Rivaroxaban Medical Valley: detailed information

Package leaflet: Information for the user

Rivaroxaban Medical Valley 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

1. What Rivaroxaban Medical Valley is and what it is used for

Rivaroxaban Medical Valley contains the active substance rivaroxaban.
Rivaroxaban Medical Valley is used in adults to:
prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body
if you have an irregular heart rhythm called non-valvular atrial fibrillation.
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 Medical Valley is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
treat blood clots and prevent their recurrence in the veins or blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Medical Valley belongs to a group of medicines called antithrombotic agents. Its effect is due to the inhibition of a clotting factor (factor Xa), resulting in reduced tendency of the blood to clot.

2. What you need to know before taking Rivaroxaban Medical Valley

Do not take Rivaroxaban Medical Valley 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 Medical Valley.

Be especially careful with Rivaroxaban Medical Valley
if you have an increased risk of bleeding, such as in the following cases:
severe kidney disease in adults or moderate to severe kidney disease in children and
adolescents, because kidney function may affect the amount of active medicine in the body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran,
apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Medical Valley”)
bleeding 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 esophagus, such as caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract or urinary tract
a blood vessel disorder in the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a history of bleeding from the lungs
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove blood clots from the lungs is planned.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Medical Valley. 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 Medical Valley before and after the procedure exactly at the times indicated 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 Medical Valley before and after the injection or catheter removal exactly at the times indicated 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 intervention may be required.

Children and adolescents
Rivaroxaban Medical Valley tablets are not recommended in children weighing less than 30 kg. There is insufficient information on the use of Rivaroxaban Medical Valley in children and adolescents for the indications approved in adults.

Other medicines and Rivaroxaban Medical Valley
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
some 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)
some antibiotics for bacterial infections (e.g. clarithromycin, erythromycin)
some 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 in the treatment of atrial fibrillation
some 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 Medical Valley, because the effect of Rivaroxaban Medical Valley 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
some 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 described above apply to you, inform your doctor before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Medical Valley and whether you need to be closely monitored.

Pregnancy and breastfeeding
Do not take Rivaroxaban Medical Valley during pregnancy or breastfeeding. If there is a possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Medical Valley. 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 Medical Valley may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). If you experience these symptoms, do not drive, ride a bicycle, or use tools or machinery.

Rivaroxaban Medical Valley 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 Medical Valley

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Rivaroxaban Medical Valley should be taken with food.
Swallow the tablet or tablets preferably with some water.
If you have difficulty swallowing the whole tablet, ask your doctor how to take Rivaroxaban
Medical Valley in another way. The tablet may be crushed and mixed with water or apple
puree immediately before administration. The mixture should be followed immediately by
eating food. If necessary, your doctor may administer the crushed Rivaroxaban Medical Valley
tablet 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 Medical Valley tablet once daily.
If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Medical
Valley tablet once daily.
If you need to undergo a procedure to treat blocked blood vessels in your heart (called PCI –
Percutaneous Coronary Intervention with stent placement), there is limited evidence supporting
reduction of the dose to one 15 mg Rivaroxaban Medical Valley tablet once daily (or one 10 mg
Rivaroxaban Medical Valley tablet if your kidneys are not working 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 Medical Valley tablet twice daily for the first
3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Medical Valley tablet
once daily.
After at least 6 months of treatment for blood clots, your doctor may decide to continue
treatment with one 10 mg tablet once daily or one 20 mg tablet once daily.
If you have kidney problems and are taking one 20 mg Rivaroxaban Medical Valley tablet once
daily, your doctor may decide to reduce the dose after 3 weeks to one 15 mg Rivaroxaban Medical
Valley 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 Medical Valley 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 Medical Valley tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more
is one 20 mg Rivaroxaban Medical Valley tablet once daily.
Take each dose of Rivaroxaban Medical Valley with a drink (e.g. water or juice) during a meal.
Take the tablets at approximately the same time each day, and 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 Medical Valley is based on body weight, it is important to attend
scheduled visits with your doctor, as the dose may need to be adjusted as weight changes.
Never adjust the dose of Rivaroxaban Medical Valley on your own. If necessary, your doctor
will adjust the dose.
Do not split the tablet in an attempt to divide a dose. If a lower dose is required, use the
alternative formulation of rivaroxaban oral suspension granules.
For children and adolescents who cannot swallow whole tablets, use rivaroxaban oral suspension
granules.
If the oral suspension is not available, the Rivaroxaban Medical Valley tablet may be crushed
and mixed with water or apple puree immediately before administration. Take food after taking
this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Medical
Valley tablet via a gastric tube.

