Ceftal 500 mg Coated Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Cefuroxime

Disponibil de la:

Rowex Ltd

Codul ATC:

J01DC; J01DC02

INN (nume internaţional):

Cefuroxime

Dozare:

500 milligram(s)

Forma farmaceutică:

Coated tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Second-generation cephalosporins; cefuroxime

Statutul autorizaţiei:

Marketed

Data de autorizare:

2006-10-13

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTAL 250 MG COATED TABLETS
CEFTAL 500 MG 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.
-
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ceftal is and what it is used for
2.
What you need to know before you take Ceftal
3.
How to take Ceftal
4.
Possible side effects
5.
How to store Ceftal
6.
Contents of the pack and other information
1.
WHAT CEFTAL IS AND WHAT IT IS USED FOR
Ceftal 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_
.
Ceftal is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Ceftal can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFTAL
DO NOT TAKE CEFTAL:
-
IF YOU ARE ALLERGIC
to cefuroxime, to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other
ingredients of this medicine (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 cefuroxime or any other cephalosporin
antibiotics.
➔
If you think this applies to you,
DON’T TAKE CEFTAL
until you have checked with your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse b

Caracteristicilor produsului

Health Products Regulatory Authority
01 March 2024
CRN00DKXP
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftal 500 mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg coated tablet contains 601.44 mg cefuroxime (as axetil).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets
White to slightly yellowish, biconvex, oblong tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftal 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)
_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/kg twice daily to a maximum of 250 mg twice daily
Health Products Regulatory Authority
01 March 2024
CRN00DKXP
Page 2 of 9
Cystitis
15 mg/kg twice daily to a maximum of 250 mg twice daily
Pyelonephritis
15 mg/kg twice daily to a maximu