CEFUROXIME ARISTO 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Cefuroxima Aristo and what is it used for

Cefuroxima Aristo contains cefuroxime as the active substance. It 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.

Cefuroxime is used to treat infections of:

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

Cefuroxime can also be used to:

• treat Lyme disease (infection transmitted by ticks).

Your doctor may analyze the type of bacteria causing your infection and check if the bacteria are sensitive to cefuroxime during treatment.

2. What you need to know before you take Cefuroxima Aristo

Do not take cefuroxime

• if you are allergic to cefuroxime or any other 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 peeling of the skin, blisters, and/or mouth sores after treatment with cefuroxime or any other cephalosporin antibiotic;
• if you think this applies to you, do not take cefuroxime until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

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.

Children

Cefuroxime 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. This will reduce the risk of possible complications. See "Symptoms to be aware of" in section 4.

If you need a blood test

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

• Tell the person performing the tests that you are taking cefuroxime.

Other medicines and cefuroxime

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

Medicines used to reduce stomach acidity (e.g., antacidsfor heartburn) may affect the action of this medicine.

• Probenecid.
• Oral anticoagulants.

• Tell 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy and breastfeeding unless your doctor has told you to do so.

If you are breastfeeding and have digestive problems (diarrhea, fungal infections) or spots, stop breastfeeding and consult your doctor immediately.

Driving and using machines

Cefuroxime may cause dizziness and other adverse effects that may impair your ability to be alert.

• Do not drive or use machines if you do not feel well.

This medicine contains sodium

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

• Check with your doctor that cefuroxime is suitable for you.

3. How to take Cefuroxima Aristo

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is

Adults

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

Children

The recommended dose of cefuroxime is 10 mg/kg (up to a maximum of 125 mg) to 15 mg/kg (up to a maximum of 250 mg) twice a day, depending on:

• the severity and type of infection.

Cefuroxime is not recommended in 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 doctor if you are affected by this problem.

Method of administration

Oral use.

Take this medicine after meals. This will help the treatment to be more effective. Swallow the cefuroxime tablets whole with water.

Do not chew or crush the tablets.

If you take more cefuroxime than you should

If you take too much cefuroxime, 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 package of this medicine.

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

If you forget to take cefuroxime

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

Do not stop taking cefuroxime without prior advice.

It is important that you complete the entire treatment with cefuroxime. Do not stop it unless your doctor tells you to do so, even if you have started to feel better. If you do not complete the treatment cycle, the infection may recur.

If you have any further questions about 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 experienced a severe allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• severe allergic reaction. The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing;
• 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);
• 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 rash with blisters and peeling of the skin. (These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis).

Other symptoms to be aware of while taking cefuroxime:

• fungal infections. Medicines like cefuroxime 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 cefuroxime has been taken for a prolonged period;
• severe diarrhea (pseudomembranous colitis). Medicines like cefuroxime 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 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

May affect up to 1 in 10 people:

• 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

May affect up to 1 in 100 people:

• feeling sick;
• skin rashes.

Uncommon side 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 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
• inflammation of the liver (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 Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxima Aristo

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 carton and blister after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from light.

Do not take this medicine if the tablets are cracked or you notice other visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima Aristo

• The active substance is cefuroxime.

Each film-coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).

• The other ingredients are:

Core of the tablet: Microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.

Coating material: Hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, microcrystalline cellulose, stearic acid.

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, white to off-white, oval-shaped, and approximately 9 mm x 18.5 mm in size.

PVC/PVdC/aluminum blisters.

Pack sizes: 10, 12, 14, 16, 20, and 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Austria Cefuroxim Aristo 500 mg Filmtabletten

Germany Cefurax 500 mg Filmtabletten

Portugal Cefuroxima Aristo 500 mg comprimidos revestidos por película

Poland Zyntax 500 mg tabletki powlekane

Spain Cefuroxima Aristo 500 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet: May 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/