If you spit out the dose or vomit

Less than 30 minutes after taking Rivaroxaban Medical Valley, take a new dose.
More than 30 minutes after taking Rivaroxaban Medical Valley, do not take a new dose.
In this case, take the next dose of Rivaroxaban Medical Valley at the usual time.
Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban
Medical Valley.

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

If you forget to take Rivaroxaban Medical Valley
Adults, children and adolescents:
If you are taking one 20 mg or one 15 mg tablet once daily and you miss a dose, take it as
soon as you remember. Do not take more than one tablet in the same day to make up for the
missed dose. Take the next tablet the following day and then continue with one tablet once
daily.

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

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

If you stop taking Rivaroxaban Medical Valley
Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor, because
Rivaroxaban Medical Valley prevents and avoids the occurrence of life-threatening conditions.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Medical Valley can cause side effects, although not
everyone experiences them.
Like other similar medicines used to reduce blood clot formation, Rivaroxaban Medical
Valley 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 visible.
Contact your doctor immediately if you or your child experience any of the following side
effects:

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 life-threatening 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 modify 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, inflammation of internal organs, blood abnormalities, and systemic diseases (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 reported 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
bleeding or fluid discharge from the surgical wound
swelling in limbs
pain in limbs
impaired kidney function (can be detected by blood tests performed by the 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
increase in certain liver enzymes in blood tests
Uncommon (may affect up to 1 in 100 people)
bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduction in platelet count; platelets are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
impaired liver function (can be detected by blood tests performed by the doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives
Rare (may affect up to 1 in 1,000 people)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (hematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)
Very rare (may affect up to 1 in 10,000 people)
accumulation of eosinophils, a type of granulocytic white blood cells causing lung inflammation (eosinophilic pneumonia)
Frequency not known (frequency cannot be estimated from the available data)
kidney failure following severe bleeding
renal bleeding, sometimes with blood in the urine, leading to impaired kidney function (Anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
In general, the 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 (a bile pigment)
thrombocytopenia (reduction in platelets, 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 bilirubin subcategory (direct bilirubin, a bile pigment)

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

5. How to store Rivaroxaban Medical Valley

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 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 Medical Valley contains
The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, pregelatinized starch, crospovidone, sodium lauryl sulfate, magnesium stearate. See section 2 “Rivaroxaban Medical Valley contains lactose and sodium”.
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), iron oxide red (E172).

Description of the appearance of Rivaroxaban Medical Valley and package contents
Rivaroxaban Medical Valley 15 mg film-coated tablets are round, biconvex, red, with a diameter of approximately 6 mm, marked with “15” on one side and smooth on the other side.
The tablets are available in blisters in packs of 42 film-coated tablets.
Rivaroxaban Medical Valley 20 mg film-coated tablets are round, biconvex, red-brown, with a diameter of approximately 7 mm, marked with “20” on one side and smooth on the other side.
The tablets are available in blisters in packs of 28 film-coated tablets.

Marketing Authorization Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturers:
Laboratorios Liconsa S.A. - Avda. De Miralcampo 7, 19200 Azuqueca de Henares (Guadalajara)
Spain

Patient information leaflet: information for the patient and user

Rivaroxaban Medical Valley 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if
their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

1. What Rivaroxaban Medical Valley is and what it is used for

Rivaroxaban Medical Valley 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, after surgery, there is an increased risk of blood clots forming.
It is also used to treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.
Rivaroxaban Medical Valley belongs to a group of medicines called antithrombotic agents. Its action is due to inhibition of a clotting factor (factor Xa), thereby reducing the tendency of blood to form clots.

1. What you need to know before taking Rivaroxaban Medical Valley

Do not take Rivaroxaban Medical Valley 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 Medical Valley.

Be especially careful with Rivaroxaban Medical Valley
if you have an increased risk of bleeding, such as in the following cases:
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), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Medical Valley”)
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 esophagus, such as that caused by gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus), or tumors located in the stomach, intestine, genital tract, or urinary tract
a blood vessel disorder in the back of the eye (retinopathy)
a lung disease with dilated bronchi filled with pus (bronchiectasis), or a previous 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 therapy 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 Medical Valley. 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 Medical Valley exactly at the times indicated by your doctor, both before and after the surgery.
If the surgery involves the use of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia for pain relief):
it is very important to take Rivaroxaban Medical Valley exactly at the times indicated 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 anesthesia, as urgent intervention may be required in such cases.

