Cefixime Nectar Lifesciences 100 mg/5 ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefixime

Available from:

NECLIFE PT UNIPESSOAL LDA

ATC code:

J01DA08

INN (International Name):

Cefixime

Dosage:

100/5 milligram(s)/millilitre

Pharmaceutical form:

Powder for oral suspension

Therapeutic area:

CEFACLOR

Authorization status:

Not marketed

Authorization date:

2018-11-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFIXIME NECTAR LIFESCIENCES 100MG/5ML POWDER FOR
ORAL SUSPENSION 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 symptoms 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 Nectar Lifesciences Lifesciences is and what it is used
for
2.
What you need to know before you take Cefixime Nectar Lifesciences
Lifesciences
3.
How to take Cefixime Nectar Lifesciences Lifesciences
4.
Possible side effects
5.
How to store Cefixime Nectar Lifesciences Lifesciences
6.
Contents of the pack and other information
1.
WHAT CEFIXIME NECTAR LIFESCIENCES LIFESCIENCES IS AND WHAT IT IS USED
FOR
Cefixime
Nectar
Lifesciences
Lifesciences
Powder
for
Oral
Suspension
(called
“Cefixime
Nectar
Lifesciences Lifesciences” in this leaflet) belongs to a group of
medicines called Cephalosporins, which
are used for treating mild to moderate infection caused by susceptible
organisms.
Cefixime Nectar Lifesciences Lifesciences can be used to treat:
•
Acute infection of the middle ear
•
Infection causing sudden worsening of long-standing bronchitis
•
Uncomplicated acute infection of the bladder
•
Acute throat infection caused by bacteria
•
Uncomplicated acute infections in the urinary tract (Uncomplicated
acute cystitis)
•
Uncomplicated acute gonorrhoea
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFIXIME NECTAR
LIFESCIENCES LIFESCIENCES DO NOT TAKE CEFIXIME NECTAR
LIFESCIENCES LIFESCIENCES IF YOU
•
Are allergic to cefixime or any of the other ingredients of this
medicine (listed in section 6). An
allergic reaction m

Summary of Product characteristics

Health Products Regulatory Authority
07 July 2023
CRN00DCRC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefixime Nectar Lifesciences 100 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains cefixime trihydrate
equivalent to 100 mg of cefixime.
Excipient(s): This medicine contains approximately 2.33g of sucrose in
each 5 ml after reconstitution.
This medicine contains 10.0 mg of sodium benzoate in each 5 ml after
reconstitution.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral suspension.
Off-white to pale yellow coloured granular powder with strawberry
guarana flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefixime is indicated for the treatment of the following infections
when caused by susceptible organisms (see sections 4.4 and
5.1):

Acute exacerbations of chronic bronchitis (AECB)

Acute otitis media (AOM)

Uncomplicated acute cystitis

Uncomplicated pyelonephritis.

Acute bacterial pharyngitis

Uncomplicated acute gonorrhoea
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.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral
ADULTS AND ADOLESCENTS OLDER THAN 12 YEARS (OR MORE THAN 50 KG BODY
WEIGHT):
The recommended dose is 400 mg daily, given either as a single dose or
in two divided doses of 200 mg every 12 hours. (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.

400 mg (in 1-2 doses) 7 up to 10 days for Acute otitis media (AOM) and
Acute bacterial pharyngitis

400 mg (in 1-2 doses) 1 to 3 days for uncomplicated acute cystitis in
female patients

400 mg (in 1 dose), 1 day for uncomplicated gonorrhoea
ELDERLY PATIENTS
Elde