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Normon S.A. - Spain


Forms and presentation
Film-coated tablets: Box of 12.

Each tablet contains: Cefuroxime: 500 mg. Excipients: microcrystalline cellulose, sodium croscarmellose, sodium laurilsulphate, colloidal silica, hydrogenated vegetable oil, hypromellose, titanium dioxide.

Cefuroxime is an antibiotic that belongs to the group of cephalosporins.

Normocef is indicated for the treatment of several infectious, of mild to moderate severity, caused by susceptible pathogens, of the upper and lower respiratory tract, the urinary tract, the skin, and soft tissue.

Hypersensitivity to cefuroxime, other cephalosporins, or to any of the other components of this medicine.

Caution is advised in patients with known hypersensitivity to penicillin or other antibiotics, if after taking this medicine any allergic reaction occurs, treatment must be discontinued and a doctor must be consulted as soon as possible.
Caution is also advised in patients with kidney disease, the dose must be reduced.
Any severe diarrhoea occurring during treatment must be reported to the doctor.
As with other antibiotics, long-term use can cause other infections, which may require treatment discontinuation.

Drug interactions
Do not use this medicine together with other antibiotics (chloramphenicol, tetracyclines, sulphamides).
Caution is advised in patients receiving concomitant treatment with potent diuretics (furosemide or ethacrynic acid), as they increase the risk of renal disorders by cephalosporins.
This medicine could affect the results of blood or urine glucose tests.

Ability to drive and use machine
No effects on the ability to drive and handle machines have been described.

Pregnancy and lactation
Pregnancy: As with any drug, Normocef must be administered with caution during pregnancy.
Lactation: Cefuroxime enters nursing milk and, consequently, caution should be exerted when administered to nursing women.

Side effects
Like all medicines, Normocef can cause side effects, although not everybody gets them.
If the patient experience breathlessness, chest tightening, swelling of the eyelids, face or lips, hives or lumps in the skin, nausea, significant diarrhoea, severe stomach pain, rectal bleeding, faeces with mucus or pus or occurrence skin or eye yellow colour, a doctor must be immediately consulted and the medicine must be stopped.
Caution is advised in patients experiencing any of the following symptoms: itching, skin decolouration or shedding, headache, diarrhoea, or mild nausea, easy bruising.
The following adverse events are very rare and can occur in less than 1 of every 10,000 patients using Normocef: Haemolytic anaemia, medicinal fever, serum disease, anaphylaxis, pseudomembranous colitis, jaundice, hepatitis, severe skin rash.
The following adverse events are uncommon and can occur in >1 in every 1,000 patients and < 1% patients using Normocef: Thrombocytopenia, leucopoenia, skin rash, vomiting.
The following adverse events are rare and can occur in >1 in every 10,000 patients and <1 in every 1,000 patients using Normocef: hives, pruritus.
The following adverse events are common and can occur in more than 1 in every 100 patients and <1 in every 10 patients using Normocef: Headache, gastrointestinal disorders, including diarrhoea, nausea, eosinophilia, transient increases in liver enzyme levels.

Dosage and administration
Normocef is administered by oral route. The tablets must be swallowed whole, without chewing or crushing, with some water or any other fluid. Normocef is more effective if taken after some food.
Adults and children over 12 years of age: the standard dose is 500 mg every 12 hrs in acute bronchitis, acute worsening of chronic bronchitis and pneumonia.
In urinary infections, the standard dose is quarter a tablet of Normocef every 12 hrs; in some patients the dose can be increased to half a tablet of Normocef every 12 hrs.
Children from 5 to 12 years: in general, quarter a tablet of Normocef 250 mg every 12 hrs. In children with otitis media, the dose can be increased to half a tablet of Normocef every 12 hrs.
It is not recommended to use the tablets in children under 5 years of age, as it is not the most appropriate.
There is not experience in children under 3 months of age.
The standard duration of treatment is 5 to 10 days. It is advisable not to prolong treatment over 10 days.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Registration Number: 218662/2010