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.
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.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential to follow the instructions regarding dosage, administration, and treatment duration as indicated by your doctor. Do not store or reuse this medication. If you have leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash. |
Cefuroxima Alter is used to treat infections of:
Cefuroxima Alter may also be used to:
Do not take CefuroximaAlter:
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:
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:
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.
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).
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:
Other symptoms to be aware of while taking cefuroxime:
Frequent side effects
May affectup to 1 in 10people:
Frequent side effects that may appear in blood tests:
Rare side effects
May affectup to 1 in 100people:
Rare side effects that may appear in blood tests:
Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown:
Side effects that may appear in blood tests:
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 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
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