rivaroxaban Teva

• 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 an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent surgery on the brain or eyes)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
• if you have acute coronary syndrome and have previously had bleeding or a blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had bleeding in the brain (stroke), or if you have had a blockage of the small arteries supplying blood to the deep tissues of the brain (lacunar stroke) or a blood clot in the brain (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 Teva and contact your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Teva.
Rivaroxaban Teva 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.
Exercise special caution with Rivaroxaban Teva

• if you have a high risk of bleeding, which may occur in situations such as:
• 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 Rivaroxaban Teva”)
• clotting disorders
• very high blood pressure not controlled by medical treatment
• 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 a history of bleeding from the lungs
• if you are over 75 years old
• if you weigh 60 kg or less
• if you suffer from coronary artery disease with severe symptomatic heart failure
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

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

• it is very important to take Rivaroxaban Teva before and after surgery exactly as directed by your doctor.
• if the surgical procedure involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
• it is very important to take Rivaroxaban Teva before and after the injection or removal of the catheter exactly as directed by your doctor
• contact 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
The 2.5 mg rivaroxaban tablets are not recommended for individuals under 18 years of age. There is insufficient information available on their use in children and adolescents.
Other medicines and Rivaroxaban Teva
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-relief medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

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

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

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Teva, as the effect of Rivaroxaban Teva may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Teva and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Teva during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Teva. 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 Teva may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Teva

Take this medicine exactly as your doctor has instructed 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 Rivaroxaban Teva at the same times every day (for example, one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Teva in another way. The tablet may be crushed and mixed with a small amount of water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed Rivaroxaban Teva tablet through a tube inserted into the stomach.
Rivaroxaban Teva will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you. If you are taking Rivaroxaban Teva 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 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 Rivaroxaban Teva
Treatment with Rivaroxaban Teva after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, no sooner than 24 hours after hospital admission and at the time when parenteral anticoagulant therapy (by injection) would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will tell you when to start treatment with Rivaroxaban Teva.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Teva than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Teva tablets. If you take an excessive amount of Rivaroxaban Teva, your risk of bleeding increases.
If you forget to take Rivaroxaban Teva
DO NOT take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at your usual time.
If you stop taking Rivaroxaban Teva
Take Rivaroxaban Teva regularly for the entire duration prescribed by your doctor.
DO NOT stop taking Rivaroxaban Teva without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or of dying from heart or blood vessel disease may increase.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Teva can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Teva can cause bleeding which may potentially be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.
Tell your doctor immediately if you notice any of the following side effects:
Signs of bleeding

• bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical help!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of serious skin reactions

• widespread and severe skin rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).

Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of

serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may 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 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 from the gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissues or body cavities (haematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• blood or fluid leakage from a surgical wound
• swelling of limbs
• limb pain
• kidney problems (can be detected by tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling unwell, constipation, diarrhoea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• lack of 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 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• 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
• liver problems (can be detected by tests performed by your doctor)
• blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives.

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

• 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
• formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm).

Frequency not known (frequency cannot be estimated from the 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 following bleeding).

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

5. How to store Rivaroxaban Teva

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

6. Package contents and other information

What Rivaroxaban Teva contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are: Tablet core: sodium lauryl sulfate, monohydrate lactose, hypromellose, sodium croscarmellose, magnesium stearate. Film coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172).

Description of the appearance of Rivaroxaban Teva and contents of the pack
Rivaroxaban Teva 2.5 mg film-coated tablets are yellow, round, film-coated tablets of approximately 8 mm in diameter, marked with "T" on one side and "2R" on the other.
The tablets are supplied in:

• Unit dose divisible blisters containing 20x1, 28x1, 56x1, 60x1, 100x1, 168x1 or 196x1 tablets.
• Bottles containing 100 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer
Teva Pharma B.V.
Swensweg 5,
Haarlem, 2031GA,
The Netherlands
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria

Package leaflet: information for the user

Rivaroxaban Teva 10 mg film-coated tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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 Rivaroxaban Teva is and what it is used for
2. What you need to know before taking Rivaroxaban Teva
3. How to take Rivaroxaban Teva
4. Possible side effects
5. How to store Rivaroxaban Teva
6. Contents of the pack and other information

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

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots increases after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking Rivaroxaban Teva

Do NOT take Rivaroxaban Teva

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

Do NOT take Rivaroxaban Teva and inform your doctor if any of the conditions listed above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Teva.
Take special care with Rivaroxaban Teva

• if you have a high risk of bleeding, which may occur in situations such as:
• moderate or severe kidney disease, because kidney function can affect the amount of active medicine in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Teva”)
• disorders of blood coagulation
• very high blood pressure not controlled by medical treatment
• 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 gastroesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus)
• a blood vessel disorder at the back of the eye (retinopathy)
• a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed
• if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure is planned to remove a blood clot from the lungs.

