Active ingredients: Fusidic acid, Fusidate sodium
Fucidin 20 mg / g Cream
Fucidin 20 mg / g Ointment
Why is Fucidin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibiotics and chemotherapy for dermatological use.
THERAPEUTIC INDICATIONS
Treatment of skin infections caused by bacteria sensitive to fusidic acid.
Contraindications When Fucidin should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Fucidin
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy, under the direct supervision of the doctor.
Bacterial resistance to Staphylococcus aureus has been found with topical use of fusidic acid. As with all antibiotics, prolonged or recurrent use of Fucidin may increase the risk of developing antibiotic resistance.
Fucidin ointment contains butylated hydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
When Fucidin ointment is used on the face, care must be taken to avoid contact with the eyes, as the excipients contained in the ointment can cause conjunctival irritation.
Interactions Which drugs or foods can modify the effect of Fucidin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin is negligible.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine
Fucidin can be used in women of childbearing age, pregnant and breastfeeding but in the latter case it is recommended to avoid applying Fucidin to the breasts.
Effects on ability to drive and use machines
Fucidin has no or negligible influence on the ability to drive or use machines.
Important information about some of the ingredients
CREAM: Fucidin cream contains butylated hydroxyanisole, cetyl alcohol and potassium sorbate which can cause local skin reactions (eg contact dermatitis). Butylhydroxyanisole can also cause irritation to the eyes and mucous membranes. Fucidin cream should therefore be used with caution when applied close to the eyes.
OIL: Fucidin ointment contains cetyl alcohol and lanolin. These excipients can cause local skin reactions (e.g. contact dermatitis). Fucidin ointment contains butylated hydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Dose, Method and Time of Administration How to use Fucidin: Posology
Adults and children: apply FUCIDIN 2 or 3 times a day.
In case of occlusive dressing, less frequent applications are recommended.
Overdose What to do if you have taken too much Fucidin
No cases of overdose have been reported.
In case of accidental ingestion / intake of FUCIDIN, notify your doctor immediately or go to the nearest hospital. If you have any questions about the use of FUCIDIN, ask your doctor or pharmacist.
Side Effects What are the side effects of Fucidin
Like all medicines, FUCIDIN can cause side effects, although not everybody gets them.
Uncommon cases of dermatitis (including contact dermatitis and eczema), rash (erythematous, pustular, vesicular, maculopapular and papular, generalized), pruritus and edema have been reported in the skin and subcutaneous tissue. There have also been rare cases of urticaria, angioedema and vesicles.
Uncommon cases of administration site conditions such as application site pain (including burning sensation on the skin) and application site irritation have been reported.
Hypersensitivity reactions have been reported rarely in the immune system; moreover, cases of conjunctivitis have been rarely reported in the eye.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
EXPIRY: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store below 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Composition and pharmaceutical form
COMPOSITION
Fucidin 20 mg / g cream
1 g of cream contains: active ingredient: fusidic acid 20 mg; excipients: butylhydroxyanisole, cetyl alcohol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white petroleum jelly, all-rac-α-tocopherol, hydrochloric acid, purified water.
Fucidin 20 mg / g ointment
1 g of ointment contains: active ingredient: sodium fusidate 20 mg (equal to 19.18 mg of fusidic acid); excipients: lanolin, cetyl alcohol, liquid paraffin, white petroleum jelly, all-rac-α-tocopherol, butylated hydroxytoluene.
PHARMACEUTICAL FORM AND CONTENT
Cream. 30 g tube.
Ointment. 30 g tube.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FUCIDIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains: active principle: fusidic acid 20 mg. Excipients: cetyl alcohol, butyl hydroxyanisole, potassium sorbate.
1 g of ointment contains: active principle: sodium fusidate 20 mg (equal to 19.18 mg of fusidic acid). Excipients: cetyl alcohol, lanolin
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Cream
Ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of skin infections caused by bacteria sensitive to fusidic acid.
