Zinnat 125 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Cefuroxime

Disponible desde:

GlaxoSmithKline (Ireland) Limited

Código ATC:

J01DC; J01DC02

Designación común internacional (DCI):

Cefuroxime

Dosis:

125 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Second-generation cephalosporins; cefuroxime

Estado de Autorización:

Marketed

Fecha de autorización:

1989-08-04

Información para el usuario

cefuroxime
ZINNAT 125 MG FILM-COATED TABLETS
ZINNAT 250 MG FILM-COATED TABLETS
ZINNAT 500 MG FILM-COATED TABLETS
cefuroxime
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 betalactam antibiotic
(penicillins, monobactams and
carbapenems).
 If you think this applies to you, DON’T
TAKE ZINNAT until you have checked
with your doctor.
WARNINGS AND P

Ficha técnica

Health Products Regulatory Authority
27 February 2019
CRN008JVP
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zinnat 125 mg film-coated tablets .
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125 mg cefuroxime (as cefuroxime axetil).
Excipients with known effect:
Each tablet contains 0.00152 mg sodium benzoate (E211)
Each tablet contains Methyl parahydroxybenzoate (E218) and Propyl
parahydroxybenzoate (E216)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
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 bronchitis.
● Cystitis.
● Pyelonephritis.
● Uncomplicated skin and soft tissue infections.
● Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days).
_Table 1. Adults and children (≥40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial sinusitis
250 mg twice daily
Acute otitis media
500 mg twice daily
Acute exacerbations of chronic bronchitis
500 mg twice daily
Cystitis
250 mg twice daily
Pyelonephritis
250 mg twice daily
Uncomplicated skin and soft tissue infections
250 mg twice daily
Lyme disease
500 mg twice daily for 14 days (range of 10 to 21 days)
Health Products Regulatory Authority
27 February 2019
CRN008JVP
Page 2 of 10
_Table 2. Children (<40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial
sinusitis
10 mg/kg twice daily to a maximum of 125 mg twice daily
Children aged two years or older with otitis media or,
where appropriate, with more severe infections
15 mg/k