Flucloxacillin 250 mg Capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Flucloxacillin

Disponibil de la:

Athlone Laboratories Ltd

Codul ATC:

J01CF; J01CF05

INN (nume internaţional):

Flucloxacillin

Dozare:

250 milligram(s)

Forma farmaceutică:

Capsule, hard

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Beta-lactamase resistant penicillins; flucloxacillin

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2011-10-14

Prospect

0013 CCRF23100 PRAC
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 250MG CAPSULES
Flucloxacillin
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 Flucloxacillin Capsules are and what they are used for
2.
What you need to know before you take Flucloxacillin Capsules
3.
How to take Flucloxacillin Capsules
4.
Possible side effects
5.
How to store Flucloxacillin Capsules
6.
Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN CAPSULES ARE AND WHAT THEY ARE 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
•
digestive system infections
•
kidney, bladder or urethra (the tube which carries urine from the
bladder) infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN CAPSULES
DO NOT TAKE FLUCLOXACILLIN CAPSULES IF YOU:
•
are allergic to flucloxacillin or any other penicillin or
cephalosporin antibiotics (such as amoxicillin
or cefaclor - see section 4, Possible side effects).
•
are allergic to any of the other ingredients of this medicine (listed
in section 6, Contents of the pack
and other information).
•
have ever suffered from jaundice or liver problems after taking
flucloxacillin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine if you:
•
S

Caracteristicilor produsului

Health Products Regulatory Authority
23 June 2023
CRN00DMCY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains flucloxacillin 250 mg as flucloxacillin sodium.
Excipient with known effect:
Contains 13.2mg of sodium per capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Size 2 hard gelatin capsule, with an opaque carmel body and opaque
grey cap each printed FXN 250 in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin capsules are indicated for the treatment of infections
due to sensitive Gram-positive organisms, including
β-lactamase-producing _staphylococci_ and _streptococci_ (see section
5.1) such as:
- Skin and soft tissue infections
- Respiratory tract infections
- Other infections caused by flucloxacillin-sensitive micro-organisms,
_e.g._ enteritis, urinary tract infections.
Parenteral use is indicated where oral dosage is inappropriate.
Consideration should be given to official guidance on the appropriate
use of antibacterial substances.
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.
For doses not practicable with this product, other strengths and
pharmaceutical forms are available.
_Usual dosage (adults including elderly patients and children over 10
years of age)_
_Oral_ - 1-3 g daily in 3-4 equally divided doses.
_Paediatric population under 10 years of age_
25-50 mg/kg/24 hours in three to four equally divided doses.
Example of posology:
Weight
Daily dose (mg/24 hours)
Daily dosing regimen
22 kg
550 – 1,100
250 mg x 3-4
25 kg
625 – 1,250
250 mg x 3-4
27 kg
675 – 1,350
250 mg x 3-4
30 kg
750 – 1,500
250 mg x 4 or 500 mg x 3
35 kg
875 – 1,750
250 mg x 4 or 500 mg x 3
Health Products Regulatory Authority
23 June 2023
CRN00DMCY
Page 2 of 8
_Renal impairment_: In common with other penicill