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

• it is very important to take Rivaroxaban Teva before and after surgery exactly as directed by your doctor.
• if the surgical procedure involves the use of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
• it is very important to take Rivaroxaban Teva exactly as directed by your doctor
• 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
Rivaroxaban Teva 10 mg tablets are 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 Teva
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 antibiotics (e.g. clarithromycin, erythromycin)
• certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
• other medicines used to prevent blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
• anti-inflammatory and pain medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

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

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

If any of the conditions listed above apply to you, inform your doctor before taking Rivaroxaban Teva, as the effect of Rivaroxaban Teva may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Teva and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Teva during pregnancy or breastfeeding. If you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Teva. 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
Rivaroxaban Teva may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.
Rivaroxaban Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Teva

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

What dose to take

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

Swallow the tablet preferably with some water.
Rivaroxaban Teva may be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Teva in another way. The tablet can be crushed and mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer the crushed Rivaroxaban Teva tablet through a tube inserted into the stomach.

When to take Rivaroxaban Teva
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day to help you remember.
Your doctor will decide how long your treatment should continue.

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

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

If you forget to take Rivaroxaban Teva
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 daily as before.
DO NOT take a double dose to make up for the forgotten tablet.

If you stop taking Rivaroxaban Teva
DO NOT stop taking Rivaroxaban Teva without first talking to your doctor, because Rivaroxaban Teva helps prevent a serious condition.

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

4. Possible side effects

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

• bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.

Signs of serious skin reactions

• widespread and severe skin rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction causing skin rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).

Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may 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)

• reduced number of 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 periods), nosebleeds, bleeding from the 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
• loss of blood or fluid from the surgical wound
• swelling of limbs
• limb pain
• kidney dysfunction (may be detected through tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling unwell, constipation, diarrhoea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• lack of 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 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (reduced number of platelets, which are cells that help blood to clot)
• allergic reactions, including skin allergic reactions
• liver dysfunction (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 number of platelets
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives.

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

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis including hepatocellular damage (liver inflammation including liver damage)
• 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 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 following bleeding).

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

5. How to store Rivaroxaban Teva

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

6. Package contents and other information

What Rivaroxaban Teva contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are: Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose, magnesium stearate. Film coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), carmine (E120), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Rivaroxaban Teva and pack contents
The 10 mg film-coated tablets of Rivaroxaban Teva are round, approximately 8 mm in diameter, film-coated, pink in colour, marked on one side with “T” and on the other side with “1R”.
The tablets are supplied in:

• Divisible unit-dose blisters in boxes containing 5x1, 10x1, 28x1, 30x1, 90x1, 98x1, 100x1 or 112x1 tablets.
• Bottles containing 100 or 200 (2x100) film-coated tablets.

It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer
Teva Pharma B.V.
Swensweg 5,
Haarlem, 2031GA,
The Netherlands
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria

Patient Information Leaflet: Information for the User

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

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if 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

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

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

Rivaroxaban Teva 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 known as non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and preventing the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

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

Rivaroxaban Teva belongs to a group of medicines called antithrombotic agents. Its action is due to the inhibition of a clotting factor (factor Xa), thereby reducing the tendency of blood to clot.

2. What you need to know before taking Rivaroxaban Teva

DO NOT take Rivaroxaban Teva

• 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 an organ of your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding

DO NOT take Rivaroxaban Teva and inform your doctor if any of the conditions described above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Teva.
Be especially careful with Rivaroxaban Teva

• if you have a high risk of bleeding, which may occur in situations such as:
• severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of active medicine in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), if you are switching anticoagulant therapy, or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Teva”)
• coagulation disorders
• very high blood pressure not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the esophagus, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus)
• 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 lung bleeding
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
• if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure has been planned to remove a blood clot from the lungs.

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

• it is very important to take Rivaroxaban Teva before and after surgery exactly as directed by your doctor.
• if the surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
• it is very important to take Rivaroxaban Teva 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 Teva tablets are not recommended in children weighing less than 30 kg. There is insufficient information on their use in children and adolescents for the indications approved for adults.
Other medicines and Rivaroxaban Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

• If you are taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless 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 abnormal heart rhythm
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

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

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

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Teva, because the effect of Rivaroxaban Teva may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Teva and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do NOT take Rivaroxaban Teva during pregnancy or breastfeeding. If you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Teva. 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 Teva may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Rivaroxaban Teva should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Teva 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.
If necessary, your doctor may administer the crushed tablet of Rivaroxaban Teva through a tube
inserted into the stomach.

