RIVAROXABAN BLUEFISH 15 mg + 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Bluefish 15 mg + 20 mg film-coated tablets EFG

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 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Rivaroxaban Bluefish contains the active substance rivaroxaban. Rivaroxaban 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 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 Bluefish

Do not take Rivaroxaban Bluefish

• 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 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 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 Bluefish

• 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 it from becoming blocked (see section "Other medications and Rivaroxaban Bluefish")
• 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, 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 if 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 the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

Other medications and Rivaroxaban Bluefish

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including medications obtained 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
• 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 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, 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 recommend that you also use a preventive treatment.

• If you are taking

• any medication for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal remedy for the treatment of 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 (a frequent side effect) or fainting (a rare 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 Bluefish contains lactose and sodium

This medication contains lactose. 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 Bluefish

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

You must 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 dose of the treatment 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 Rivaroxaban Bluefish

Take the tablets every day, until your doctor indicates otherwise.

Try to take the tablets at the same time every day to remember when to take them.

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

If you take more Rivaroxaban Bluefish than you should

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

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

If you forget to take Rivaroxaban Bluefish

• 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 Rivaroxaban Bluefish

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

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 will experience them.

Like other similar medications for reducing blood clot formation, rivaroxaban may 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 apparent.

Inform your doctor immediatelyif 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.

• 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), nasal bleeding, gum bleeding
• 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 in 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 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 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(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 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaroxaban Bluefish

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 after CAD or EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple sauce 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 SIGRE collection point at your pharmacy. If you are unsure, 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 Bluefish

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.

• The other ingredients are:

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

Coating: macrogol, hypromellose, titanium dioxide (E171), red iron oxide (E172).

Appearance and package contents of the product

Rivaroxaban Bluefish 15 mg film-coated tablets are biconvex, round, red tablets, marked with “1” on one side and with a diameter of approximately 5 mm.

Rivaroxaban Bluefish 20 mg film-coated tablets are biconvex, round, reddish-brown tablets, marked with a “2” on one side.

Initial treatment pack for the first 4 weeks of treatment containing PVC/PVdC//Al blisters of 49 film-coated tablets:

• 42 film-coated tablets of Rivaroxaban Bluefish 15 mg
• 7 film-coated tablets of Rivaroxaban Bluefish 20 mg.

Marketing authorisation holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Sofarimex-Indústria Química e Farmacêutica, S.A.

Avenida das Indústrias, Alto de Colaride,

2735-213 Cacém, Portugal.

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

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid,

Sucursal 36

This medicine is authorised in other EEA countries 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/).