RIXACAM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rixacam 10 mg film-coated tablets EFG

rivaroxaban

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

• Keep this package 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Rixacam and what is it used for

Rixacam contains the active ingredient rivaroxaban and is used in adults for:

• if you bleed excessively to prevent 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.
• to treat 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.

Rixacam 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 Rixacam

Do not take Rixacam

• 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 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 may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rixacam and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

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

Be particularly careful with this medication

• 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 Rixacam")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• diseases of the stomach or intestine that may cause bleeding, such as inflammation of the stomach or intestine, inflammation of the esophagus (throat), e.g., due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), or tumors located in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or have had a previous bleeding in the lungs

(bronchiectasis) or have had a previous bleeding in the lungs

• 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 this medication. 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 this medication before and after the operation, 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 this medication exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems in the intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

This medication 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 Rixacam

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take 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 and pain relievers (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medication for the treatment of irregular heartbeat
• certain medications for the treatment of 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 this medication, as the effect of this medication may be increased. 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 may recommend that you also use a preventive treatment for ulcers.

• If you are taking

• any medication for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum) a medicinal plant for the treatment of depression,
• rifampicin, an antibiotic.

If any of the above circumstances apply to you, tell your doctorbefore taking this medication, as the effect of this medication may be reduced. 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 this medication if you are pregnant or breastfeeding. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking this medication. If you become pregnant while taking this medication, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

This medication 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.

Rixacam 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 Rixacam

Follow your doctor's instructions for taking this medication exactly. 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 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.

Swallow the tablet, preferably with water.

This medication can be taken with or without food.

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

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

When to take Rixacam

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.

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 tablet 6 to 10 hours after the operation.

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 Rixacam than you should

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

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

If you forget to take Rixacam

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 Rixacam

Do not stop taking this medication without talking to your doctor first, as this medication 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 gets them.

Like other similar medications to reduce blood clot formation, this medication 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 evident.

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 of 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 whether to keep you under closer observation or change 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 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 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, bleeding gums
• bleeding in the eye (including bleeding in the white 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
• alteration of kidney function (may be seen in tests performed by the 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
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• 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
• accumulation of blood (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(frequency 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 (compartment syndrome after bleeding)

Reporting side effects

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

5. Storage of Rixacam

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 blister and on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Rixacam

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

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

Tablet film coating: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E171), and red iron oxide (E172).

Appearance and package contents of the product

Rixacam 10 mg film-coated tablets are light pink, round, biconvex tablets, engraved with the number "10" on one side.

They are packaged in blisters, in packs of 10, 30, 98, or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorizedin the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:January 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.