Rivaroxaban Mylan: detailed information

Package leaflet: Information for the patient

Rivaroxaban Mylan 10 mg hard capsules

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

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

Contents of this leaflet:

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

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

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

preventing the formation of 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Mylan belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before taking Rivaroxaban Mylan

Do not take Rivaroxaban Mylan
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 Rivaroxaban Mylan 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 Mylan.

Take special care with Rivaroxaban Mylan
if you have a high risk of bleeding, which may occur in situations such as:
moderate or 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 Mylan”)
bleeding disorders
very high blood pressure that is not controlled with medication
stomach or intestinal diseases that may cause bleeding, e.g.
inflammation of the intestine or stomach, or inflammation of the oesophagus, such as
caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back
into the oesophagus) or tumours located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder 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 your treatment needs to be changed
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 listed above apply to you, inform your doctor before taking Rivaroxaban Mylan.
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 Mylan before and after surgery exactly as directed by your doctor.
If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia for pain relief):
it is very important to take Rivaroxaban Mylan exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Rivaroxaban Mylan 10 mg capsules are not recommended for patients under 18 years of age.
There is insufficient information available on its use in children and adolescents.

Other medicines and Rivaroxaban Mylan
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 they are applied only to the skin
ketoconazole tablets (used to treat Cushing's syndrome, a condition 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 atrial fibrillation
certain antidepressants (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 Mylan, because the effect of Rivaroxaban Mylan 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 believes you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment for ulcers.

If you are taking:

certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
St John's wort (Hypericum perforatum), a herbal remedy for depression
rifampicin, an antibiotic

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

Driving and using machines
Rivaroxaban Mylan 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 Mylan contains lactose monohydrate (a type of sugar) 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 capsule, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Mylan

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

What dose to take

To prevent blood clots in the veins after hip or knee replacement surgery
The recommended dose is one 10 mg capsule 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 either one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed you Rivaroxaban Mylan 10 mg once daily.

Swallow the capsule preferably with some water.
Rivaroxaban Mylan may be taken with or without food.

If you have difficulty swallowing the capsule whole, ask your doctor how else to take Rivaroxaban Mylan. The contents of the capsule may be mixed with a small amount of water or apple puree immediately before taking.

If necessary, your doctor may administer the dispersed contents of the Rivaroxaban Mylan capsule through a tube inserted into the stomach.

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

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

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

If you forget to take Rivaroxaban Mylan
If you forget a dose, take it as soon as you remember. Take the next capsule the following day and then continue as before with one capsule daily.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Rivaroxaban Mylan
Do not stop taking Rivaroxaban Mylan without first talking to your doctor, because Rivaroxaban Mylan helps prevent serious conditions.

If you have any doubts 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 everybody gets them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Mylan 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.
Contact your doctor immediately if you notice any of the following side effects:
Signs of bleeding

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

Signs of severe skin reactions

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

Signs of severe allergic reactions

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

Complete list of possible side effects
Common (may affect up to 1 in 10 people)
reduction in red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (haematoma, bruising)
coughing up blood
bleeding from or under the skin
bleeding after surgery
bleeding or fluid discharge from surgical wound
swelling in limbs
pain in limbs
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)
general decrease in strength and energy (weakness, fatigue), headache, dizziness
rash, itchy skin
increased levels of certain liver enzymes in blood tests
Uncommon (may affect up to 1 in 100 people)
bleeding in the brain or inside the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (may be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased levels of certain pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives
Rare (may affect up to 1 in 1,000 people)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a heart procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)
Very rare (may affect up to 1 in 10,000 people)
accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia)
Frequency not known (frequency cannot be estimated from the available data)
kidney impairment following severe bleeding
renal bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, 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 Rivaroxaban Mylan

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 blister and carton after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The capsule contents 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 Mylan contains

The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
The other components are: capsule contents: sodium lauryl sulfate (E 487), monohydrate lactose, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), hypromellose (E 464), magnesium stearate (E 470b); 265

capsule shell: gelatin (E 441), yellow iron oxide (E 172), red iron oxide (E 172);
capsule ink: shellac glaze 45% (20% esterified) in ethanol (E 904), black iron oxide (E 172), propylene glycol (E 1520), 28% ammonium hydroxide (E 527). See also section 2, “Rivaroxaban Mylan contains monohydrate lactose (a type of sugar) and sodium”.

