Rivaroxaban Normon 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Rivaroxaban Normon 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 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 tendency of the blood to form clots.

2. What you need to know before starting Rivaroxaban Normon

Do not take Rivaroxaban Normon

• 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 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 Rivaroxaban Normon and inform your doctor if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Exercise special caution with Rivaroxaban Normon

• 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, since kidney function may affect the amount of drug active in the 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 it from becoming blocked (see section “Other medicines and Rivaroxaban Normon”)

• hemorrhagic disorders

• very high blood pressure, uncontrolled by medical treatment

• stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease— a condition in which stomach acid flows back up into the esophagus), or tumors located in the stomach, intestines, genital tract, 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 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 surgical procedure to remove a blood clot from your lungs

Tell your doctor if you are in any of these situations before taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If you need a surgical procedure

• It is very important to take rivaroxaban before and after surgery exactly at the times indicated by your doctor.

• If your operation requires the placement of a catheter or injection into the spine (for example, 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 you.

• Inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anesthesia, as urgent medical attention is required.

Children and adolescents

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

Other Medicines and Rivaroxaban Normon

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

• a medicine for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except if applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)

• a medicine for bacterial infections (e.g., clarithromycin, erythromycin)

• an 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 situations apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If your doctor considers that you have an increased risk of developing a gastric or intestinal ulcer, they may recommend that you also use preventive treatment.

• If you are taking

• a 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 situations apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you need to be more closely monitored.

Pregnancy and Breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility that 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 Use of 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 Normon contains lactose and sodium

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

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

3. How to take Rivaroxaban Normon

Follow exactly your doctor's instructions on how to take this medicine. 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 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 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 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 rivaroxaban 15 mg tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one rivaroxaban 20 mg 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 medical appointments, 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. If a lower dose is required, please use the alternative oral suspension granule formulation of rivaroxaban.

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 administration. Give some food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric feeding tube.

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.

When to take Rivaroxaban Normon

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

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 is necessary to restore normal heart rhythm using a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you forget to take Rivaroxaban Normon

• Adults, children and adolescents:

If you are taking a 20 mg tablet or a 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 your next tablet the following day, and then continue taking one tablet each day as usual.

• 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 one day. If you forgot to take 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 next day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Normon than you should

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 medication and the amount taken. Taking too much rivaroxaban increases the risk of bleeding.

If you stop treatment with Rivaroxaban Normon

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 will experience them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Inform 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 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; breathing difficulties; 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 of 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 increased levels of 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, the cells that help blood to clot)
• allergic reaction, including skin allergy
• impaired liver function (may be seen in 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 adverse effects (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
• 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 (may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of granulocyte white blood cell causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding or bleeding into 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 after 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 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 increased 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 increased levels 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 Normon

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 after "EXP".

The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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 properly 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 Normon

• The active substance is rivaroxaban. Each tablet contains 20 mg of rivaroxaban.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, monohydrate lactose, hypromellose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.

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

Appearance of the product and contents of the pack

Rivaroxaban Normon 20 mg are film-coated, reddish-brown, round, biconvex tablets with a diameter of 6.9 mm, marked with "R 20" on one side and unmarked on the other.

Rivaroxaban Normon 20 mg is available in packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89322/P_89322.html