Zinnat 250 mg film-coated tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Malta Medicines Authority

Διαθέσιμο από:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Φαρμακολογική κατηγορία (ATC):

J01DC02

INN (Διεθνής Όνομα):

CEFUROXIME AXETIL 250 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

CEFUROXIME AXETIL 250 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIBACTERIALS FOR SYSTEMIC USE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-09-15

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINNAT 125 MG FILM-COATED TABLETS
ZINNAT 250 MG FILM-COATED TABLETS
ZINNAT 500 MG FILM-COATED TABLETS
cefuroxime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zinnat is and what it is used for
2.
What you need to know before you take Zinnat
3.
How to take Zinnat
4.
Possible side effects
5.
How to store Zinnat
6.
Contents of the pack and other information
1.
WHAT ZINNAT IS AND WHAT IT IS USED FOR
Zinnat is an antibiotic used in adults and children. It works by
killing bacteria that cause infections. It
belongs to a group of medicines called _cephalosporins_.
Zinnat is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Zinnat can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
Your doctor may test the type of bacteria causing your infection and
monitor whether the bacteria are
sensitive to Zinnat during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZINNAT
DO NOT TAKE ZINNAT:
•
IF YOU ARE ALLERGIC to cefuroxime axetil or ANY CEPHALOSPORIN
ANTIBIOTICS or any of the other
ingredients of Zinnat (listed in section 6).
•
if you have ever had a severe allergic (hypersensitive) reaction to
any other type of beta-lactam
antibiotic (penicillins, monobactams and carbapenems).
•
if you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
treatment with cefurox

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zinnat 250 mg film-coated tablets
Zinnat 500 mg film-coated tablets
Zinnat 125 mg/5 ml granules for oral suspension
Zinnat 250 mg/5 ml granules for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinnat 250 mg film-coated tablets
Each tablet contains 250 mg cefuroxime (as cefuroxime axetil).
Zinnat 500 mg film-coated tablets
Each tablet contains 500 mg cefuroxime (as cefuroxime axetil).
Zinnat 125 mg/5 ml granules for oral suspension
125 mg cefuroxime per 5 ml (as 150 mg cefuroxime axetil).
Zinnat 250 mg/5 ml granules for oral suspension
250 mg cefuroxime per 5 ml (as 300 mg cefuroxime axetil).
Excipient(s) with known effect:
Zinnat 250 mg film-coated tablets
Each tablet contains 0.00203 mg sodium benzoate (E211)
Zinnat 500 mg film-coated tablets
Each tablet contains 0.00506 mg sodium benzoate (E211)
Zinnat 125 mg/5 ml granules for oral suspension
Contains 0.021 g aspartame (E951) per 5 ml dose
Contains 3.1 g of sucrose per 5 ml dose
Contains 6 mg of propylene glycol (E1520) per 5 ml dose
Contains 4.5 mg benzyl alcohol (E1519) per 5 ml dose
Zinnat 250 mg/5 ml granules for oral suspension
Contains 0.045 g aspartame (E951) per 5 ml dose
Contains 2.3 g of sucrose per 5 ml dose
Contains 4.6 mg benzyl alcohol (E1519) per 5 ml dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
250 mg, 500 mg film-coated tablets
Film-coated tablet (tablet)
125 mg/5 ml, 250 mg/5 ml granules for oral suspension
Granules for oral suspension
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinnat is indicated for the treatment of the infections listed below
in adults and children from the age of 3
months (see sections 4.4 and 5.1).
•
Acute streptococcal tonsillitis and pharyngitis.
•
Acute bacterial sinusitis.
•
Acute otitis media.
•
Acute exacerbations of chronic obstructive pulmonary disease.
•
Cystitis.
•
Pyelonephritis.
•
Uncomplicated skin and soft tissue infections.
•
Treatment of early Lyme disease.
Consider