RIVAROXABAN MACLEODS PHARMA 15 mg + 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

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

Starter pack for treatment initiation

Not for use in children.

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, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience 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 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 occurring again in the blood vessels of the legs and/or lungs.

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 have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent bleeding or injury, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching to a different anticoagulant treatment or when heparin is administered through a venous or arterial catheter to prevent blockage
• 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 conditions apply to you.

Warnings and precautions

Consult your doctor or pharmacist before taking Rivaroxaban Macleods.

Be careful with Rivaroxaban Macleods

• if you have an increased risk of bleeding, such as in the following situations:
• • severe kidney problems, 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 to a different anticoagulant treatment or when receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban Macleods")
  • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin), when switching to a different anticoagulant treatment or when receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and ")
  • bleeding disorders
  • uncontrolled high blood pressure
  • 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 in the stomach, intestines, genital tract, or urinary tract
  • problems with blood vessels in 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 have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if treatment modification is necessary.
• 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 closely monitored.

If you need to have 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 into 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 catheter removal, exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

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

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.

• If you are taking

• any medicine for a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess 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 or 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 these conditions apply to you, tell your doctorbefore taking Rivaroxaban Macleods, as 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 closely monitored.

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 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 these conditions apply to you, tell your doctorbefore taking Rivaroxaban Macleods, as 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 closely monitored.

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 this medicine. 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 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 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 whole tablet, 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

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.

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

Once this pack is finished, treatment will continue with Rivaroxaban Macleods 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 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.

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 each day to remember when to take them.

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

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 taken.

If you forget to take Rivaroxaban Macleods

• If you are taking one 15 mg tablet twice a day, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss 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 miss a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the next day and, after that, continue taking one tablet each day.

If you stop taking Rivaroxaban Macleods

Do not stop taking Rivaroxaban Macleods without consulting your doctor first, as 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 to reduce blood clot formation, Rivaroxaban Macleods 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 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, 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.

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 adverse effects

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 in a joint, which causes 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 (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 cells that cause 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, which causes pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

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 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 sauce for up to 4 hours.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines 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 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 components 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.

Only some 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/).