Cefuroxime 250mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Cefuroxime axetil

Disponible depuis:

Sandoz Ltd

Code ATC:

J01DC02

DCI (Dénomination commune internationale):

Cefuroxime axetil

Dosage:

250mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05010201; GTIN: 5050650009019

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SZ00000LT000
WHAT IS IN THIS LEAFLET:
1.
What Cefuroxime is and what it is used for
2.
What you need to know before you take Cefuroxime
3.
How to take Cefuroxime
4.
Possible side effects
5.
How to store Cefuroxime
6.
Contents of the pack and other information
Cefuroxime 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._
Cefuroxime is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Cefuroxime can also be used:
•
to treat Lyme disease (an infection spread by parasites called
ticks).
DO NOT TAKE CEFUROXIME:
•
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 betalactam antibiotic (penicillins,
monobactams and carbapenems).

If you think this applies to you, DON’T TAKE Cefuroxime until
you have checked with your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Cefuroxime.
Cefuroxime IS NOT RECOMMENDED FOR CHILDREN AGED UNDER 3
MONTHS, as the safety and effectiveness are not known in this
age group.
You must look out for certain symptoms, such as allergic
reactions, fungal infections (such as _candida_) and severe
diarrhoea _(pseudomembranous colitis)_ while you are taking
Cefuroxime. This will reduce the risk of any problems. See
‘Conditions you need to look out for’ in Section 4.
IF YOU NEED A BLOOD TEST
Cefuroxime can affect the results of a test for blood sugar levels,
or a blood screen called the _Coombs test._
If you need a blood test:

TELL THE PERSON TAKING THE SAMPLE that you are taking
Cefuroxime.
OTHER MEDICINES AND CEFUROXIME
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicine. This

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250 mg coated tablet contains 300.72 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 scored on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime axetil 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
Cystitis
15 mg/kg twice daily to a maximum of
250 mg twice daily
Pyelonephritis
15 mg/kg twice daily to a maximum of
250 mg twice daily for 10 to 14 days
Uncomplicated skin and soft
tissue infections
15 mg/kg twice daily