RIVAXA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaxa 15 mg film-coated tablets EFG

Rivaxa 20 mg film-coated tablets EFG

rivaroxaban

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 Rivaxa and what is it used for
2. What you need to know before you take Rivaxa
3. How to take Rivaxa
4. Possible side effects
5. Storage of Rivaxa

1. Contents of the pack and further information

1. What is Rivaxa and what is it used for

Rivaxa contains the active substance rivaroxaban.

Rivaroxaban is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat 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 happening again in the veins of the legs and/or lungs.

Rivaroxaban 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 Rivaxa

Do not take Rivaxa

• 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 injury or bleeding in the brain or a recent operation on the brain or eyes)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing from one anticoagulant treatment to another or while being treated with heparin through a venous or arterial catheter to prevent blockage of the catheter
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breast-feeding.

Do not take Rivaxa and inform your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before taking rivaroxaban.

Be careful with Rivaxa

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney problems in adults as kidney function may affect the amount of medicine that works in the body
  • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when changing from one anticoagulant treatment to another or while being treated with heparin through a venous or arterial catheter to prevent blockage of the catheter (see section "Other medicines and Rivaxa")
  • bleeding disorders
  • very high blood pressure that is not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), or tumors located in the stomach, intestines, genital or urinary tract
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• if you have a heart valve replacement
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that he can decide whether it may be necessary to modify the treatment.
• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo a surgical procedure to remove a blood clot from your lungs.

Inform your doctor if any of these situations apply to youbefore taking rivaroxaban. 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 rivaroxaban before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia, or pain relief):
• • It is very important to take rivaroxaban before and after the injection or removal of the catheter, 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 intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban tablets are not recommended in children and adolescents. There is not enough information on the use of rivaroxaban in children and adolescents.

Other medicines and Rivaxa

Inform your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

• If you are taking
• • any medicine for a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin
  • tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces too much cortisol)
  • any medicine for bacterial infections (e.g. clarithromycin, erythromycin)
  • any antiviral medicine for HIV/AIDS (e.g. ritonavir)
  • other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
  • anti-inflammatory medicines and pain relievers (e.g. naproxen or acetylsalicylic acid)
  • dronedarone, a medicine for the treatment of irregular heartbeat
  • certain medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above applies to you, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban 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 considers that you have a higher risk of developing a stomach or intestinal ulcer, he may recommend that you also use a preventive treatment.

• If you are taking
• • any medicine for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal medicine for the treatment of depression
  • rifampicin, an antibiotic.

If any of the above applies to you, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take rivaroxaban if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4 "Possible side effects"). You should not drive, ride a bicycle or use tools or machines if you are affected by these symptoms.

Rivaxa contains lactose and sodium

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

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

3. How to take Rivaxa

Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

You must take rivaroxaban with food. Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple puree, immediately before taking it. Then take food.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

What dose to take

• Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body.

The recommended dose is one rivaroxaban 20 mg tablet once a day.

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

If you need to undergo 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 15 mg tablet once a day (or to one rivaroxaban 10 mg tablet once a day in case your kidneys do not work 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 these blood clots from happening again.

The recommended dose is one rivaroxaban 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one rivaroxaban 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 10 mg tablet once a day or one 20 mg tablet once a day.

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

Take each dose of rivaroxaban 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.

Do not divide the tablet to try to get a fraction of the tablet dose. If a smaller dose is required, please use the alternative rivaroxaban granule presentation for oral suspension.

If the oral suspension is not available, you can crush the rivaroxaban 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 administer the crushed rivaroxaban tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do nottake a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Call your doctor if after taking rivaroxaban you spit out the dose or vomit repeatedly.

When to take Rivaxa

Take the tablets every day, until your doctor tells you to stop.

Try to take the tablets at the same time every day to remember when you should take them. The doctor will decide how long you should continue taking the treatment.

