Cefuroxime 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefuroxime axetil

Available from:

CST Pharma Ltd

ATC code:

J01DC02

INN (International Name):

Cefuroxime axetil

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5055946802398

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SZ00901LT05A
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 (hypersensitive) 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, DONʼT TAKE Cefuroxime until
you have checked with your doctor.
WARNINGS AND PRECAUTIONS
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
ʻConditions you need to look out forʼ 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 any other
medicines, if youʼve started taking any recently or you start
taking new ones. This includes medicines you can obtain
w

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefuroxime 250 mg Tablets contain 300.72 mg cefuroxime axetil which is
equivalent
to 250 mg cefuroxime per tablet.
Excipients with known effect:
1 tablet contains
0.3 mg aspartame (E951)
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 tablets are indicated for the treatment of mild to
moderately
severe infections caused by micro-organisms susceptible to cefuroxime,
such
as:
- upper respiratory tract infections: acute otitis media, sinusitis,
tonsillitis and
pharyngitis
- acute bronchitis, acute exacerbations of chronic bronchitis
- lower uncomplicated urinary tract infections: cystitis
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- treatment of early stage Lyme disease (stage I) and subsequent
prevention of
late complications in adults and children above 12 years of age.
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