Flucloxacillin 250mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flucloxacillin

Available from:

Athlone Laboratories Ltd

ATC code:

J01CF; J01CF05

INN (International Name):

Flucloxacillin

Dosage:

250 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta-lactamase resistant penicillins; flucloxacillin

Authorization status:

Marketed

Authorization date:

2010-10-08

Patient Information leaflet

0023
CCRF23100
IE/H/0916/001/IAIN/0016
PATIENT INFORMATION LEAFLET (RMS)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION
Flucloxacillin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
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
(chemist).
-
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 Flucloxacillin 250mg/5ml Oral Solution is and what it is used for
2.
What you need to know before you take Flucloxacillin 250mg/5ml Oral
Solution
3.
How to take Flucloxacillin 250mg/5ml Oral Solution
4.
Possible side effects
5.
How to store Flucloxacillin 250mg/5ml Oral Solution
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION IS AND WHAT IT IS
USED FOR
Flucloxacillin is an antibiotic used to treat infections by killing
the bacteria that can cause them. It
belongs to a group of antibiotics called “penicillins”.
Flucloxacillin is used to treat:
•
chest infections
•
throat or nose infections
•
ear infections
•
skin and soft tissue infections
•
heart infections
•
bone and joint infections
•
meningitis
•
digestive system infections
•
blood infections
•
kidney, bladder or urethra (the tube which carries urine from the
bladder) infections.
Flucloxacillin can also be used to prevent infections during major
surgery, particularly heart or
orthopaedic surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN
250MG/5ML ORAL SOLUTION
DO NOT TAKE FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION IF:
-
You are allergic to flucloxacillin or any other penicillin antibiotics
(see symptoms in section 4).
-
You are allergic t

Summary of Product characteristics

Health Products Regulatory Authority
29 June 2023
CRN00DP3V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml contains 250mg flucloxacillin as
flucloxacillin sodium.
Excipients with known effect:
Each 5ml dose contains 2.96g sucrose.
Each 5ml dose contains 24.09mg sodium.
Each 5ml dose contains 5mg sodium benzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
Free flowing pink coloured powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections due to sensitive Gram-positive organisms,
including infections caused by β-lactamase-producing_ _
_Staphylococci _and_ Streptococci_.
Typical indications include:
_Skin and soft tissue infections:_
Boils
Infected burns
Impetigo
Furunculosis
Abscesses
Protection for skin grafts
Infected wounds
Cellulitis
Carbuncles
Infected skin conditions e.g. Ulcers, eczema and acne
_Respiratory tract infections:_
Pneumonia
Pharyngitis
Lung abscess
Tonsillitis
Empyema
Quinsy
Sinusitis
Otitis media and externa
Other infections caused by flucloxacillin-sensitive organisms:
Osteomyelitis
Septicaemia
Enteritis
Meningitis
Endocarditis
Urinary-tract infection
Flucloxacillin is also indicated for use as a prophylactic during
major surgical procedures such as cardiothoracic and
orthopaedic surgery. Parenteral usage is indicated where oral dosage
is inappropriate.
Consideration should be given to official local guidance (e.g.
national recommendations) on the appropriate use of
antibacterial agents.
Health Products Regulatory Authority
29 June 2023
CRN00DP3V
Page 2 of 9
Susceptibility of the causative organism to the treatment should be
tested (if possible), although therapy may be initiated
before the results are available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on age, weight and renal function of the patient,
as well as the severity of the infection.
_A