Children and adolescents
Rivaroxaban Medical Valley 10 mg tablets are not recommended for individuals under
18 years of age. There is insufficient information available on the use of this medicine in children and adolescents.

Other medicines and Rivaroxaban Medical Valley
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
some 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)
some antibiotics (e.g. clarithromycin, erythromycin)
some antiviral medicines for HIV/AIDS (e.g. ritonavir)
other medicines used to inhibit blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
anti-inflammatory and pain-relief medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
some medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

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

If you are taking
some 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 listed above apply to you, inform your doctor before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Medical Valley and whether you need to be closely monitored.

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

2. How to take Rivaroxaban Medical Valley

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
What dose to take
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
The recommended dose is one 10 mg Rivaroxaban Medical Valley tablet once daily.
To treat blood clots in the leg veins 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 Medical Valley 10 mg once daily.
Swallow the tablet preferably with some water.
Rivaroxaban Medical Valley can be taken independently of meals.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Medical Valley in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer the crushed Rivaroxaban Medical Valley tablet via a tube inserted into the stomach.
When to take Rivaroxaban Medical Valley
Take the tablet every day until your doctor tells you to stop.
Try to take the tablets at the same time each day, to help you remember.
Your doctor will decide how long your treatment should continue.
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6–10 hours after surgery.
If you have undergone major hip surgery, you will generally need to take the tablets for 5 weeks.
If you have undergone major knee surgery, you will generally need to take the tablets for 2 weeks.
If you take more Rivaroxaban Medical Valley than you should
Seek immediate medical advice if you have taken too many Rivaroxaban Medical Valley tablets. If you have taken an excessive amount of Rivaroxaban Medical Valley, your risk of bleeding increases.
If you forget to take Rivaroxaban Medical Valley
If you have forgotten a dose, take it as soon as you remember. Take the next tablet the following day and then continue with one tablet per day as before.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Rivaroxaban Medical Valley
Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor, because Rivaroxaban Medical Valley prevents conditions that may be life-threatening.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

3. Possible side effects

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

Signs of bleeding: bleeding in the brain or skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, reduced level of consciousness, and neck stiffness. A medical emergency that is life-threatening. 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 may 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 systemic illness (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 people).
Signs of serious allergic reactions: swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).

Complete list of possible side effects
Common (may occur in 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
loss of blood or fluid from the surgical wound
swelling in limbs
pain in limbs
impaired kidney function (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)
general decrease in strength and energy (weakness, fatigue), headache, dizziness, rash, itchy skin
increase in certain liver enzymes in blood tests
Uncommon (may occur in up to 1 in 100 people)
bleeding in the brain or inside the skull (see above, signs of bleeding)
joint bleeding causing pain and swelling
thrombocytopenia (reduced number of platelets, which are the cells that allow blood to clot)
allergic reactions, including allergic skin reactions
impaired liver function (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 occur in 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 occur in up to 1 in 10,000 people)

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

Frequency not known (frequency cannot be estimated from the available data)
kidney failure following severe bleeding
renal bleeding sometimes with blood in 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 after bleeding)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

4. How to store Rivaroxaban Medical Valley

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.

5. Contents of the pack and other information

What Rivaroxaban Medical Valley contains
The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
The other components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, povidone K30, pregelatinized starch, crospovidone, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Medical Valley contains lactose and sodium"
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), iron oxide red (E172)
Description of the appearance of Rivaroxaban Medical Valley and pack sizes
Rivaroxaban Medical Valley 10 mg film-coated tablets are round, biconvex, pink film-coated tablets with a diameter of approximately 6 mm, imprinted with "10" on one side and smooth on the other side.
The tablets are available in blisters in packs of 10 and 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Manufacturers:
Laboratorios Liconsa S.A., Avda. De Miralcampo 7, 19200 Azuqueca de Henares (Guadalajara), Spain

Patient Information Leaflet: Information for the User

Rivaroxaban Medical Valley 2.5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

