RIVAROXABAN BIOPHARM 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban Biopharm 15 mg Film-Coated Tablets EFG

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

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

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

Do not take Rivaroxaban Biopharm

• 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 injury, 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 heparin is given through a vein or artery to keep it open
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Biopharm and inform your doctorif any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting Rivaroxaban Biopharm.

Be careful with Rivaroxaban Biopharm

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

• severe kidney disease, as your kidney function may affect the amount of the 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 switching to this medicine or when heparin is given through a vein or artery to keep it open (see section “Other medicines and Rivaroxaban Biopharm”)
• bleeding disorders
• uncontrolled high blood pressure
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach, or inflammation of the esophagus (e.g. due to gastroesophageal reflux disease)
• a problem with the blood vessels in the back of the eyes (retinopathy)

• a lung disease where the airways 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 increases the risk of blood clots), tell your doctor who will decide if 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.

Tell your doctor if you have any of these situationsbefore taking Rivaroxaban Biopharm. 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 Biopharm before and after the operation, 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 Biopharm 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 the legs or problems with the intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban is not recommended in children and adolescents under 18 years of age.There is not enough information about its use in children and adolescents.

Other medicines and Rivaroxaban Biopharm

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. ketoconazole, itraconazole, voriconazole, posaconazole), except if 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)
• 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
• 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 Biopharm, as the effect of Rivaroxaban Biopharm 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 a stomach or intestinal ulcer, they may recommend that you also take a preventive treatment.

• 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 Biopharm may be reduced. Your doctor will decide if you should be treated with Rivaroxaban Biopharm and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If you could become pregnant, use a reliable contraceptive while taking Rivaroxaban Biopharm. 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 Biopharm may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, “Possible side effects”). Do not drive or use machines if you are affected by these symptoms.

Rivaroxaban Biopharm 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 (23 mg of sodium) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Rivaroxaban Biopharm

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask 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:

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

If you have kidney problems, the dose may be reduced to one 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 15 mg tablet of Rivaroxaban once a day (or one 10 mg tablet of Rivaroxaban 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 tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet once a day.

If you have kidney problems and are taking one 20 mg tablet of Rivaroxaban once a day, your doctor may decide to reduce the dose of the treatment to one 15 mg tablet once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

Swallow the tablets, preferably with water.

Take Rivaroxaban Biopharm with food.

If you have difficulty swallowing the whole tablet, ask your doctor about other ways to take Rivaroxaban Biopharm. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may also administer the crushed Rivaroxaban tablet through a gastric tube.

When to take Rivaroxaban Biopharm

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.

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 Biopharm than you should

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

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

If you forget to take Rivaroxaban Biopharm

• If you are taking one 20 mg tablet 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 every day.

• 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 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 stop taking Rivaroxaban Biopharm

.

Do not stop taking Rivaroxaban Biopharm without talking to your doctor first, as Rivaroxaban Biopharm 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, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines (antithrombotics), Rivaroxaban Biopharm may cause bleeding that 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 Adverse Effects that May be Signs of Bleeding:

Inform your doctor immediatelyif you experience any of the following symptoms:

• 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 change your treatment.

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

Inform your doctor immediatelyif you experience skin reactions such as:

• 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). The frequency of this adverse effect is very rare (less than 1 in 10,000).
• a pharmacological reaction that causes skin rash, fever, inflammation of internal organs, hematological abnormalities, and systemic diseases (Dress Syndrome). This adverse effect is very rare (up to 1 in 10,000).

Possible Adverse Effects that May be Signs of Severe Allergic Reactions

Tell your doctor immediatelyif you experience 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. These adverse effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and rare (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 patients):

• - decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal hemorrhage, 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)
• bloody cough
• 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 analyzes 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, skin itching

-

• blood tests may show an increase in some liver enzymes

Rare(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, which are cells that help blood clot)
• allergic reaction, including skin allergic reaction

alteration of liver function (may be seen in analyzes 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

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

• bleeding in a muscle
• cholestasis (decrease in bile flow), hepatitis including hepatocellular injury (inflamed liver, including liver damage).

• localized swelling
• yellowing of the skin and eyes (jaundice)
• 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.
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensitivity, numbness, or paralysis (compartment syndrome after bleeding)

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 is 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 Biopharm

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" 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 thrown away through 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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban Biopharm

The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban, respectively.

The other components are:

Core of the tablet:

Hypromellose (E464)

Sodium lauryl sulfate

Microcrystalline cellulose (E460)

Lactose monohydrate

Croscarmellose sodium

Magnesium stearate

Coating:

Macrogol 3350

Hypromellose (E464)

Titanium dioxide (E171)

Red iron oxide (E172).

Appearance of the Product and Package Contents

Coated tablet.

Rivaroxaban Biopharm 15 mg: Red, round, biconvex, film-coated tablets with "15" engraved on one side and flat on the other side.

Package with 10, 14, 28, 42, 98, or 100 film-coated tablets

Rivaroxaban Biopharm 20 mg: Brown-red, round, biconvex, film-coated tablets with "20" engraved on one side and flat on the other side.

Package with 10, 14, 28, 98, or 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Biopharm LTD

5A Triaditza Str.,

Sofia 1000

Bulgaria

Manufacturer

Genepharm S.A.

18 km Marathonos Avenue,

153 51 Pallini Attiki

Greece

Pharmadox Healthcare Ltd.

KW2OA Kordin Industrial Park,

Paola PLA3000,

Malta

This medicine is authorized in the EEA Member States with the following names:

Portugal Rivaroxaban Biopharm

Date of the Last Revision of this Leaflet: April 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/