Rivaroxaban CINFA 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban cinfa 15 mg hard capsules EFG

Rivaroxaban cinfa 20 mg hard capsules 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 adverse 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 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, 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 the blood to form clots.

2. What you need to know before taking Rivaroxaban cinfa

Do not take Rivaroxaban cinfa

• if you are allergic to rivaroxaban or 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, brain injury or hemorrhage, or recent surgery on the brain or eyes)
• if you are taking medications 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 you start taking rivaroxaban.

Take special care with Rivaroxaban cinfa

• if you have an increased risk of bleeding, such as 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 drug active in the body
  • if you are taking other medications to prevent blood clotting (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 gastric inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid flows back up into the esophagus]), or tumors in the stomach, intestines, genital tract, or urinary tract
  • a blood vessel problem in the back of your eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus

(bronchiectasis) or 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 your treatment needs to be adjusted.
• if your doctor determines 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 procedure requires placement of a catheter or injection into your 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 specified.
  • Inform your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after anesthesia, 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 cinfa

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, in which the body produces excess cortisol)
  • any medicine for bacterial infections (e.g., clarithromycin, erythromycin)
  • antiviral medicines 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 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 this medicine 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 gastric 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 this medicine 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 possibility you could become pregnant, use a reliable contraceptive method 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 should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rivaroxaban cinfa 15 and 20 mg 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 capsule, i.e., essentially “sodium-free”.

3. How to take Rivaroxaban cinfa

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

Swallow the capsule whole, preferably with water. This medicine should be taken with food. If you have difficulty swallowing the capsule whole, consult your doctor about other ways of taking rivaroxaban. The contents of the capsule may be mixed with water or apple puree immediately before administration. Then take food.

If necessary, your doctor may also administer the capsule contents of rivaroxaban sprinkled 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 capsule once daily. If you have kidney problems, the dose may be reduced to one 15 mg capsule once daily.

If you need 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 capsule once daily (or one 10 mg capsule 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 capsule twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg capsule once daily.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily.

If you have kidney problems and are taking one 20 mg capsule once daily, your doctor may decide to reduce your treatment dose to one 15 mg capsule 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 capsule once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg capsule once daily.

Take each dose of rivaroxaban with a drink (e.g., water or juice) during a meal. Take the capsules 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 pour out the capsule contents in an attempt to obtain a fraction of the capsule dose. If a lower dose is required, please use the alternative product containing rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow the capsules whole, please use a product containing rivaroxaban in granule form for oral suspension.

If the oral suspension is not available, you may empty the contents of the rivaroxaban capsule 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 emptied capsule contents of rivaroxaban 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 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 capsules every day until your doctor tells you otherwise.

Try to take the capsules 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 heart rhythm by a procedure called cardioversion, take rivaroxaban at the times your doctor has indicated.

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 91 562 04 20, indicating the medicine and the amount ingested.

Call your doctor immediately if you have taken too many rivaroxaban capsules. 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 capsule or one 15 mg capsule once daily and you miss a dose, take it as soon as you remember. Do not take more than one capsule in a single day to make up for a missed dose. Take the next capsule the following day, and then continue taking one capsule daily.

• Adults:

If you are taking one 15 mg capsule twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in a single day. If you missed a dose, you may take two 15 mg capsules together to obtain a total of two capsules (30 mg) in one day. The following day, resume taking one 15 mg capsule twice daily.

If you stop taking Rivaroxaban cinfa

Do not stop treatment with rivaroxaban without first consulting your doctor, as 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 experiences 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 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 (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 urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissue or body cavities (bruising, hematomas)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (may be seen in blood 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 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 reactions
• impaired liver function (may be seen in blood 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 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 from 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 (frequency 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 observed 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 (a 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, a bile pigment)

Reporting of adverse effects

If you experience any adverse effect, talk to 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. Rivaroxaban cinfa Storage Instructions

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 the blister, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Rivaroxaban cinfa

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

Capsule contents: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate and magnesium stearate.

Capsule coating: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172) and black iron oxide (E-172).

Appearance of the product and contents of the pack

Rivaroxaban cinfa 15 mg hard capsules EFG

19.4 mm long hard capsule (size "1") with opaque light brown cap and body.

Supplied in PVC/PVdC/Aluminum and Aluminum/Aluminum blisters containing 28, 42 or 100 (hospital pack) capsules.

Rivaroxaban cinfa 20 mg hard capsules EFG

21.7 mm long hard capsule (size "0") with opaque dark brown cap and body.

Supplied in PVC/PVdC/Aluminum and Aluminum/Aluminum blisters containing 28 or 100 (hospital pack) capsules.

Patient Information Card: handling instructions

A Patient Information Card is attached to the outer packaging, or your doctor may provide you with a similar one. This Patient Information Card is located on the outside of the packaging as a detachable flap, which you should peel off starting from the lower area, as indicated by the arrow, and then tear from the right side of the packaging.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

ZENTIVA S.A.

B-Dul Theodor Pallady nr 50, Sector 3

1. Bucharest – Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: July 2024

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

Rivaroxaban cinfa 15 mg hard capsules 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 the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html

QR code link: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html

Rivaroxaban cinfa 20 mg hard capsules 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 the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html/

QR code link: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html