FLOXAPEN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUCLOXACILLIN SODIUM

Available from:

Actavis Group PTC ehf

ATC code:

J01CF05

INN (International Name):

FLUCLOXACILLIN SODIUM

Dosage:

500 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

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

Therapeutic area:

flucloxacillin

Authorization status:

Marketed

Authorization date:

1979-01-18

Patient Information leaflet

Floxapen 250 mg & 500 mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOXAPEN 250 MG & 500 MG CAPSULES
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Floxapen is and what it is used for
2.
What you need to know before you use Floxapen
3.
How to use Floxapen
4.
Possible side effects
5.
How to store Floxapen
6.
Contents of the pack and other information
1. WHAT FLOXAPEN 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 capsules are used to treat a wide range of infections caused
by bacteria, such as:

chest infections

throat or nose infections

ear infections

skin and soft tissue infections

meningitis

digestive system infections

kidney, bladder or urethra (the tube which carries urine from the
bladder) infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN
DO NOT USE FLOXAPEN

if you are ALLERGIC (hypersensitive) 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 or pharmacist before using Floxapen if you:

have LIVER or KIDNEY problems.
Floxapen 250 mg & 500 mg Capsules

have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Floxapen 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg flucloxacillin (as flucloxacillin sodium)
Excipients with known effect
Each capsule has a sodium content of 25 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules hard.
Hard gelatine capsules with carmel body and black cap overprinted in
white with ‘500’containing a white 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.
The dosage may be increased if necessary.
_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.
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