6. What Rivaroxaban Medical Valley is and what it is used for

Rivaroxaban Medical Valley has been prescribed for you because
you have been diagnosed with acute coronary syndrome (a group of conditions that includes
heart attack and unstable angina, a severe form of chest pain), and an
increase in certain cardiac markers has been detected in blood tests.
In adults, Rivaroxaban Medical Valley reduces the risk of another heart attack or the risk
of dying from a disease related to the heart or blood vessels.
Rivaroxaban Medical Valley will not be administered to you alone. Your doctor will also prescribe:

acetylsalicylic acid or
acetylsalicylic acid plus clopidogrel or ticlopidine

or
you have been diagnosed with a high risk of blood clots due to
coronary artery disease or peripheral artery disease causing symptoms.
Rivaroxaban Medical Valley reduces, in adults, the risk of clot formation (atherothrombotic events). Rivaroxaban Medical Valley will not be administered to you alone. Your doctor
will also prescribe acetylsalicylic acid. In some cases, if you need to take Rivaroxaban
Medical Valley following a procedure to dilate a narrowed or blocked artery in the leg
to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.
Rivaroxaban Medical Valley contains the active substance rivaroxaban and belongs to a group of
medicines called antithrombotic agents. Its action is due to the inhibition of a coagulation factor (factor Xa), resulting in reduced tendency of the blood to form clots.

7. What you should know before taking Rivaroxaban Medical Valley

Do not take Rivaroxaban Medical Valley
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 your body that increases the risk of severe
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 heparins), except when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open
if you have acute coronary syndrome and previously had bleeding or a blood clot in the brain (stroke)
if you have coronary artery disease or peripheral artery disease and previously had a stroke, a blockage in the small arteries supplying blood to deep brain tissues (lacunar stroke), or a blood clot in the brain (non-lacunar ischemic stroke) within the previous month
if you have a liver disease that increases the risk of bleeding
during pregnancy or breastfeeding

Do not take Rivaroxaban Medical Valley 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 Medical Valley.
Rivaroxaban Medical Valley must not be used in combination with certain medicines that reduce blood clotting, such as prasugrel or ticagrelor, except for acetylsalicylic acid and clopidogrel/ticlopidine.

Be especially careful with Rivaroxaban Medical Valley
if you have an increased risk of bleeding, such as in the following cases:
severe kidney disease, because kidney function may affect the amount of active medicine in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran,
apixaban or heparin), when switching anticoagulant therapy or when receiving heparins through a venous or arterial catheter to keep it open (see section “Other medicines and Rivaroxaban Medical Valley”)
coagulation disorders
very high blood pressure not controlled with medication
stomach or intestinal diseases that may cause bleeding, for example inflammation of the intestine or stomach or inflammation of the esophagus, such as caused by gastroesophageal reflux disease (a condition in which stomach acid rises into the esophagus), or tumors 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 previous bleeding from the lungs
if you are over 75 years old
if you weigh less than 60 kg
if you have coronary artery disease with severe symptomatic heart failure
if you have a prosthetic heart valve
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

If any of the conditions described above apply to you, inform your doctor before taking Rivaroxaban Medical Valley. 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 Medical Valley 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 Medical Valley before and after the injection or removal of the catheter exactly as directed by your doctor
inform your doctor immediately if you experience numbness or weakness in your legs, or problems with your bowel or bladder after the anaesthesia, as urgent medical intervention may be required.

Children and adolescents
Rivaroxaban Medical Valley 2.5 mg tablets are not recommended for individuals under 18 years of age. There is insufficient information available on the use of this medicine in children and adolescents.

Other medicines and Rivaroxaban Medical Valley
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, prasugrel and ticagrelor (see section “Warnings and precautions”))
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat atrial fibrillation
certain antidepressants (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 Medical Valley, as the effect of Rivaroxaban Medical Valley 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 ulcer treatment.

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

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

Driving and using machines
Rivaroxaban Medical Valley may cause dizziness (common side effect) or fainting (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.

