CEFUROXIME SUN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxima SUN 500 mg film-coated tablets EFG

Cefuroxima (as cefuroxima axetil)

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 or 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 experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cefuroxima SUN and what is it used for
2. What you need to know before you take Cefuroxima SUN
3. How to take Cefuroxima SUN
4. Possible side effects
   1. Storage of Cefuroxima SUN

1. Contents of the pack and further information

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

Cefuroxima 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.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

It is important to follow the dosage, administration, and treatment duration instructions indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Cefuroxima is used to treat infections of:

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

Cefuroxima can also be used to:

• treat Lyme disease (infection transmitted by ticks).

Your doctor may analyze the type of bacteria that cause your infection and check if the bacteria are sensitive to Cefuroxima SUN during treatment.

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

Do not take Cefuroxima SUN:

• if you are allergicto cefuroxima (as axetil) or to any cephalosporin antibioticor 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 carbapenem derivatives)
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

If you think this applies to you, do not take Cefuroxima SUNuntil you have consulted 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 immediate medical attention 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 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 Cefuroxima 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 tests or the Coombs test. If you need a blood test:

• Tell the person doing the testthat you are taking Cefuroxima SUN.

Taking Cefuroxima SUN with other medicines

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., antacidsto treat heartburn) may affect the action of Cefuroxima SUN.

Probenecid (a medicine used to treat gout)

Oral anticoagulants (medicines used to reduce blood clotting ability)

Tell your doctor or pharmacistif 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.

Driving and using machines

Cefuroxima SUN may cause dizzinessand other side effects that may make you lose alertness.

Do not drive or use machinesif you do not feel well.

Important information about some ingredients of Cefuroxima SUN

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

3. How to take Cefuroxima SUN

Follow the administration instructionsof this medicineindicated by your doctoror pharmacist. If in 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 dose of Cefuroxima SUN is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Children

The recommended dose of Cefuroxima SUN is 10 mg/kg of the child's weight (up to a maximum of 125 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.

Cefuroxima SUNis 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.

If you take more Cefuroxima SUN than you should

If you take too much Cefuroxima SUN, you may experience neurological disorders, in particular, you may have a higher probability 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 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 medicine and the amount ingested.

If you forget to take Cefuroxima SUN

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

If you stop taking Cefuroxima SUN

Do not stop taking Cefuroxima SUN without prior advice.

It is important that you complete the entire treatment of Cefuroxima SUN.Do not stop it unless your doctor tells you to, 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 Cefuroxima SUN 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
• skin rash,which can cause blisters,that look like small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• widespread skin rashwith blisters and skin peeling.(These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome 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 be aware of while taking Cefuroxima SUN include:

• fungal infections.Medicines like Cefuroxima SUN 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 you have taken Cefuroxima SUN for a prolonged period
• severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxima SUN 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 Cefuroxima SUN 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):

• vomiting
• 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 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
• liver inflammation (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 and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxima SUN

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 the letters EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefuroxima SUN

• The active substance is cefuroxima (as axetil). Each tablet contains 500 mg of cefuroxima (as axetil).
• The other ingredients (excipients) are:

Core:

Microcrystalline cellulose (PH101), microcrystalline cellulose (PH112), sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silica.

Coating:

Opadry White OY-S-58910 (contains hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b)).

Appearance of the product and pack contents

White to almost white film-coated tablets, capsule-shaped, smooth on one side and engraved with "500" on the other. The tablets are 18.0 mm long, 9.0 mm wide, and 6.95 mm thick. Each box contains 6, 10, 12, 14, 15, 20, 24, 30, 50, 100, 120, or 500 tablets (clinical packaging) in PVC/ACLAR/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

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 Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona, Spain

Phone: +34 93 342 78 90

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

Netherlands: Cefuroxim SUN 250 mg film-coated tablets

Cefuroxim SUN 500 mg film-coated tablets

Czech Republic: Znobact 500 mg film-coated tablets

Hungary: Ceroxim 250 mg (500 mg) film-coated tablets

Germany: CEFUROX BASICS 250mg (500mg) film-coated tablets

Poland: Ceroxim

Slovakia: Cefuroxim SUN 500 mg film-coated tablets

Spain: Cefuroxima SUN film-coated tablets EFG

Date of last revision of this leaflet:May 2023

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