Description of the appearance of Rivaroxaban Mylan and package contents
Rivaroxaban Mylan 10 mg consists of hard capsules (capsules) with an orange body and a red cap, printed with “10 mg”, approximately 19.4 mm in length. The capsule contents are a white or almost white powder, which may be slightly compacted.
The hard capsules are packed in blisters.
Rivaroxaban Mylan 10 mg is available in packs of 10, 30 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Ul. Pelplińska 19
83-200 Starogard Gdański
Poland

Patient information leaflet

Rivaroxaban Mylan 15 mg hard capsules, 20 mg hard capsules

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 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rivaroxaban Mylan is and what it is used for
What you need to know before taking Rivaroxaban Mylan
How to take Rivaroxaban Mylan
Possible side effects
How to store Rivaroxaban Mylan
Package contents and other information

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

Rivaroxaban Mylan contains the active substance rivaroxaban.
Rivaroxaban Mylan 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. Rivaroxaban Mylan 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 recurrence in the veins or blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

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

2. What you need to know before taking Rivaroxaban Mylan

Do not take Rivaroxaban Mylan

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) 267
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 a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding.

Do not take Rivaroxaban Mylan 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 Mylan.
Take special care with Rivaroxaban Mylan

if you have a high risk of bleeding, which may occur in situations such as:
- severe kidney disease in adults and moderate to severe kidney disease in children and adolescents, 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 Mylan”)
- coagulation disorders
- very high blood pressure not controlled by medication
- stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach, or inflammation of the oesophagus, such as caused by gastro-oesophageal reflux disease (a condition in which stomach acid flows back into the oesophagus), or tumours located in the stomach, intestine, genital tract, or urinary tract
- a blood vessel disorder at the back of the eye (retinopathy)
- a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed
if your doctor finds that your blood pressure is unstable or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Mylan. 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 Mylan exactly as directed by your doctor, both before and after surgery.
If your surgery involves the use of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia for pain relief):
o it is very important to take Rivaroxaban Mylan exactly as directed by your doctor, both before and after insertion or removal of the catheter.
o inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia wears off, as urgent intervention may be required.

Children and adolescents
Rivaroxaban Mylan capsules are not recommended for children weighing less than 30 kg. There is insufficient information available on the use of rivaroxaban in children and adolescents for the indications approved in adults.
Other medicines and Rivaroxaban Mylan
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:
o certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are applied only to the skin, or ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
o certain antibacterial medicines (e.g. clarithromycin, erythromycin)
o certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
o other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol)
o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
o dronedarone, a medicine used in the treatment of atrial fibrillation
o 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 Mylan, because the effect of Rivaroxaban Mylan 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 treatment for ulcers.

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

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

Pregnancy and breastfeeding
Do not take Rivaroxaban Mylan during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Mylan. 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 Mylan 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 machines.
Rivaroxaban Mylan contains lactose monohydrate 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 capsule, i.e. essentially “sodium-free”.

3. How to take Rivaroxaban Mylan

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
You must take Rivaroxaban Mylan with food.
Swallow the capsule or capsules preferably with some water.
If you have difficulty swallowing the capsule whole, ask your doctor how to take Rivaroxaban Mylan in
another way. The contents of the capsule may be mixed with a small amount of water or apple puree
immediately before taking. After taking this mixture, you must immediately eat a meal.
If necessary, your doctor may administer the dispersed contents of the Rivaroxaban Mylan capsule
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 capsule once daily. If you have kidney problems, the dose may be reduced to one 15 mg capsule 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 reducing the dose to one 15 mg capsule once daily (or one 10 mg capsule once daily 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 capsule twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg capsule once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily. If you have kidney problems and are taking one 20 mg capsule once daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg capsule once daily if the risk of bleeding is greater than the risk of developing another blood clot.
Children and adolescents The dose of Rivaroxaban Mylan depends on body weight and will be calculated by your doctor.
o The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one 15 mg capsule once daily.
o The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg capsule once daily. Take each dose of Rivaroxaban Mylan with a drink (e.g. water or juice) during a meal. Take the capsules at approximately the same time each day. Consider setting an alarm to remind you. For parents or caregivers: please observe the child to ensure they take the full dose.