8. How to take Rivaroxaban Medical Valley

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
What dose to take
The recommended dose is one 2.5 mg tablet taken twice daily. Take Rivaroxaban Medical Valley at the same times each day (for example, one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the tablet whole, ask your doctor how to take Rivaroxaban Medical Valley in another way. The tablet may be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer the crushed Rivaroxaban Medical Valley tablet through a tube inserted into the stomach.
Rivaroxaban Medical Valley will not be given to you alone.
Your doctor will also prescribe acetylsalicylic acid for you.
If you are taking Rivaroxaban Medical Valley after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking Rivaroxaban Medical Valley following a procedure to dilate a narrowed or blocked leg artery to restore blood flow, your doctor may also prescribe clopidogrel, which you will take for a short period in combination with acetylsalicylic acid.
Your doctor will prescribe the correct dose of these medicines (usually 75 mg to 100 mg of acetylsalicylic acid per day, or a daily dose of 75 mg–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 Medical Valley
Treatment with Rivaroxaban Medical Valley after an acute coronary syndrome should begin as soon as possible after stabilization of the acute coronary syndrome, but not earlier than 24 hours after hospital admission and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued.
If you have been diagnosed with coronary artery disease or peripheral artery disease, your doctor will tell you when to start treatment with Rivaroxaban Medical Valley.
Your doctor will decide how long your treatment should continue.
If you take more Rivaroxaban Medical Valley than you should
Contact your doctor immediately if you have taken too many Rivaroxaban Medical Valley tablets. If you have taken an excessive amount of Rivaroxaban Medical Valley, your risk of bleeding increases.
If you forget to take Rivaroxaban Medical Valley
Do not take a double dose to make up for the forgotten dose. If you miss a dose, take the next dose at your usual time.
If you stop taking Rivaroxaban Medical Valley
Take Rivaroxaban Medical Valley regularly for the entire duration prescribed by your doctor.
Do not stop taking Rivaroxaban Medical Valley without first discussing it with 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 doubts about how to use this medicine, consult your doctor or pharmacist.

9. Possible side effects

Like all medicines, Rivaroxaban Medical Valley can cause side effects, although not everybody experiences them.
Like other similar medicines, in order to reduce blood clot formation, Rivaroxaban Medical Valley may cause bleeding, which can potentially be life-threatening.
Severe 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 life-threatening 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 may change your treatment.
Signs of serious 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 serious allergic reactions

swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.
The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 people).
Complete list of possible side effects
Common (may affect up to 1 in 10 people)
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 of limbs
pain in limbs
impaired kidney function (can be detected by blood tests performed by your doctor)
fever
stomach pain, indigestion, feeling unwell, constipation, diarrhoea
low blood pressure (symptoms include dizziness or fainting when standing up)
general decrease in strength and energy (weakness, fatigue), headache, dizziness, rash, itchy skin
increase in certain liver enzymes in blood tests
Uncommon (may affect up to 1 in 100 people)
bleeding in the brain or within the skull (see above, signs of bleeding)
joint bleeding, causing pain and swelling
thrombocytopenia (reduced number of platelets, which are blood cells that help blood to clot)
allergic reactions, including allergic skin reactions
impaired liver function (can be detected by blood tests performed by your doctor)
blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
fainting
feeling unwell
rapid heartbeat
dry mouth
hives
Rare (may affect up to 1 in 1,000 people)
muscle bleeding
cholestasis (reduced flow of bile, a substance produced by the liver), hepatitis, including hepatocellular injury (liver inflammation including liver damage)
yellowing of the skin and eyes (jaundice)
localized swelling
formation of a blood collection (haematoma) in the groin as a complication of a cardiac procedure involving insertion of a catheter into the leg artery (pseudoaneurysm)
Very rare (may affect up to 1 in 10,000 people)

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

Frequency not known (frequency cannot be estimated from the available data)
kidney failure following severe bleeding
renal bleeding sometimes with blood in urine leading to kidney dysfunction (Anticoagulant-related nephropathy)
increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)
Reporting of side effects
If you experience any side 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 the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

10. How to store Rivaroxaban Medical Valley

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.

11. Package contents and other information

What Rivaroxaban Medical Valley contains
The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, pregelatinized starch, crospovidone, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Medical Valley contains lactose and sodium".
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), iron oxide yellow (E172).

Description of the appearance of Rivaroxaban Medical Valley and the contents of the pack
Rivaroxaban Medical Valley 2.5 mg film-coated tablets are film-coated, round, biconvex, yellow tablets with a diameter of approximately 6 mm, imprinted with "2.5" on one side and smooth on the other side.
The tablets are available in blisters in packs of 56 film-coated tablets.

Marketing Authorization Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturers:
Laboratorios Liconsa S.A. - Avda. De Miralcampo 7, 19200 Azuqueca de Henares (Guadalajara)
Spain