Flucloxacillin 125mg/5ml Oral Solution BP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-06-2023
Summary of Product characteristics
(SPC)
30-06-2023
Active ingredient:
FLUCLOXACILLIN SODIUM
Available from:
Athlone Laboratories Ltd
ATC code:
J01CF; J01CF05
INN (International Name):
FLUCLOXACILLIN SODIUM
Dosage:
125 mg/5ml
Pharmaceutical form:
Powder for oral solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Beta-lactamase resistant penicillins; flucloxacillin
Authorization status:
Not marketed
Authorization date:
2011-10-14
Patient Information leaflet
0015 CCRF23100 PRAC
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION BP
Flucloxacillin
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 Flucloxacillin Oral Solution BP is and what it is used for
2.
What you need to know before you take Flucloxacillin Oral solution BP
3.
How to take Flucloxacillin Oral solution BP
4.
Possible side effects
5.
How to store Flucloxacillin Oral solution BP
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN ORAL SOLUTION BP 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:
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chest infections
-
throat or nose infections
-
ear infections
-
skin and soft tissue infections
-
heart infections
-
bone and joint infections
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meningitis
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digestive system infections
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blood infections
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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 ORAL SOLUTION BP
DO NOT TAKE FLUCLOXACILLIN ORAL SOLUTION IF YOU:
-
Are allergic to flucloxacillin or any other penicillin or
cephalosporin antibiotics (such as
amoxicillin or cefaclor - see symptoms listed in section 4)
-
Are allergic to any of the other ingredients of this medicine (listed
in se
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
30 June 2023
CRN00DMDP
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 125mg/5ml Oral Solution BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed each 5 ml contains flucloxacillin 125
mg as flucloxacillin sodium.
Excipients with known effect:
Contains 18 mg sodium, 3.1 g of sucrose and 5mg sodium benzoate per
5ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Unreconstituted powder: a pink granular powder with a characteristic
odour of pineapple.
Reconstituted solution: a pink coloured solution with a characteristic
flavour and odour of pineapple
4 CLINICAL PARTICULARS
Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of
antibiotics which exerts a bactericidal effect upon many
Gram-positive organisms including β-lactamase-producing staphylococci
and streptococci.
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin 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, impetigo
_Respiratory tract infections:_
Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media
and externa, tonsillitis, quinsy
_Other infections caused by flucloxacillin-sensitive organisms:_
Osteomyelitis, urinary tract infection, enteritis, meningitis,
endocarditis, septicaemia
Flucloxacillin is also indicated for use as a prophylactic agent
during major surgical procedures when appropriate; for example
cardiothoracic and orthopaedic surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMIN
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