Since the dose of Rivaroxaban Mylan is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted as body weight changes.
Never adjust the dose of Rivaroxaban Mylan by yourself. If needed, your doctor will adjust the dose.
Do not empty the capsule contents in an attempt to administer only part of the dose. If a lower dose is required, use the alternative product containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who cannot swallow the capsules whole, use the product containing rivaroxaban as granules for oral suspension.
If the oral suspension is not available, you may pour out the contents of the Rivaroxaban Mylan capsule and mix them with water or apple puree immediately before administration. After taking this mixture, eat food. If necessary, your doctor may administer the dispersed contents of the Rivaroxaban Mylan capsule through a tube inserted into the stomach.

If you spit out the dose or vomit

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

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

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

If you forget to take Rivaroxaban Mylan

Adults, children and adolescents: If you are taking one 20 mg capsule or one 15 mg capsule once daily and you miss a dose, take it as soon as you remember. Do not take more than one capsule in one day to make up for the missed dose. Take the next capsule the following day and continue with one capsule per day.
Adults: If you are taking one 15 mg capsule twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in one day. If you miss a dose, you may take two 15 mg capsules together to achieve a total of two capsules (30 mg) in one day. The next day, continue taking one 15 mg capsule twice daily.

If you stop taking Rivaroxaban Mylan
Do not stop taking Rivaroxaban Mylan without first talking to your doctor, because Rivaroxaban Mylan helps prevent serious conditions 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, this medicine can cause side effects, although not everyone gets them.
Like other similar medicines used to reduce the formation of blood clots, Rivaroxaban Mylan 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.
Contact your doctor immediately if you notice any of the following side effects in yourself or in the child:

Signs of bleeding
- bleeding in the brain or skull (symptoms may include headache, weakness on one side, vomiting, seizures, reduced level of consciousness, and neck stiffness. A serious medical emergency. Seek immediate medical help!)
- prolonged or excessive blood loss
- unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. Your doctor may decide to monitor you closely or change your treatment.
Signs of serious skin reactions
- widespread and severe rash, blisters or mucosal lesions, for example in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
- a drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and diseases affecting the whole body (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
Signs of serious allergic reactions
- swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

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

reduction in red blood cells, which may cause pale skin, weakness or shortness of breath
bleeding in the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
bleeding in the eye (including bleeding in the white part of the eye)
bleeding into tissues or body cavities (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 of discomfort or malaise, constipation, diarrhea
low blood pressure (symptoms include dizziness or fainting when standing)
general decrease in strength and energy (weakness, fatigue), headache, dizziness
skin rash, itchy skin
increased liver enzymes in blood tests

Uncommon (may affect up to 1 in 100 people)

bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
liver dysfunction (can be detected through tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives

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

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

Very rare (may affect up to 1 in 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cells causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be determined from available data)

kidney impairment following severe bleeding
kidney bleeding sometimes with blood in the urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the arms or legs after bleeding, causing pain, swelling, altered sensitivity, numbness or paralysis (compartment syndrome following bleeding)

Side effects in children and adolescents
In general, side effects observed in children and adolescents treated with rivaroxaban have been similar to those observed 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 (bile pigment)
thrombocytopenia (reduction in the number of platelets, which are the cells that allow blood to clot)
heavy menstrual periods

Uncommon (may affect up to 1 in 100 people)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, bile pigment)

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

5. How to store Rivaroxaban Mylan

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 blister and carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The capsule contents 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 Mylan contains

The active substance is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
The other components are: capsule content: sodium lauryl sulfate (E 487), monohydrate lactose, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), hypromellose (E 464), magnesium stearate (E 470b); capsule shell: gelatin (E 441), yellow iron oxide (E 172) (only in 15 mg capsules), red iron oxide (E 172); capsule printing ink: shellac glaze 45% (20% esterified) in ethanol (E 904), black iron oxide (E 172), propylene glycol (E 1520), 28% ammonium hydroxide (E 527).

Description of the appearance of Rivaroxaban Mylan and package contents
Rivaroxaban Mylan 15 mg consists of hard capsules with a yellow body and an orange cap, printed with “15 mg”, approximately 14.3 mm in length. The contents are white or almost white powder, which may be slightly compacted.
The hard capsules are packed in blisters.
Rivaroxaban Mylan 15 mg is available in packs of 28, 42 or 98 hard capsules.
Rivaroxaban Mylan 20 mg consists of hard capsules with a red body and red cap, printed with “20 mg”, approximately 15.9 mm in length. The contents are white or almost white powder, which may be slightly compacted.
The hard capsules are packed in blisters.
Rivaroxaban Mylan 20 mg is available in packs of 28 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Ul. Pelplińska 19
83-200 Starogard Gdański
Poland