Prospecto: information for the user

Cefuroxima SUN 500 mg film-coated tablets EFG

Cefuroxima (as cefuroxime axetil)

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacistor nurse.
• This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist or nurse,evenifthey are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to take Cefuroxima SUN

3.How to take Cefuroxima SUN

4.Adverse effects

1. Storage of Cefuroxima SUN

6.Contents of the package and additional information

Cefuroxima is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medications calledcephalosporins.

Cefuroxima is used to treat infections of:

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

Cefuroxima may also be used to:

• treat Lyme disease (infection transmitted by ticks)

Your doctor may analyze the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxima SUN during treatment

Do not take Cefuroxima SUN:

• if you are allergictocefuroxima (as axetilo) or to 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 other type of beta-lactam antibiotic (penicillins, monobactam, and carbapenem derivatives)
• if you have ever developed severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

If you consider this applies to you,do not take Cefuroxima SUNuntil you have consulted with your

doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxima SUN.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxima treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children

Cefuroxima SUN is not recommended for children under 3 months, as the safety and efficacy for this age group have not been established.

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

If you need a blood test

Cefuroxima SUN may affect the results of blood sugar levels in blood tests, or theCoombs test.If you need a blood test:

• Inform the person performing the testthat you are takingCefuroxima SUN.

Taking Cefuroxima SUN with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Medicines used toreduce stomach acidity(e.g.antacidsfor treatingheartburn) may affect the mechanism of action of Cefuroxima SUN.

Probenecid (a medicine used to treat gout)

Oral anticoagulants (medicines used to reduce blood clotting)

?Inform your doctor or pharmacistif you are taking any of these types of medicines.

Pregnancy and 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 medicine.

Driving and operating machinery

Cefuroxima SUNmay cause dizzinessand other adverse effects that may impair your ability to stay alert.

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

Important information about some components of Cefuroxima SUN

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

Follow exactly the administration instructionsof this medicationindicated by your doctoror pharmacist.In case of doubt, consult your doctor or pharmacist again.

Take Cefuroxima SUN after meals.This will help make the treatment more effective.

Swallow the Cefuroxima SUN tablets whole with water.

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

Recommended dose

Adults

The recommended doseof Cefuroxima SUNis 250mg to 500 mg twice a day,depending on the severity and type of infection.

Children

The recommended doseof Cefuroxima SUN is10 mg/kg of the child's weight (up to a maximum of 125mg) to15 mg/kg of the child's weight (up to a maximum of 250mg) twice a day,depending on the severity and type of infection.

Cefuroxima SUNis not recommended in children under 3 months, as the safety and efficacy for this patient group is unknown.

Depending on the disease 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 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 Cefuroxima SUN than you should

If you take too muchCefuroxima SUN you may experience neurological disturbances, particularly you may be more likely to haveseizures (epileptic attacks).

Do not delay.Contact your doctor immediately or go to the nearest hospital emergency department.

hospital. If possible, show them the Cefuroxima SUN 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 medication and the amount ingested.

If you forgot to take Cefuroxima SUN

Do not take a double dose to make up for the missed doses.Simply continue with the next dose as usual.

If you interrupt treatment withCefuroxima SUN

Do not interrupt treatment with Cefuroxima SUN without prior advice.

It is essential that you complete the entire treatment ofCefuroxima SUN.Do not interrupt it unless your doctor tells you to, even if you start feeling better. If you do not complete the treatment cycle, the infection may recur.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of

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

Other symptoms to be aware of while taking Cefuroxima SUN include:

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

Frequent side effects(may affect up to 1 in 10 people):

• yeast infection (such asCandida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain.

Frequent side effects that may appear in blood tests:

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

Rare side effects(may affect up to 1 in 100 people):

• vomiting
• skin rash.

Rare side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood to clot)
• decreasein 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 (colitis pseudomembranosa)
• allergic reactions
• skin rash (which may 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after the letters CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Cefuroxima SUN Composition

• The active ingredient is cefuroxime (as axetil). Each tablet contains 500 mg of cefuroxime (as axetil).
• The other components (excipients) are:

Core:

Microcrystalline cellulose (PH101), microcrystalline cellulose (PH112), sodium croscarmellose, sodium lauryl sulfate

Hydrogenated vegetable oil, anhydrous colloidal silica.

Coating:

Opadry Blanco OY-S-58910 (contains hypromellose (E464), titanium dioxide (E171), macrogol

(E1521), talc (E553b)).

Product appearance and packaging content

Coated tablets with a white to almost white film, capsule-shaped, smooth on one side and engraved with "500" on the other. The tablets have a length of 18.0 mm, a width of 9.0 mm, and a thickness of 6.95 mm. Each box contains 6, 10, 12, 14, 15, 20, 24, 30, 50, 100, 120, or 500 tablets (clinical packaging) in ablister of PVC / ACLAR / Aluminum

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible manufacturer

Alkaloida Chemical Company Zrt.

4400 Tiszavasvári

Kabay János u.29

Hungary

or

Terapia, S.A.

124, Fabricii Street

400 632 – Cluj Napoca

Romania

or

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87 - Hoofddorp - 2132 JH - Netherlands

Local representative

Sun Pharma Laboratories, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Cefuroxim SUN 250 mg filmomhulde tabletten

Cefuroxim SUN 500 mg filmomhulde tabletten

Czech Republic:Znobact500 mgpotahované tablety

Hungary: Ceroxim 250 mg (500 mg) filmtabletta

Germany: CEFUROX BASICS 250mg (500mg) Filmtabletten

Poland: Ceroxim

Slovakia:Cefuroxim SUN500 mgfilmom obalené tablety

Spain:Cefuroxima SUN comprimidos recubiertos con película EFG

Last review date of this leaflet:May 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es