RIVAROXABAN HEC PHARM 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban HEC Pharm 15 mg film-coated tablets EFG

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

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

Rivaroxaban HEC 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 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 blood vessels of the legs and/or lungs.

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

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

Do not take Rivaroxaban HEC

• 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 lesion in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to this medicine or when being treated with heparin through a venous or arterial catheter 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 and inform your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Be particularly careful with Rivaroxaban HEC

• if you have an increased risk of bleeding, such as in the following situations:

• severe kidney problems, as kidney function can affect the amount of medicine that works in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to keep it from getting blocked (see section “Other medicines and Rivaroxaban HEC”)
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• diseases of the stomach or intestines that can cause bleeding, such as inflammation of the stomach or intestines, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus)
• a problem in the blood vessels of the back of the eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous lung hemorrhage

• if you have a heart valve prosthesis
• 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 situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medicine and if 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 the spinal column (e.g. for epidural or spinal anesthesia, 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 in your intestines or bladder at the end of anesthesia, as urgent attention is needed.

Children and adolescents

This medicine is not recommended for persons under 18 years. There is not enough information about its use in children and adolescents.

Other medicines and Rivaroxaban HEC

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), unless it is only applied to the skin
• tablets with 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 and pain-relieving medicines (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 this medicine, as the effect of rivaroxaban 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 stomach or intestinal ulcers, he will recommend that you use a preventive treatment for ulcers.

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

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. 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

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). You should not drive or use machines if you are affected by these symptoms.

Rivaroxaban HEC 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 HEC

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

What dose to take

• 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 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 to 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 dose of the treatment 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.

Take each dose of rivaroxaban preferably with water during a meal.

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.

When to take Rivaroxaban HEC

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 keep 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 rivaroxaban at the times your doctor has indicated.

If you take more Rivaroxaban HEC than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

If you forget to take Rivaroxaban HEC

• 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 each day.

• 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 stop taking Rivaroxaban HEC

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

Like other similar medicines (antithrombotic agents), 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. Possible secondary effects that may be a sign of hemorrhage.

Possible Adverse Effects that May be Signs of Bleeding:

Inform your doctor immediatelyif you experience skin reactions such as:

• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, as they may be signs of bleeding.

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

Possible Adverse Effects that May be Signs of Severe Skin Reaction:

Inform your doctor immediatelyif you experience any of the following side effects:

• 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 patients).

Possible Adverse Effects that May be Signs of Severe Skin Reaction:

Inform your doctor immediatelyif you suffer from any of the following adverse effects:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequencies of these adverse effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 patients) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 patients).

General List of Possible Adverse Effects:

Frequent(may affect up to 1 in 10 patients)

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

• bleeding in the brain or inside the skull
• bleeding in a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clot)
• 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 cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

Frequency Not Known(frequency 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)

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 prospectus. 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 HEC

Keep this medicine out of 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.

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 SIGRE point in the pharmacy. 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. Package Contents and Additional Information

Composition ofRivaroxaban HEC

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, and magnesium stearate. See section 2 "Rivaroxaban HEC contains lactose and sodium"

Coating of the tablet:

Rivaroxaban 15 mg film-coated tablets EFG: poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Rivaroxaban 20 mg film-coated tablets EFG: poly(vinyl alcohol), macrogol, titanium dioxide (E171), and talc.

Appearance of Rivaroxaban HEC and Package Contents

Rivaroxaban HEC Pharm 15 mg film-coated tablets (5 mm in diameter) are round, yellow or light yellow film-coated tablets, with the inscription "L31" on one side and blank on the other.

Rivaroxaban HEC Pharm 20 mg film-coated tablets (6 mm in diameter) are round, white or off-white film-coated tablets, with the inscription "L85" on one side and blank on the other.

15 mg: They are packaged in blisters, in blister packs of 14, 28, 42, or 98 film-coated tablets.

20 mg: They are packaged in blisters, in blister packs of 28 or 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17,

10963 Berlin,

Germany

Manufacturer

Formula Pharmazeutische And Chemische Entnicklungs GmbH

Goerzalle 305 b

Lichterfelde, D-14167 Berlin

Germany

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

Date of Last Revision of this Prospectus:February 2022.

Other Sources of Information

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/