Cefuroxime Sandoz 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefuroxime Sandoz 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 or pharmacist.
• 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Cefuroxime is used to treat infections of:

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

Cefuroxime may also be used:

• to treat Lyme disease (an illness transmitted by parasites called ticks).

2. What you need to know before taking Cefuroxime Sandoz

Do not take Cefuroxime Sandoz:

• if you are allergic to cefuroxime 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 reaction (hypersensitivity) to any type of beta-lactam antibiotic (penicillins, monobactams, carbapenems),
• if you have ever developed severe skin rash or peeling, 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 until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting cefuroxime.

The use of cefuroxime is not recommended in children under 3 months of age, as safety and efficacy have not been established in this age group.

While taking cefuroxime, you should be aware of certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of possible complications. See “Symptoms to be aware of” in section 4.

Take special care with Cefuroxime Sandoz

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and 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 severe skin reactions described in section 4.

If you need a blood test

Cefuroxime may affect the results of a blood test used to determine blood glucose levels, or a test called the Coombs test.

If you need a blood test:

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

Other medicines and Cefuroxime Sandoz

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

This includes medicines you can buy without a prescription.

Medicines used to reduce the amount of acid in your stomach (for example, antacids used to treat heartburn) may affect how cefuroxime works.

Probenecid

Oral anticoagulants

?Consult 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will weigh the benefits of treating you with cefuroxime against the risk to your baby.

Driving and using machines

Cefuroxime may cause dizziness and other side effects that may reduce your alertness.

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

Cefuroxime Sandoz contains sodium

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

3. How to take Cefuroxima Sandoz

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 after meals. This will help make the treatment more effective.

Swallow the cefuroxime tablets with some water.

Do not chew, crush, or split the tablets; doing so may make the tablets difficult to swallow and reduce the effectiveness of the treatment.

Recommended dose:

Adults and children weighing 40 kg or more

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

Children weighing less than 40 kg

The recommended dose of cefuroxime is 10 mg/kg of body weight (up to a maximum of 250 mg) to 15 mg/kg of body weight (up to a maximum of 250 mg) twice daily, depending on the severity and type of infection.

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

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

Patients with kidney problems

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

?Inform your doctor if this applies to you.

If you take more Cefuroxima Sandoz than you should

If you take too much cefuroxime, you may experience neurological disturbances, in particular, you may be more likely to have seizures (convulsions).

?Do not delay. Contact your doctor or pharmacist immediately, go to the nearest emergency department, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount taken. If possible, show them the Cefuroxima Sandoz packaging.

If you forget to take Cefuroxima Sandoz

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking Cefuroxima Sandoz

Do not stop taking Cefuroxima Sandoz without prior medical advice.

It is important that you complete the full course of treatment with Cefuroxima Sandoz. Do not stop unless advised by your doctor, even if you are feeling better. If you do not complete the entire 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 will experience them.

Stop taking cefuroxime and seek medical attention immediately if you notice any of the following symptoms:

• Red, flat, non-elevated patches, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A widespread red, scaly rash with skin bumps and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis).

Symptoms to 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 and itching, swelling, sometimes of the face or mouth causing difficulty breathing,
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• chest pain during allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

Other symptoms to watch for while taking cefuroxime may include:

• fungal infections. Medicines like cefuroxime can cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as vaginal candidiasis). This adverse effect is more common if cefuroxime is taken for a long time,
• severe diarrhoea (pseudomembranous colitis). Medicines like cefuroxime can cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, stomach pain, and fever,
• Jarisch-Herxheimer reaction. Some patients may experience high temperature (fever), chills, headache, muscle pain, and skin rash while being treated with cefuroxime for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last for a few hours or up to one day.

?Contact your doctor immediately if you have any of these symptoms.

Frequent adverse effects

May affect up to 1 in 10 people:

• fungal infections (such as Candida),
• headache,
• dizziness,
• diarrhoea,
• feeling unwell,
• stomach pain.

Frequent adverse effects that may appear in blood tests:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• nausea,
• skin rashes.

Uncommon adverse effects that may appear in blood tests:

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

Other adverse effects

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

• severe diarrhoea (pseudomembranous colitis),
• allergic reactions,
• skin reactions (which may become severe),
• high temperature (fever),
• yellowing of the whites of the eyes or of the skin,
• inflammation of the liver (hepatitis).

Adverse effects that may appear in blood tests:

• red blood cells being destroyed too quickly (haemolytic anaemia).

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime Sandoz

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

Do not use this medicine after the expiry date stated on the label and the carton after CAD/EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature.

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

6. Contents of the pack and other information

Composition of Cefuroxime Sandoz

• The active substance is cefuroxime. Each tablet contains 601.44 mg of cefuroxime axetil (equivalent to 500 mg of cefuroxime).
• The other components (excipients) are: sodium lauryl sulfate, copovidone, sodium croscarmellose (E468), magnesium stearate (E470B), anhydrous colloidal silica (E551), granulated mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), talc (E553B), mannitol (E421), hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide (E171).

Nature of the product and pack contents

White to slightly yellowish, biconvex, oblong coated tablets.

Packaged in cardboard containers with blister pack(s) or strip(s) containing 8, 10, 12, 14, 15, 16, 20, 24, and 500 coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

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

Austria Cefuroxim Sandoz 500 mg – Filmtabletten

Belgium Cefuroxim Sandoz 500 mg omhulde tabletten

Czech Republic Xorimax 500 mg potahované tablety

Hungary Xorimax 500 mg bevont tabletta

Lithuania Xorimax 500 mg dengtos tabletes

Latvia Xorimax 500 mg apvalkotas tabletes

Netherlands Cefuroximaxetil 500, omhulde tabletten 500 mg

Poland Xorimax 500

Slovak Republic Xorimax 500 mg

Date of the most recent review of this Patient Information Leaflet: March 2025

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/