Rivaroxaban Krka 15 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Krka 15 mg film-coated tablets EFG

Rivaroxaban Krka 20 mg film-coated tablets EFG

Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Rivaroxaban Krka contains the active substance rivaroxaban and is used in adults for:

• preventing 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 known as non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring in the blood vessels of the legs and/or lungs.

Rivaroxaban is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more for:

• treating blood clots and preventing the recurrence of these blood clots in the veins or in the blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

2. What you need to know before starting Rivaroxaban Krka

Do not take Rivaroxaban Krka:

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6)

• if you are bleeding excessively

• if you have a disease or condition affecting an organ in your body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes)

• if you are taking medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching between anticoagulant treatments or while receiving heparin through a venous or arterial catheter to prevent blockage.

• if you have liver disease that increases the risk of bleeding

• if you are pregnant or breastfeeding

Do not take this medicine and inform your doctor if any of these situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Take special care with Rivaroxaban Krka

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

  • severe renal impairment in adults, or moderate to severe renal impairment in children and adolescents, since kidney function may affect the amount of medicine active in your 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 while receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban Krka")
  • bleeding disorders
  • very high blood pressure that is not controlled by medical treatment
  • stomach or intestinal diseases that could cause bleeding, such as intestinal or gastric inflammation, oesophageal inflammation (e.g., due to gastro-oesophageal reflux disease (a condition in which stomach acid rises up into the oesophagus), or tumours located in the stomach, intestines, genital tract, or urinary tract
  • a problem with the blood vessels at the back of your eyes (retinopathy)
  • a lung disease in which the bronchi are widened and filled with pus (bronchiectasis), or previous lung bleeding

• if you have a heart valve prosthesis

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be needed.

• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo a procedure to remove a blood clot from your lungs.

Inform your doctor if any of these situations apply to you before taking this medicine. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery

• It is very important to take this medicine before and after surgery exactly at the times your doctor tells you.

• If your surgery requires placement of a catheter or injection into your spine (e.g., for epidural or spinal anaesthesia, or pain relief):

• It is very important to take this medicine before and after the injection or removal of the catheter exactly at the times your doctor has instructed.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical attention is required.

Children and adolescents

This medicine is not recommended for children weighing less than 30 kg. There is insufficient information on its use in children and adolescents.

Other medicines and Rivaroxaban Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

-If you are taking

• a medicine for fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)
• a medicine for bacterial infections (e.g., clarithromycin, erythromycin)
• 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 or acenocoumarol)
• anti-inflammatory medicines and pain relievers (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat irregular heartbeat
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If any of the above apply to you, inform your doctor before 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 need closer monitoring. If your doctor considers you at higher risk of developing a stomach or intestinal ulcer, they may recommend preventive treatment.

-If you are taking

• a medicine for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St John's wort (Hypericum perforatum), a herbal remedy used to treat depression
• rifampicin, an antibiotic

If any of the above apply to you, inform your doctor before taking rivaroxaban, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

If you are pregnant or breastfeeding, do not take this medicine. If there is any chance you could become pregnant, use a reliable method of contraception while taking this medicine. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on appropriate treatment.

Driving and using machines

This medicine may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect) (see section 4 "Possible side effects"). You should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rivaroxaban Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Rivaroxaban Krka

Follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again.

You should take this medicine with food.

Swallow the tablets whole, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking this medicine. The tablet may be crushed and mixed with water or apple purée immediately before administration. Immediately afterwards, take food.

If necessary, your doctor may also administer crushed rivaroxaban tablets through a gastric tube.

What dose to take

• Adults

• To prevent blood clots in the brain (stroke) or in other blood vessels of the body
  The recommended dose is one 20 mg tablet once daily.
  If you have kidney problems, the dose may be reduced to one 15 mg tablet once daily.
  If you require a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting reducing the dose to one Rivaroxaban Krka 15 mg tablet once daily (or one Rivaroxaban Krka 10 mg tablet once daily if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the leg veins and in the blood vessels of the lungs, and to prevent blood clots from recurring
  The recommended dose is one 15 mg tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet once daily.
  After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily.
  If you have kidney problems and are taking one 20 mg Rivaroxaban Krka tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg tablet once daily after 3 weeks, if the risk of bleeding is higher than the risk of developing another blood clot.

• Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one rivaroxaban 15 mg tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one rivaroxaban 20 mg tablet once daily.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to help you remember.

For parents or caregivers: observe the child to ensure they take the full dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled doctor visits, as the dose may need to be adjusted as body weight changes.

Never adjust the dose of rivaroxaban on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, please use the alternative formulation of rivaroxaban granules for oral suspension.

For children and adolescents who cannot swallow the tablets whole, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, the rivaroxaban tablet may be crushed and mixed with water or apple purée immediately before administration. After taking this mixture, eat some food. If necessary, your doctor may also administer crushed rivaroxaban tablets through a tube inserted into the stomach.

If you spit out the dose or vomit

• Less than 30 minutes after taking rivaroxaban, take a new dose.
• More than 30 minutes after taking rivaroxaban, do not take a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Call your doctor if you repeatedly spit out or vomit the dose after taking rivaroxaban.

When to take Rivaroxaban Krka

Take the tablets every day until your doctor tells you otherwise.

Try to take the tablets at the same time each day to help you remember.

Your doctor will decide how long you should continue treatment.

To prevent blood clots in the brain (stroke) or in other blood vessels: If it becomes necessary to normalize your heart rhythm using a procedure called cardioversion, take this medicine at the times your doctor has instructed.

If you forget to take Rivaroxaban Krka

• Adults, children and adolescents

If you are taking one 20 mg tablet or one 15 mg tablet once daily, and you miss a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day, and then continue taking one tablet daily.

• Adults

If you are taking one 15 mg tablet twice daily, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you miss a dose, you may take two 15 mg tablets at once, for a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Krka than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. Taking too much medicine increases the risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Rivaroxaban Krka

Do not stop treatment with this medicine without first consulting your doctor, 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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 neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina.

Your doctor will decide whether to keep you under closer monitoring or change your treatment.

Signs of serious skin reactions

• severe skin rashes that spread, blisters, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; difficulty breathing; sudden drop in blood pressure.
• The frequencies of serious 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 in adults, children, and adolescents

Frequent (may affect up to 1 in 10 patients)

• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• bleeding from the stomach or intestines, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into body tissue or cavity (bruising, hematoma)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• impaired kidney function (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or lightheadedness, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• blood tests may show an increase in certain liver enzymes

Uncommon (may affect up to 1 in 100 patients)

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be seen in tests performed by your doctor)
• blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including traumatic hepatocellular injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin as a complication after cardiac surgery involving catheter insertion 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 cells causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, sensory disturbances, numbness, or paralysis (compartment syndrome following bleeding)

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar in type to those seen in adults, and their severity was mostly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

Very common (may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people)

• increased heart rate
• blood tests may show increased 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 increased levels in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rivaroxaban Krka Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on each blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Krka

• The active substance is rivaroxaban.

15 mg: Each film-coated tablet contains 15 mg of rivaroxaban.

20 mg: Each film-coated tablet contains 20 mg of rivaroxaban.

• The other components (excipients) are mannitol, microcrystalline cellulose, polyethylene glycol, poloxamer, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica and sodium stearyl fumarate in the core, and hypromellose, polyethylene glycol, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172) – only for the 15 mg film-coated tablets. See section 2 “Rivaroxaban Krka contains sodium”.

Appearance of the product and contents of the pack

15 mg:

Reddish-orange to brownish-orange, round, slightly biconvex, film-coated tablets, engraved with the mark “15” on one side of the tablet.

Dimensions: diameter of approximately 6.5 mm.

20 mg:

Pink to dark pink, round, slightly biconvex, film-coated tablets, engraved with the mark “20” on one side of the tablet.

Dimensions: diameter of approximately 7 mm.

Rivaroxaban Krka is available in packs containing:

Non-perforated blister: 10, 15, 30, 50, 60, 90 and 100 film-coated tablets.

Single-dose perforated blister: 10 x 1, 30 x 1, 50 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets.

Non-perforated calendar blister: 14, 28, 42, 56, 98, 168 and 196 film-coated tablets.

A patient alert card is included in each pack of this medicine.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann Straße 5, 27472 Cuxhaven, Germany

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: February 2024

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/