Leaflet: information for the user

Cefuroxima Normon 250 mg film-coated tablets

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, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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 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 (an infection transmitted by ticks).

Do not take Cefuroxima Normon:

• If you are allergic to cefuroxima, to cephalosporinsor 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 carbapenems).
• If you think this applies to you,do not take Cefuroxima Normonuntil you have consulted your doctor.
• 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.

Be especially careful with Cefuroxima Normon:

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 Normon

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 possible complications. See“Symptoms to be aware of”in section 4.

If you need blood tests

Cefuroxima may affect the results of blood sugar levels or theCoomb's test.If you need a blood test:

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

Taking Cefuroxima Normon 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.

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 Normon, you should use additionalbarrier methods of contraception(such as condoms). Consult your doctor.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the benefit of being treated with cefuroxima against the risk to your child.

Driving and operating machinery

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

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

Cefuroxima Normon 250 mg contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) 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 Cefuroxima Normon after meals.This will help make the treatment more effective.

Swallow the tablets ofCefuroxima Normonwith water.

Cefuroxima Normon 250 mg tablets can be divided into equal doses.

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

Recommended dose

Adults

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

Children

The recommended dose of cefuroxima 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 is not recommended for 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 Cefuroxima Normon than you should

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

• Do not delay. Contact your doctor or the emergency department of the nearest hospital immediately. If possible, show them the Cefuroxima Normon packaging.

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

If you forgot to take Cefuroxima Normon

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

Do not interrupt the treatment with Cefuroxima Normon without prior advice.

It is essential that you complete the entire treatment of Cefuroxima Normon.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 may cause side effects, although not everyone will experience them.

Symptoms to 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:

• Generalized 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 allergic-induced heart attack (Kounis syndrome).
• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing
• Skin rash,which may causeblistering,appearing assmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• Widespread skin rashwithblistering and skin peeling.(These may be symptoms ofStevens-Johnson syndromeortoxic epidermal necrolysis)
• Fungal infections.Medicines like cefuroxime can cause an increase in fungal growth (Candida), in the body that can lead to fungal infections (such as mouth ulcers). 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.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 affect up to 1 in 10 people):

• Fungal infection (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 affect up to 1 in 100 people):

• 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 Coomb 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
• Liver inflammation (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 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.

Store in the original packaging to protect it from light and moisture.

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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cefuroxima Normon

The active ingredient is cefuroxima. Each tablet contains 250 mg of cefuroxima (as cefuroxima axetilo).

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, colloidal silicon dioxide, hydrogenated vegetable oil, hypromellose, and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Coated tablets with a white or almost white film coating, elongated, biconvex, and scored. Each box contains 10, 15, or 20 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

NORMON Laboratories, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Responsible for manufacturing:

NORMON Laboratories, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:July 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