04.2 Posology and method of administration
Adults and children: apply FUCIDIN 2 or 3 times a day.
In case of occlusive dressing, less frequent applications are recommended.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy, under the direct supervision of the doctor.
Bacterial resistance has been found with the use of fusidic acid. As with all antibiotics, prolonged or recurrent use of Fucidin may increase the risk of developing antibiotic resistance.
CREAM: Fucidin cream contains butylated hydroxyanisole, cetyl alcohol and potassium sorbate which can cause local skin reactions (eg contact dermatitis). Butylated hydroxyanisole can also cause irritation to the eyes and mucous membranes
OIL: When Fucidin ointment is applied to the face, it is recommended to avoid contact with the eyes as sodium fusidate can cause conjunctival irritation.
Due to the content of cetyl alcohol and lanolin, Fucidin ointment can cause local skin reactions (e.g. contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
Nothing to report.
04.6 Pregnancy and lactation
In pregnant and lactating women, the product should be administered in cases of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
Not reported.
04.8 Undesirable effects
Very common: ≥ 1/10
common: ≥ 1/100,
uncommon: ≥ 1/1000,
rare: ≥ 1/10000,
very rare:
Undesirable effects are classified according to MedDRA terms and are reported in order of decreasing severity.
Based on unified clinical data for Fucidin cream and ointment, an undesirable effect may occur in approximately 5% of patients.
Skin and subcutaneous tissue disorders
Uncommon: rash (erythematous, maculopapular and pustular), application site irritation (pain, stinging, burning sensation), pruritus, contact dermatitis
Rare: urticaria, angioneurotic edema, eczema, periorbital edema, erythema.
Disorders of the immune system
Rare: allergic reactions
Eye disorders
Rare: conjunctival irritation.
04.9 Overdose
Nothing to report.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
D06AX01 fusidic acid / sodium fusidate
Fusidic acid is an antibiotic active against Gram (+) bacteria. Some pathogens characteristic of the skin are very sensitive to fusidic acid, such as Staphylococcus aureus, the Propionibacterium acnes and the Corynebacteria.
Fusidic acid exerts its antibacterial activity by inhibiting protein synthesis in bacteria. After 30 years of use in therapy, resistance to Fucidin was rare (1 - 2%).
Penicillin resistant bacteria are very often sensitive to fusidic acid.
05.2 Pharmacokinetic properties
The systemic absorption of fusidic acid and its sodium salt is negligible.
05.3 Preclinical safety data
There are no other relevant preclinical safety data than already described in other sections of the summary of product characteristics
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
FUCIDIN 20 mg / g CREAM: butylhydroxyanisole, cetyl alcohol, glycerol, polysorbate 60, liquid paraffin, potassium sorbate, white petroleum jelly, purified water.
FUCIDIN 20 mg / g Ointment: lanolin, cetyl alcohol, liquid paraffin, white petroleum jelly.
06.2 Incompatibility
Nothing to report.
06.3 Period of validity
Fucidin 20 mg / g Cream: 3 years
Fucidin 20 mg / g Ointment: 3 years.
06.4 Special precautions for storage
Store at a temperature below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
FUCIDIN CREAM: aluminum tubes, containing 30 g of cream - 15 g of cream
FUCIDIN UNGUENTO: aluminum tubes, containing 30 g of ointment - 15 g of ointment
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Leo Pharma A / S, Industriparken 55, 2750 Ballerup (DK)
Dealer in Italy: LEO Pharma S.p.A. Via Amsterdam 125 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
FUCIDIN 20 mg / g CREAM, 30 g tube A.I.C. n. 034266039
FUCIDIN 20 mg / g CREAM, tube of 15 g A.I.C. n. 034266027
FUCIDIN 20 mg / g UNGUENTO, 30 g tube A.I.C. n. 034266054
FUCIDIN 20 mg / g UNGUENTO, tube of 15 g A.I.C. n. 034266041
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2010
10.0 DATE OF REVISION OF THE TEXT
February 2012
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