PATIENT INFORMATION LEAFLET NELABOCIN ... - Pharmathen

PATIENT INFORMATION LEAFLET
NELABOCIN
CEFUROXIME AXETIL
1. DESCRIPTION OF MEDICINAL PRODUCT
1.1 NAME: NELABOCIN
1.2 COMPOSITION
Active substance: Cefuroxime axetil.
Excipients: Mannitol, Citric Acid Anhydrous, Crospovidone,
Τalk, Sodium lauryl sulfate, Sodium Bicarbonate,
Colloidal silica dioxide.
Coating: Povidone, Titanium Dioxide, Sodium Docusate,
Propylene Glycol
1.3 PHARMACEUTICAL FORM
Film coated tablets.
1.4 STRENGTH OF ACTIVE SUBSTANCE
F. C. Tablets: 250mg/tab, 500mg/tab
1.5 DESCRIPTION- PACKAGE
F. C. Tablets 250mg/tab Cardboard box containing 14
tablets in blister PVC/ACLAR/Aluminium with instructions
on usage.
F. C. Tablets 500mg/tab: Cardboard box containing 14
tablets in blister PVC/ACLAR/Aluminium with instructions
on usage.
1.6 PHARMACOTHERAPEUTIC CATEGORY
Antibiotic of the cephalosporin group.
1.7 MARKETING AUTHORISATION HOLDER AND
DISTRIBUTOR IN GREECE
PHARMATHEN HELLAS S.A:
144 MARATHONOS AV. 153 51 PALLINI – ΑΤΤΙΚIS
ΤEL.: (0030) 210-66 64 805 FAX: (0030) 210-66 64 804
EXPORT LICENCE HOLDER
PHARMATHEN S.A.:
6 DERVENAKION STR., 15351 PALLINI – ΑΤΤΙΚIS
ΤEL.: (0030) 210-6665067 FAX: (0030) 210-6666749
1.8 MANUFACTURER
FAMAR S.A. (FACTORY D)- 48ο klm Athinon- Lamias NR,
19011, Τel: (0030) 2295-041246,
(0030) 2295-041248
2. INFORMATION REGARDING THE MEDICINE AD-
MINISTERED TO YOU BY YOUR DOCTOR.
2.1 GENERAL INFORMATION
Cefuroxime axetil is an oral pro-drug of the bactericidal
cephalosporin Cefuroxime. It is an antibiotic that belongs
in the group of the 2nd generation semi synthetic cephalosporins,
is resistant to β- lactamases and active in a great
number of Gram- positive and Gram- negative microbes.
2.2 INDICATIONS
It is indicated for the treatment of infections caused by
sensitive to it microbes.
The indications include:
- Infections of the upper respiratory tract such as otorhinolaryngologic
infections, such as acute otitis media, acute
nasosinusitis, chronic nasosinusitis (in combination with an
imidazole), tonsillitis and pharyngitis.
- Infections of the lower respiratory tract such as pneumonia,
acute bronchitis and acute aggravations of chronic
bronchitis.
- Infections of the urogenital system by enterobacterials
resistant to ampicillin or 1st generation cephalosporins
such as pyelonephritis, cystitis and urethritis.
- Skin and soft tissue infections such as furunculosis, pyodermatitis
and infectious impetigo.
- Gonorrhoea, acute uncomplicated gonococcal urethritis
and cervicitis.
2.3 CONTRAINDICATIONS
Hypersensitivity to cephalosporins or history of anaphylaxis
and allergic shock to penicillin.
2.4 SPECIAL PRECAUTIONS AND WARNINGS FOR
USE
2.4.1 General:
Before the initiation of treatment with cefuroxime axetil,
information regarding the patient’s medical history must
be carefully collected in order to define whether he/she
has developed hypersensitivity reactions to cephalosporins,
penicillins or other drugs during the past. The particular
drug should be administered with caution to patients
who are sensitive to penicillin.
In the case of an allergic reaction caused by the administration
of cefuroxime axetil, the drug administration
should be discontinued and the administration
of corticosteroids or antihistamines may be
required. In severe cases of acute hypersensitivity,
the administration of adrenaline and of other emergency
treatment measures may be required.
Antibiotics, including cefuroxime axetil, should be administered
with caution to every patient, who has developed
any form of allergy, especially to drugs.
As with other antibiotics, the prolonged use of cefuroxime
axetil may cause the development of non- sensitive
microbes (e.g. Candida, Enterococci, Clostridium difficile),
so discontinuation of the treatment may be needed.
Pseudomembranoid colitis has been reported with the use
of wide spectrum antibiotics and should, therefore, be
considered as possible in cases of patients, who develop
diarrhoea with the use of antibiotics.
In patients taking cefuroxime axetil, the level of blood
glucose is recommended to be determined using those
methods where glucose oxadase or hexokinase is used.
Cefuroxime axetil does not affect the creatinine test with
picrate alkali.
2.4.2 Elderly patients:
Cefuroxime axetil may be used in elderly patients.
2.4.3 Pregnancy:
In experimental studies, no embryopathies or teratogenesis
caused by cefuroxime axetil were reported but as with
all drugs, it should be administered with caution during
the first months of pregnancy.
2.4.4 Lactation:
Cefuroxime is also excreted in the breast milk so caution is
required when the drug is administered to a breastfeeding
mother.
2.4.5 Children:
See dosage and administration.
2.4.6 Effects on the ability to drive and use
machinery:
None.
2.4.7 Special warnings for the included excipients:
Do not take the medicine if you are allergic o any of its
excipients.
2.5 Interactions with other medicinal products or
substances.
As with other antibiotics containing the β- lactam ring,
the renal excretion of cefuroxime axetil is inhibited by
probenecid. Drugs that reduce the gastric acidity may
result in reduction of cefuroxime axetil’s bioavailability
in comparison with patients at a state of fasting, while
there is a tend of reduction in the absorption of the drug

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