RIVAROXABAN FARMALIDER 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Rivaroxaban Farmalider 10 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Rivaroxaban Farmalider and what is it used for
2. What you need to know before taking Rivaroxaban Farmalider
3. How to take Rivaroxaban Farmalider
4. Possible side effects
5. Storage of Rivaroxaban Farmalider
6. Packaging contents and additional information

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

Rivaroxaban 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 medication because after surgery you are at a higher risk of forming blood clots.
• treating 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 belongs to a group of medications called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Farmalider

Do not take Rivaroxaban Farmalider

• if you are allergic to rivaroxaban or any of the other components of this medication

(including those 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 surgery in the brain or eyes)
• 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 particularly careful with Rivaroxaban Farmalider

• 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 Farmalider")

bleeding disorder

very high blood pressure, not controlled by medical treatment

stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestine, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital tract, or urinary tract

problems in the blood vessels of the back of the eyes (retinopathy)

pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary 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 it may be necessary to modify the treatment.
• 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 doctor if 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 into 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 10 mg tablets are 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 Farmalider

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 only applied to the skin

ketoconazole tablets (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, inform 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 this medication.

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, inform your doctorbefore taking Rivaroxaban, as the effect of rivaroxaban may be decreased. Your doctor will decide if you should be treated with this medication 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, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (frequent side effect) or fainting (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 Farmalider 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 tablet; this is essentially "sodium-free".

3. How to take Rivaroxaban Farmalider

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 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 recurring.

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

You should take Rivaroxaban with food.

Swallow the tablets, preferably with water.

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

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

When to take Rivaroxaban Farmalider

Take one tablet every day, until your doctor tells you to stop.

Try to take one tablet at the same time every day, to help you remember. The 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 tablet 6 to 10 hours after surgery.

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

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

If you take more Rivaroxaban Farmalider than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

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

If you forget to take Rivaroxaban Farmalider

If you forget to take a dose, take it as soon as you remember. Take the next tablet the next day and, after that, take one tablet every day, as usual.

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

If you stop taking Rivaroxaban Farmalider

Do not stop taking rivaroxaban without talking to 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, rivaroxaban can cause side effects, although not everyone will experience them.

Like other similar medications for reducing blood clot formation, rivaroxaban can 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. Seek medical attention immediately!)

prolonged or excessive bleeding

• exceptional weakness, fatigue, pallor, 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

• severe 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 (affecting up to 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria 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 pallor and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• 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
• pain in the limbs
• 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 decrease in strength and 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 into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clot)
• 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 into 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 (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 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 Farmalider

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on each blister or bottle, after "CAD" or "EXP". The expiry date is the last day of the month indicated.

No special storage conditions are required.

Crushed tablets

Crushed tablets are stable in water or apple puree for up to 4 hours.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Farmalider

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica. (See section 2 "Rivaroxaban Farmalider contains lactose").

Film coating: macrogol, hypromellose, titanium dioxide (E 171), red iron oxide (E 172).

Appearance and package contents of the product

Rivaroxaban Farmalider 10 mg film-coated tablets are round, light red, film-coated, biconvex tablets, engraved with "C5" on one side and smooth on the other side. Diameter: 6.10 mm ± 0.20 mm.

They are presented

• In PVC/PVDC/aluminum blister packs in packs of 10 and 30 film-coated tablets.

Marketing authorization holder

Farmalider, S.A.

C/ La Granja, 1

28108 Alcobendas (Madrid)

Spain

Manufacturer

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this leaflet:November 2024

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