Epicar 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Epicar 15 mg film-coated tablets EFG

Epicar 20 mg film-coated tablets EFG

Rivaroxaban

Read the entire package 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 personally; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Epicar is and what it is used for

Epicar contains the active substance rivaroxaban.

Epicar 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 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 starting to take Epicar

Do not take Epicar

• 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 problem in the 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 Epicar and inform your doctor if any of these circumstances apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rivaroxaban.

Take special care with Epicar

• if you have an increased risk of bleeding, as may occur in the following situations:

• severe renal impairment in adults and 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 Epicar”)

• 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 esophagus (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid moves up into the esophagus]), or tumors in the stomach, intestines, genital tract, or urinary tract

• a blood vessel problem in the back of the 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 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 needed

• if your doctor determines your blood pressure is unstable or you are scheduled to receive another treatment or undergo a 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 has instructed.

• If your surgery requires placement of a catheter or injection into the spine (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 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 anesthesia, as urgent medical attention is required.

Children and adolescents

Rivaroxaban tablets are not recommended in children with body weight below 30 kg. There is insufficient information on the use of rivaroxaban in children and adolescents for adult indications.

Other medicines and Epicar

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

If you are taking

• any medicine for fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin
• tablets containing ketoconazole (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 medicines and pain relievers (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 circumstances 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 stomach or intestinal ulcers, they may recommend you also use an ulcer-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 circumstances 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 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 how you should be treated.

Driving and use of machines

Rivaroxaban may cause dizziness (a common adverse effect) or fainting (an uncommon adverse 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.

Epicar contains lactose and sodium

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

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

3. How to take Epicar

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, 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 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 need to undergo 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 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 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 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 maintenance dose to one 15 mg rivaroxaban tablet once daily after 3 weeks if your risk of bleeding is higher than the risk of 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 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. You may 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 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 your usual time.

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

When to take Epicar

Take the tablet every day, for as long as your doctor tells you to.

Try to take the tablet at the same time each day to help you remember.

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 using a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you forget to take Epicar

• Adults, children and adolescents:

If you are taking one 20 mg tablet or one 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 a missed dose. Take the next tablet the following day and then continue taking one tablet each day.

• Adults:

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, 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 Epicar 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 medication and the amount ingested.

If you stop taking Epicar

Do not stop treatment with rivaroxaban without first talking to your doctor, because rivaroxaban prevents the development of a serious condition.

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, which may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Contact 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 monitoring 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; 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 reported 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 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 tissue or body cavities (bruising, hematoma)
• coughing up blood
• bleeding from 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 blood tests performed by your doctor)
• 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
• skin rash, 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, the cells that help blood clot)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be detected in blood tests performed by your doctor)
• blood tests may show increased bilirubin, increased 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 hepatocellular liver injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery involving catheter insertion into the leg artery (pseudoaneurysm)

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 impaired kidney function (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

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 seen 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 bilirubin (bile pigment)
• thrombocytopenia (low platelet count, the 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 effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect 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 Epicar

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 or bottle, following "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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Epicar

• The active substance is rivaroxaban.

Each Epicar 15 mg tablet contains 15 mg of rivaroxaban.

Each Epicar 20 mg tablet contains 20 mg of rivaroxaban.

• The other components are

Epicar 15 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate and corn starch. See section 2 “Epicar contains lactose and sodium”.

Film coating of the tablet: macrogol, hypromellose (E-464), lactose monohydrate, titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172) and black iron oxide (E-172).

Epicar 20 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate and corn starch. See section 2 “Epicar contains lactose and sodium”.

Film coating of the tablet: macrogol, hypromellose (E-464), lactose monohydrate, titanium dioxide (E-171) and red iron oxide (E-172).

Appearance of the product and contents of the container

Epicar 15 mg film-coated tablets are dark pink, round and biconvex.

Epicar 15 mg film-coated tablets are available in packs of 14, 28 and 42 film-coated tablets, with a diameter of 5.0 mm.

Epicar 20 mg film-coated tablets are red-brown, round and biconvex.

Epicar 20 mg film-coated tablets are available in packs of 28 film-coated tablets, with a diameter of 6.0 mm.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

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

Spain: Epicar film-coated tablets EFG

Portugal: Epicar coated tablets

Date of the most recent review of this leaflet: 11/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.