RIVAROXABAN HUAHAI 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Huahai 15mg film-coated tablets EFG

Rivaroxaban Huahai 20mg film-coated tablets EFG

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

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

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

This medicine contains the active substance rivaroxaban and 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 Huahai 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 of 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 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 Huahai

Do not take Rivaroxaban

• 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 to this medicine 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 and inform your doctorif any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban.

Be careful with Rivaroxaban

• if you have an increased risk of bleeding, as may happen 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 Huahai")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, or inflammation of the esophagus (e.g. due to gastroesophageal reflux disease)
• 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 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 treatment needs to be changed
• 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 doctorif you have any of these conditionsbefore 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 surgery:

• It is very important to take rivaroxaban before and after surgery, exactly at the times your doctor tells you.
• 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 after anesthesia, as urgent attention is needed.

Children and adolescents

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

There is not enough information about the use of rivaroxaban 15mg/20mg in children and adolescents for the indications in adults.

Other medicines and Rivaroxaban Huahai

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

? 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 the treatment of irregular heartbeat

? some 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, 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 thinks you are at increased risk of stomach or intestinal ulcers, they may recommend that you also take a medicine to prevent 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 these conditions apply to you, tell your doctorbefore taking rivaroxaban, 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 (common side effect) or fainting (uncommon side effect) (see section 4, "Possible side effects"). You should not drive or use machines if you are affected by these symptoms.

Rivaroxaban Huahai 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 Huahai

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

You must take rivaroxaban with food.

Swallow the tablets, preferably with water.

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 puree, immediately before taking it. Then take food.

If necessary, your doctor may also give you the crushed tablet through a gastric tube.

• Adults

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

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

If you have kidney problems, the dose may be reduced to one rivaroxaban 15 mg 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 rivaroxaban 15 mg tablet once a day (or to one rivaroxaban 10 mg tablet once a day if your kidneys do not work properly) in addition to an antiplatelet medicine such as clopidogrel.

• To treatblood clots in the veins of the legs and in the blood vessels of the lungs, and to preventthese blood clots from happening again:

The recommended dose is one rivaroxaban 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one rivaroxaban 20 mg tablet once a day.

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

If you have kidney problems and are taking one rivaroxaban 20 mg tablet once a day, your doctor may decide to reduce your treatment dose to one rivaroxaban 15 mg 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 mg tablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one rivaroxaban 20 mg tablet 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: watch the child to make sure 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 the dose may need to be adjusted as the 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 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 granules for oral suspension.

If the oral suspension is not available, you can crush the rivaroxaban tablet and mix it with water or apple puree 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 Huahai

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

Try to take a tablet at the same time every day, to help you remember.

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 you need to have a procedure to restore a normal heartbeat, called cardioversion, take rivaroxaban at the times your doctor has indicated.

If you forget to take Rivaroxaban Huahai

• Adults, children, and adolescents:

• If you are taking one 20 mg or one 15 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 then continue taking one tablet each day.

• Adults:

• 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 take more Rivaroxaban Huahai 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 Huahai

Do not stop taking rivaroxaban without talking to your doctor first, because rivaroxaban prevents the development of a serious condition.

If you have any further questions on the use of this medicine, 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, rivaroxaban can cause bleeding, which 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.

Tell your doctor immediately if you or your child suffer from 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. 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 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.

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

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 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 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 cell that causes inflammation in the lung (eosinophilic pneumonia).

Frequency not known(cannot be estimated from the 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 (hemorrhagic compartment syndrome)

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 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 Huahai

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

Rivaroxaban Huahai 15 mg:

This medicine does not require special storage conditions.

Rivaroxaban Huahai 20 mg:

Blister: Do not store above 25°C

Bottle: This medicine does not require special storage conditions.

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 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 Huahai

• The active ingredient is rivaroxaban.

Rivaroxaban Huahai 15 mg: each tablet contains 15 mg of rivaroxaban.

Rivaroxaban Huahai 20 mg: each tablet contains 20 mg of rivaroxaban.

• The other ingredients are:
• Core of the tablet: sodium lauryl sulfate, sodium croscarmellose, hypromellose, microcrystalline cellulose, lactose monohydrate, magnesium stearate.
• Coating:

-Rivaroxaban Huahai 15 mg: partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E 171), macrogol, talc, red iron oxide (E 172).

-Rivaroxaban Huahai 20 mg: partially hydrolyzed poly(vinyl alcohol), red iron oxide (E 172), talc, macrogol, yellow iron oxide (E 172), titanium dioxide (E 171), lecithin, black iron oxide (E 172).

Appearance of the product and package contents

-Rivaroxaban Huahai 15 mg: film-coated tablets, pink, round, and biconvex, engraved with "056" on one side and "S" on the other side.

They are packaged

• in blisters, in boxes of 10, 30, or 100 film-coated tablets, or
• in bottles containing 500 film-coated tablets.

-Rivaroxaban Huahai 20 mg: film-coated tablets, dark red, triangular, engraved with "057" on one side and "S" on the other side.

They are packaged

• in blisters, in boxes of 10, 30, or 100 film-coated tablets, or
• in bottles containing 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Huahai Pharma Europe GmbH

Werner-Eckert, Strasse 4

81829 Munich

Germany

Manufacturer

L-A-W Services GmbH

Leipziger Arzneimittelwerk

Elisabeth-Schumacher-Str. 54/56

04328 Leipzig

Germany

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

Germany: Rivaroxaban Huahai 15 mg/20 mg Filmtabletten

Belgium: Rivaroxaban Huahai 15 mg/20 mg filmomhulde tabletten

Spain: Rivaroxabán Huahai 15 mg/20 mg comprimidos recubiertos con película EFG

France: Rivaroxaban Huahai 15 mg/20 mg comprimé pelliculé

Italy: Rivaroxaban Huahai 15 mg/20 mg compressa rivestite con film

Netherlands: Rivaroxaban Huahai 15 mg/20 mg filmomhulde tabletten

Date of the last revision of this leaflet:04/2025

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/