CEFUROXIME STADA 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefuroxime STADA 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

1. What is Cefuroxime Stada and what is it used for
2. What you need to know before you take Cefuroxime Stada
3. How to take Cefuroxime Stada
4. Possible side effects
5. Storage of Cefuroxime Stada
6. Contents of the pack and further information

1. What is Cefuroxime Stada and what is it 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:

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

Cefuroxime can also be used to:

• treat Lyme disease (infection transmitted by ticks).

2. What you need to know before you take Cefuroxime Stada

Do not take Cefuroxime Stada:

• If you are allergic to cefuroxime, 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 cefuroximeuntil you have consulted your doctor.
• 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.

Be cautious with Cefuroxime Stada

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 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 Cefuroxime Stada.

Cefuroxime 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 (such as Candida), and severe diarrhea (pseudomembranous colitis) while taking cefuroxime.

This will reduce the risk of possible complications. See “Symptoms to be aware of”in section 4.

If you need a blood test

Cefuroxime 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 cefuroxime.

Other medicines and Cefuroxime Stada

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 action of cefuroxime.

Probenecid

Oral anticoagulants

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

Contraceptive pill

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while taking cefuroxime, 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 are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Your doctor will weigh the benefits of being treated with cefuroxime against the risks to your child.

Driving and using machines

Cefuroxime 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.

Cefuroxime Stada contains sodium

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

3. How to take Cefuroxime Stada

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

Take Cefuroxime Stada 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.

Usual dose

Adults

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

Use in children and adolescents

The recommended dose of cefuroxime 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

Cefuroxime 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 Cefuroxime Stada than you should

If you take too much cefuroxime, you may experience neurological disorders, in particular, you may have a higher risk of having epileptic seizures (convulsions).

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Cefuroxime Stada

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 Cefuroxime Stada without prior advice.

It is important that you complete the entire treatment with cefuroxime.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 further questions on 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 cefuroxime presented with a severe allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• 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,that look like 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 cefuroxime can cause an increase in the growth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely to occur if you have taken cefuroxime for a long time
• 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 as Jarisch-Herxheimer reaction.The symptoms usually last from a few hours to a day.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• chest painin the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).
• 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
• liver inflammation (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, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime Stada

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefuroxime Stada

• The active substance is cefuroxime. Each tablet contains 250 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: pregelatinized corn starch, croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil. The other ingredients (excipients) of the coating are: hypromellose E464, titanium dioxide E171, propylene glycol E1520, brilliant blue FCF E133, carmine indigo E132.

Appearance of the product and packaging contents

Light blue film-coated tablets, biconvex, capsule-shaped.

Each carton contains 10, 15, or 20 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960- Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Farmalider S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 – Alcobendas (Madrid)

Spain

or

Laboratorios Atral, S.A.

Rua da Estação, 1 e 1A

2600 726 Castanheira do Ribatejo

Portugal

Date of the last revision of this leaflet:February 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es