Cefixime 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefixime

Available from:

Rivopharm (UK) Ltd

ATC code:

J01DD08

INN (International Name):

Cefixime

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5060388650612

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFIXIME 400 MG FILM-COATED TABLETS
(cefixime)
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 Cefixime is and what it is used for
2.
What you need to know before you take Cefixime
3.
How to take Cefixime
4.
Possible side effects
5.
How to store Cefixime
6.
Contents of the pack and other information
1. WHAT CEFIXIME IS AND WHAT IT IS USED FOR
Cefixime belongs to a group of medicines called cephalosporins, which
are used for treating infections
caused by bacteria.
Cefixime is used to treat:
−
infection of the middle ear
−
infection which may cause green or yellow discharge from your nose and
severe pain in your
cheeks, eyes or forehead (sinus infection)
−
throat infection
−
infection causing sudden worsening of long-standing bronchitis
−
lung infections (pneumonia) which you catch outside of hospital
−
infections in the water (urinary) tract including some infections of
the kidneys
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFIXIME
_ _
DO NOT TAKE CEFIXIME IF YOU:
−
are allergic to cefixime or any of the other ingredients of this
medicine (listed in section 6). An
allergic reaction may include rash, itching, difficulty breathing or
swelling of the face, lips, throat
or tongue.
−
are allergic to any other cephalosporin type of antibiotic.
−
have ever had a severe allergic reaction to a penicillin antibiotic or
to any other beta-lactam type of
antibiotic.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Cef

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Cefixime 400 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 447.63 mg cefixime trihydrate,
equivalent to 400 mg
cefixime anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to off white, film-coated, rectangular shaped tablet having
partial break
line on both sides.
4.1
THERAPEUTIC INDICATIONS
Cefixime is an orally active cephalosporin antibiotic indicated for
the treatment of the
following infections when caused by susceptible organisms (see section
5.1):
Acute exacerbations of chronic bronchitis
Community-acquired Pneumonia
Uncomplicated lower urinary tract infections
Uncomplicated pyelonephritis
In the treatment of:
Otitis media
Sinusitis
Pharyngitis
The use of cefixime should be reserved for infections in which the
causative organism
is known or suspected to be resistant to other commonly used
antibacterial agents or
when treatment failure may carry significant risk.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents aged 12 years and above
The recommended dose is 400 mg daily taken as a single dose or 2 x
200mg daily
dose (see section 4.4 and 5.1).
The usual course of treatment is 7 days. This may be continued for up
to 14 days if
required.
Elderly
Elderly patients may be given the same dose as recommended for adults.
Renal
function should be assessed and dosage should be adjusted in severe
renal impairment
(see above and section 4.4).
Paediatric population
_Children from 6 months to 11 years of age_ or weighing less than 50
kg
It is recommended that cefixime is given as an oral suspension. The
recommended
dosage for children is 8 mg / kg body weight / day administered as a
single dose or in
two divided doses.
_Children less than 6 months of age_
The safety and efficacy in children aged less than 6 months has not
been established.
Renal impairment
Cef