Flucloxacillin 125mg/5ml Granules for Oral Solutions

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUCLOXACILLIN

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN 125 mg/5ml

Pharmaceutical form:

GRANULES FOR ORAL SOLUTION

Composition:

FLUCLOXACILLIN 125 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2019-03-26

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
FLUCLOXACILLIN 125MG/5ML GRANULES FOR ORAL SOLUTION
Please read all of this leaflet carefully before you start taking this
medicine.
Keep the leaflet; you may need to read it again. If you have any
questions or are not sure
about anything, ask your doctor or pharmacist.
This medicine is for you. Only a doctor can prescribe it. Never give
the medicine to someone
else. It may harm them even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What this medicine is and what it is used for
2.
Before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Further information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Each 5ml of oral solution contains 125mg of flucloxacillin (as
flucloxacillin sodium) as the
active ingredient.
This medicine belongs to the penicillin group of antibiotics. It is
used to treat various bacterial
infections by killing the bacteria or preventing their growth. These
include skin and soft tissue
infections, throat and chest infections, other infections such as
urinary tract infection and
prevention of an infection occurring during surgery.
2.
BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF:
•
you are allergic to any penicillin or other kind of antibiotic or to
any of the other
ingredients listed (see section 6)
•
you have ever had any liver problems after taking flucloxacillin.
CHECK WITH YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF:
•
you have a history of allergy
•
you have liver or kidney problems
•
you have any serious illness
•
you are 50 years old or over
•
you are giving this medicine to a newborn child.
The use of flucloxacillin, especially in high doses, may reduce the
potassium levels in the blood
(hypokalaemia). Your doctor may measure your potassium levels
regularly during the therapy with
higher dose

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 125 mg/5ml Granules for Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flucloxacillin sodium 136.00 mg equivalent to 125 mg flucloxacillin
per 5 ml of reconstituted
product.
Excipients with known effect: Each 5 ml contains 3 g of sucrose, 9 mg
of sodium, 5 mg of
aspartame, 0.3 mg of amaranth, 2 mg of sodium propyl
parahydroxybenzoate and 6 mg of
sodium methyl parahydroxybenzoate.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Granules for oral solution
Red granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flucloxacillin 125 mg/5ml Granules for Oral Solution is indicated for
the treatment of
infections due to gram-positive organisms including infections caused
by β-lactamase-
producing staphylococci associated with:
SKIN AND SOFT TISSUE: boils, abscesses, carbuncles, infected skin
conditions
_e.g._
ulcer,
eczema, and acne, furunculosis, cellulitis, infected wounds and burns,
protection for skin
grafts and impetigo.
RESPIRATORY
TRACT:
pneumonia,
lung
abscess,
empyema,
sinusitis,
pharyngitis,
tonsillitis and quinsy.
OTHER INFECTIONS: otitis media and externa, osteomyelitis, enteritis,
endocarditis,
urinary tract infection, meningitis, septicaemia.
AS A PROPHYLACTIC: agent during major surgical procedures where
appropriate
_e.g._
cardiothoracic and orthopaedic surgery.
Consideration should be given to official local guidance (
_e.g._
national recommendations) on
the appropriate use of antibacterial agents.
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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 the age, weight and renal function of the
patient, as well as the severity
of the infection.
ADULTS (INCLUDING ELDERLY): 250 mg four times daily. The dose may be
doubled
where necessary.
Osteomyelitis, endocarditis: Up to 8g daily, in divid