Cefuroxime Sun 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime SUN 500 mg film-coated tablets EFG

Cefuroxime (as cefuroxime axetil)

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

Leaflet contents

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

2. What you need to know before taking Cefuroxime SUN

3. How to take Cefuroxime SUN

4. Possible side effects

5. How to store Cefuroxime SUN

6. Contents of the pack and other information

1. What Cefuroxima SUN 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in 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 (a tick-borne infection).

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

2. What you need to know before taking Cefuroxime SUN

Do not take Cefuroxime SUN:

• 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 peeling skin, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

If you think any of the above apply to you, do not take Cefuroxime SUN until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefuroxime SUN.

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

Children

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

You should be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida) and severe diarrhoea (pseudomembranous colitis) while taking Cefuroxime SUN. This will help reduce the risk of possible complications. See “Symptoms to watch for” in section 4.

If you need a blood test

Cefuroxime SUN 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 SUN.

Taking Cefuroxime SUN 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 action of Cefuroxime SUN.

Probenecid (a medicine used to treat gout)

Oral anticoagulants (medicines used to reduce the blood's ability to clot)

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

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.

Driving and using machines

Cefuroxime SUN 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.

Important information about some ingredients of Cefuroxime SUN

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

3. How to take Cefuroxime SUN

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 SUN after meals. This will help make the treatment more effective.

Swallow the Cefuroxime SUN 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 SUN is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children

The recommended dose of Cefuroxime SUN 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 SUN 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 it may be necessary to administer more than one course of treatment.

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 SUN than you should

If you take too much Cefuroxime SUN, you may experience neurological disorders, in particular you may have 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 SUN 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 name of the medicine and the amount ingested.

If you forget to take Cefuroxime SUN

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

If you stop taking Cefuroxime SUN

Do not stop treatment with Cefuroxime SUN without prior medical advice.

It is important that you complete the full course of treatment with Cefuroxime SUN. Do not stop unless instructed by your doctor, even if you start to feel better. If you do not complete the full course of treatment, 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 gets them.

Symptoms to watch for

A small number of people who took Cefuroxime SUN 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 blisters 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 a heart attack triggered by allergy (Kounis syndrome).

Other symptoms to watch for while taking Cefuroxime SUN include:

• Fungal infections. Medicines like Cefuroxime SUN 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 SUN has been taken for a prolonged period.

• Severe diarrhoea (pseudomembranous colitis). Medicines like Cefuroxime SUN 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 SUN 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.

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

• Fungal infection (such as Candida)
• Headache
• Dizziness
• Diarrhoea
• Nausea
• Stomach pain

Common adverse effects that may appear in blood tests:

• Increase in the 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 it is a possible adverse effect 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 SUN

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

Do not use this medicine after the expiry date stated on the packaging after the letters CAD. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima SUN

• The active substance is cefuroxime (as axetil). Each tablet contains 500 mg of cefuroxime (as axetil).
• The other components (excipients) are:

Core:

Microcrystalline cellulose (PH101), microcrystalline cellulose (PH112), sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica.

Coating:

Opadry White OY-S-58910 (contains hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b)).

Appearance of the medicinal product and contents of the pack

Film-coated tablets, white to almost white, capsule-shaped, smooth on one side and engraved with "500" on the other. The tablets are 18.0 mm in length, 9.0 mm in width and 6.95 mm in thickness. Each box contains 6, 10, 12, 14, 15, 20, 24, 30, 50, 100, 120 or 500 tablets (clinical pack) in PVC / ACLAR / Alu blisters.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Manufacturer

Alkaloida Chemical Company Zrt.
4400 Tiszavasvári
Kabay János u. 29
Hungary

or

Terapia, S.A.
124, Fabricii Street
400 632 – Cluj Napoca
Romania

or

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
Polarisavenue, 87 - Hoofddorp - 2132 JH - The Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona, Spain
Tel.: +34 93 342 78 90

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Cefuroxim SUN 250 mg filmomhulde tabletten
Cefuroxim SUN 500 mg filmomhulde tabletten

Czech Republic: Znobact 500 mg potahované tablety

Hungary: Ceroxim 250 mg (500 mg) filmtabletta

Germany: CEFUROX BASICS 250mg (500mg) Filmtabletten

Poland: Ceroxim

Slovakia: Cefuroxim SUN 500 mg filmom obalené tablety

Spain: Cefuroxima SUN film-coated tablets EFG

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 Health Products (AEMPS) http://www.aemps.gob.es