Package Leaflet: Information for the User

Cefuroxime Cinfa 500 mg Film-Coated Tablets

Cefuroxime (as axetil)

Read this 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. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Contents of the pack and additional information.

cefuroxima cinfa 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 called cephalosporins .

Cefuroxima is used to treat infections of:

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

Cefuroxima may also be used to:

• treat Lyme disease (tick-borne infection).

Your doctor may analyze the type of bacteria causing your infection and check if the bacteria are sensitive to cefuroxima during treatment.

Do not take cefuroxima cinfa

• If you are allergictocefuroxima (as axetilo) 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, 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 think this applies to you,do not take cefuroximauntil you have consulted your doctor.

Be especially careful with cefuroxima cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take cefuroxima cinfa.

Children

Cefuroxima is not recommended for children under 3 months, as its safety and efficacy for this age group are unknown.

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

If you need a blood test

Cefuroxima may affect the results of blood sugar levels or theCoombs test.

If you need a blood test:

• Inform the person performing the testthat you are taking cefuroxima.

Other medicines and cefuroxima cinfa

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

Medicines used toreduce stomach acid(e.g.antacidsfor treatingheartburn) may affect the mechanism of action of cefuroxima.

Probenecid

Oral anticoagulants.

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

Birth control pill

Cefuroxima may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while taking cefuroxima, you should use additional barrier methods (such ascondoms). Consult your doctor.

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 medicine.

Driving and operating machinery

Cefuroximamay cause dizzinessand other adverse effects that may impair your ability to be alert.

• Do not drive or operate machineryif you are not feeling well.

Cefuroxima cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take cefuroxime after meals.This will help make the treatment more effective. Swallow the cefuroxime 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 cefuroxime is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Children

The recommended dose of cefuroxime 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

Cefuroxime is not recommended in children under 3 months, as the safety and efficacy for this group of patients 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 cefuroxime than you should

If you take too much cefuroxime, you may experience neurological disturbances, particularly you may have a higher probability of havingseizures (epileptic attacks).

• Do not delay. Contact your doctor immediately or go to the nearest hospital emergency department. If possible, show them the cefuroxime packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takecefuroxime

Do not take a double dose to compensate for the missed doses.Simply continue with the next dose as recommended.

If you interrupt the treatment withcefuroxime

Do not interrupt the treatment with cefuroxime without prior advice.

It is essential that you complete the entire cefuroxime treatment.Do not interrupt 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 other doubts 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 you should be aware of

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

• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing

• Skin rash,which may causeblistering,which appear likesmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)

• Widespread skin rash withblistering and skin peeling.(These may be symptoms ofStevens-Johnson syndromeortoxic epidermal necrolysis)

• Generalized rash, high body temperature, and swollen lymph nodes.(DRESS syndrome or drug hypersensitivity syndrome)

• Chest painin the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome)

Other symptoms you should be aware of while taking cefuroxime

• Fungal infections.Medicines like cefuroxime can cause an increase in fungal growth (Candida), in the body that may lead to fungal infections (such as thrush). This side effect is more likely to occur if cefuroxime has been taken for a prolonged period
• Severe diarrhea (pseudomembranous colitis).Medicines like cefuroxime 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 cefuroxime to treat Lyme disease. This is known asJarisch-Herxheimer reaction. The symptoms usually last for a few hours to a day.

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

Frequent side effects

May affectup to 1 in 10patients:

• Fungal infections (such asCandida)
• Headache
• Dizziness
• Diarrhea
• Nausea
• Stomach pain.

Frequent side effects that may appear in blood tests:

• Increased count of a type of white blood cell (eosinophilia)
• Increased levels of liver enzymes.

Rare side effects

May affectup to 1 in 100patients:

• Vomiting
• Skin rash.

Rare side effects that may appear in blood tests:

• Decreased number of platelets in the blood (cells that help blood to clot)
• Decreased 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 rash (which may be severe)
• High fever
• Yellowing of the white 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 the Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special conditions for conservation.

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

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

Composition ofcefuroxima cinfa

• The active ingredient is cefuroxima. Each tablet contains 500 mg of cefuroxima (as cefuroxima axetilo).

-The other components are:

Core:pregelatinized cornstarch, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil.

Coating:hypromellose (E-464), titanium dioxide (E-171), propylene glycol (E-1520), brilliant blue FCF (E-133) and indigo carmine (E-132).

Appearance of the product and contents of the package

Tablets with a clear blue film coating, in capsule shape, marked with "500" on one face and "P126" on the other face.

Presented in PVC/aluminum blisters.

Each package contains10, 15, 20 or 500 (clinical package)film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Farmalider, S.A

Aragoneses, 2

28108 (Alcobendas) Madrid

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 – Alcobendas (Madrid)

or

Laboratorios Atral, S.A.

Rua da Estação, 1 e 1A,

Castanheira do Ribatejo, 2600-726, Portugal

Last review date of this leaflet:May 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/72261/P_72261.html

QR code to:https://cima.aemps.es/cima/dochtml/p/72261/P_72261.html