To prevent blood clots in the brain (stroke) or in other blood vessels: If it is necessary to normalize your heartbeat through a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you take more Rivaxa than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

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

If you forget to take Rivaxa

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

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

If you stop taking Rivaxa

Do not stop taking rivaroxaban without consulting your doctor first, as rivaroxaban treats and prevents serious conditions.

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

4. Possible side effects

Like all medicines, rivaroxaban can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, rivaroxaban can cause bleeding that can put your life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

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

• Signs of bleeding
• • bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side, vomiting, seizures, decreased level of consciousness and stiff neck. This is a serious medical emergency. Go to the doctor immediately!)
  • prolonged or excessive bleeding
  • exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor may decide to keep you under closer observation or change your treatment.

?

• severe skin rash that spreads, blisters or lesions on the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic disease (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).

Warning

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

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

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

Common(may affect up to 1 in 10 people)

• Decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• Bleeding from the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• Bleeding in the eye (including bleeding in the white part of the eye)
• Bleeding into a tissue or cavity of the body (hematoma, bruising)
• Coughing up blood
• Bleeding from the skin or under the skin
• Bleeding after surgery
• Purulent discharge of blood or fluid from a surgical wound
• Swelling of the limbs
• Pain in the limbs
• Alteration of kidney function (may be seen in tests performed by the doctor)
• Fever
• Stomach pain, indigestion, nausea or feeling of nausea, constipation, diarrhea
• Low blood pressure (symptoms may be dizziness or fainting when standing up)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness,
• Rash, itching of the skin
• Blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people)

• Bleeding in the brain or inside the skull (see above, signs of bleeding)
• Bleeding in a joint, causing pain and swelling
• Thrombocytopenia (low platelet count, cells that help blood clotting)
• Allergic reaction, including skin allergic reaction
• Alteration of liver function (may be seen in tests performed by the doctor)
• Blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• Fainting
• Feeling of discomfort
• Increased heart rate
• Dry mouth
• Hives

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

• Bleeding in a muscle
• Cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• Yellowish discoloration of the skin and eyes (jaundice)
• Localized swelling
• Accumulation of blood (hematoma) in the groin after a complication in cardiac surgery where 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).

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

• Kidney failure after severe bleeding.
• Bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (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)

Adverse effects in children and adolescents

In general, the adverse 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.

Adverse 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)

• Accelerated heart rate
• Blood tests may show an increase in bilirubin (bile pigment)
• Thrombocytopenia (low platelet count, cells that help blood clotting)
• 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 nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaxa

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

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

This medicine does not require special storage conditions.

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

6. Package contents and additional information

Composition of Rivaxa

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

Core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxa contains lactose and sodium".

Coating of the tablet: hypromellose, titanium dioxide (E 171), macrogol, red iron oxide (E 172).

Appearance and packaging of the product

Rivaxa 15 mg are film-coated tablets, red, round, biconvex (5.6 mm in diameter), marked with "15" on one side and smooth on the other side.

They are packaged in blister packs, in boxes of 10, 14, 28, 30, 42, 45, or 98 film-coated tablets.

Rivaxa 20 mg are film-coated tablets, dark red, round, biconvex (6.5 mm in diameter), marked with "20" on one side and smooth on the other side.

They are packaged in blister packs, in boxes of 10, 14, 28, 30, 45, or 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, Praha 4

140 78 Czech Republic

Manufacturer:

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Adalvo Ltd

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann

SGN 3000, Malta

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Rivaxa 15 mg Filmtabletten, Rivaxa 20 mg Filmtabletten

Denmark Rivaxa

Spain Rivaxa 15 mg film-coated tablets EFG, Rivaxa 20 mg film-coated tablets EFG

Finland Rivaxa

Norway Rivaxa

Czech Republic Rivaxa 15 mg potahované tablety, Rivaxa 20 mg potahované tablety

Sweden Rivaxa

Date of the last revision of this prospectus:May 2024.

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