Rivaroxaban Krka 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Krka 10 mg film-coated tablets EFG

Read the 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 they are effects 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 to

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you have a higher risk of developing blood clots after surgery.
• 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 recurring in the veins of the legs and/or lungs.

Rivaroxaban 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 clot.

2. What you need to know before starting to take 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 organ condition that increases the risk of serious bleeding (for example, 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 heparin is being administered through a venous or arterial catheter to prevent it from becoming blocked
• 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 to take this medicine.

Take special care with Rivaroxaban Krka

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

  • moderate or severe kidney impairment, 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 between anticoagulant treatments or while receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban Krka")
  • bleeding disorders
  • uncontrolled high blood pressure despite medical treatment
  • stomach or intestinal diseases that could cause bleeding, such as inflammation of the stomach or intestines, inflammation of the oesophagus (throat), for example 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 blood vessel disorder in the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous lung haemorrhage

• 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 your treatment needs to be adjusted.

• 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 to be more closely monitored.

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 operation requires placement of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia, or pain relief):

• it is very important to take this medicine exactly at the times your doctor tells you

• inform your doctor immediately if you experience numbness or weakness in the 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 use in children and adolescents under 18 years of age. There is insufficient information on its use in this population.

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)

• an 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 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 situations apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If your doctor considers you at higher risk of developing stomach or intestinal ulcers, they may recommend you also use an ulcer-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 situations apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

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 possibility you could become pregnant, use a reliable contraceptive method while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide on the 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 the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

What dose to take

• To prevent blood clots in veins after hip or knee replacement surgery:

The recommended dose is one Rivaroxaban Krka 10 mg tablet once daily.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring:

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

Swallow the tablets, preferably with water.

This medicine can be taken with or without food.

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

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

When to take Rivaroxaban Krka

Take the tablet every day, for as long as your doctor instructs.

Try to take one tablet 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 veins after hip or knee replacement surgery:

Take the first tablet between 6 and 10 hours after surgery.

If you have undergone major hip surgery, you will usually take tablets for 5 weeks.

If you have undergone major knee surgery, you will usually take tablets for 2 weeks.

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 of this medicine increases the risk of bleeding. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Rivaroxaban Krka

If you forget to take a dose, take it as soon as you remember. Take your next dose the following day, and then continue taking one tablet daily as usual.

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

If you stop taking Rivaroxaban Krka

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

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 cause 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 within 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, difficulty breathing, 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 with eosinophilia and systemic symptoms, causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

The frequency of this adverse effect is very rare (affecting 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

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 tissue or body cavities (hematoma, bruising)
• coughing up blood
• bleeding of the skin 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 blood tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• skin rash, itching
• blood tests may show increased levels of certain liver enzymes

Uncommon (may affect up to 1 in 100 patients)

• bleeding in the brain or within the skull (see above, signs of bleeding)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count, the cells that help blood clot)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be seen in blood tests performed by your doctor)
• blood tests may show increased bilirubin, certain 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 hepatocellular liver injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication following 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, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Reporting of adverse effects

If you experience any adverse effect, talk to 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 the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on each blister, following "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. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to properly discard medicines and packaging 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. Each tablet contains 10 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) and iron oxide red (E172) in the tablet coating. See section 2 “Rivaroxaban Krka contains sodium”.

Appearance of the product and contents of the pack

Film-coated brownish-red tablets, round, slightly biconvex, engraved with the mark “10” on one side of the tablet.

Dimensions: approximate diameter of 6.5 mm.

Rivaroxaban Krka is available in boxes containing:

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

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

Calendarized non-perforated blister packs: 14, 28, 42, 56, 98, 168 and 196 film-coated tablets.

A patient alert card is included in each package 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, please 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 last revision of this leaflet: February 2024

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