Cefuroxime Aurovitas 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cefuroxime Aurovitas 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• 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 or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Cefuroxime Aurovitas is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not keep or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Cefuroxime Aurovitas is used to treat infections of:

• the throat
• the nasal sinuses
• the middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues

Cefuroxime Aurovitas may also be used to:

• treat Lyme disease (an infection transmitted by ticks)

Your doctor may identify the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxime Aurovitas during treatment.

2. What you need to know before starting to take Cefuroxime Aurovitas

Do not take Cefuroxime Aurovitas

• If you are allergic to any cephalosporin antibiotic or to any of the other ingredients of this medicine (listed in section 6).

• If you have ever had a severe allergic (hypersensitivity) reaction to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

→ If you think this applies to you, do not take Cefuroxime Aurovitas until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Aurovitas.

Children

Cefuroxime Aurovitas is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.

Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Cefuroxime Aurovitas. This will help reduce the risk of possible complications. See "Symptoms to be aware of" in section 4.

Take special care with Cefuroxime Aurovitas:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. Seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need blood tests

Cefuroxime Aurovitas may affect the results of blood sugar levels or the Coombs test. If you need a blood test:

→ Inform the person performing the test that you are taking Cefuroxime Aurovitas.

Taking Cefuroxime Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Medicines used to reduce stomach acid (e.g. antacids used to treat heartburn) may affect the mechanism of action of Cefuroxime Aurovitas.

Probenecid

Oral anticoagulants

→ Inform your doctor or pharmacist if you are taking any of these medicines.

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 using this medicine.

Talk to your doctor before taking Cefuroxime Aurovitas:

• If you are pregnant, think you may be pregnant, or plan to become pregnant.
• If you are breastfeeding.

Your doctor will assess the benefit of treating you with Cefuroxime Aurovitas against the potential risk to your baby.

Driving and using machines

Cefuroxime Aurovitas may cause dizziness and other adverse effects that could impair your ability to remain alert.

→ Do not drive or operate machinery if you do not feel well.

Cefuroxime Aurovitas contains sodium

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

3. How to take Cefuroxima Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take Cefuroxima Aurovitas after meals. This will help make the treatment more effective. Swallow the Cefuroxima Aurovitas tablets whole with water.

Do not chew, crush or split the tablets — this may make the treatment less effective.

Recommended dose

Adults and children weighing 40 kg or more

The recommended dose of Cefuroxima Aurovitas is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children weighing less than 40 kg

Children weighing less than 40 kg should preferably be treated with cefuroxime oral suspension or oral sachets.

The recommended dose of Cefuroxima Aurovitas is 10 mg/kg body weight (up to a maximum of 250 mg) to 15 mg/kg body weight (up to a maximum of 250 mg) twice daily, depending on:

• the severity and type of infection.

Cefuroxima Aurovitas is not recommended for children under 3 months of age, as the safety and efficacy in this patient group are unknown.

Depending on the illness and how you or your child responds to treatment, the initial dose may be adjusted or it may be necessary to administer more than one course of treatment.

Patients with kidney problems

If you have kidney problems, your doctor may adjust your dose.

? Consult your doctor if you are affected by this condition.

If you take more Cefuroxima Aurovitas than you should

If you take too much Cefuroxima Aurovitas, you may experience neurological disorders, particularly an increased risk of epileptic seizures (convulsions).

? Do not delay. Contact your doctor immediately or go to the nearest hospital emergency department. If possible, show them the Cefuroxima Aurovitas packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxima Aurovitas

Do not take a double dose to make up for forgotten doses. Simply continue with the next dose as usual.

If you stop taking Cefuroxima Aurovitas

It is important that you complete the entire course of treatment with Cefuroxima Aurovitas. Do not stop unless instructed by your doctor, even if you start to feel better. If you do not complete the treatment course, the infection may recur.

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.

Symptoms you should be aware of

A small number of people who took Cefuroxime Aurovitas experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome),
• severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,
• skin rash, which may cause blisters, appearing like small targets (a dark spot in the center surrounded by a paler area, with a dark ring around the edge),
• widespread skin rash with blisters and peeling of the skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other symptoms you should be aware of while taking Cefuroxime Aurovitas:

• fungal infections. Medicines such as Cefuroxime Aurovitas can cause increased growth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if Cefuroxime Aurovitas has been taken for a prolonged period,
• severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Aurovitas can cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually accompanied by blood and mucus, stomach pain, and fever,
• Jarisch-Herxheimer reaction. Some patients may experience an increase in body temperature (fever), chills, headache, muscle pain, and skin rash while taking Cefuroxime Aurovitas to treat Lyme disease. This is known as Jarisch-Herxheimer reaction. Symptoms usually last from a few hours to one day.

→Contact a doctor or nurse immediately if you experience any of these symptoms.

Frequent adverse effects

These may affect up to 1 in 10 people:

• fungal infection (such as Candida)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain

Frequent adverse effects that may appear in blood tests:

• increase in the count of a type of white blood cells (eosinophilia)
• increased levels of liver enzymes

Uncommon adverse effects

These may affect up to 1 in 100 people:

• vomiting
• skin rashes

Uncommon adverse effects that may appear in blood tests:

• decrease in the number of blood platelets (cells that help blood to clot)
• decrease in the number of white blood cells
• positive Coombs test

Other adverse effects

Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin rashes (which may be severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis)

Adverse effects that may appear in blood tests:

• rapid destruction of red blood cells (haemolytic anaemia)

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. Cefuroxime 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime Aurovitas

• The active substance is cefuroxime.

Cefuroxime Aurovitas 500 mg film-coated tablets contain 601.44 mg of cefuroxime axetil, equivalent to 500 mg of cefuroxime.

• The other components (excipients) are:

Tablet core: microcrystalline cellulose (E460), sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil (hydrogenated cottonseed oil), and colloidal anhydrous silica.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400.

Nature and contents of the container

Film-coated tablet.

Cefuroxime Aurovitas 500 mg:

Film-coated, capsule-shaped tablets, white to off-white, marked with "A34" on one side and smooth on the other. Size: 20.1 mm x 8.6 mm.

Cefuroxime Aurovitas film-coated tablets are available in blisters and white opaque HDPE bottles. The HDPE bottle also contains silica gel as a desiccant.

Pack sizes:

Blister: 6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100 and 500 film-coated tablets.

HDPE bottle: 20, 60 and 500 film-coated tablets.

Only some pack sizes may 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

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Cefuroxim PUREN 500 mg Filmtabletten

Ireland: Cefuroxime Aurobindo 500 mg film-coated tablets

Poland: Cefuroxime Axetil Aurovitas

Portugal: Cefuroxima Aurobindo

Romania: Cefuroxima Atb 500 mg comprimate filmate

Spain: Cefuroxima Aurovitas 500 mg comprimidos recubiertos con película EFG

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

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