RIVAROXABAN TARBIS 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Tarbis 15 mg film-coated tablets EFG

Rivaroxaban Tarbis 20 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms 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 package leaflet. See section 4.

Contents of the package leaflet

1. What is Rivaroxaban Tarbis and what is it used for
2. What you need to know before you take Rivaroxaban Tarbis
3. How to take Rivaroxaban Tarbis
4. Possible side effects
5. Storing Rivaroxaban Tarbis
6. Package contents and further information

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

Rivaroxaban Tarbis contains the active substance rivaroxaban.

Rivaroxaban Tarbis 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 or lungs.

Rivaroxaban Tarbis 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 lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Tarbis 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 Tarbis

Do not take Rivaroxaban Tarbis

• 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 injury or bleeding in the brain or a 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 when heparin is given through a vein or artery 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 Tarbis and inform your doctorif any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Tarbis.

Be careful with Rivaroxaban Tarbis

• 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 when receiving heparin through a vein or artery to keep it from getting blocked (see section "Other medicines and Rivaroxaban Tarbis")
• bleeding disorders
• very high blood pressure that is 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 (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 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 Tarbis. 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 Tarbis before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take Rivaroxaban Tarbis 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

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

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

Other medicines and Rivaroxaban Tarbis

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 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 Tarbis, as the effect of Rivaroxaban Tarbis 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 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 Tarbis, as the effect of Rivaroxaban Tarbis 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 Tarbis if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxaban Tarbis. 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 Tarbis 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 Tarbis 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 Tarbis

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 must take Rivaroxaban Tarbis 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

• Adults

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

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

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban 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 15 mg rivaroxaban tablet once a day (or one 10 mg rivaroxaban tablet once a day if 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 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.

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 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the treatment dose 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.

• Children and adolescents

The dose of Rivaroxaban Tarbis depends on body weight and will be calculated by the 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 a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one rivaroxaban 20 mgtablet once a day.

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 the doctor, as it may be necessary to adjust the dose as the weight changes.

Never adjust the dose of Rivaroxaban Tarbis 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 rivaroxaban granule presentation for oral suspension. In children and adolescents who cannot swallow whole tablets, please use rivaroxaban granule 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 Tarbis.

When to take Rivaroxaban Tarbis

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

If you forget to take Rivaroxaban Tarbis

• 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 take more Rivaroxaban Tarbis than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban 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 stop taking Rivaroxaban Tarbis

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

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

4. Possible Adverse Effects

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

Like other similar medicines to reduce blood clot formation, Rivaroxaban Tarbis 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:

• Bleeding signs

• 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

• intensive 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 found in adults, children, and adolescents 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, 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 liquid 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

Adverse effects 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

Adverse effects 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 heart surgery where a catheter is inserted into the leg artery (pseudoaneurysm)

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 Tarbis 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 any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: 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 Tarbis

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 "CAD" or "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Shelf life after first opening of the HDPE container: 90 days

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 unused medicines in the pharmacy's SIGRE point. 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. Contents of the Rivaroxaban Tarbis packaging

Composition of Rivaroxaban Tarbis

The active substance is rivaroxaban.

Rivaroxaban Tarbis 15 mg film-coated tablets

Each tablet contains 15 mg of rivaroxaban.

Rivaroxaban Tarbis 20 mg film-coated tablets

Each tablet contains 20 mg of rivaroxaban.

The other ingredients are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (2910), sodium lauryl sulfate, magnesium stearate.

Tablet film coating: hypromellose (2910), macrogol (E1521), titanium dioxide (E 171), black iron oxide (E172), yellow iron oxide (E172).

Appearance and packaging of the product

Rivaroxaban Tarbis 15 mg film-coated tablets

Biconvex, round, film-coated tablets, gray in color, with a diameter of approximately 5.7 mm and engraved with "R22" on one side and "H" on the other side.

Rivaroxaban Tarbis 20 mg film-coated tablets

Biconvex, round, film-coated tablets, light gray in color, with a diameter of approximately 6.4 mm and engraved with "R23" on one side and "H" on the other side.

Transparent PVC/PVDC-aluminum blisters in boxes of 10, 14, 28, 42, 50, 98, and 100 film-coated tablets.

HDPE bottles with child-resistant plastic caps containing 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

Netherlands

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

Germany: Rivaroxaban Amarox 15 mg/20 mg film-coated tablets

Spain: Rivaroxaban Tarbis 15 mg/20 mg film-coated tablets EFG

Netherlands: Rivaroxaban Amarox 15 mg/20 mg filmomhulde tabletten

Date of the last revision of this leaflet:

11/23

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/