Cefuroxime 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefuroxime axetil

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINNAT
® 250 MG TABLETS
(CEFUROXIME AXETIL)
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 side effects, talk to your doctor or pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet.
See section 4.
•
The name of this medicine is Zinnat
®
250 mg Tablets but will be
referred to as Zinnat throughout the remainder of this leaflet.
•
Zinnat
®
250 mg Tablets are also available in other strengths.
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 betalactam antibiotic (penicillins, monobactams and
ca

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