RIVAROXABAN POLPHARMA 15 mg + 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Polpharma 15 mg + 20 mg film-coated tablets EFG

Initial Treatment Pack

Not suitable for children

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, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

This medicine contains the active substance rivaroxaban and is used in adults to:

• 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 occurring again in the blood vessels of the legs and/or lungs.

This medicine 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 taking Rivaroxaban Polpharma

Do not take Rivaroxaban Polpharma

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6).
• if you have excessive bleeding
• if you have a condition or disease of an organ in your body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given intravenously or arterially to keep the blood vessel open
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Rivaroxaban Polpharma and tell your doctorif any of these cases apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Be particularly careful with Rivaroxaban Polpharma

• if you are at increased risk of bleeding, as may be the case in the following situations:
• • severe kidney disease, as your kidney function may affect the amount of medicine that works in your body
  • if you are taking medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), in the case of changing anticoagulant treatment or when heparin is given intravenously or arterially to keep the blood vessel open (see section "Other medicines and Rivaroxaban Polpharma")
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines or stomach, or inflammation of the esophagus (throat), e.g., due to gastroesophageal reflux disease (a disease in which stomach acid rises towards the esophagus) or tumors located in the stomach, intestines, genital tract, or urinary tract
  • a problem with the blood vessels in the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are enlarged and filled with pus (bronchiectasis), or previous lung bleeding

• if you have a prosthetic heart valve
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide whether it is necessary to change the treatment
• if your doctor determines that your blood pressure is unstable or if you are scheduled for another treatment or surgical procedure to remove the blood clot from your lungs.

If any of these cases apply to you, tell your doctorbefore taking this medicine. Your doctor will decide whether you should be treated with this medicine and whether you should be under closer observation.

If you need to have surgery:

• it is very important to take this medicine before and after the operation, exactly at the time your doctor has indicated.
• If your operation involves the use of a catheter or injection into your spinal column (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 time your doctor has indicated
• tell your doctor immediately if you feel numbness or weakness in your legs, or problems with your intestines or bladder after the anesthesia, as urgent attention will be needed.

Children and adolescents

The initial treatment pack with Rivaroxaban Polpharma is not recommended for persons under 18 years of ageas it is specifically designed for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

Use of Rivaroxaban Polpharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take

• If you are taking:
• • some medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
  • ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
  • certain medicines for bacterial infections (e.g., clarithromycin, erythromycin)
  • certain antiviral medicines for HIV/AIDS (e.g., ritonavir)
  • other medicines to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin and acenocoumarol)
  • anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid)
  • dronedarone, a medicine to treat abnormal heart rhythms
  • some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of these cases apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may increase. Your doctor will decide whether you should be treated with this medicine and whether you should be under closer observation.

If your doctor believes you are at higher risk of developing stomach or intestinal ulcers, they may also use a preventive treatment for ulcers.

• If you are taking:
• • certain medicines for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hypericum perforatum), a herbal product used for depression
  • rifampicin, an antibiotic

If any of these cases apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with Rivaroxaban Polpharma and whether you should be under closer observation.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If you could become pregnant, use an effective method of birth control while taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately, and they will decide how you should be treated.

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

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'). Do not drive or ride a bicycle, or use any tools or machines if you are affected by these symptoms.

This medicine 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 23 mg of sodium (1 mmol) per tablet; this is essentially 'sodium-free'.

3. How to take Rivaroxaban Polpharma

Follow the instructions for administration of this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist again.

Take Rivaroxaban Polpharma with food.

Swallow the tablet preferably with water.

If you have difficulty swallowing a whole tablet, talk to your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or apple puree immediately before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may also administer a crushed tablet of this medicine through a gastric tube.

How much to take

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

This initial treatment pack with Rivaroxaban Polpharma 15 mg and 20 mg is only for the first 4 weeks of treatment. After completing this pack, treatment will continue with Rivaroxaban Polpharma 20 mg once a day, as your doctor has indicated.

If you have kidney problems, your doctor may decide to reduce the dose for treatment after 3 weeks to one 15 mg tablet of Rivaroxaban Polpharma once a day, if the risk of bleeding is higher than the risk of having another blood clot.

When to take Rivaroxaban Polpharma

Take the tablet(s) every day until your doctor tells you to stop.

Try to take the tablet(s) at the same time every day to help you remember. Your doctor will decide how long you should be treated.

If you take more Rivaroxaban Polpharma than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much of this medicine increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rivaroxaban Polpharma

• 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 may take two 15 mg tablets at the same time to get 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 are taking one 20 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 the missed dose. Take the next tablet the next day and then continue taking one tablet once a day.

If you stop taking Rivaroxaban Polpharma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, this medicine can cause bleeding that can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following side effects:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck.

A serious medical emergency. Seek immediate medical attention)

• prolonged or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina.

Your doctor may decide to keep you under closer observation or change the treatment.

• Signs of severe skin reaction

• widespread severe skin rash, blisters, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• A drug reaction that causes skin rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome).

This side effect is very rare (less than 1 in 10,000 people).

• Signs of severe allergic reaction

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

These side effects 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 side effects:

Common(may affect up to 1 in 10 people):

• reduction in the number of red blood cells that can cause pale skin and weakness or shortness of breath
• bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding in the gums
• bleeding in the eye (including bleeding in the white part of the eyes)
• bleeding into tissue or a body cavity (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 in the limbs
• pain in the limbs
• changes in kidney function (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling sick or being sick, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, tiredness), headache, dizziness
• rash, skin irritation
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people):

• bleeding in the brain or within the skull (see above, signs of bleeding)
• bleeding into a joint that causes pain and swelling
• thrombocytopenia (low platelet count, which are cells that help blood to clot)
• allergic reactions, including skin allergic reactions
• changes in liver function (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 people):

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis including hepatocellular injury (inflamed liver, including liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• collection of blood (hematoma) in the groin, as a complication of a cardiac procedure in which a catheter is inserted into the artery of the leg (pseudoaneurysm)

Very rare(may affect up to 1 in 10,000 people):

• accumulation of eosinophils, a type of white blood cell that causes inflammation in the lung (eosinophilic pneumonia)

Unknown(frequency cannot be estimated from the available data):

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy)
• increase in pressure within the muscles of the legs or arms after a hemorrhage that causes pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after a hemorrhage)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Polpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”. The expiry date is the last day of the month indicated.

This medicine does not require any 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. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofRivaroxaban Polpharma

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.
• The other ingredients are:

Tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. See section 2 “This medicine contains lactose and sodium”.

Coating of Rivaroxaban Polpharma 15 mg (Opadry II Pink 33G240024): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide, red (E172), iron oxide, black (E172).

Coating of Rivaroxaban Polpharma 20 mg (Opadry II Red 33G250007): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide, red (E172), iron oxide, yellow (E172).

Appearance and package contents of the product

Rivaroxaban Polpharma 15 mg film-coated tablets are pink, round, biconvex, and have “15” engraved on one side.

Rivaroxaban Polpharma 20 mg film-coated tablets are reddish-brown, round, biconvex, and have “20” engraved on one side.

The starter pack for the first 4 weeks of treatment: each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:

42 film-coated tablets of rivaroxaban 15 mg and 7 film-coated tablets of rivaroxaban 20 mg.

Marketing authorisation holder andmanufacturer

Marketing authorisation holder

Zaklady Farmaceutyczne POLPHARMA S.A.

ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland

Manufacturer

FARMAPROJECTS S.A.U.

Parc Cientific de Barcelona

C/ Baldiri Reixac, 4/12 i 15

08028 Barcelona, Spain

Date of last revision of this leaflet:November 2023

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/)