RIVAROXABAN TAD 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban TAD 15 mg film-coated tablets EFG

Rivaroxaban TAD 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 TAD and what is it used for
2. What you need to know before you take Rivaroxaban TAD
3. How to take Rivaroxaban TAD
4. Possible side effects
5. Storing Rivaroxaban TAD
6. Contents of the pack and other information

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

Rivaroxaban TAD contains the active substance rivaroxaban. It 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 heartbeat 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 TAD 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 medications used to treat blood clots.

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reduces the tendency of the blood to form clots.

2. What you need to know before you take Rivaroxaban TAD

Do not take Rivaroxaban TAD:

• 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 lesions in the brain 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 from one anticoagulant treatment to another or while being administered heparin 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 breast-feeding

Do not take this medicine and inform your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be careful with Rivaroxaban TAD

• if you have an increased risk of bleeding, such as 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 to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban TAD")
  • bleeding disorders
  • uncontrolled high blood pressure
  • 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 located 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 (a disorder of the immune system that increases the risk of blood clots), 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.

Tell your doctor if you have any of these conditionsbefore taking this medicine. 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 this medicine 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 spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take this medicine, 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 with your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

This medicine is not recommended in children with a body weight below 30 kg.There is not enough information on its use in children and adolescents.

Other medicines and this medicine

Tell your doctor or pharmacist if you are using, have recently used or might use 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), except if 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 or pain relievers (e.g. naproxen or acetylsalicylic acid)
  • dronedarone, a medicine for treating irregular heartbeat
  • certain medicines for treating 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 this medicine, as the effect of this medicine 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 take a preventive treatment.

• If you are taking
  • any medicine for treating epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal medicine for treating depression
  • rifampicin, an antibiotic.

If any of the above applies to you, tell your doctorbefore taking rivaroxaban, as the effect of this medicine 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breast-feeding, do not take this medicine. 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

This medicine may cause dizziness (common 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.

Rivaroxaban TAD contains sodium

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

3. How to take Rivaroxaban TAD

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

You should take this medicine with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it. If necessary, your doctor may also administer the crushed rivaroxaban 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:

The recommended dose is one 20 mg tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg tablet once daily.

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 15 mg rivaroxaban tablet once daily (or to one 10 mg rivaroxaban tablet once daily if your kidneys do not work properly) in addition to an antiplatelet medicine 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 15 mg tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet once daily.

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

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce the dose of treatment to one 15 mg tablet once daily 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 depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one rivaroxaban 15 mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one rivaroxaban 20 mgtablet once daily.

Take each dose of rivaroxaban 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 is based on body weight, it is important to attend scheduled visits with your doctor, as it may be necessary to adjust the dose as weight changes.

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

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

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

If the oral suspension is not available, you can crush the rivaroxaban 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 tablet through a gastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban TAD

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 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 this medicine at the times indicated by your doctor.

If you forget to take Rivaroxaban TAD

• Adults, children and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncedaily, 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 then continue taking one tablet every day.

• Adults:

If you are taking one 15 mg tablet twicedaily, 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 daily.

If you take more Rivaroxaban TAD than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much medicine 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 stop taking Rivaroxaban TAD

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, this medicine 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.

Tell your doctor immediately if you or your child 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 of the neck. 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.

Your doctor will decide whether to keep you under closer observation or change your treatment.

Signs of severe skin reaction

• 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 reaction

• 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 in adults, children, and adolescents

Frequent(may affect up to 1 in 10 patients)

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

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding in a joint that 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 patients)

• 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 as a complication after 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 granulocytic white blood cells that cause 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 malfunction (anticoagulant-related nephropathy)
• increase in pressure in the muscles of the legs or arms after bleeding, which causes 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 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 of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rivaroxaban TAD

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.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 TAD

• The active ingredient is rivaroxaban.

15 mg: Each film-coated tablet contains 15 mg of rivaroxaban.

20 mg: Each film-coated tablet contains 20 mg of rivaroxaban.

• The other ingredients (excipients) are mannitol, microcrystalline cellulose, macrogol, poloxamer, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, and sodium stearyl fumarate in the core, and hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172) - only for the 15 mg film-coated tablets. See section 2 "Rivaroxaban TAD contains sodium".

Appearance of the product and package contents

15 mg:Film-coated tablets, orange-red to orange-brown in color, round, slightly biconvex, engraved with the mark "15" on one face of the tablet.

Dimensions: diameter of approximately 6.5 mm.

20 mg:Film-coated tablets, pink to dark pink in color, round, slightly biconvex, engraved with the mark "20" on one face of the tablet.

Dimensions: diameter of approximately 7 mm.

Rivaroxaban TAD is available in packs containing:

Non-perforated blister: 100 film-coated tablets.

Perforated unit-dose blister: 100 x 1 film-coated tablets.

Non-perforated calendar blister: 14, 28, and 42 film-coated tablets.

The patient alert card is included in each pack of this medicine.

Only certain pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

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

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of last revision of this leaflet:February 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/