Rivaroxaban Normon 15 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Normon 15 mg film-coated tablets EFG

Read the entire 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, ask 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, 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 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 side 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 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 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, 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

inhibiting a clotting factor (factor Xa), thereby reducing the tendency of blood to form clots.

2. What you need to know before starting to take 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 organ condition that increases the risk of serious bleeding (for example, stomach ulcer, brain injury or hemorrhage, or recent brain or eye surgery),
• 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 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, as may occur in the following situations:

• severe renal impairment in adults and moderate or severe renal impairment in children and adolescents, since kidney function may affect the amount of medication 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”)

• 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 located 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 prior 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.

Inform your doctor if you have any of these conditions before taking rivaroxaban.

Your doctor will decide whether you should be treated with this medication and whether you should be kept under observation.

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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 procedure requires the placement of a catheter or an 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, itraconazol, voriconazole, posaconazole), except when applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces an excess of 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 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 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 to treat 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 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 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 use 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 him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, "sodium-free".

3. How to take Rivaroxaban Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 administration. 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 of the body.

The recommended dose is one rivaroxaban 20 mg tablet once daily.

If you have kidney problems, the dose may be reduced to one rivaroxaban 15 mg 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 rivaroxaban 15 mg tablet once daily (or one rivaroxaban 10 mg 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 rivaroxaban 15 mg tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one rivaroxaban 20 mg 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 rivaroxaban 20 mg tablet once daily, your doctor may decide to reduce your treatment dose to one rivaroxaban 15 mg tablet once daily after 3 weeks, if the 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 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 remind you.

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 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.

In 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 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 Rivaroxaban Normon

Take the tablets every day, for as long as your doctor advises.

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.

• 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 forget a dose, you may take two 15 mg tablets at once to achieve a total of two tablets (30 mg) in a 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, contact 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 taking 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 may 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 inside 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 characterized by 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; and 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 adverse effects (may affect up to 1 in 10 people)

• Decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• Stomach or intestinal bleeding, 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 body tissue or cavity (hematoma, bruising)
• Coughing up blood
• Bleeding of the skin 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 detected in laboratory tests performed by the doctor)
• Fever
• Stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness
• Rash, itching of the skin
• 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, cells that help blood clotting)
• Allergic reaction, including skin allergic reaction
• Impaired liver function (may be detected in laboratory tests performed by the doctor)
• Blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count
• Fainting
• Feeling of malaise
• 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 traumatic hepatocellular injury (liver inflammation or damage)
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Blood collection (hematoma) in the groin following a complication from cardiac surgery involving catheter insertion 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 cell causing lung inflammation (eosinophilic pneumonia)

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

• Kidney failure following severe bleeding, bleeding into the kidney, sometimes with blood in the urine, leading to inability of the kidneys to function properly (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 hemorrhage)

Adverse effects in children and adolescents

In general, adverse effects observed in children and adolescents treated with rivaroxaban were of a similar 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 levels (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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if
these are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Normon

Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information.

Composition of Rivaroxaban Normon

• The active substance is rivaroxaban. Each tablet contains 15 mg of rivaroxaban.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, lactose monohydrate, 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 medicinal product and contents of the container

Rivaroxaban Normon 15 mg are red, film-coated, round, biconvex tablets with a diameter of 6.2 mm, marked on one side with "R 15" and unmarked on the other.

Rivaroxaban Normon 15 mg is available in packs containing 28 and 42 film-coated tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

Detailed information on this medicinal product 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 the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89321/P_89321.html