Fucidin 250mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sodium fusidate

Saatavilla:

Leo Laboratories Limited

ATC-koodi:

J01XC; J01XC01

INN (Kansainvälinen yleisnimi):

Sodium fusidate

Annos:

250 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Steroid antibacterials; fusidic acid

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1990-03-13

Pakkausseloste

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® 250 MG TABLETS
sodium fusidate
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.

In this leaflet Fucidin
®
250 mg Tablets will be called Fucidin Tablets.
WHAT IS IN THIS LEAFLET
1.
What Fucidin
®
Tablets are and what they are used for
2.
What you need to know before you take Fucidin
®
Tablets
3.
How to take Fucidin
®
Tablets
4.
Possible side effects
5.
How to store Fucidin
®
Tablets
6.
Contents of the pack and other information
1. WHAT FUCIDIN
® TABLETS ARE AND WHAT THEY ARE USED FOR
Fucidin Tablets contain sodium fusidate. It is a type of antibiotic.
Fucidin Tablets work by killing germs (bacteria) that cause
infections.
Fucidin Tablets are used to treat infections such as those caused by a
bacteria called _Staphylococcus._
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUCIDIN
® TABLETS
DO NOT TAKE FUCIDIN TABLETS:

If you are allergic to sodium fusidate or any of the other ingredients
of this medicine (listed in
section 6).

If you are taking statins, medicines to lower blood cholesterol.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fucidin Tablets if:

You are taking statins (medicines to lower blood cholesterol)

You have problems with your liver or if you have recently been
jaundiced (skin and whites of eyes
appear yellow)

You have a blockage or a problem with your bile duct, e.g. gallstones

You are taking some medicines called HIV-Protease Inhibitors used to
treat the HIV virus.
When you are taking

Valmisteyhteenveto

Health Products Regulatory Authority
26 January 2021
CRN009ZFT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 250mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of sodium fusidate.
Excipient with known effect
Lactose monohydrate 71.9 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white greyish marbled film-coated oval tablet without
embossing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of infections due to micro-organisms sensitive to
this anti-infective, such as Staphylococci.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults only: The usual total daily dose is 1500 mg in divided doses.
In severe infections doses may be doubled or appropriate combined
therapy may be used.
Since fusidic acid is excreted in the bile, no dosage modifications
are needed in renal impairment. The dosage in patients
undergoing haemodialysis needs no adjustment as fusidic acid is not
significantly dialysed.
_Paediatric population_
Children: The usual total daily dose is 20 to 50 mg/kg in divided
doses.
Method of administration
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Concomitant treatment with statins (HMG-CoA reductase inhibitors).
(See section 4.4, 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not
be co-administered, (see section 4.3). There have been
reports of rhabdomyolysis (including fatalities) in patients receiving
this combination. Statin treatment should be discontinued
throughout the duration of treatment with systemic Fucidin. The
patient should be advised to seek medical advice immediately
if they experience any symptoms of muscle weakness, pain or
tenderness. Statin therapy may be re-introduced 7 days after the
last dose of systemic Fucidin.
Health Products Regulatory Authority
26 January 202