Aksef 500 mg film-coated tablets (cefuroxime) – bacterial infections of the throat, sinuses, ear, airways and urinary tract

Aksef is a cephalosporin antibiotic containing the active substance cefuroxime (as cefuroxime axetil). It works by killing the bacteria that cause infections and is used in adults and children from 3 months of age.

In Serbia it is authorised as Aksef 500 mg film-coated tablets (pack of 10 tablets). It is dispensed on a single-use (non-renewable) prescription.

What is Aksef 500 mg used for and how is it taken correctly?

Key facts about the medicine

What is Aksef used for?

According to the approved documentation, Aksef is intended for adults and children from 3 months of age to treat infections caused by susceptible bacteria:

• acute streptococcal pharyngitis and tonsillitis (throat infections);
• acute bacterial sinusitis;
• acute middle ear infection (otitis media);
• acute exacerbation of chronic bronchitis;
• urinary tract infections – cystitis and pyelonephritis;
• uncomplicated skin and soft tissue infections;
• early Lyme disease (an infection transmitted by ticks).

The doctor takes official guidance on antibiotic use into account and may check whether the bacteria are susceptible to the medicine.

How is it used and dosed?

The usual adult dose is 250 mg to 500 mg twice daily, depending on the severity and type of infection. The usual duration of treatment is 7 days (5 to 10 days). According to the SmPC:

• Take the medicine after a meal for better absorption, swallowed whole with a glass of water; do not chew or crush the tablets.
• Children under 40 kg: the doctor doses by body weight, 10–15 mg/kg twice daily (maximum 125–250 mg per dose depending on the infection). Doses below 250 mg cannot be given with the 500 mg tablet – another form of cefuroxime is then used.
• Cefuroxime tablets and cefuroxime granules for oral suspension are not interchangeable on a milligram-for-milligram basis.

Special patient groups

• Children: not recommended in children under 3 months. For doses below 250 mg an appropriate form of cefuroxime is needed.
• Kidney impairment: according to the SmPC, with creatinine clearance ≥ 30 mL/min no adjustment is needed; at 10–29 mL/min the standard dose is given once daily; below 10 mL/min every 48 hours; in haemodialysis an additional dose at the end of each dialysis. The dose is decided by the doctor.
• Liver impairment: no data; as cefuroxime is excreted mainly by the kidneys, no effect on its pharmacokinetics is expected.

Contraindications – when the medicine must not be used

Do not take Aksef:

• if you are allergic to cefuroxime, any cephalosporin antibiotic or any ingredient of the medicine;
• if you have ever had a severe allergic reaction to another beta-lactam antibiotic (penicillins, monobactams, carbapenems);
• if you have had a severe rash, skin peeling, blisters or mouth sores after treatment with cefuroxime or another cephalosporin.

Precautions and warnings

• During treatment watch for allergic reactions, fungal infections (e.g. candidiasis) and severe diarrhoea (pseudomembranous colitis).
• Serious skin reactions have been reported with cefuroxime: Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS – seek help immediately if such symptoms occur.
• The medicine may affect the results of blood sugar tests and the Coombs test; tell the person taking your blood that you are taking Aksef.
• The medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially „sodium-free“.

Interactions with other medicines, alcohol and food

• Medicines that reduce stomach acid (e.g. antacids) may affect how Aksef works.
• Probenecid and oral anticoagulants may affect how the medicine works.
• Aksef may reduce the effectiveness of contraceptive pills – during treatment use an additional barrier method (e.g. a condom) and ask your doctor for advice.
• Swallow the tablet whole with a glass of water after a meal.

Pregnancy and breastfeeding

Before taking the medicine tell your doctor if you are pregnant, think you may be pregnant, are planning a pregnancy or are breastfeeding. The doctor will weigh the benefit of treatment against the possible risk to the baby.

Driving and using machines

Aksef may cause dizziness and other side effects that reduce alertness. Do not drive or operate machinery if you do not feel well.

Possible side effects

• Common (up to 1 in 10): fungal infections (Candida), headache, dizziness, diarrhoea, nausea, stomach pain; in blood tests increased eosinophils and liver enzymes.
• Uncommon (up to 1 in 100): vomiting, skin rash; in blood tests decreased platelets and white blood cells, positive Coombs test.
• Not known: severe diarrhoea (pseudomembranous colitis), allergic reactions, skin reactions (including severe), fever, yellowing of the skin or eyes, hepatitis, haemolytic anaemia.
• Conditions to look out for: severe allergic reaction, target-like rash, widespread rash with blisters and peeling skin, Jarisch-Herxheimer reaction during treatment of Lyme disease (fever, headache, muscle pain, rash – usually a few hours to one day), DRESS syndrome and chest pain as part of an allergic reaction (Kounis syndrome).

Suspected side effects can be reported to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: neurological disturbances, most likely seizures, may occur. Contact a doctor or emergency service immediately and take the pack with you.
• Missed dose: do not take a double dose; take the next dose at the usual time.
• Stopping treatment: do not stop without your doctor's advice – if you do not complete the prescribed course, the infection may come back.

Related information

• When and how to take probiotics with antibiotics
• How dangerous is a tick bite and how to remove a tick safely

For additional care and support with diarrhoea during and after antibiotic treatment, see also the Products with probiotics category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Each film-coated tablet contains 500 mg cefuroxime (as cefuroxime axetil).
• Excipients – core: pregelatinised starch; crospovidone; croscarmellose sodium; sodium lauryl sulfate; magnesium stearate; colloidal anhydrous silica. Coating: Opadry Complete 03A38601 White (hypromellose E464, microcrystalline cellulose E460, stearic acid E570, titanium dioxide E171).
• Oval white film-coated tablets with a score line on one side and „NOBEL“ on the other; PVC/TE/PVDC-Al blister of 10 tablets.
• Marketing authorisation holder: Predstavništvo Nobel Ilac Sanayii ve Ticaret AS Beograd (Vračar), Brane Crnčevića 5, Belgrade.
• Manufacturer: Nobel Ilac Sanayii ve Ticaret A.S., Düzce, Turkey.

Storage

• Store below 25 °C in the original package to protect from light.
• Shelf life: 3 years.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Should Aksef be taken before or after meals?

After meals. Taking it after a meal increases absorption and effectiveness. Swallow the tablet whole with a glass of water.

Does Aksef reduce the effect of contraceptive pills?

Yes, according to the leaflet Aksef may reduce the effectiveness of contraceptive pills. Use an additional barrier method, e.g. a condom, during treatment and ask your doctor.

What if I get diarrhoea during treatment?

Diarrhoea is a common side effect. If it is severe, watery, bloody or mucous and accompanied by abdominal pain and fever, it may be a sign of pseudomembranous colitis – contact your doctor immediately.

Can Aksef 500 mg be given to a child?

The medicine is intended for children from 3 months, but in children under 40 kg the dose is calculated by body weight. Doses below 250 mg cannot be achieved with the 500 mg tablet, so the doctor then prescribes another form of cefuroxime.

Sources

• ALIMS – Patient leaflet Aksef® 500 mg film-coated tablets (approved March 2026, Serbian)
• ALIMS – Summary of Product Characteristics Aksef® 500 mg film-coated tablets (authorisation 002555800 2025 of 03.03.2026, Serbian)
• ALIMS – List of new authorisations and renewals 01.02.–31.03.2026 (Aksef 500 mg, 1 x 10 tablets)

Sources checked on: 23 October 2026.