Leaflet: information for the user

Cefuroxima Stada 500 mg film-coated tablets

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

Cefuroxima 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 calledcephalosporins.

Cefuroxima 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.

Cefuroxima may also be used to:

• treat Lyme disease (a tick-borne infection).

Do not take Cefuroxima Stada:

• If you are allergic to cefuroxima, to cephalosporins, or to any of the other ingredients of this medication (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 consider this applies to you, do not take cefuroxima until you have consulted with your doctor.
• If you have ever developed severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

Be especially careful with Cefuroxima Stada

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been associated with cefuroxima treatment. Seek medical attention immediately 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 Stada.

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

You should be aware of certain symptoms such as allergic reactions, fungal infections (such as 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 blood tests

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

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

Other medications and Cefuroxima Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications used to reduce stomach acidity (e.g., antacids for treating heartburn) may affect the mechanism of action of cefuroxima.

Probenecid

Oral anticoagulants

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

Birth control pill

Cefuroxima may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while taking cefuroxima, you should use additional barrier methods (such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

Cefuroxima may cause dizziness and other adverse effects that may impair your ability to stay alert.

• Do not drive or operate machinery if you are not feeling well.

Cefuroxima Stada contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take Cefuroxima Stada after meals.This will help make the treatment more effective.

Swallow the cefuroxima enteric-coated tablets with water.

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

Usual dose

Adults

The recommended dose of cefuroxima 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 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 the safety and efficacy for this group of patients is 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 Stada than you should

If you take too much cefuroxima, you may experience neurological disturbances, particularly you may have a higher probability of havingseizures (epileptic attacks).

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

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

If you forgot to take Cefuroxima Stada

Do not take a double dose to compensate for the missed doses. Simply continue with the next dose as usual.

Do not interrupt the treatment with Cefuroxima Stada without prior advice.

It is essential that you complete the entire cefuroxima treatment.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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Symptoms to be aware of

A small number of people who took cefuroxime presented an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing
• Skin rash,which may causeblistering,which appear likesmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• Widespread skin rashwithblistering and skin peeling.(These may be symptoms ofStevens-Johnson SyndromeorToxic Epidermal Necrolysis)
• Fungal infections.Medicines like cefuroxime can cause an increase in the growth of fungi (Candida), in the body that can lead to fungal infections (such as mouth ulcers). This side effect is more likely to occur if cefuroxime has been taken for a prolonged period
• 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 asJarisch-Herxheimer reaction. The symptoms usually last for a few hours to a day.
• Generalized rash,high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest painin the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
• Contact a doctor or nurse immediately if you experience any of these symptoms.

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

• Fungal infection (such asCandida)
• Headache
• Dizziness
• Diarrhea
• Nausea
• Stomach pain.

Frequent side effects that may appear in blood tests:

• Increased count of a type of white blood cell (Eosinophilia)
• Increased levels of liver enzymes.

Less frequent side effects(may affect up to 1 in 100 people):

• Vomiting
• Skin rash.

Less frequent side effects that may appear in blood tests:

• Decreased number of platelets in the blood (cells that help blood to clot)
• Decreased 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 rash (which may be severe)
• High fever
• Yellowing of the white of the eyes or skin
• Liver inflammation (hepatitis).

Side effects that may appear in blood tests:

• Quick destruction of red blood cells (Hemolytic Anemia).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Cefuroxima Stada Composition

• The active ingredient is cefuroxima. Each tablet contains 500 mg of cefuroxima (as cefuroxima axetilo).
• The other components are: pregelatinized cornstarch (cornstarch), sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil. The other components (excipients) of the coating are: hypromellose E464, titanium dioxide E171, propylene glycol E1520, brilliant blue FCF E133, indigo carmine E132.

Appearance of the product and contents of the packaging

Blue film-coated, biconvex, capsule-shaped tablets.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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

Last review date of this leaflet: February 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es