Flucloxacillin Sugar Free Powder for Oral Solution 125mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Novelgenix Therapeutics Limited 20, Oliver Business Park, Oliver Road, Park Royal, London, NW10 7JB, United Kingdom

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

FLUCLOXACILLIN SODIUM 125/5 milligram(s)/millilitre

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2018-05-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLOXACILLIN 125MG/5ML & 250MG/5ML POWDER FOR ORAL SOLUTION, SUGAR
FREE
Flucloxacillin Sodium
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. Do not pass it onto 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 Flucloxacillin is and what it is used for
2.
What you need to know before you take Flucloxacillin
3.
How to take Flucloxacillin
4.
Possible side effects
5.
How to store Flucloxacillin
6.
Contents of the pack and other information
1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR
Flucloxacillin 125mg/5ml & 250mg/5ml Powder for Oral Solution, Sugar
Free contains the active
substance flucloxacillin. 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
•
bones and joints infection
•
meningitis
•
digestive system infections
•
blood infections
•
kidney, bladder or the 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: DO NOT TAKE FLUCLOXACILLIN AND TELL YOUR DOCTOR IF YOU OR YOUR CHILD:
•
are
ALLERGIC
to flucloxacillin, penicillin, any other antibiotic or any of the
other ingredients of
this medicine (listed in section 6).
•
have ever had
LIV

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 125mg/5ml Powder for Oral Solution Sugar Free
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml reconstituted solution contains Flucloxacillin sodium
equivalent to 125mg Flucloxacillin.
Excipients with known effect:
Each 5ml dose contains
Sodium 15.28mg
Mannitol 326. 5mg
Aspartame 5.00mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution
White granular powder
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Flucloxacillin Sugar Free Powder for Oral Solution is indicated for
the treatment of infections due
to sensitive Gram-positive organisms, including β-lactamase-producing
Staphylococci and
Streptococci. Typical indications include:
_Skin and soft tissue infections: _
Boils, Cellulitis, Infected burns, Abscesses, Infected skin
conditions, e.g. ulcer, eczema, and acne,
Protection for skin grafts, Carbuncles, Furunculosis, Infected wounds
and Impetigo
_Respiratory tract infections: _
Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis, Otitis media
and externa, Tonsillitis
and Quinsy
_Other infections caused by Flucloxacillin sensitive organisms:_
Osteomyelitis, Urinary tract infection, Enteritis, Meningitis,
Endocarditis and Septicaemia
Flucloxacillin is also indicated for use as a prophylactic during
major surgical procedures when
appropriate; for example cardiothoracic and orthopaedic surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
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Consideration should be given to official local guidance (e.g.
national recommendations) on the
appropriate use of antibacterial agents.
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 depends on the age, weight and renal function of the patient, as
well as the severity of the
infection.
Adults (including elderly patients)
Oral - 2