Cefuroxime CINFA 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cefuroxime cinfa 500 mg film-coated tablets EFG

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

Contents of the leaflet

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

Contents of the pack and other information.

1. What cefuroxime cinfa is and what it is used for

Cefuroxime cinfa 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 are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Cefuroxime 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

Cefuroxime may also be used to:

• treat Lyme disease (an infection transmitted by ticks).

Your doctor may identify the type of bacteria causing your infection and monitor whether the bacteria are sensitive to cefuroxime during treatment.

2. What you need to know before taking cefuroxime cinfa

Do not take cefuroxime cinfa

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

If you think any of the above applies to you, do not take cefuroxime until you have consulted your doctor.

Take special care with cefuroxime cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take cefuroxime cinfa.

Children

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 you should be aware of" in section 4.

If you need a blood test

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.

Other medicines and cefuroxime cinfa

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 for treating heartburn) may affect the action of cefuroxime.

Probenecid

Oral anticoagulants

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

Contraceptive pill

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

Pregnancy, breast-feeding and fertility

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

Driving and using machines

Cefuroxime 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 cinfa contains sodium

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

3. How to take cefuroxime cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in 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 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 for children under 3 months of age, as the 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 cinfa 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 immediately or go to the nearest hospital emergency department. If possible, show them the cefuroxime packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested.

If you forget to take cefuroxime cinfa

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

If you stop treatment with cefuroxime cinfa

Do not stop treatment with cefuroxime without prior medical advice.

It is important that you complete the full course of cefuroxime 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 return.

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 experiences them.

Symptoms you should be aware of

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

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

• Skin rash, which may cause blisters, appearing 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 blistering and peeling of the skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis)

• Generalized 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 an allergic-triggered heart attack (Kounis syndrome).

Other symptoms you should be aware of while taking cefuroxime

• Fungal infections. Medicines like cefuroxime can 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 like cefuroxime can 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 a 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 patients:

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

Frequent adverse effects that may appear in blood tests:

• increase in the count of a type of white blood cells (eosinophilia)
• increase in liver enzyme levels.

Uncommon adverse effects

May affect up to 1 in 100 patients:

• 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
• yellowish discoloration 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 it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of cefuroxime cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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. Dispose of unused medicines and their containers at a SIGRE point.

6. Contents of the pack and other information

Composition of cefuroxime cinfa

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

• The other components are:

Core: pregelatinized corn starch, croscarmellose sodium, 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 medicinal product and contents of the pack

Film-coated, light blue, capsule-shaped tablets, marked "500" on one side and "P126" on the other.

Presented in PVC/aluminum foil blisters.

Each pack contains 10, 15, 20 or 500 (hospital pack) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

Date of the most recent revision of this leaflet: May 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/72261/P_72261.html

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