RIVAROXABAN MACLEODS PHARMA 15 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 Storage 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 type 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 veins 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 and prevent blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Macleods belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reducing the tendency of the 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 have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach or intestinal ulcer, recent bleeding or lesions in the brain or spinal surgery)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant treatment to another or when heparin is given through an intravenous or arterial line to keep it from getting blocked
• 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 you.

Warnings and precautions

Consult your doctor or pharmacist before starting Rivaroxaban Macleods.

Be careful with Rivaroxaban Macleods

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may affect the amount of medicine that works in the body
  • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching from one anticoagulant treatment to another or when receiving heparin through an intravenous or arterial line to keep it from getting blocked (see section "Other medicines and Rivaroxaban Macleods")
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines or stomach, 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 in the stomach, intestines, genital 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 replacement
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if treatment needs to be changed.
• 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 conditionsbefore 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 your doctor indicates.
• If your operation requires the placement of a catheter or injection in the spine (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 your doctor has indicated.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder after anesthesia, as urgent attention is needed.

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 taking, have recently taken or might take 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
• ketoconazole tablets (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 medicines and pain relievers (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 applies 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, he may recommend that you also take 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 applies 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 (common 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 some sugars, consult him 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 administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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 sauce, 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 work properly) in addition to an antiplatelet medicine like 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 take 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 your 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 mgtablet 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 they take the entire dose.

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

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

Do not split the tablet to try to get 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 sauce 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 to take them.

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

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

If you need to have a procedure to restore a normal heartbeat (called cardioversion), take Rivaroxaban Macleods at the times your doctor has indicated.

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 then continue taking 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 first consulting your doctor, because Rivaroxaban Macleods treats and prevents serious conditions.

If you have any further questions on 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 to reduce 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. Go to the doctor immediately!)
• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina pectoris, 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)
• bloody cough
• 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 granulocytic white blood cell 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)
• increased 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 their severity was mainly mild to moderate.

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 heartbeats
• 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 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 leaflet. 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 that appears on the packaging and on each blister after "CAD". 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 puree for up to 4 hours.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you 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 thisleaflet:

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/).