PATIENT INFORMATION LEAFLET NELABOCIN ... - Pharmathen

observed after the uptake of food.
The concomitant administration of cephalosporins with
tetracyclines or chloramphenicol is of antagonizing result.
When cefuroxime axetil is administered in large doses
along with nephrotoxic drugs such as aminoglycosides, the
risk of nephrotoxicity increases.
2.6 Posology and method of administration
Cefuroxime axetil should be taken after meals, so as for
greater absorption to be reached.
Adults: Most infections respond to 250mg twice daily.
Urinary infections: A dose of 125mg twice daily is usually
enough. In pyelonephritis, the recommended dose is
250mg twice daily.
Infections of the lower respiratory system of light to mean
severity such as bronchitis:
250mg twice daily.
More severe infections of the lower respiratory system or
in the suspicion of pneumonia: 500mg twice daily.
Uncomplicated gonococcal urethritis: 1g once daily.
Patients with renal impairment
The safety and effectiveness of cefuroxime axetil in
patients with renal impairment has not been proved. Since
cefuroxime axetil is excreted by the kidneys, its half- life
shall be prolonged in the case of these patients.
Children: Due to their bitter taste, the cefuroxime axetil
tablets should not be crumbled. They are, therefore, inappropriate
for children under 5.
2.7 Overdosage- Treatment
Cephalosporins’ overdose may cause brain irritation with
potential spasms. The cefuroxime serum level is reduced
by hemodialysis or peritoneal dialysis.
In case of an overdosage please contact your nearest
poisoning centre.2.8 Undesirable effects
The undesirable effects of cefuroxime axetil are generally
mild and transient. As with other cephalosporins,
polymorphis erythema, Stevens-Johnson syndrome, toxic
epidermic necrolysis (exanthematous necrolysis) and
hypersensitivity reactions including skin rash, cnidosis,
itch, pharmaceutical fever, seronosia and anaphylaxis have
rarely been reported. A small percentage of patients who
used cefuroxime axetil developed gastrointestinal disorders
such as diarrhoea, nausea and vomiting. As with other
wide spectrum antibiotics, cases of pseudomembranoid
colitis have been reported. Cephalalgia has also been
reported. Superinfections by the development of resistant
strains may appear. During the cefuroxime axetil treatment,
eosinophilia and a transient increase in the hepatic
enzymes’ levels [ALT(SGPT), AST(SGOT) and LDH] were
observed. As with other cephalosporins, jaundice was
rarely reported.
Dizziness, hallucinations, confusion, itching of the genitals
and vaginitis have also been rarely reported.
In the case of patients receiving cephalosporins, positive
reaction to Coombs test may appear and very rarely
haemolytic anaemia may develop.
Disorders in the blood’s coagulability, leukopenia, neutropenia,
thrombopenia, renal malfunction and toxic
nephropathy may also appear.
2.9 What the patient should do in case of missing
a dose
If you must be receiving the drug continuously and you
miss a dose, you should replace it as soon as possible.
However, if the time for the next dose is near, do not take
the dose you have missed but continue your treatment
normally.
Do not double doses.
2.10 Product expiry date
Inscribed on the external and internal package.
In case this date has passed, do not use the drug.
2.11 Special precautions for storage
Keep at room temperature between 15 – 25 0 C and out of
reach and sight of children.
2.12 Date of last revision of the text
Prot. No.:
3. INFORMATION REGARDING THE CORRECT USE
OF DRUGS
- This medicine has been prescribed to you by your doctor
not give it to other people or use it for a different disease,
- If during treatment a problem regarding the drug appears,
immediately notify your doctor or pharmacist.
- If there are any questions regarding the information
related to the drug you receive or if you need to be better
informed for your medical problem, do not hesitate to ask
your doctor of pharmacist.
- In order for the drug administered to you to be effective
and safe, it should be taken according to the given
instructions.
- For your safety and health, it is necessary to carefully
read all information related to the drug.
- Do not keep drugs in bathroom cupboards because heat
and moisture may alter the drug and place it as harmful
for your health.
- Do not keep drugs you no longer need or have expired.
- For greater safety, keep all drugs in a safe place and out
of reach and sight for children.
4. LEGAL CATEGORY
Nelabocin is a Prescription only Medicine.
5. MARKETING AUTHORISATION NUMBER in
Greece
Tablets 250mg : 48063/14-10-2008
Tablets 500mg :48064/14-10-2008