CEFUROXIME AUROVITAS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxime Aurovitas 500 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 or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

It is important that you follow the instructions regarding the dose, the number of doses, and the duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Cefuroxime Aurovitas is used to treat infections of:

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

Cefuroxime Aurovitas can also be used to:

• treat Lyme disease (infection transmitted by ticks)

Your doctor may analyze the type of bacteria that cause your infection and check if the bacteria are sensitive to Cefuroxime Aurovitas during treatment.

2. What you need to know before you 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 reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

• If you have ever developed a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth 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

Consult your doctor or pharmacist before starting to take Cefuroxime Aurovitas.

Children

Cefuroxime Aurovitas is not recommended for children under 3 months, as safety and efficacy for this age group are unknown.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhea (pseudomembranous colitis) while taking Cefuroxime Aurovitas. This will reduce the risk of possible complications. See “Symptoms to be aware of” in section 4.

Be particularly careful 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 a blood test

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

→ Tell the person performing the testthat 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 take any other medicines.

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

Probenecid

Oral anticoagulants

→ Tell your doctor or pharmacistif you are taking any of these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor before taking Cefuroxime Aurovitas:

• If you are pregnant, think you may be pregnant, or are planning to have a baby.
• If you are breastfeeding.

Your doctor will assess the benefit of being treated with Cefuroxime Aurovitas against the risk to your child.

Driving and using machines

Cefuroxime Aurovitas may cause dizzinessand other side effects that may impair your ability to be alert.

→ Do not drive or use machinesif you do not feel well.

Cefuroxime Aurovitas contains sodium

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

3. How to take Cefuroxime Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Recommended dose

Adults and children weighing 40 kg and over

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

Children under 40 kg

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

The recommended dose of Cefuroxime Aurovitas is 10 mg/kg of the child's weight (up to a maximum of 250 mg) to 15 mg/kg of the child's weight (up to a maximum of 250 mg) twice a day, depending on:

• the severity and type of infection.

Cefuroxime Aurovitas is not recommended for children under 3 months, as safety and efficacy for this age group are unknown.

Depending on the disease and how you or your child respond to treatment, the initial dose may be adjusted or it may be necessary to administer more than one treatment cycle.

Patients with kidney problems

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

? Consult your doctorif you are affected by this problem.

If you take more Cefuroxime Aurovitas than you should

If you take too much Cefuroxime Aurovitas, you may experience neurological disorders, in particular, you may have a higher risk of having epileptic seizures (convulsions).

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

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

If you forget to take Cefuroxime 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 Cefuroxime Aurovitas

It is important that you complete the entire treatment of Cefuroxime Aurovitas.Do not stop it unless your doctor tells you to, even if you have started to feel better. If you do not complete the treatment cycle, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

A small number of people who took Cefuroxime Aurovitas experienced a severe allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

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

Other symptoms to be aware of while taking Cefuroxime Aurovitas:

• fungal infections.Medicines like Cefuroxime Aurovitas can cause an increase in fungal growth (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely to occur if you have taken Cefuroxime Aurovitas for a long time,
• severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxime Aurovitas can cause inflammation of the colon (large intestine), which produces severe diarrhea, 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. The symptoms usually last from a few hours to a day.

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

Common side effects

These may affect up to 1 in 10people:

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

Common side effects that may appear in blood tests:

• increase in the count of a type of white blood cell (eosinophilia)
• increase in liver enzyme levels

Uncommon side effects

These may affect up to 1 in 100people:

• vomiting
• skin rashes

Uncommon side effects that may appear in blood tests:

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

Other side effects

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

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

Side effects that may appear in blood tests:

• rapid destruction of red blood cells (hemolytic anemia)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime Aurovitas

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 after EXP. The expiry date refers to the last day of the month shown.

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. Return any unused medicine to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This 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 ingredients (excipients) are:

Core of the tablet:microcrystalline cellulose (E460), sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil (hydrogenated cottonseed oil), and anhydrous colloidal silica.

Coating of the tablet:hypromellose, titanium dioxide (E171), macrogol 400.

Appearance of the product and packaging contents

Film-coated tablet.

Cefuroxime Aurovitas 500 mg:

Film-coated tablets, capsule-shaped, white to off-white, marked with “A34” on one side and smooth on the other. The size is 20.1 mm x 8.6 mm.

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

Pack sizes:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avenida 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 medicine is authorized in the Member States of the European Economic Area 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 film-coated tablets

Spain: Cefuroxima Aurovitas 500 mg film-coated tablets EFG

Date of last revision of this leaflet:November 2024

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