Rivaroxaban CINFA 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban cinfa 15 mg film-coated tablets EFG

Rivaroxaban cinfa 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Rivaroxaban cinfa contains the active substance rivaroxaban.

Rivaroxaban is used in adults for:

• preventing 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.
• 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, 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 blood's tendency to form clots.

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

Do not take Rivaroxaban cinfa

• 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 (e.g., 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 heparin is being administered through a venous or arterial catheter to prevent blockage
• if you have a 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 starting to take rivaroxaban.

Take special care with Rivaroxaban cinfa

• if you have an increased risk of bleeding, as may occur 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 cinfa”)
  • 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, oesophageal inflammation (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid flows back up into the oesophagus]), or tumours in the stomach, intestines, genital 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 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 your treatment needs to be adjusted
• if your doctor determines that your blood pressure is unstable or 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 exactly at the times your doctor tells you to, both before and after surgery.
• If your procedure 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 exactly at the times your doctor has instructed, both before and after the injection or catheter removal.
  • 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 for children weighing less than 30 kg. There is insufficient information on its use in children and adolescents for the adult indications.

Other medicines and Rivaroxaban cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• 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, in which the body produces too much cortisol)
  • any antibiotic 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 antidepressants (selective serotonin reuptake inhibitors [SSRIs] or serotonin-norepinephrine 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 at higher risk of developing a stomach or intestinal ulcer, they may recommend you also use 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 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 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 chance 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 course of treatment.

Driving and using machines

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 operate tools or machinery if you are affected by these symptoms.

Rivaroxaban cinfa contains lactose

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

Rivaroxaban cinfa 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 Rivaroxaban cinfa

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. 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 eat a meal.

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 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 to 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 leg veins 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 higher than your risk of developing 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 the 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, please use the alternative formulation of rivaroxaban granules for oral suspension.

For children and adolescents who cannot swallow the tablets whole, 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. Then eat a meal 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 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 cinfa

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. 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 indicated by your doctor.

If you take more Rivaroxaban cinfa than you should

In case of overdose or accidental ingestion, contact 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.

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

If you forget to take Rivaroxaban cinfa

• Adults, children and adolescents:

If you are taking one 20 mg or one 15 mg tablet once daily and you forget a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. 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 forget a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you forget 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 stop taking Rivaroxaban cinfa

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, 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 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.

Tell 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, which may be signs of bleeding.

Your doctor may decide to monitor you more closely or change 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 with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic illness.

The frequency of these adverse effects is very rare (up to 1 in 10,000).

• 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 adverse effects (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 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 from 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 feeling dizzy, 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 an increase in certain liver enzymes.

Uncommon adverse effects (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, 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 an increase in bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives.

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

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including hepatocellular injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin following a complication during heart surgery where a catheter is inserted into the leg artery (pseudoaneurysm).

Very rare adverse effects (may affect up to 1 in 10,000 people)

• eosinophilia (accumulation of eosinophils, a type of granulocytic white blood cell) causing inflammation in the lung (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 impaired kidney function (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, the adverse effects observed in children and adolescents treated with rivaroxaban were similar in type to those seen in adults, and their severity was mostly 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 an increase in 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 an increase in a subcategory of bilirubin (direct bilirubin, bile pigment).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Rivaroxaban cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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 containers and unused medicines at the SIGRE collection point at the pharmacy. If you are in doubt, please 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 cinfa

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

Tablet core: microcrystalline cellulose, hypromellose, sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, lactose monohydrate, povidone, crospovidone, magnesium stearate.

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

Appearance of the product and contents of the pack

Rivaroxaban 15 mg film-coated tablets are red, cylindrical, biconvex (size: 5.5 mm ± 0.3 mm) with "2" on one side.

Rivaroxaban 20 mg film-coated tablets are reddish-brown, cylindrical, biconvex (size: 6 mm ± 0.3 mm) with "3" on one side.

Rivaroxaban cinfa 15 mg:

Supplied in unit-dose PVC-PVDC/aluminum blister packs containing 28, 42 or 100 (clinical pack) film-coated tablets.

Rivaroxaban cinfa 20 mg:

Supplied in unit-dose PVC-PVDC/aluminum blister packs containing 28 or 100 (clinical pack) film-coated tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: August 2023

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

Rivaroxaban cinfa 15 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88885/P_88885.html

QR code link: https://cima.aemps.es/cima/dochtml/p/88885/P_88885.html

Rivaroxaban cinfa 20 mg film-coated tablets EFG

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88886/P_88886.html

QR code link: https://cima.aemps.es/cima/dochtml/p/88886/P_88886.html