RIVAROXABAN POLPHARMA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Polpharma 10 mg 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 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 package leaflet

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after an operation you are at a higher risk of forming blood clots.
• 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 of the legs and/or lungs.

This medicine 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 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 bleeding problems
• if you have a disease or condition 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 by injection into a vein or artery to keep it open
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breast-feeding

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

Be particularly careful with Rivaroxaban Polpharma

• if you are at an increased risk of bleeding, as may be the case in the following situations:
• • moderate or 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 case of changing anticoagulant treatment or when heparin is given by injection into a vein or artery to keep it 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 oesophagus (gullet), e.g. due to gastro-oesophageal reflux disease (a disease in which stomach acid rises towards the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract
  • a problem with the blood vessels in the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are widened and filled with pus (bronchiectasis), or previous lung bleeding

• if you have an artificial heart valve
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased 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 another treatment or surgical procedure is planned 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 kept 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 anaesthesia, or pain relief):

• it is very important to take this medicine 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 bowel or bladder after the anaesthesia has finished, as urgent attention will be needed.

Children and adolescents

Rivaroxaban Polpharma 10 mg tablets are not recommended for persons under 18 years of age.There is not enough information on its 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 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 believes you are at a higher risk of developing stomach or intestinal ulcers, they may also use a preventative 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 kept under closer observation.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable method of contraception 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 breast-feeding, 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 cycle, 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, contact 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 told by your doctor.

In case of doubt, consult your doctor or pharmacist again.

How much to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg tablet of this medicine once a day.

• To treat blood clots in the veins of the legs and blood clots in the blood vessels of the lungs, and to prevent these blood clots from happening again

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Polpharma 10 mg once a day.

Swallow the tablet with water.

This medicine can be taken with or without food.

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 sauce immediately before taking it.

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

When to take Rivaroxaban Polpharma

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

Try to take the tablet at the same time every day to help you remember. Your doctor will decide how long you should take the treatment.

To prevent the formation of blood clots in the veins after hip or knee replacement surgery: Take the first tablet 6-10 hours after the operation.

If you have had major hip surgery, you will usually take the tablets for 5 weeks. If you have had major knee surgery, you will usually take the tablets for 2 weeks.

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 have missed a dose, take it as soon as you remember. Take the next tablet the next day and then continue taking one tablet once a day as normal.

Do not take a double dose to make up for forgotten doses.

If you stop taking Rivaroxaban Polpharma

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

If you have any further questions on the use of this product, 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 medicines that reduce the formation of blood clots, this medicine can cause bleeding that can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, the bleeding may not be obvious.

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

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms can 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

• intensive skin rash that spreads, 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 (may affect up to 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 oedema; 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 of the eyes)
• bleeding into tissue or a body cavity (haematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after an operation
• oozing of blood or fluid from a surgical wound
• swelling in the limbs
• pain in the limbs
• alteration of kidney function (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, feeling sick or being sick, constipation, diarrhoea
• low blood pressure (symptoms can be dizziness or fainting when standing up)
• reduced general strength and 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)
• allergic reactions, including skin allergic reactions
• alteration of 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 heart rate
• 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)
• yellowing of the skin and eyes (jaundice)
• localised swelling
• collection of blood (haematoma) in the groin, as a complication of the 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):

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

Not known(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 (anticoagulant-related nephropathy)
• increase in pressure within the muscles of the legs or arms after bleeding that causes pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 “CAD/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 puree 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 10 mg of rivaroxaban.
• The other ingredients are:

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

Tablet film coating (Opadry II Rosa 33G34170): hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide, yellow (E172), iron oxide, black (E172), and iron oxide, red (E172).

Appearance and package contents of the product

Rivaroxaban Polpharma 10 mg film-coated tablets are pink, round, biconvex, and have “10” engraved on one side.

They are available in blisters, in cartons containing 5, 10, 28, 30, or 98 film-coated tablets.

Not all pack sizes may be marketed.

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/)