Cefuroxime Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Normon 500 mg film-coated tablets EFG

Read the entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Cefuroxime Normon is and what it is used for
2. What you need to know before taking Cefuroxime Normon
3. How to take Cefuroxime Normon
4. Possible adverse effects
5. How to store Cefuroxime Normon

Pack contents and additional information

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

Cefuroxime 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.

Cefuroxime is used to treat infections of:

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

Cefuroxime may also be used to:

• treat Lyme disease (an infection transmitted by ticks)

2. What you need to know before taking Cefuroxime Normon

Do not take Cefuroxime Normon:

• If you are allergic to cefuroxime, to cephalosporins, or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had a severe allergic (hypersensitivity) reaction to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• If you think this applies to you, do not take Cefuroxime Normon until you have consulted your doctor.
• If you have ever developed severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

Take special care with Cefuroxime Normon:

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with cefuroxime. Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cefuroxime Normon.

Cefuroxime is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.

Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking cefuroxime. This will help reduce the risk of possible complications. See "Symptoms to which you should pay attention" in section 4.

If you need blood tests

Cefuroxime may affect test results for blood sugar levels or the Coombs test. If you need a blood test:

• Inform the person performing the test that you are taking cefuroxime.

Taking Cefuroxime Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Medicines used to reduce stomach acidity (e.g. antacids used to treat heartburn) may affect the mechanism of action of Cefuroxime Normon.

Probenecid

Oral anticoagulants

• Inform your doctor or pharmacist if you are taking any medicine of this type.

Oral contraceptives

Cefuroxime may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while using Cefuroxime Normon, you should also use barrier contraceptive methods (such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess the benefit of treatment with Cefuroxime Normon against the potential risk to your baby.

Driving and using machines

Cefuroxime Normon may cause dizziness and other adverse effects that could impair your ability to remain alert.

• Do not drive or operate machinery if you do not feel well.

Cefuroxime Normon 500 mg contains sodium

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

3. How to take Cefuroxime Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take Cefuroxime Normon after meals. This will help make the treatment more effective.

Swallow the Cefuroxime Normon tablets with water.

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

Recommended dose

Adults

The recommended dose of cefuroxime is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children

The recommended dose of cefuroxime is 10 mg/kg of the child's body weight (up to a maximum of 125 mg) to 15 mg/kg of the child's body weight (up to a maximum of 250 mg) twice daily, depending on the severity and type of infection.

Cefuroxime is not recommended in children under 3 months of age, as safety and efficacy in this patient group are unknown.

Depending on the illness and how you or your child responds to treatment, the initial dose may be adjusted or more than one treatment cycle may be required.

Patients with kidney problems

If you have kidney problems, your doctor may adjust your dose.

• Consult your doctor if you are affected by this condition.

If you take more Cefuroxime Normon than you should

If you take too much cefuroxime, you may experience neurological disturbances, particularly an increased risk of epileptic seizures (convulsions).

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Cefuroxime Normon

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

Do not stop treatment with Cefuroxime Normon without prior advice.

It is important that you complete the full course of Cefuroxime Normon treatment. Do not stop unless instructed by your doctor, even if you start to feel better. If you do not complete the treatment course, the infection may recur.

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

4. Possible adverse effects

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

Symptoms to watch for

A small number of people who took cefuroxime have experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

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

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

• Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing.

• Skin rash, possibly causing blisters, that look like small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge).

• Widespread skin rash with blisters and peeling skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis).

• Fungal infections. Medicines such as cefuroxime may cause increased growth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if cefuroxime has been taken for a prolonged period.

• Severe diarrhoea (pseudomembranous colitis). Medicines such as cefuroxime may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, 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 as Jarisch-Herxheimer reaction. Symptoms usually last from a few hours to one day.

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

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

• fungal infection (such as Candida)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain.

Frequent adverse effects that may appear in blood tests:

• increased count of a type of white blood cells (eosinophilia)
• increased levels of liver enzymes.

Uncommon adverse effects (may affect up to 1 in 100 people):

• vomiting
• skin rashes.

Uncommon adverse effects that may appear in blood tests:

• decrease in the number of blood platelets (cells that help blood to clot)
• decrease in the number of white blood cells
• positive Coombs test.

Other adverse effects

Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin rashes (which may be severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).

Adverse effects that may appear in blood tests:

• rapid destruction of red blood cells (haemolytic anaemia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime Normon

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

Store in the original packaging to protect it 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima Normon

The active substance is cefuroxime. Each tablet contains 500 mg of cefuroxime (as cefuroxime axetil).

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

Appearance of the product and contents of the pack

Film-coated tablets, white or almost white, elongated and biconvex. Each package 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 most recent revision of this leaflet: July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/ dochtml/p/68115/P_68115.html