RIVAROXABAN TECNIGEN 15 mg FILM-COATED TABLETS

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

Rivaroxaban TecniGen contains the active substance rivaroxaban.

Rivaroxaban 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 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 initial treatment for at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban 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 TecniGen

Do not take Rivaroxaban TecniGen

• 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 recent surgery in the brain or eyes),
• 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 drip into 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 breast-feeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking rivaroxaban.

Be particularly careful with Rivaroxaban TecniGen

• 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 from one anticoagulant treatment to another or when receiving heparin through a drip into a vein or artery to keep it from getting blocked (see section “Other medicines and Rivaroxaban TecniGen”).
  • 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 oesophagus (gullet), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the oesophagus) or tumours in the stomach, intestines, genital or urinary tract.
  • a problem in the blood vessels in the back of your eyes (retinopathy).
  • a lung disease in which the bronchi are widened 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 so that they can decide whether it may be necessary to change your 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 any of these situations apply to youbefore taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

If you need to have surgery

• It is very important to take rivaroxaban before and after surgery, exactly at the times your doctor has indicated.
• If your operation requires the insertion of a catheter or injection into your spine (e.g. for epidural or spinal anaesthesia, or pain relief):
• • It is very important to take rivaroxaban 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 with your bowel or bladder after the anaesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban tablets are not recommended in children with a body weight below 30 kg. There is not enough information about the use of rivaroxaban in children and adolescents for the same indications as in adults.

Other medicines and Rivaroxaban TecniGen

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.
  • tablets containing 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 medicines and painkillers (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, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

If your doctor considers that you are at higher risk of developing a stomach or intestinal ulcer, they may recommend that you also take a medicine to prevent this.

• 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, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take rivaroxaban if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. 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 (a common side effect) or fainting (an uncommon side effect) (see section 4 “Possible side effects”). You should not drive, cycle or use tools or machines if you are affected by these symptoms.

Rivaroxaban TecniGen contains lactose

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

Rivaroxaban TecniGen 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 TecniGen

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You should take rivaroxaban with food. Swallow the tablets with water, preferably with food.

If you have difficulty swallowing the tablet whole, talk to 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 give you 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 of the body

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 have 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 to one 10 mg rivaroxaban tablet once a day 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 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 your 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 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 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 about 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 TecniGenon 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 rivaroxaban granules for oral suspension. In children and adolescents who cannot swallow whole tablets, 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 give you the crushed rivaroxaban tablet through a gastric tube.

If you spit up 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 up the dose or vomit repeatedly after taking rivaroxaban.

When to take Rivaroxaban TecniGen

Take the tablets every day, until your doctor tells you to stop.

Try to take the tablets at the same time every day to help you remember when to take them. Your doctor will decide how long you should keep taking the treatment.

To prevent blood clots in the brain (stroke) or in other blood vessels: If it is necessary to restore a normal heartbeat through a procedure called cardioversion, take rivaroxaban at the times your doctor has indicated.

If you forget to take Rivaroxaban TecniGen

• Adults, children and adolescents:

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

• Adults:

If you are taking one 15 mg tablet twicea 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 take more Rivaroxaban TecniGen 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you stop taking Rivaroxaban TecniGen

Do not stop taking rivaroxaban without first talking to your doctor, because rivaroxaban 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 can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, rivaroxaban can cause bleeding, which 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 experience any of the following adverse effects:

• 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 in the neck. 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

Your doctor will decide to keep you under closer observation or modify 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

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, 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 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 cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

Frequency not known(cannot be estimated from available data)

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

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 does not appear in this prospectus. You can also report it directly through the Spanish Medicines and Health Products Agency: 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 TecniGen

Keep this medicine out of 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. It does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple puree 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 at the SIGRE point in the pharmacy. 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 TecniGen

• The active ingredient is rivaroxaban.

Rivaroxaban TecniGen15 mg film-coated tablets EFG:Each film-coated tablet contains 15 mg of rivaroxaban.

Rivaroxaban TecniGen20 mg film-coated tablets EFG:Each film-coated tablet contains 20 mg of rivaroxaban.

• The other components (excipients) are:

Rivaroxaban TecniGen15 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, cornstarch.

Coating material: macrogol, hypromellose, lactose monohydrate, titanium dioxide (E-171), red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172).

Rivaroxaban TecniGen20 mg film-coated tablets EFG:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate, calcium silicate, cornstarch.

Coating material: macrogol, hypromellose, lactose monohydrate, titanium dioxide (E-171), red iron oxide (E-172).

Appearance of the product and package contents

Rivaroxaban TecniGen15 mg film-coated tablets EFG:are dark pink, round, and biconvex, 5.0 mm in diameter.

Available in packages of 28 or 42 film-coated tablets.

Rivaroxaban TecniGen 20 mg film-coated tablets EFG:are reddish-brown, round, and biconvex, 6.0 mm in diameter.

Available in packages of 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Date of the last revision of this prospectus: January 2023

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/