CEFUROXIME NORMON 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxima Normon 250 mg Film-Coated Tablets EFG

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 get 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 and other information:

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

Contents of the pack and further information

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

Cefuroxima is an antibiotic used in adults and children. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

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).

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

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 a severe skin rash or skin peelingand/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

Be careful with Cefuroxima Normon:

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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefuroxima Normon

Cefuroxima 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 (Candida), 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 a blood test

Cefuroxima may affect the results of blood sugar tests or the Coomb test. If you need a blood test:

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

Taking Cefuroxima Normon 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 mechanism of action of Cefuroxima.

Probenecid

Oral anticoagulants

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

Contraceptive pill

Cefuroxima may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while taking Cefuroxima Normon, you should also use barrier contraceptive methods(such as condoms). 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.

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

Driving and using machines

Cefuroxima Normon may cause dizzinessand other side effects that may impair your ability to be alert.

• Do not drive or use machineryif you do not feel well.

Cefuroxima Normon 250 mg contains sodium

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

3. How to take Cefuroxima Normon

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take Cefuroxima Normon after meals.This will help the treatment be more effective.

Swallow the Cefuroxima Normon tablets with water.

The 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 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 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 disorders, in particular, you may have a higher probability of having seizures (convulsions).

• 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxima Normon

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

Do not interrupt treatment with Cefuroxima Normon without prior advice.

It is important that you complete the entire treatment of Cefuroxima Normon.Do not interrupt it unless your doctor indicates it, 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 experienced an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• Widespread rash, high body temperature, and enlarged 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).
• 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, resembling 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)
• Fungal infections.Medicines like cefuroxima can cause an increase in fungal growth (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely to occur if cefuroxima has been taken for a prolonged period.
• Severe diarrhea (pseudomembranous colitis).Medicines like cefuroxima can cause inflammation of the colon (large intestine), leading to 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 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 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 rashes (which can 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect 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 Normon

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. 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 Normon

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

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

Appearance of the product and packaging contents

White or almost white, elongated, biconvex, and scored film-coated tablets. Each carton contains 10, 15, or 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios NORMON, S.A.

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

Manufacturer:

Laboratorios NORMON, S.A.

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

Date of the last revision of this leaflet:July 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (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/68114/P_68114.html