Rixavarte 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Rixavarte 15 mg film-coated tablets EFG

Rixavarte 20 mg film-coated tablets EFG

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, ask 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 may 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.

Leaflet Contents

1. What Rixavarte is and what it is used for
2. What you need to know before taking Rixavarte
3. How to take Rixavarte
4. Possible side effects
5. How to store Rixavarte
6. Contents of the pack and other information

1. What Rixavarte is and what it is used for

Rixavarte 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 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 recurring in the blood vessels of the legs and/or lungs.

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

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

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 form clots.

2. What you need to know before taking Rixavarte

Do not take Rixavarte

• 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 condition affecting an organ in your body that increases the risk of serious bleeding (for example, stomach ulcer, 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 receiving heparin through a venous or arterial catheter to prevent it from becoming blocked,
• if you have a liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting rivaroxaban.

Take special care with Rixavarte

• if you have an increased risk of bleeding, such as in the following situations:
  • severe renal impairment in adults, or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine active in your body.
  • if you are taking other medicines 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 Rixavarte”).
  • bleeding disorders.
  • very high blood pressure not controlled by medical treatment.
  • stomach or intestinal diseases that could cause bleeding, such as intestinal or stomach inflammation, inflammation of the esophagus (e.g., due to gastroesophageal reflux disease [a condition where stomach acid flows back into the esophagus], or tumors in the stomach, intestines, genital or urinary tract).
  • a blood vessel problem in the back of your eyes (retinopathy).
  • a lung disease where the bronchi are widened and filled with pus (bronchiectasis), or previous lung bleeding.
• if you have a heart 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 your treatment needs to be adjusted.
• 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 you before taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery

• It is very important to take rivaroxaban before and after surgery exactly at the times your doctor tells you.
• If your operation requires placement of a catheter or injection into your spine (e.g., for epidural or spinal anaesthesia, or pain relief):
  • It is very important to take rivaroxaban before and after the injection or removal of the catheter exactly at the times your doctor has instructed.
  • 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 attention is required.

Children and adolescents

Rivaroxaban tablets are not recommended for children weighing less than 30 kg. There is insufficient information on the use of rivaroxaban in children and adolescents for adult indications.

Other medicines and Rixavarte

Tell 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 fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin.
  • ketoconazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol).
  • any medicine for bacterial infections (e.g., clarithromycin, erythromycin).
  • any antiviral medicines for HIV/AIDS (e.g., ritonavir).
  • other medicines that reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol).
  • non-steroidal anti-inflammatory drugs and pain relievers (e.g., naproxen or acetylsalicylic acid).
  • dronedarone, a medicine used to treat irregular heartbeat.
  • certain antidepressants (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 closer monitoring.

If your doctor considers you at higher risk of developing a stomach or intestinal ulcer, they may recommend additional preventive treatment.

• If you are taking
  • any medicine for 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 closer monitoring.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide on the appropriate course of treatment.

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”). You should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rixavarte contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

Rixavarte contains sodium

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

3. How to take Rixavarte

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking 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 crushed rivaroxaban tablets 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 in the body

The recommended dose is one 20 mg rivaroxaban tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban 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 15 mg rivaroxaban tablet once daily (or to one 10 mg rivaroxaban tablet once daily if your kidneys do not function 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 blood clots.

The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban 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 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg rivaroxaban tablet once daily after 3 weeks if your risk of bleeding is higher than the risk of having another blood clot.

• Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one 15 mg rivaroxaban tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

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

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as body weight changes.

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

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, please use rivaroxaban granules for oral suspension. For children and adolescents who cannot swallow whole tablets, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking. Take 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

• Within 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 your next dose of rivaroxaban at the usual time.

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

When to take Rixavarte

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

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 becomes necessary to normalize your heart rhythm using a procedure called cardioversion, take rivaroxaban at the times your doctor has instructed.

If you forget to take Rixavarte

• 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 a single day to make up for a missed dose. Take the next tablet the following day, and then continue taking one tablet each day.

• 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 a single day. If you missed a dose, you may take two 15 mg tablets at once to obtain a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rixavarte than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much medication increases the risk of bleeding. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Rixavarte

Do not stop treatment with rivaroxaban without first consulting your doctor, because 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 may cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding, which may be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, 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, weakness on one side of the body, 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 will decide whether to keep you under closer observation or modify your treatment.

• Signs of serious skin reactions

• severe skin rashes that spread, blisters, or mucosal lesions, 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 (affecting up to 1 in 10,000 people).

• Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; breathing difficulties; 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

Frequent (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 hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or body cavity (hematoma, bruising)
• coughing up blood
• bleeding from 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 seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or lightheadedness, constipation, diarrhea
• low blood pressure (symptoms may include feeling dizzy or fainting upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• 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, blood cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be seen in tests performed by your doctor)
• 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
• accumulation of blood (hematoma) in the groin as a complication after heart surgery involving insertion of a catheter into the leg artery (pseudoaneurysm)

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rixavarte

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

Do not use this medicine after the expiry date stated on the packaging and on each blister after "EXP".

The expiry date refers to the last day of the month indicated. No special storage conditions are required.

Crushed tablets

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. 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 Rixavarte

• The active substance is rivaroxaban.

Rixavarte 15 mg film-coated tablets EFG: Each film-coated tablet contains 15 mg of rivaroxaban.

Rixavarte 20 mg film-coated tablets EFG: Each film-coated tablet contains 20 mg of rivaroxaban.

• The other components (excipients) are:

Rixavarte 15 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch.

Coating material: macrogol, hypromellose, lactose monohydrate, titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172).

Rixavarte 20 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, maize starch.

Coating material: macrogol, hypromellose, lactose monohydrate, titanium dioxide (E-171), red iron oxide (E-172).

Appearance of the product and contents of the pack

Rixavarte 15 mg film-coated tablets EFG: dark pink, round, biconvex tablets with a diameter of 5.0 mm.

Available in packs of 28 or 42 film-coated tablets.

Rixavarte 20 mg film-coated tablets EFG: reddish-brown, round, biconvex tablets with a diameter of 6.0 mm.

Available in packs of 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Date of the most recent revision of this leaflet: January 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/