FLUCLON 500 Milligram Capsules Hard
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
PIL active_ingredient:
FLUCLOXACILLIN SODIUM
MAH:
Clonmel Healthcare Ltd
ATC_code:
J01CF05
INN:
FLUCLOXACILLIN SODIUM
dosage:
500 Milligram
pharmaceutical_form:
Capsules Hard
prescription_type:
Product subject to prescription which may not be renewed (A)
therapeutic_area:
Beta-lactamase resistant penicillins
authorization_status:
Authorised
authorization_date:
1995-02-14
PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLON 250 MG HARD CAPSULES
FLUCLON 500 MG HARD CAPSULES
ACTIVE SUBSTANCE: 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 Fluclon Capsules are and what they are used for
2. What you need to know before you take Fluclon Capsules
3. How to take Fluclon Capsules
4. Possible side effects
5. How to store Fluclon Capsules
6. Contents of the pack and other further information
1. WHAT FLUCLON CAPSULES ARE AND WHAT THEY ARE USED FOR
‘Fluclon’ is an antibiotic medicine and contains the active ingredient flucloxacillin. It is a penicillin
antibiotic used to treat infections in different parts of your body caused by bacteria. It belongs to a
group of medicines called penicillinase-resistant antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLON CAPSULES
DO NOT TAKE FLUCLON CAPSULES IF YOU:
- have ever had an allergic reaction to flucloxacillin, any other penicillin antibiotics or
cephalosporins (see possible side effects, section 4), or to any of the other ingredients of this
medicine (listed in section 6)
- have had liver problems in the past as a result of
taking flucloxacillin.
W
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SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluclon 500 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains flucloxacillin sodium equivalent to 500 mg flucloxacillin.
Excipients with known effect: contains up to 25 mg of sodium per capsule.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Size 0 elongated, hard gelatin capsules with a blue cap and body printed with a twin triangle logo and the identifying
code ‘FXN 500’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluclon is indicated for the treatment of infections due to penicillinase-producing staphylococci and other gram-
positive organisms susceptible to this anti-infective.
Consideration should be given to official guidence on the appropriate use of antibiotic agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on severity and nature of the infection.
The dosage may be increased if necessary.
Usual Adult (and children
over 10 years of age) dosage:
250 – 500 mg three times a day.
Children under 10 years of age:
Not recommended.
Osteomyelitis, endocarditis:
Up to 8 g daily in divided doses six to eight-hourly.
Abnormal renal function:
In common with other penicillins, flucloxacillin usage in patients with renal impairment does not usually require
dosage reduction. In patients with severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an
extension of the dose interval should be considered. In high dose regimens the maximum recommended dose is 1 g
every 8 to 12 hours. Since flucloxacillin is not removed by dialysis no supplementary dosages need be administered.
Method of administration: Oral
4.3 CONTRAINDICATIONS
Hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalo
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