Cefuroxime Teva-Ratio 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Teva-ratio 250 mg film-coated tablets EFG

Read this 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 you should not give it 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, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Cefuroxime Teva-ratio is and what it is used for

Cefuroxime Teva-ratio 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 Teva-ratio is used to treat infections of:

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

Cefuroxime Teva-ratio 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 Teva-ratio during treatment.

2. What you need to know before taking Cefuroxime Teva-ratio

Do not take Cefuroxime Teva-ratio:

• If you are allergic to cefuroxime (as acetyl) or 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 carbapenem derivatives).

• If any of the above applies to you, do not take Cefuroxime Teva-ratio until you have consulted your doctor.

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

Take special care with Cefuroxime Teva-ratio

Serious 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 symptoms related to these serious skin reactions described in section 4.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime Teva-ratio.

Children

Cefuroxime Teva-ratio is not recommended for children under 3 months of age, as safety and efficacy have not been established for 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 Teva-ratio. This will help reduce the risk of possible complications. See “Symptoms to watch for” in section 4.

If you need a blood test

Cefuroxime Teva-ratio may affect test results for blood sugar levels or the Coombs test. If you need a blood test:

• Inform the person performing the test that you are taking cefuroxime.

Taking Cefuroxime Teva-ratio 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 acidity (e.g. antacids used to treat heartburn) may affect the action of Cefuroxime Teva-ratio.

Probenecid

Oral anticoagulants

• Inform your doctor or pharmacist if you are taking any medicine of this type.

Oral contraceptives

Cefuroxime Teva-ratio may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while on cefuroxime, you should also use barrier contraceptive methods (such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Cefuroxime Teva-ratio 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 Teva-ratio contains sodium

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

3. How to take Cefuroxime Teva-ratio

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

Take Cefuroxime Teva-ratio after meals. This will help make the treatment more effective.

Swallow the 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 this medicine is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Use in children weighing less than 40 kg

The recommended dose of this medicine is 10 to 15 mg/kg of the child's body weight (up to a maximum of 250 mg) twice daily, depending on:

• the severity and type of infection

Cefuroxime is not recommended in children under 3 months of age, as 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 Cefuroxime Teva-ratio than you should

If you take too much cefuroxime, you may experience neurological disturbances, and in particular, you may have 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 medicine's packaging.

You may also contact your pharmacist 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 Cefuroxime Teva-ratio

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 Teva-ratio

Do not stop treatment with this medicine without prior medical advice.

It is important that you complete the entire course of cefuroxime treatment. 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 return.

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 experiences them.

Symptoms you should watch for

A small number of people who have taken cefuroxime have experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• 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 as small target-like spots (a 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 may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

Other symptoms you should watch for while taking cefuroxime:

• Fungal infections. Medicines such as cefuroxime may cause increased growth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if cefuroxime has been taken for a prolonged period.

• Severe diarrhoea (pseudomembranous colitis). Medicines such as cefuroxime may 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 to treat Lyme disease. This is known as the 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

May affect up to 1 in 10 patients:

• 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)
• increase in liver enzyme levels.

Uncommon adverse effects

May affect up to 1 in 100 patients:

• 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
• liver inflammation (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 type of 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. Storage of Cefuroxime Teva-ratio

No special storage conditions are required.

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.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime Teva-ratio

• The active substance is cefuroxime. Each tablet contains 250 mg of cefuroxime (as axetil).
• The other components (excipients) are: pregelatinized starch (from maize), croscarmellose sodium (AC-Disol SD-711), sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil, and Opadry.

Appearance of the medicine and contents of the pack

Light blue, biconvex, film-coated tablets with a capsule-like shape. Each pack contains 10, 15, 20 or 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 - Alcobendas-Madrid

Spain

or

FARMALIDER S.A

C/ Aragoneses 2

28108 - Alcobendas (Madrid)

Spain

or

Laboratórios Atral SA

Rua da Estação, 1 e 1A

2600-726 Castanheira do Ribatejo Portugal

Date of the most recent review of this leaflet: February 2026.

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).

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69954/P_69954.html

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