FLOXAPEN SYRUP 125 MG/5ml Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN MAGNESIUM

Available from:

Actavis Group PTC ehf

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN MAGNESIUM

Dosage:

125 MG/5ml

Pharmaceutical form:

Powder for Oral Suspension

Prescription type:

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

Therapeutic area:

Beta-lactamase resistant penicillins

Authorization status:

Authorised

Authorization date:

2008-02-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOXAPEN SYRUP 125 MG/5 ML POWDER FOR ORAL SUSPENSION
FLOXAPEN SYRUP 250 MG/5 ML POWDER FOR ORAL SUSPENSION
Flucloxacillin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 WHAT FLOXAPEN SYRUP IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN SYRUP
3 HOW TO USE FLOXAPEN SYRUP
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE FLOXAPEN SYRUP
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT FLOXAPEN SYRUP IS AND WHAT IT IS USED FOR
Floxapen is an antibiotic used to treat infections by killing the
bacteria that can cause them. It belongs
to a group of antibiotics called “penicillins”.
Floxapen syrup may be used to treat:
• chest infections.
• throat or nose infections.
• ear infections.
• skin and soft tissue infections.
• meningitis.
• digestive system infections.
• kidney, bladder or the urethra (the tube which carries urine from
the bladder) infections.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN SYRUP
DO NOT USE FLOXAPEN SYRUP:
• if you are ALLERGIC to flucloxacillin, penicillin, any other
antibiotic or any of the other ingredients of this
medicine (listed in section 6).
• if you have had an allergic reaction to β-lactam antibiotics
(e.g. penicillins, cephalosporins).
• if you have a previous history of flucloxacillin associated
jaundice/liver dysfunction.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USINGFLOXAPEN SYRUP IF
YOU:
• have LIVER or KIDNEY problems.
• have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Floxapen Syrup 125mg/5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed each 5 ml contains 125 mg
flucloxacillin as Flucloxacillin Magnesium.
Excipients with known effect:
Contains sucrose 2.9g/5ml
This medicinal product contains 10.3mg sodium per dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
A white free flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Floxapen is indicated for the treatment of infections due to
-lactamase-producing staphylococci and other sensitive
Gram-positive organisms such as streptococci (see section 5.1 for
details on sensitive strains). Typical indications
include:
_Skin and soft tissue infections:_
- Boils, abscesses, carbuncles, furunculosis, cellulites, infected
burns, infected wounds, impetigo, protection for skin
grafts, infected skin conditions e.g. ulcer, eczema, and acne
_Respiratory tract infections:_
- Pneumonia, lung abscess, sinusitis, tonsillitis, quinsy,
pharyngitis, empyema, otitis media and externa
_Other infections caused by Floxapen-sensitive organisms:_
- Urinary tract infection, small intestine and colon infection,
meningitis
Consideration should be given to official guidance 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 and nature of the infection.
_Adults and children over 10 years of age:_
Total daily dosage of 1 g to 3 g, administered in three to four
equally divided doses.
_Children under 10 years of age:_
25-50 mg/kg/24 hours in three to four equally divided doses.
The dosage may be increased if necessary.
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