Package Insert: Information for the User

Cefuroxima Alter 500 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 package insert. See section 4.

Cefuroxima Alter is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medications calledcephalosporins.

Cefuroxima Alter is used to treat infections of:

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

Cefuroxima Alter may also be used to:

• treat Lyme disease (infection transmitted by ticks).
• Your doctor may analyze the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxima Alter during treatment.

Do not take CefuroximaAlter:

• If you are allergicto cefuroxima (as axetilo)or to any cephalosporin antibioticor to any of the other components 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, monobactam, and carbapenem derivatives).
• If you consider this applies to you, do not take Cefuroxima Alteruntil 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 Alter

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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 Alter

Cefuroxima Alteris not recommended for children under 3 months, as thesecurity and efficacy for this age group have not been established.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such asCandida), and severe diarrhea (pseudomembranous colitis) while taking Cefuroxima Apotex. This will reduce the risk of possible complications. See“Symptoms to be aware of”in section 4.

If you need a blood test

Cefuroxima Alter may affect the results of blood sugar levels in blood tests, or theCoomb test.If you need a blood test:

• Inform the person performing the testthat you are taking cefuroxima.

Other medicines and Cefuroxima Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes medicines obtained without a prescription.

Medicines used toreduce stomach acid(e.g.antacidsto treatheartburn) may affect the mechanism of action of Cefuroxima Alter.

Probenecid

Oral anticoagulants

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

Birth control pill

Cefuroxima Alter may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while taking CefuroximaAlter, 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 medicine.

Driving and operating machinery

Cefuroxima Altermay cause dizzinessand other adverse effects that may impair your ability to be alert.

?Do not drive or operate machineryif you do not feel well.

??Check with your doctor thatCefuroximaAlteris suitable for you.

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 Alterafter meals.This will help make the treatment more effective.

Swallow the Cefuroxima Alter tabletswhole with water.

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

Recommended dose

Adults

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

Children

The recommended dose of Cefuroxima Alter 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 Alteris not recommended in children under 3 months, as the safety and efficacy for this patient group 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 Alterthan you should

If you take too much Cefuroxima Alter you may experience neurological disturbances, particularly you may be more likely to haveseizures (convulsions).

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cefuroxima Alter

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

If you interrupt treatment with Cefuroxima Alter

Do not interrupt treatment with Cefuroxima Alterwithout prior advice.

It is essential that you complete the entire Cefuroxima Alter treatment.Do not interrupt it unless your doctor tells you to, even if you start feeling better. If you do not complete the treatment cycle, the infection may recur.

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

Like all medicines, this medicine can 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 pinpricks(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)
• Generalized rash, high body temperature, and swollen lymph nodes.(DRESS syndrome or drug hypersensitivity syndrome)
• Chest pain in the context of allergic reactions,which may be a symptom of an allergic-induced heart attack (Kounis syndrome)

Other symptoms to be aware of while taking cefuroxime:

• Fungal infections.Medicines like Cefuroxime Altercan cause an increase in fungal growth (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 Altercan 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 Alterto treat Lyme disease. This is known asJarisch-Herxheimer reaction.The symptoms usually last for a few hours to a day.

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

Frequent side effects

May affectup to 1 in 10people:

• Fungal infections (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.

Rare side effects

May affectup to 1 in 100people:

• Vomiting
• Skin rash.

Rare 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
• Inflammation of the liver (hepatitis).

Side effects that may appear in blood tests:

• Rapid destruction of red blood cells (hemolytic anemia).

Reporting 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 Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No requires special conditions for conservation.

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

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

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Cefuroxima Alter Composition

• The active ingredient is cefuroxima. Each tablet contains 500 mg of cefuroxima (as cefuroxima axetilo).

The other components (excipients) are: pregelatinized cornstarch (cornstarch), croscarmelosa sodium (AC-Disol SD-711), sodium laurilsulfate, microcrystalline cellulose, anhydrous colloidal silica, hydrogenated vegetable oil, Opadry(hydroxypropylmethylcellulose, titanium dioxide, propan-1,2-diol (propylene glycol), brilliant blue FCF, carmine, indigo).

Product appearance and packaging contents

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

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Responsible manufacturer:

Farmalider, S.A.

C/ Aragoneses 2

28108 Alcobendas

Madrid

or

Laboratorios Atral, S.A.

Rua da Estação1 e 1A

2600-726 Castanheira do Ribatejo.

Portugal

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Last review date of this leaflet: February 2023

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