Zinnat 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefuroxime

Available from:

Sandoz Pharmaceuticals d.d.

ATC code:

J01DC; J01DC02

INN (International Name):

Cefuroxime

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Second-generation cephalosporins; cefuroxime

Authorization status:

Marketed

Authorization date:

1989-08-04

Patient Information leaflet

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 cefur

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2024
CRN00F19Z
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zinnat 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg cefuroxime (as cefuroxime axetil).
Excipients with known effect:
Each tablet contains 0.00506 mg sodium benzoate (E211)
Each tablet contains 0.18 mg methyl parahydroxybenzoate (E218) and
0.15 mg 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 obstructive pulmonary disease.

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). The dose of cefuroxime that is selected to treat an
individual infection should take into account:

The expected pathogens and their likely susceptibility to cefuroxime
axetil

The severity and the site of the infection

The age, weight and renal function of the patient; as shown below.The
duration of therapy should be determined
by the type of infection and the response of the patient and should
generally not be longer than recommended.
_Table 1. Adults and children (>40 kg)_
Health Products Regulatory Authority
04 January 2024
CRN00F19Z
Page 2 of 10
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial sinusitis
250 mg twice daily
Acute otitis media
500 mg twice daily
Acute exacerbations of chronic obstructive pulmona