Rivaxa 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaxa 15 mg film-coated tablets EFG

Rivaxa 20 mg film-coated tablets EFG

rivaroxaban

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Rivaxa is and what it is used for

2. What you need to know before taking Rivaxa

3. How to take Rivaxa

4. Possible side effects

5. Storage of Rivaxa

6. Contents of the pack and other information

1. What Rivaxa is and what it is 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 known as 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 recurring in the veins of the legs and/or lungs.

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

2. What you need to know before starting to take Rivaxa

Do not take Rivaxa

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or organ condition that increases the risk of serious bleeding (for example, stomach ulcer, brain injury or bleeding in the brain, or recent surgery on the brain or eyes)
• if you are taking medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while heparin is being administered through a venous or arterial catheter to prevent it from becoming blocked
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaxa and inform your doctor if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Exercise special caution with Rivaxa

• if you have an increased risk of bleeding, such as in the following situations:
  • severe renal impairment in adults, since kidney function may affect the amount of drug active in the body
  • if you are taking other medications to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment, or while receiving heparin through a venous or arterial catheter to prevent it from becoming blocked (see section “Other medicines and Rivaxa”)
  • hemorrhagic disorders
  • very high blood pressure not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as intestinal or gastric inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid moves up into the esophagus]), or tumors located in the stomach, intestines, genital tract, or urinary tract
  • a problem in the blood vessels at the back of your eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or previous lung hemorrhage
• if you have a cardiac valve prosthesis
• 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 treatment adjustment may be necessary
• 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 you are in any of these situations before taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you require closer monitoring.

If you need a surgical procedure

• It is very important to take rivaroxaban before and after surgery exactly at the times indicated by your doctor.
• If your procedure requires the placement of a catheter or an injection into the spine (for example, 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 the legs or problems with the bowel or bladder at the end of anesthesia, as urgent medical attention is required.

Children and adolescents

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

Other medicines and Rivaxa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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), except if applied only to the skin
  • tablets containing ketoconazole (used to treat Cushing's syndrome, a condition in which the body produces too much cortisol)
  • any medicine for bacterial infections (e.g., clarithromycin, erythromycin)
  • 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 or acenocoumarol)
  • anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid)
  • dronedarone, a medicine used to treat irregular heartbeat
  • certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above situations apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban could be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If your doctor considers that you have an increased risk of developing a stomach or intestinal ulcer, they may recommend that you also use a preventive treatment.

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

If any of the above situations apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban could be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility that you could become pregnant, use a reliable contraceptive method while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately; your doctor will decide how you should be treated.

Driving and operating machinery

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

Rivaxa contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medication.

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

3. How to take Rivaxa

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

You should 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 may be crushed and mixed with water or apple puree immediately before taking. 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 daily.

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

If you require a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting reducing the dose to one rivaroxaban 15 mg tablet once daily (or to one rivaroxaban 10 mg tablet once daily if your kidneys are not functioning properly), in addition to an antiplatelet medication such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring:

The recommended dose is one rivaroxaban 15 mg tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one rivaroxaban 20 mg tablet once daily.

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

If you have kidney problems and are taking one rivaroxaban 20 mg tablet once daily, your doctor may decide to reduce your treatment dose to one rivaroxaban 15 mg tablet once daily after 3 weeks, if your risk of bleeding is higher than the risk of developing 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 help you remember.

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, please use the alternative oral suspension formulation of rivaroxaban granules.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking it. Eat some food after taking this mixture. If necessary, your doctor may also administer crushed rivaroxaban tablets through a tube inserted into the stomach.

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 not take a new dose. In this case, take the next dose of rivaroxaban at the usual time.

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

When to take Rivaxa

Take the tablets every day, as long as your doctor advises.

Try to take the tablets at the same time each day to help you remember when to take them. Your doctor will decide how long you should continue treatment.

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

If you take more Rivaxa than you should

Contact 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rivaxa

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

• If you are taking a 15 mg tablet twice daily and you forget a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forgot to take a dose, you may take two 15 mg tablets at once, for a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you interrupt treatment with Rivaxa

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

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

4. Possible adverse effects

Like all medicines, rivaroxaban can cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

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

• Signs of bleeding
  • bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)
  • prolonged or excessive bleeding
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain, or angina.

Your doctor may decide to monitor you more closely or change your treatment.

? Signs of severe skin reactions

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

? Signs of serious allergic reactions

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

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

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

Common (may affect up to 1 in 10 people)

• Decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• Bleeding from the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• Bleeding in the eye (including bleeding in the white part of the eye)
• Bleeding into body tissue or cavities (hematoma, bruising)
• Coughing up blood
• Bleeding of the skin or under the skin
• Bleeding after surgery
• Discharge of blood or fluid from a surgical wound
• Swelling of the limbs
• Limb pain
• Impaired kidney function (may be detected in laboratory tests performed by a physician)
• Fever
• Stomach pain, indigestion, dizziness or lightheadedness, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness
• Rash, itching of the skin
• Blood tests may show increased levels of certain 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 into a joint, causing pain and swelling
• Thrombocytopenia (low platelet count, platelets being cells that help blood clot)
• Allergic reaction, including skin allergic reaction
• Impaired liver function (may be detected in laboratory tests performed by a physician)
• Blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count
• Fainting
• Feeling unwell
• Increased heart rate
• Dry mouth
• Hives

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

• Bleeding into a muscle
• Cholestasis (reduced bile flow), hepatitis, including traumatic hepatocellular injury (liver inflammation or damage)
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Blood collection (hematoma) in the groin following a complication from cardiac surgery involving catheter insertion 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 cell causing lung inflammation (eosinophilic pneumonia)

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

• Kidney failure following severe bleeding
• Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys' inability to function properly (anticoagulant-related nephropathy)
• Increased pressure in the muscles of the legs or arms following bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Adverse effects in children and adolescents

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

Adverse 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 levels of bilirubin (bile pigment)
• Thrombocytopenia (low platelet count, platelets being cells that help blood clot)
• Heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

• Blood tests may show increased levels in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Rivaxa Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaxa

• 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, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate. See section 2 “Rivaxa contains lactose and sodium”.

Tablet film coating: hypromellose, titanium dioxide (E 171), macrogol, iron oxide red (E 172).

Appearance of the product and contents of the package

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

They are packaged in blisters, in cartons containing 10, 14, 28, 30, 42, 45 or 98 film-coated tablets.

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

They are packaged in blisters, in cartons containing 10, 14, 28, 30, 45 or 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, Praha 4

140 78 Czech Republic

Manufacturer responsible:

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

Further information on this medicinal product is available upon request by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product 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 latest review of this leaflet: May 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).