RIVAROXABAN CINFA 10 mg HARD CAPSULES

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 medication (listed in section 6)
• if you bleed excessively
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent brain or eye surgery)
• if you are taking medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become obstructed
• 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 doctorif any of these circumstances apply to you.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Be careful with Rivaroxaban Cinfa

• if you have an increased risk of bleeding, as may occur in the following situations:
• • moderate or severe kidney failure, as kidney function may affect the amount of medication that acts in your body
  • if you are taking other medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become obstructed (see section "Other medications and Rivaroxaban Cinfa")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital tract, or urinary tract
  • a problem in the blood vessels of the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding

(bronchiectasis) or previous lung bleeding

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), inform your doctor to decide if treatment modification may be necessary
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Tell your doctorif you have any of these situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery

• 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 in the spinal column (e.g., for epidural or spinal anesthesia, or pain relief):
• • It is very important to take rivaroxaban exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder at the end of anesthesia, as urgent attention is necessary.

Children and Adolescents

Rivaroxaban is not recommended for children under 18 years of age.There is not enough information about its use in children and adolescents.

Other Medications and Rivaroxaban Cinfa

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

• If you are taking
• • any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin
  • tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces excess cortisol)
  • any medication for bacterial infections (e.g., clarithromycin, erythromycin)
  • any antiviral medication for HIV/AIDS (e.g., ritonavir)
  • other medications to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
  • anti-inflammatory medications or pain relievers (e.g., naproxen or acetylsalicylic acid)
  • dronedarone, a medication for treating irregular heartbeat
  • certain medications for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you, tell your doctorbefore taking rivaroxaban, as the effect of this medication may increase. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, they will recommend using a preventive treatment for ulcers in addition to rivaroxaban.

• If you are taking
• • any medication for treating epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal remedy for treating depression
  • rifampicin, an antibiotic

If any of the above circumstances apply to you, tell your doctorbefore taking rivaroxaban, as the effect of this medication may be reduced. Your doctor will decide if you should be treated with rivaroxaban and if you should be kept under closer observation.

Pregnancy and Breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medication, tell your doctor immediately, who will decide how you should be treated.

Driving and Using Machines

Rivaroxaban may cause dizziness (a frequent side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Cinfa contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

3. How to take Rivaroxaban Cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor. If you are 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 capsule once a day.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from occurring again. After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed rivaroxaban 10 mg once a day.

Swallow the capsule, preferably with water. This medication can be taken with or without food. If you have difficulty swallowing the capsule whole, consult your doctor about other ways to take rivaroxaban. The contents of the capsule can be mixed with water or apple sauce, immediately before taking it.

If necessary, your doctor may also administer the contents of the rivaroxaban capsule through a gastric tube.

When to take Rivaroxaban Cinfa

Take the capsule every day, until your doctor indicates otherwise. Try to take one capsule at the same time every day, to help you remember.

Your doctor will decide how long you should continue taking the treatment.

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

Take the first capsule 6 to 10 hours after surgery.

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

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

If you take more Rivaroxaban Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you forget to take a dose, take it as soon as you remember. Take the next capsule the next day and, after that, take one capsule every day, as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Rivaroxaban Cinfa

Do not stop taking rivaroxaban without consulting your doctor first, as rivaroxaban prevents the development of a serious condition.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Like other similar medications to reduce blood clot formation, rivaroxaban may cause bleeding, which can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

Tell your doctor immediately if you experience any of the following side effects:

• Signs of bleeding
  • bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Go to the doctor immediately!)
  • prolonged or excessive bleeding
  • exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain, or angina

Your doctor will decide to keep you under closer observation or modify your treatment.

• Signs of severe skin reactions
  • intense skin rashes that spread, blisters, or lesions on the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
  • drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

The frequency of these side 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 frequency of severe allergic reactions is 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 side effects

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• kidney function changes (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness, or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding in a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• liver function changes (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

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

• bleeding in a muscle
• cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery in which 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 white blood cell granulocyte that causes inflammation in the lung (eosinophilic pneumonia)

Frequency not known(cannot be estimated from available data)

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaroxaban Cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister, after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Rivaroxaban Cinfa Composition

• The active ingredient is rivaroxaban. Each hard capsule contains 10 mg of rivaroxaban.
• The other components are:

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

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

Product Appearance and Packaging Content

Hard capsule of 15.9 mm in length (size "3") with opaque cap and body of beige color.

They are presented in PVC/PVdC/Aluminum and Aluminum/Aluminum blisters with 10, 30, or 100 (clinical packaging) capsules.

Patient Information Card: Information Handling

You will find a Patient Information Card 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 that you should peel off starting from the lower area, as indicated by the arrow, and then tear off 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 Last Revision of this Prospectus: July 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus 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/XXXXX/P_XXXXX.html

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