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

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

FLUCLOXACILLIN SODIUM PH. EUR.

Dostupné z:

Brillpharma (Ireland) Limited

ATC kód:

J01CF; J01CF05

INN (Medzinárodný Name):

FLUCLOXACILLIN SODIUM PH. EUR.

Dávkovanie:

125 mg/5ml

Forma lieku:

Powder for oral solution

Terapeutické oblasti:

Beta-lactamase resistant penicillins; flucloxacillin

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2020-07-24

Príbalový leták

Page
1
of
8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 125 MG / 5ML POWDER FOR ORAL SOLUTION, SUGAR FREE
flucloxacillin (as sodium).
FLUCLOXACILLIN 250 MG / 5ML POWDER FOR ORAL SOLUTION, SUGAR FREE
flucloxacillin (as 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 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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
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
Page
2
of
8

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 THIS MEDICINE
DO NOT TAKE THIS MEDICINE:

if you are allergic to the active substance, other penicillin
antibiotics (see
symptoms in section 4) or any of the other ingredients of this
medicine (listed in
section 6).

Have suffered before from jaundice or liver pr

Súhrn charakteristických

Health Products Regulatory Authority
15 July 2021
CRN00C748
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 125 mg/5 ml Powder for Oral Solution, Sugar Free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml reconstituted solution contains flucloxacillin sodium
equivalent to 125 mg flucloxacillin.
Excipients with known effect:
Aspartame (E951) 5 mg / 5 ml
Mannitol (E421) 326.50 mg / 5 ml
Sodium 10.61 mg/5 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
Free flowing white granular powder for oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in the 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 Impetigo
Abscesses Infected wounds
Carbuncles Infected burns
Furunculosis Protection for skin grafts
Cellulitis
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.
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.
Health Products Regulatory Authority
15 July 2021
CRN00C748
Page 2 of 8
Usual adults dosage (including elderly patients)
Oral: - 250 mg four times a day.
In serious infections,