What dose to take
Adults

• To prevent blood clots in the brain (stroke) and in other blood vessels of the body: The recommended dose is one 20 mg Rivaroxaban Teva tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Teva tablet once daily.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI, i.e. percutaneous coronary intervention with stent placement), limited evidence supports reducing the dose to one 15 mg Rivaroxaban Teva tablet once daily (or one 10 mg Rivaroxaban Teva tablet if your kidneys do not function properly), in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of clots: The recommended dose is one 15 mg Rivaroxaban Teva tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Teva tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Rivaroxaban Teva tablet once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Teva tablet once daily if the risk of bleeding is greater than the risk of developing a new blood clot.

Children and adolescents
The dose of Rivaroxaban Teva depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and 50 kg is one 15 mg Rivaroxaban Teva tablet once daily.
• The recommended dose for children and adolescents with a body weight equal to or above 50 kg is one 20 mg Rivaroxaban Teva tablet once daily.

Take each dose of Rivaroxaban Teva with a drink (e.g. water or juice) during a meal. Take the tablets at approximately the same time each day. Consider setting an alarm to help you remember.
For parents or caregivers: please observe the child to ensure the full dose is taken.
Since the dose of Rivaroxaban Teva is based on body weight, it is important to attend scheduled appointments with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Teva by yourself. If adjustment is needed, your doctor will do so.
Do not split the tablet in an attempt to reduce the dose. If a lower dose is required, other formulations are available.
For children and adolescents who cannot swallow whole tablets, please use another pharmaceutical form.
If another pharmaceutical form is not available, the Rivaroxaban Teva tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, food should be taken. If necessary, your doctor may also administer the crushed Rivaroxaban Teva tablet via a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Teva, take a new dose.
• more than 30 minutes after taking Rivaroxaban Teva, do not take a new dose. In this case, take the next dose of Rivaroxaban Teva at your usual time.

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

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

If you forget to take Rivaroxaban Teva
Adults, children and adolescents:

• 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.

Adults:

• If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in the same day. If you miss a dose, you may take two 15 mg tablets together to achieve a total of two tablets (30 mg) in one day. The next day, continue with one 15 mg tablet twice daily.

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

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

4. Possible side effects

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

Signs of bleeding

• bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.

Signs of serious skin reactions

• widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction causing rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).

Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives; breathing difficulties; sudden drop in blood pressure. The frequencies of these 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 observed in adults, children and adolescents
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Frequency not known (frequency cannot be estimated from the 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 following bleeding).

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

• headache
• fever
• nosebleeds
• vomiting.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• blood tests may show increased levels of a specific bilirubin subtype (direct bilirubin, a bile pigment).

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

5. How to store Rivaroxaban Teva

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

6. Package contents and other information

What Rivaroxaban Teva contains

• The active substance is rivaroxaban. Each tablet contains either 15 mg or 20 mg of rivaroxaban.
• The other components are: Tablet core: sodium lauryl sulfate, monohydrate lactose, hypromellose, sodium croscarmellose, magnesium stearate. Film coating of the 15 mg tablet: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), red iron oxide (E172). Film coating of the 20 mg tablet: partially hydrolysed polyvinyl alcohol (E1203), macrogol 3350, talc (E553b), red iron oxide (E172).

Description of the appearance of Rivaroxaban Teva and contents of the pack
Rivaroxaban Teva 15 mg film-coated tablets are round, approximately 7 mm in diameter, film-coated, orange in colour, marked with “T” on one side and “3R” on the other.
Rivaroxaban Teva 20 mg film-coated tablets are round, approximately 8 mm in diameter, film-coated, red in colour, marked with “T” on one side and “7R” on the other.
The tablets are supplied as:

• Rivaroxaban Teva 15 mg: in unit-dose divisible blisters of 10x1, 14x1, 28x1, 30x1, 42x1, 90x1, 98x1, 100x1 or 112x1 tablets.
• Rivaroxaban Teva 20 mg: in unit-dose divisible blisters of 10x1, 14x1, 28x1, 30x1, 90x1, 98x1, 100x1 or 112x1 tablets.
• in bottles containing 100 or 200 (2x100) film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer
Teva Pharma B.V.
Swensweg 5,
Haarlem, 2031GA,
The Netherlands
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria

Package leaflet: information for the user

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

Initial treatment pack
Not for use in children
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 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

7. What Rivaroxaban Teva is and what it is used for
8. What you need to know before taking Rivaroxaban Teva
9. How to take Rivaroxaban Teva
10. Possible side effects
11. How to store Rivaroxaban Teva
12. Contents of the pack and other information

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

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

• 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 the lungs.

