CEFUROXIME SANDOZ 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cefuroxime Sandoz 500 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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 side effects.
5. Storage of Cefuroxime Sandoz.
6. Package Contents and Additional 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 the bacteria that cause infections. It belongs to a group of medications called cephalosporins.

Cefuroxime is used to treat infections of:

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

Cefuroxime can also be used:

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

2. What you need to know before taking Cefuroxime Sandoz

Do not take Cefuroxime Sandoz:

• if you are allergicto cefuroxime or any cephalosporin antibioticor to any of the other components of this medication (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 a 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 cefuroximeuntil you have consulted your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take cefuroxime.

Cefuroxime is not recommended for use in children under 3 months, as its 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 (like Candida), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of potential complications. See "Symptoms to watch out for" in section 4.

Be cautious with Cefuroxime Sandoz

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 may affect the results of a blood test to determine glucose levels or a test called the Coomb's test.

If you need a blood test:

Tell the person performing the testthat you are taking cefuroxime.

Other medications and Cefuroxime Sandoz

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

This includes medications that can be obtained without a prescription.

Medications used to reduce stomach acid(such as antacidsused to treat heartburn) may affect the functioning of cefuroxime.

Probenecid

Oral anticoagulants

Consult your doctor or pharmacistif you are taking any of these medications.

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 medication.

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

Driving and using machines

Cefuroxime may cause dizzinessand other side effects that make you less alert.

Do not drive or operate machineryif you do not feel well.

Cefuroxime Sandoz contains sodium

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

3. How to take Cefuroxime Sandoz

Follow the administration instructions for this medication exactly as indicated 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 break the tablets; this may make the tablets difficult to swallow and the treatment less effective.

The recommended dose is:

Adultsand children weighing 40 kg or more

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

Childrenweighing less than 40 kg

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

Depending on the disease and how you or your child respond to treatment, the initial dose may be changed or more than one treatment cycle may be needed.

Patients with kidney problems

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

Tell your doctorif this applies to you.

If you take more Cefuroxime Sandoz than you should

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

Do not delay. Contact your doctor or pharmacist immediately, go to the nearest emergency department, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.If possible, show them the Cefuroxime Sandoz packaging.

If you forget to take Cefuroxime 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 Cefuroxime Sandoz

Do not stop taking Cefuroxime Sandoz without prior advice.

It is essential that you complete the full treatment of Cefuroxime Sandoz.Do not stop it unless your doctor advises you to, even if you are already feeling better. If you do not complete the entire treatment, the infection may recur.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• Red, target-like, or circular patches, often with central blisters, skin peeling, mouth ulcers, and ulcers on the genitals and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• A red, scaly, and widespread rash with bumps and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Symptoms to watch out for

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

• severe allergic reaction. The 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 or drug hypersensitivity syndrome),
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).

Other symptoms to watch out for while taking cefuroxime may include:

• fungal infections. Medications like cefuroxime can cause an overgrowth of fungi (Candida) in the body, leading to fungal infections (such as vaginal candidiasis). This side effect is more common if you take cefuroxime for a long time,
• severe diarrhea(pseudomembranous colitis). Medications like cefuroxime can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, stomach pain, and fever,
• Jarisch-Herxheimer reaction. Some patients may experience high body 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. The symptoms usually last a few hours or up to a day.

Contact your doctor immediately if you experience any of these symptoms.

Common side effects

May affect up to 1 in 10people:

• fungal infections (like Candida),
• headache,
• dizziness,
• diarrhea,
• feeling unwell,
• stomach pain.

Common side effects that may appear in blood tests:

• increase in a type of white blood cell (eosinophilia),
• increase in liver enzyme levels.

Uncommon side effects

May affect up to 1 in 100people:

• nausea,
• 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 Coomb's test.

Other side effects

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

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

Side effects that may appear in blood tests:

• red blood cells that are destroyed too quickly (hemolytic anemia).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cefuroxime Sandoz

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

Do not use this medication after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medications should not be thrown away in drains or trash. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Cefuroxime Sandoz Composition

• The active ingredient is cefuroxime. Each film-coated 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).

Product Appearance and Package Contents

White to slightly yellowish, biconvex, and oblong film-coated tablets.

Available in cardboard boxes with blister(s) or strip(s) containing 8, 10, 12, 14, 15, 16, 20, 24, and 500 film-coated tablets.

Not all pack sizes may be marketed.

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 medication 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 last revision of this package leaflet:March 2025

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