Rivaroxaban Aurovitas 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Aurovitas 15 mg film-coated tablets EFG

Rivaroxaban Aurovitas 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start using this medicine, because 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Rivaroxaban Aurovitas contains the active substance rivaroxaban and is used in adults for:

• Preventing 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.
• Treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing 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 for:

• Treating blood clots and preventing the recurrence of these blood clots in the veins or in the blood vessels of the lungs, following 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 blood to form clots.

2. What you need to know before starting to take Rivaroxaban Aurovitas

Do not take Rivaroxaban Aurovitas

• 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 between anticoagulant treatments or while receiving heparin through a venous or arterial catheter to prevent blockage.
• If you have liver disease that increases the risk of bleeding.
• If you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Rivaroxaban.

Take special care with Rivaroxaban

• 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 blockage (see section “Other medicines and Rivaroxaban Aurovitas”).
  • bleeding disorders.
  • very high blood pressure not controlled by medical treatment.
  • stomach or intestinal diseases that could cause bleeding, such as inflammation of the stomach or intestines, inflammation of the oesophagus (e.g. due to gastro-oesophageal reflux disease (a condition in which stomach acid moves up into the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract.
  • a blood vessel disorder at the back of the eyes (retinopathy).
  • a lung disease in which 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 so they can 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 procedure to remove a blood clot from your lungs.

Inform your doctor if you have any of these conditions 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 is not recommended in 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 Rivaroxaban Aurovitas

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), unless applied only to the skin.
• Ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess 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 and pain-relief 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-noradrenaline reuptake inhibitors (SNRIs)).

If any of the above apply to you, inform your doctor before 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 need closer monitoring.

If your doctor considers you have a higher risk of developing stomach or intestinal ulcers, they may recommend additional preventive ulcer 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 apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you need closer monitoring.

Pregnancy, breastfeeding and fertility

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 how you should be treated.

Driving and using machines

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

Rivaroxaban contains lactose and sodium

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

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

3. How to take Rivaroxaban Aurovitas

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

Take rivaroxaban with food.

Swallow the tablet, preferably with water.

If you have difficulty swallowing the whole tablet, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before administration. 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 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 one 10 mg rivaroxaban tablet once daily if your kidneys are not functioning 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 blood clots from recurring:

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 the risk of bleeding is greater 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 weight changes.

Never adjust the dose of rivaroxaban on your own. 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, use the alternative formulation of rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow the tablets whole, 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 it. After taking this mixture, eat some food. If necessary, your doctor may also administer the crushed rivaroxaban tablet via a tube inserted into the stomach.

If you spit out or vomit the dose

• 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 you repeatedly spit out or vomit the dose after taking rivaroxaban.

When to take Rivaroxaban Aurovitas

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 restore normal heart rhythm using a procedure called cardioversion, take rivaroxaban at the times your doctor has instructed.

If you take more Rivaroxaban Aurovitas 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rivaroxaban Aurovitas

• 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 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 the same time to achieve a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you stop taking Rivaroxaban Aurovitas

Do not stop treatment with rivaroxaban without first talking to 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, this medicine can cause adverse effects, although not everyone will experience them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding, which may be life-threatening. Excessive bleeding may 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 severe 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 (up to 1 in 10,000 people).

• Signs of severe allergic reactions:
  • Swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; 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 observed in adults, children, and adolescents

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

• Decrease in red blood cells, which may cause paleness, weakness, or difficulty breathing.
• Bleeding from the stomach or intestine, urogenital hemorrhage (including blood in the 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 a tissue or body cavity (hematoma, bruising).
• Coughing up blood.
• Bleeding of or under the skin.
• Bleeding after surgery.
• Oozing of blood or fluid from a surgical wound.
• Swelling of the limbs.
• Limb pain.
• Impaired kidney function (may be detected in tests performed by your doctor).
• Fever.
• Stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea.
• Low blood pressure (symptoms may include feeling dizzy or faint upon standing).
• General decrease in strength and energy (weakness, fatigue), headache, dizziness.
• Rash, itching of the skin.
• Blood tests may show an increase in 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, the cells that help blood to clot).
• Allergic reaction, including skin allergic reaction.
• Impaired liver function (may be detected in tests performed by your doctor).
• Blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or 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 (inflammation or liver 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).

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 (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 after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome due to hemorrhage).

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 their severity was mainly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

Very frequent (may affect more than 1 in 10 people):

• Headache.
• Fever.
• Nosebleeds.
• Vomiting.

Frequent (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, the cells that help blood to 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Aurovitas

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

Do not use this medicine after the expiry date which is stated on the label, blister, packaging, or container after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Rivaroxaban Aurovitas

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

Tablet core: microcrystalline cellulose (Grades 101 and 102), lactose monohydrate, sodium croscarmellose, hypromellose type 2910 (3 cPs), sodium lauryl sulfate, magnesium stearate.

Tablet coating: polyvinyl alcohol, Macrogol 3350, talc, titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the pack

Rivaroxaban Aurovitas 15 mg:

Film-coated red tablets, round, biconvex, marked with “M” on one side and “15” on the other.

Rivaroxaban Aurovitas 20 mg:

Film-coated dark red to reddish-brown tablets, oval, biconvex, marked with “M” on one side and “20” on the other.

Rivaroxaban Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister packs: 5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196 and 200 film-coated tablets.

HDPE bottles: 30, 100, 250 and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer Responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany:	Rivaroxaban PUREN 15 mg/20 mg Film-coated tablets
Belgium:	Rivaroxaban AB 15 mg/20 mg, film-coated tablets
Spain:	Rivaroxaban Aurovitas 15 mg film-coated tablets EFG Rivaroxaban Aurovitas 20 mg film-coated tablets EFG
France:	Rivaroxaban Arrow 15 mg/20 mg film-coated tablet
Netherlands:	Rivaroxaban Aurobindo 15 mg/20 mg, film-coated tablets
Poland:	Rivaroxaban Aurovitas
Portugal:	Rivaroxaban Aurovitas

Date of the last revision of this leaflet: December 2023

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/).