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

2. What you need to know before taking Rivaroxaban Teva

DO NOT take Rivaroxaban Teva

• 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 (bleeding)
• if you have a disease or condition affecting an organ in your body that increases the risk of serious bleeding (e.g. stomach ulcers, wounds or bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when receiving heparin through a venous or arterial catheter to keep it open
• if you have a liver disease that increases the risk of bleeding
• during pregnancy or breastfeeding. DO NOT take Rivaroxaban Teva and inform your doctor if any of the conditions described above apply to you.

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

• 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), when switching anticoagulant therapy or while receiving heparin through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Teva”)
• disorders of blood coagulation
• very high blood pressure not controlled by medical treatment
• 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 at the back of the eye (retinopathy)
• a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous 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 your treatment needs to be changed
• if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure is planned to remove a blood clot from the lungs.

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

• it is very important to take Rivaroxaban Teva before and after surgery exactly as scheduled by your doctor.
• 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 Rivaroxaban Teva before and after the injection or removal of the catheter exactly as scheduled by your doctor
• inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
The starter pack of Rivaroxaban Teva is not recommended for people under 18 years of age, as it is specifically designed for initiating treatment in adult patients and is not suitable for use in children and adolescents.
Other medicines and Rivaroxaban Teva
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 antibiotics (e.g. clarithromycin, erythromycin)
• certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
• other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

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

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

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Teva, as the effect of Rivaroxaban Teva may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Teva and whether you need to be closely monitored.
Pregnancy and breastfeeding
Do not take Rivaroxaban Teva during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Teva. 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 Teva may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle or use tools or machinery.
Rivaroxaban Teva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Rivaroxaban Teva 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 Rivaroxaban Teva 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 Rivaroxaban Teva tablets through a tube inserted into the stomach.

What dose to take
The recommended dose is one 15 mg Rivaroxaban Teva tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Teva tablet once daily.
This starter pack containing 15 mg and 20 mg Rivaroxaban Teva tablets is intended for use only during the first 4 weeks of treatment. Once this pack is finished, treatment will continue with Rivaroxaban Teva 20 mg 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 Rivaroxaban Teva tablet once daily, if the risk of bleeding is greater than the risk of developing a new blood clot.

When to take Rivaroxaban Teva
Take the tablet(s) 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.

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

If you forget to take Rivaroxaban Teva

• 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 taking 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. Take the next tablet the following day and continue taking one tablet once daily.

If you stop taking Rivaroxaban Teva
DO NOT stop taking Rivaroxaban Teva without first talking to your doctor, because Rivaroxaban Teva treats serious conditions and helps prevent their occurrence.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!)
• prolonged or excessive blood loss
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or adjust your treatment.

Signs of serious skin reactions

• widespread and severe skin rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction causing skin rash, fever, internal organ inflammation, blood abnormalities and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).

Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives; breathing difficulties; sudden drop in blood pressure. The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may 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)

• reduced number of 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 periods), nosebleeds, bleeding gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissues or body cavities (haematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• blood or fluid leakage from a surgical wound
• swelling of the limbs
• limb pain
• kidney dysfunction (can be detected through blood tests performed by your doctor)
• fever
• stomach ache, indigestion, feeling unwell, constipation, diarrhoea
• low blood pressure (symptoms include dizziness or fainting when standing up)
• lack of energy and strength (weakness, fatigue), headache, dizziness
• skin rash, itching
• increased liver enzymes in blood tests.

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

• kidney failure 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 can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Teva

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.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rivaroxaban Teva contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
• The other components are:
  Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose, magnesium stearate.
  Film coating of the 15 mg tablet: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
  Film coating of the 20 mg tablet: partially hydrolysed polyvinyl alcohol (E1203), macrogol 3350, talc (E553b), red iron oxide (E172).

Description of the appearance of Rivaroxaban Teva and contents of the pack
Rivaroxaban Teva 15 mg film-coated tablets are round, approximately 7 mm in size, film-coated, orange-coloured tablets, marked with “T” on one side and “3R” on the other.
Rivaroxaban Teva 20 mg film-coated tablets are round, approximately 8 mm in size, film-coated, red-coloured tablets, marked with “T” on one side and “7R” on the other.
The starter pack for the first 4 weeks of treatment contains 49 film-coated tablets:
42 film-coated tablets of Rivaroxaban Teva 15 mg and 7 film-coated tablets of Rivaroxaban Teva 20 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
Milan
Italy

Manufacturer
Teva Pharma B.V.
Swensweg 5,
Haarlem, 2031GA,
The Netherlands

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria