RIVAXA 15 MG + 20 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaxa 15 mg + 20 mg film-coated tablets EFG

rivaroxaban

Starter Pack for Treatment Initiation

Not for use in children

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 doubts, 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaxa and what is it used for
2. What you need to know before taking Rivaxa
3. How to take Rivaxa
4. Possible side effects
5. Storage of Rivaxa

1. Contents of the pack and further information

1. What is Rivaxa and what is it used for

Rivaxa contains the active substance rivaroxaban and is used in adults 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 re-occurring 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 factor involved in blood clotting (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaxa

Do not take Rivaxa

• 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 to prevent obstruction
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaxa 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 Rivaxa

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney failure, as kidney function may affect the amount of medication that acts in the 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 to prevent obstruction (see section "Other medications and Rivaxa")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, or 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 your eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (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 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.

Inform 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 before and after the injection or catheter removal, exactly at the times indicated by your doctor.
  • Inform 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

The starter pack for rivaroxaban treatment is not recommended for persons under 18 years of age,as it is specifically designed for treatment initiation in adult patients and is not suitable for use in children and adolescents.

Other Medications and Rivaxa

Inform 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, inform your doctorbefore taking rivaroxaban, as the effect of rivaroxaban 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 a stomach or intestinal ulcer, they may also recommend using a preventive treatment.

• 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 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 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.

Rivaxa 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 Rivaxa

Follow your doctor's instructions for taking this medication exactly. If in doubt, 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 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.

What Dose to Take

The recommended dose is one 15 mg rivaroxaban tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once a day.

This starter pack for rivaroxaban treatment with 15 mg and 20 mg is only for the first 4 weeks of treatment.

Once this pack is finished, treatment will continue with rivaroxaban 20 mg once a day, as indicated by your doctor.

If you have kidney problems, your doctor may decide to reduce the treatment dose to one 15 mg rivaroxaban tablet once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

When to Take Rivaxa

Take the tablets every day, until your doctor tells you to stop.

Try to take the tablets at the same time every day to remember when to take them. The doctor will decide how long you should continue treatment.

If You Take More Rivaxa 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 Rivaxa

• If you are taking one 15 mg tablet twice a day, and you forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time, for a total of two tablets (30 mg) in one day. The next day, you should continue taking one 15 mg tablet twice a day.
• If you are taking one 20 mg tablet once a day, and you forget to take a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for a forgotten dose. Take the next tablet the next day and, after that, continue taking one tablet every day.

If You Stop Taking Rivaxa

Do not stop taking rivaroxaban without consulting your doctor first, as rivaroxaban treats and prevents serious conditions.

If you have any other doubts 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 that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Tell 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, 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 may decide to keep you under closer observation or change your treatment.

• severe skin rash that spreads, 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).

• 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 clotting)
• 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
• blood accumulation (hematoma) in the groin after a complication in 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 or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaxa

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

This medicine does not require any special storage conditions.

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 Rivaxa

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxa contains lactose and sodium".

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

Appearance and Package Contents

Rivaxa 15 mg are film-coated tablets, red, round, biconvex (5.6 mm in diameter), marked with "15" on one side and smooth on the other side.

Rivaxa 20 mg are film-coated tablets, dark red, round, biconvex (6.5 mm in diameter), marked with "20" on one side and smooth on the other side.

Initial treatment pack for the first 4 weeks: each pack of 49 film-coated tablets for initial treatment contains: 42 film-coated tablets with 15 mg of rivaroxaban and 7 film-coated tablets with 20 mg of rivaroxaban.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, Praha 4

140 78 Czech Republic

Manufacturer:

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Adalvo Ltd

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann

SGN 3000, Malta

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Germany Rivaxa 15 mg and 20 mg Filmtabletten Starterpackung

Denmark Rivaxa

Spain Rivaxa 15 mg + 20 mg film-coated tablets EFG

Finland Rivaxa

Norway Rivaxa

Czech Republic Rivaxa 15 mg + 20 mg film-coated tablets – pack for initiation of treatment

Sweden Rivaxa

Date of last revision of this leaflet: March 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/).