RIVAROXABAN POLPHARMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Polpharma15 mg film-coated tablets EFG

Rivaroxaban Polpharma20 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rivaroxaban Polpharma and what is it used for
2. What you need to know before you take Rivaroxaban Polpharma
3. How to take Rivaroxaban Polpharma
4. Possible side effects
5. Storage of Rivaroxaban Polpharma
6. Pack contents and further information

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

This medicine contains the active substance rivaroxaban.

Rivaroxaban Polpharma is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels in the body if you have a type of 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 these blood clots from occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban Polpharma is used in children and adolescents under 18 years of age with a body weight of 30 kg or more for:

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

Rivaroxaban Polpharma belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood that is involved in blood clotting (factor Xa), and thus reduces the tendency of the blood to form clots.

2. What you need to know before you take Rivaroxaban Polpharma

Do not take Rivaroxaban Polpharma

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6).
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching from these medicines to Rivaroxaban Polpharma, or when given heparin by injection or infusion to keep a line open
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breast-feeding

Do not take Rivaroxaban Polpharma and tell your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be particularly careful with Rivaroxaban Polpharma

• if you are at increased risk of bleeding, as may be the case in the following situations:
• • severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as your kidney function may affect the amount of medicine that works in your body
  • if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), in case of switching from these medicines to Rivaroxaban Polpharma, or when given heparin by injection or infusion to keep a line open (see section “Other medicines and Rivaroxaban Polpharma”)
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastro-oesophageal reflux disease (a disease where stomach acid rises towards the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract
  • a problem with the blood vessels in the back of the eyes (retinopathy)
  • a lung disease where the airways become wider and filled with pus (bronchiectasis), or previous lung bleeding

• if you have an artificial heart valve
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide whether it is necessary to change treatment
• if your doctor determines that your blood pressure is unstable or if you are scheduled for another treatment or surgical procedure to remove the blood clot from your lungs.

If any of these apply to you, tell your doctorbefore taking this medicine. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

If you need to have surgery:

• it is very important to take this medicine before and after the operation, exactly at the time your doctor has told you.
• If your operation involves the use of a catheter or injection into your spine (e.g. for epidural or spinal anaesthesia, or pain relief):

• it is very important to take this medicine before and after the injection or removal of the catheter, exactly at the time your doctor has told you
• tell your doctor immediately if you feel numbness or weakness in your legs, or problems with your bowels or bladder after the anaesthesia has finished, as urgent attention will be needed.

Children and adolescents

Rivaroxaban Polpharma tablets are not recommended for children with a body weight below 30 kg.There is not enough information on the use of Rivaroxaban Polpharma in children and adolescents for the indications in adults.

Using Rivaroxaban Polpharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take

• If you are taking:
• • some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
  • ketoconazole tablets (used to treat Cushing’s syndrome, when the body produces too much cortisol)
  • certain medicines for bacterial infections (e.g. clarithromycin, erythromycin)
  • certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
  • other medicines to reduce 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 to treat irregular heartbeats
  • some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of these apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may be increased. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

If your doctor thinks that you are at higher risk of getting stomach or intestinal ulcers, he may also use a treatment to prevent ulcers.

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

If any of these apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Polpharma and whether you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable method of contraception while you are taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately, and he will decide how you should be treated.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, ‘Possible side effects’). Do not drive or cycle, or use any tools or machines if you are affected by these symptoms.

This medicine contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, “sodium-free”.

3. How to take Rivaroxaban Polpharma

Always take this medicine exactly as your doctor has told you.

If you are not sure, check with your doctor or pharmacist.

You should take Rivaroxaban Polpharma with food.

Swallow the tablet(s) with water.

If you have difficulty swallowing a whole tablet, talk to your doctor about other ways to take this medicine. The tablet may be crushed and mixed with water or apple puree immediately before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may also give you a crushed tablet of this medicine through a gastric tube.

How much to take

• Adults

• For preventing blood clots in the brain (stroke) and in other blood vessels in your body, the recommended dose is one Rivaroxaban Polpharma 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one Rivaroxaban Polpharma 15 mg tablet once a day.

If you need a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention – PCI with stent insertion), there is limited evidence to reduce the dose to one Rivaroxaban Polpharma 15 mg tablet once a day (or to one Rivaroxaban Polpharma 10 mg tablet once a day in case of impaired kidney function), in addition to an antiplatelet medicine such as clopidogrel.

• For treating blood clots in the veins of the legs and blood clots in the blood vessels of the lungs, and for preventing these blood clots from occurring again

The recommended dose is one Rivaroxaban Polpharma 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Polpharma 20 mg tablet once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one Rivaroxaban Polpharma 10 mg tablet once a day or one Rivaroxaban Polpharma 20 mg tablet once a day.

If you have kidney problems and are taking one Rivaroxaban Polpharma 20 mg tablet once a day, your doctor may decide to reduce the dose for treatment after 3 weeks to one Rivaroxaban Polpharma 15 mg tablet once a day, if the risk of bleeding is greater than the risk of having another blood clot.

• Children and adolescents

The dose of Rivaroxaban Polpharma 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 less than 50 kg is one Rivaroxaban Polpharma 15 mg tablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Polpharma 20 mg tablet once a day.

Take each dose of Rivaroxaban Polpharma with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: please observe the child to ensure that they take the full dose.

