Rivaroxaban Alter 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Alter 15 mg film-coated tablets EFG

Rivaroxaban Alter 20 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take 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, as 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.

Package leaflet

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

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

Rivaroxaban Alter contains the active substance rivaroxaban.

Rivaroxaban 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 heart rhythm 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 reoccurring 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 clot.

2. What you need to know before starting Rivaroxaban Alter

Do not take Rivaroxaban Alter

• 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, 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 blockage
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Alter 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 Rivaroxaban Alter

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

• severe kidney impairment in adults and moderate to severe kidney 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 Alter”)

• 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—GERD, in which stomach acid rises up into the esophagus), or tumors in the stomach, intestines, genital tract, or urinary tract

• a problem with blood vessels at the back of the eyes (retinopathy)

• a lung disease in which the bronchi are widened and filled with pus (bronchiectasis) or a previous lung hemorrhage

• 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 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 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 catheter removal 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 anesthesia ends, as urgent medical attention is required.

Children and adolescents

Rivaroxaban is 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 Rivaroxaban Alter

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 fungal infection (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-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 circumstances 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 closer monitoring is needed.

If your doctor considers you at 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 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 closer monitoring is needed.

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, who will decide on the appropriate treatment.

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

Rivaroxaban Alter 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; hence, it is essentially “sodium-free”.

3. How to take Rivaroxaban Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 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 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 your 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. You may crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking it. Take 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

• 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 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 Alter

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

Try to take one 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 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 Rivaroxaban Alter

• 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 one 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 Rivaroxaban Alter 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 pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Rivaroxaban Alter

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 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 may cause 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 inside 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 (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 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 (hematoma, bruising)
• coughing up blood
• bleeding of the skin 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 lightheadedness, 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, 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 inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be detected in 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 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 following cardiac 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 (compartment syndrome due to hemorrhage)

Adverse effects in children and adolescents

In general, 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, cells that help blood clotting)
• 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 a side effect not listed in this leaflet. You can also report them directly through 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 Rivaroxaban Alter

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 packaging and on each blister or container, 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. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Alter

• The active substance is rivaroxaban.

Each tablet contains 15 mg of rivaroxaban.

Each tablet contains 20 mg of rivaroxaban.

• The other components are

Rivaroxaban Alter 15 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate and maize starch. See section 2 “Rivaroxaban Alter 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).

Rivaroxaban Alter 20 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate and maize starch. See section 2 “Rivaroxaban Alter 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 pack

Rivaroxaban Alter 15 mg film-coated tablets are dark pink, round and biconvex, with a diameter of 5.0 mm.

Rivaroxaban Alter 15 mg film-coated tablets are available in packs of 14, 28 and 42 film-coated tablets.

Rivaroxaban Alter 20 mg film-coated tablets are red-brown, round and biconvex, with a diameter of 6.0 mm.

Rivaroxaban Alter 20 mg film-coated tablets are available in packs of 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer Responsible for Manufacturing

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 European Economic Area member states under the following names:

Spain: Rivaroxabán Alter film-coated tablets EFG

Portugal: Rivaroxabano Alter film-coated tablets

France: Rivaroxaban Alter film-coated tablets

Italy: Rivaroxaban Alter film-coated tablets

Date of latest review of this leaflet: 11/2024

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/.