RIVAROXABAN MACLEODS PHARMA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Rivaroxaban Macleods 15 mg film-coated tablets EFG

Rivaroxaban Macleods 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rivaroxaban Macleods and what is it used for
2. What you need to know before you take Rivaroxaban Macleods
3. How to take Rivaroxaban Macleods
4. Possible side effects

5 Conservation of Rivaroxaban Macleods

1. Contents of the pack and other information

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

Rivaroxaban Macleods contains the active substance rivaroxaban.

Rivaroxaban Macleods is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
• 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 happening again in the blood vessels of the legs and/or lungs.

Rivaroxaban Macleods is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medications used to treat blood clots.

Rivaroxaban Macleods 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 you take Rivaroxaban Macleods

Do not take Rivaroxaban Macleods

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you bleed excessively
• if you have a disease or problems 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 another anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become clogged
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Macleods and inform your doctorif any of these circumstances apply to your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rivaroxaban Macleods.

Be careful with Rivaroxaban Macleods

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney failure in adults and moderate or severe kidney failure in children and adolescents, 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, so that it does not become clogged (see section "Other medicines and Rivaroxaban Macleods")
  • 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 clogged (see section "Other medicines and")
  • bleeding disorder
  • very high blood pressure, not controlled by medical treatment
  • diseases of the stomach or intestine 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 (a disorder of the immune system that increases the risk of blood clot formation), inform your doctor so that they can decide if it is 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.

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

If you need surgery

• It is very important to take Rivaroxaban Macleods 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 Macleods, before and after the injection or removal of the catheter, 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 intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban Macleods tablets are not recommended in children with a body weight below 30 kg.

There is not enough information about the use of Rivaroxaban Macleods in children and adolescents for the indications in adults.

Other medicines and Rivaroxaban Macleods

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

• Tell your doctor if you are taking

• any medicine 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 too much cortisol)
• any medicine for bacterial infections (e.g. clarithromycin, erythromycin)
• any antiviral medicine for HIV/AIDS (e.g. ritonavir)
• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for the treatment of irregular heartbeat
• certain medicines 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 Rivaroxaban Macleods, because the effect of Rivaroxaban Macleods may be increased. Your doctor will decide if you should be treated with this medicine 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.

• Tell your doctor if you are taking

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

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

Pregnancy and breastfeeding

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

Driving and using machines

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

Rivaroxaban Macleods contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Rivaroxaban Macleods

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult again with your doctor or pharmacist.

You must take Rivaroxaban Macleods with food.

Swallow the tablets, preferably with water.

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

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

What dose to take

• Adults
• • to prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body

The recommended dose is one Rivaroxaban Macleods 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one Rivaroxaban Macleods 15 mg tablet once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent insertion), there is limited evidence to reduce the dose to one Rivaroxaban Macleods 15 mg tablet once a day (or to one Rivaroxaban Macleods 10 mg tablet once a day in case your kidneys do not function properly) in addition to an antiplatelet medication such as clopidogrel.

• to treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent these blood clots from happening again.

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

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day.

If you have kidney problems and are taking one Rivaroxaban Macleods 20 mg tablet once a day, your doctor may decide to reduce the treatment dose to one Rivaroxaban Macleods 15 mg tablet once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

• Children and adolescents

The dose of Rivaroxaban Macleods depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kgis one Rivaroxaban Macleods 15 mgtablet once a day
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxaban Macleods 20 mg tablet once a day.

Take each dose of Rivaroxaban Macleods with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure that they take the entire dose.

Since the dose of Rivaroxaban Macleods is based on body weight, it is important to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of Rivaroxaban Macleods on your own. Your doctor will adjust the dose if necessary.

Do not divide the tablet to try to obtain a fraction of the tablet dose. If a smaller dose is required, please use the alternative presentation of rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow whole tablets, please use the alternative presentation of rivaroxaban granules for oral suspension.

If the oral suspension is not available, you can crush the Rivaroxaban Macleods tablet and mix it with water or apple puree immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the crushed Rivaroxaban Macleods tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Macleods, take a new dose.
• more than 30 minutes after taking Rivaroxaban Macleods, do nottake a new dose. In this case, take the next dose of Rivaroxaban Macleods at the usual time.

Call your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Macleods.

When to take Rivaroxaban Macleods

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 you should take them.

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

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heartbeat through a procedure called cardioversion, take Rivaroxaban Macleods at the times indicated by your doctor.

If you take more Rivaroxaban Macleods than you should

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

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 medicine and the amount ingested.

If you forget to take Rivaroxaban Macleods

Adults, children and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncea 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, take one tablet every day.

Adults:

If you are taking one 15 mg tablet twicea 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 stop taking Rivaroxaban Macleods

Do not stop taking Rivaroxaban Macleods without consulting your doctor first, because Rivaroxaban Macleods treats and prevents serious conditions.

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

4. Possible Adverse Effects

Like all medicines, Rivaroxaban Macleods can cause adverse effects, although not all people suffer from them.

Like other similar medicines for reducing blood clot formation, Rivaroxaban Macleods can cause bleeding that can endanger the patient's life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Inform 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, unilateral weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek medical attention immediately!)
• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, which can be signs of bleeding.

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 adverse 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.

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 adverse effects found in adults, children, and adolescents

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• bleeding in the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, 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
• 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 be 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 (decrease in 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 cardiac surgery where 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)

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

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with Rivaroxaban Macleods were similar to those observed in adults and were mainly mild to moderate in severity.

Adverse effects that were more frequently observed in children and adolescents:

Very frequent(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Frequent(may affect up to 1 in 10 people)

• accelerated heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban Macleods

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

Do not use this medicine after the expiration date stated on the packaging and on each blister after "EXP". The expiration date is the last day of the month indicated.

Store below 30°C.

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. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Macleods

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

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

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

Appearance of the product and package contents

Rivaroxaban Macleods 10 mg film-coated tablets are pink, round, biconvex, engraved with "J 8" on one side and smooth on the other.

They are packaged in blisters in packs of 10, 28, 30, and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Macleods Pharma España, S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

Rabowicka 15, Swarzedz,

62-020, Poland

Date of the last revision of thisprospectus:

January 2024.

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