Rivaroxaban Aurovitas 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Aurovitas 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, consult 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, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

• Preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing blood clots after surgery.
• 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 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 taking Rivaroxaban Aurovitas

Do not take Rivaroxaban Aurovitas

• 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 severe bleeding (for example, stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes).
• If you are taking medications 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 it from becoming blocked.
• If you have a liver disease that increases the risk of bleeding.
• If you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Rivaroxaban Aurovitas.

Take special care with Rivaroxaban

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

  • moderate or severe renal impairment, as kidney function may affect the amount of medicine active in your body.
  • if you are taking other medications 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 Aurovitas”).
  • 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 (e.g., due to gastro-oesophageal reflux disease—where stomach acid rises into the oesophagus), or tumours in the stomach, intestines, genital or urinary tract.
  • a blood vessel problem in the back of the eyes (retinopathy).
  • a lung disease in which the bronchi are dilated 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 your treatment needs to be adjusted.

• If your doctor determines that your blood pressure is unstable or if 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 rivaroxaban. 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 rivaroxaban before and after surgery exactly at the times specified by your doctor.
• If your operation 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 rivaroxaban exactly at the times specified by your doctor.
  • 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

Rivaroxaban is not recommended for use in individuals under 18 years of age. There is insufficient information on its use in children and adolescents.

Other medicines and Rivaroxaban Aurovitas

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:

• Any medicine for a 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).
• Any medicine 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 and painkillers (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-noradrenaline reuptake inhibitors (SNRIs)).

If any of the above apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban 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 stomach or intestinal ulcers, they may recommend you also use preventive ulcer treatment.

-If you are taking:

• Any 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 rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you need closer monitoring.

Pregnancy, breastfeeding, and fertility

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately, so they can decide on the appropriate treatment.

Driving and use of machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). Do not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rivaroxaban contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Rivaroxaban Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose to take

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

The recommended dose is one 10 mg rivaroxaban tablet once daily.

• To treat blood clots in 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 rivaroxaban tablet once daily or one 20 mg rivaroxaban tablet once daily. Your doctor has prescribed you 10 mg of rivaroxaban once daily.

Swallow the tablet, preferably with water.

Rivaroxaban may be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking rivaroxaban.

The tablet may be crushed and mixed with water or apple puree, immediately before taking it. If necessary, your doctor may also administer the crushed rivaroxaban tablet via a gastric tube.

When to take Rivaroxaban Aurovitas

Take the tablet every day, as long as your doctor instructs you to do so.

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 the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.

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

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

If you take more Rivaroxaban Aurovitas than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban 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 forget to take Rivaroxaban Aurovitas

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

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

If you stop taking Rivaroxaban Aurovitas

Do not stop treatment with rivaroxaban without first speaking to your doctor, because rivaroxaban 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, rivaroxaban can cause bleeding, which may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Contact your doctor immediately if you experience any of the following adverse effects:

• 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, difficulty breathing, chest pain, or angina.

Your doctor will decide whether to keep you under closer observation or modify 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 (DRESS syndrome), which causes rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.

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:

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

• Decrease in red blood cells, which 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 (hematoma, bruising).
• Coughing up blood.
• Bleeding from or under the skin.
• Bleeding after surgery.
• Oozing 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 feeling dizzy, constipation, diarrhea.
• Low blood pressure (symptoms may include feeling dizzy or faint upon standing).
• General decrease in strength and energy (weakness, fatigue), headache, dizziness.
• Rash, skin itching.
• Blood tests may show increased levels of certain liver enzymes.

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

• 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, the cells that help blood to clot).
• Allergic reaction, including skin allergic reaction.
• Impaired liver function (may be seen in tests performed by your doctor).
• Blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or platelet count.
• Fainting.
• Feeling unwell.
• Increased 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 (liver inflammation or damage).
• Yellowing of the skin and eyes (jaundice).
• Localized swelling.
• Blood collection (hematoma) in the groin as a complication after heart surgery involving insertion of a catheter into the leg artery (pseudoaneurysm).

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

• Eosinophil accumulation, a type of granulocytic white blood cell causing lung inflammation (eosinophilic pneumonia).

Frequency not known (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 (hemorrhagic compartment syndrome).

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 may 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 Aurovitas Storage

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

Do not use this medicine after the expiry date stated on the label, blister pack, carton, or container after "EXP". The expiry date refers to 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 purée for up to 4 hours.

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

6. Contents of the pack and other information

Composition of Rivaroxaban Aurovitas

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose (Grades 101 and 102), lactose monohydrate, sodium croscarmellose, hypromellose type 2910 (3 cPs), sodium lauryl sulfate, magnesium stearate.

Tablet coating: polyvinyl alcohol, Macrogol 3350, talc, titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and pack contents

Light red, film-coated, round tablets (6.1 mm in diameter), biconvex, marked with "M" on one side and "10" on the other.

Rivaroxaban Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister packs: 5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196 and 200 film-coated tablets.

HDPE bottles: 30, 100, 250 and 500 film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: December 2023

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).