Rivaroxaban Normon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Normon 10 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 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at higher risk of developing blood clots after surgery.
• 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 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 taking 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 problems in the body that increase the risk of severe bleeding (for example, stomach ulcer, injury or bleeding in the brain, 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 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:

• moderate or severe renal impairment, since kidney function may affect the amount of drug 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 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 may cause bleeding, such as inflammation of the stomach or intestines, inflammation of the esophagus (e.g., due to gastroesophageal reflux disease—where stomach acid moves up into the esophagus), or tumors in the stomach, intestines, genital or urinary tract

• a blood vessel problem in the back of the eyes (retinopathy)

• a lung disease in which the bronchi are dilated 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 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 medicine and whether you should be kept under closer monitoring.

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 spinal column (for example, for epidural or spinal anesthesia, or pain relief):

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

• 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 10 mg tablets are not recommended in individuals under 18 years of age. There is insufficient information available regarding its use in children and adolescents.

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

• any medicine for a fungal infection (e.g., fluconazole, itraconazol, voriconazole, posaconazole), unless applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces an excess of 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 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 you to be at higher risk of developing stomach or intestinal ulcers, they will recommend that you also receive preventive treatment for ulcers.

• If you are taking

• any medicine used 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 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 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 operating machinery

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 that you have an intolerance to certain sugars, consult with them before taking this medication.

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 the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one 10 mg rivaroxaban tablet once daily.

• To treat blood clots in the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring.

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you rivaroxaban 10 mg once daily.

Swallow the tablet, preferably with water. Rivaroxaban can be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take rivaroxaban. The tablet may be crushed and mixed with water or apple puree, immediately before taking it.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

When to take Rivaroxaban Normon

Take the tablet every day, for as long as your doctor prescribes it.

Try to take one tablet at the same time each day to help you remember. Your doctor will decide how long you should continue the treatment.

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after the operation.

If you have undergone major hip surgery, you will usually take the tablets for 5 weeks.

If you have undergone major knee surgery, you will usually take the tablets for 2 weeks.

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 forget to take Rivaroxaban Normon

If you forget to take a dose, take it as soon as you remember. Take your next tablet the following day, and then continue taking one tablet each day as usual.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Rivaroxaban Normon

Do not stop treatment with rivaroxaban without first speaking to your doctor, as rivaroxaban prevents the development of a serious condition.

If you have any further questions about using 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, which may be life-threatening. Excessive bleeding may 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 adverse effects:

• Signs of bleeding
  • bleeding in the brain or within 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 with eosinophilia and systemic symptoms 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 severe 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 severe 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

Frequent (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 bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into 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 the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or faintness 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 (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 the doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• feeling of malaise
• 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 liver injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin as a complication after cardiac 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 inflammation in the lung (eosinophilic pneumonia)

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

• renal failure following severe bleeding
• 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 (hemorrhagic compartment syndrome)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves 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 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 should 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 container and additional information

Composition of Rivaroxaban Normon

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, lactose monohydrate, hypromellose, sodium lauryl sulfate, sodium croscarmellose, and 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 pack

Rivaroxaban Normon 10 mg are light red, round, biconvex, film-coated tablets with a diameter of 6.2 mm, marked on one side with "R 10" and plain on the other.

Rivaroxaban Normon 10 mg is available in packs containing 10 and 30 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 for Medicines and Health Products (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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89320/P_89320.html