Fucidin 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium fusidate

Available from:

LEO Pharma

ATC code:

J01XC01

INN (International Name):

Sodium fusidate

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5702191004946 5702191000931

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
®
TABLETS
SODIUM FUSIDATE
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects become serious, or you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist.
0 2 3 4 5 5 - 0 5
IN THIS LEAFLET:
1. What Fucidin
®
Tablets are and what they are used for
2. Before you take Fucidin
®
Tablets
3. How to take Fucidin
®
Tablets
4. Possible side effects
5. How to store Fucidin
®
Tablets
6. Further 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:
• Infections of the skin and wounds
• Infections of the blood such as septicaemia
• Infections of the bone and heart tissue
• Infections of the lungs such as pneumonia
• Infections connected with the condition cystic fibrosis.
2. BEFORE YOU TAKE FUCIDIN
®
TABLETS
DO NOT TAKE FUCIDIN
®
TABLETS
• If you are allergic (hypersensitive) to fusidic acid or sodium
fusidate.
• If you are allergic (hypersensitive) to any of the other
ingredients in
your medicine. You can find a list of these ingredients in section 6
of
this leaflet.
• If you know that you have any sugar intolerance. You may have
inherited
this condition from someone else in your family.
TAKE SPECIAL CARE WITH FUCIDIN
®
TABLETS
Before you take Fucidin
®
Tablets, tell your doctor:
• If you are taking statins (medicines to lower blood cholesterol).
• If you have problems with your liver
• If you have recently been jaundiced.
When you are taking Fucidin
®
Tablets your doctor may

Summary of Product characteristics

OBJECT 1
FUCIDIN TABLETS
Summary of Product Characteristics Updated 04-Feb-2014 | Leo
Laboratories Limited
1. Name of the medicinal product
Fucidin
®
Tablets
2. Qualitative and quantitative composition
Each tablet contains Sodium Fusidate Ph.Eur. 250 mg.
3. Pharmaceutical form
Tablet
4. Clinical particulars
4.1 Therapeutic indications
Fucidin
®
is indicated in the treatment of all staphylococcal infections due to
susceptible organisms such
as: cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound
infections, endocarditis,
superinfected cystic fibrosis.
Fucidin
®
should be administered intravenously whenever oral therapy is
inappropriate, which includes
cases where absorption from the gastro-intestinal tract is
unpredictable.
4.2 Posology and method of administration
For staphylococcal cutaneous infections:
Adults:
Standard Dose: 250mg (one tablet) sodium fusidate (equivalent to 240mg
fusidic acid) twice
daily for 5-10 days.
For staphylococcal infections such as osteomyelitis, pneumonia,
septicaemia, wound infections,
endocarditis, superinfected cystic fibrosis.
Adults:
Standard dose: 500mg (two tablets) sodium fusidate (equivalent to
480mg fusidic acid) three
times daily.
In severe cases of fulminating infections, the dosage may be doubled
or appropriate combined therapy
may be used.
Elderly: No dosage alterations are necessary in the elderly.
Since Fucidin
®
is excreted in the bile, no dosage modifications are needed in renal
impairment.
The dosage in patients undergoing haemodialysis needs no adjustment as
Fucidin
®
is not significantly
dialysed.
4.3 Contraindications
Hypersensitivity to fusidic acid and its salts, or to any of the
excipients.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
Fucidin
®
must not be co-administered with statins. There have been reports of
rhabdomyolysis (including
some fatalities) in patients receiving this c