As the dose of Rivaroxaban Polpharma is based on body weight, it is important to keep scheduled visits to your doctor because it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of Rivaroxaban Polpharma yourself. Your doctor will adjust the dose if necessary.

Do not break the tablet in an attempt to provide a fraction of the tablet dose. If a smaller dose is required, use other medicines in the form of granules for oral suspension.

For children and adolescents who cannot swallow whole tablets, use other medicines in the form of granules for oral suspension.

If you do not have an oral suspension, you can crush the Rivaroxaban Polpharma tablet and mix it with water or apple puree immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also give you the crushed Rivaroxaban Polpharma tablet through a gastric tube.

If you spit up the dose or vomit

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

Contact your doctor if you spit up the dose or vomit repeatedly after taking Rivaroxaban Polpharma.

When to take Rivaroxaban Polpharma

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

Try to take the tablet(s) at the same time every day to help you remember. Your doctor will decide how long you should take this medicine.

To prevent blood clots in the brain (stroke) and in other blood vessels in your body:

If your heart rhythm needs to be restored to normal through a procedure called cardioversion, take this medicine at the time your doctor has told you.

If you forget to take Rivaroxaban Polpharma

• Adults, children and adolescents

• If you are taking one 20 mg or one 15 mg tablet once a day and you have missed a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day and then continue to take one tablet once a day.

• Adults

• If you are taking one 15 mg tablet twice a day and you have missed 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 at the same time to get a total of two tablets (30 mg) in one day. The next day, you should continue to take one 15 mg tablet twice a day.

If you take more Rivaroxaban Polpharma than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much of this medicine increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you stop taking Rivaroxaban Polpharma

Do not stop taking this medicine without talking to your doctor first, as this medicine treats and prevents serious conditions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, this medicine can cause bleeding that can be fatal. Excessive bleeding can cause a sudden drop in blood pressure (shock). In certain cases, the bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following adverse effects:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, unilateral weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness.

A serious medical emergency. Seek medical attention immediately)

• prolonged or excessive bleeding
• exceptional weakness, fatigue, pallor, dizziness, headache, unexplained swelling, dyspnea, chest pain or angina.

Your doctor may decide to keep you under stricter observation or change the treatment.

• Signs of severe skin reaction

• intense skin rash that spreads, blisters, or mucous membrane lesions, for example, in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• A drug reaction that causes skin rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

This adverse effect is very rare (up to 1 in 10,000 people).

• Signs of severe allergic reaction

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria and respiratory difficulties; sudden drop in blood pressure.

These adverse effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible adverse effects detected in adults, children, and adolescents:

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

• reduction in the number of red blood cells that can cause pale skin and weakness or dyspnea
• bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nasal bleeding, bleeding in the gums
• bleeding in the eye (including bleeding in the white part of the eyes)
• bleeding in tissue or a body cavity (hematoma, bruise)
• bloody cough
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling in the limbs
• pain in the limbs
• alteration of kidney function (may be observed in tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling sick or being sick, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• decrease in general strength and energy (weakness, fatigue), headache, dizziness
• rash, skin irritation
• blood tests may show an increase in some liver enzymes

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

• bleeding in the brain or within the skull (see above, signs of bleeding)
• bleeding in a joint that causes pain and swelling
• thrombocytopenia (low platelet count, which are cells that help blood clot)
• allergic reactions, including skin allergic reactions
• alteration of liver function (may be observed in tests performed by your doctor)
• blood tests may show an increase in bilirubin levels, some pancreatic or liver enzymes, or platelet count
• fainting
• discomfort
• faster heartbeats
• dry mouth
• urticaria

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

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis including hepatocellular injury (inflamed liver, including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin, as a complication of the cardiac procedure in which a catheter is inserted 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 that cause inflammation in the lung (eosinophilic pneumonia)

Unknown(frequency cannot be estimated from available data):

• renal failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (anticoagulant-related nephropathy)
• increase in pressure within the muscles of the legs or arms after bleeding that causes pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

Adverse effects in children and adolescents

In general, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mainly mild to moderate in severity.

Side effects that were more frequently observed in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Common(may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clot)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine

5. Storage of Rivaroxaban Polpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "CAD/EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple sauce for up to 4 hours.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment

6. Package contents and additional information

Composition of Rivaroxaban Polpharma

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:

Tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. See section 2 "This medicine contains lactose and sodium".

Coating of Rivaroxaban Polpharma 15 mg (Opadry II Pink 33G240024): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide, red (E172), iron oxide, black (E172).

Coating of Rivaroxaban Polpharma 20 mg (Opadry II Red 33G250007): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide, red (E172), iron oxide, yellow (E172).

Appearance and package contents of the product

Rivaroxaban Polpharma 15 mg film-coated tablets are pink, round, biconvex, and have "15" engraved on one side.

They are available in blister packs, in cartons containing 10, 14, 28, 42, 98, or 100 film-coated tablets.

Rivaroxaban Polpharma 20 mg film-coated tablets are reddish-brown, round, biconvex, and have "20" engraved on one side.

They are available in blister packs, in cartons containing 10, 14, 28, 98, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zaklady Farmaceutyczne POLPHARMA S.A.

ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland

Manufacturer

FARMAPROJECTS S.A.U.

Parc Cientific de Barcelona

C/ Baldiri Reixac, 4/12 i 15

08028 Barcelona, Spain

Date of last revision of this leaflet:November 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)