Active ingredients: Fusidic acid, Betamethasone
Fucicort 20 mg / g + 1 mg / g cream
Indications Why is Fucicort used? What is it for?
Fucicort contains two active ingredients. One is an antibiotic (fusidic acid) and the other is a corticosteroid (betamethasone valerate). Fusidic acid stops the growth of bacteria while betamethasone reduces swelling, redness and itching of the skin.
Fucicort is used in adults and children to treat inflammation of the skin (eczematous dermatitis) with simultaneous infection caused by bacteria sensitive to fusidic acid.
Contraindications When Fucicort should not be used
Do not use Fucicort
- If you are allergic to fusidic acid, betamethasone or any of the other ingredients of this medicine (listed in section 6).
- If you have a "systemic infection caused by fungi (a" deep infection caused by fungi)
- If you have skin infections caused by fungi, bacteria or viruses that have not been treated with other medicines or treated, but not controlled
- If you have skin manifestations related to tuberculosis that are not treated with other medicines or treated, but not controlled
- If you suffer from rosacea (severe redness, especially in the center of the face)
- If you have eczema around your mouth
Precautions for use What you need to know before taking Fucicort
Talk to your doctor or pharmacist before using Fucicort.
Do not use Fucicort for longer than your doctor has told you, in any case do not use Fucicort for more than 14 days.
Avoid contact with eyes, open wounds or mucous membranes (e.g. mouth or nostrils). Use this medicine with caution when applying it close to your eyes, as it may have eye discomfort (see section 4 "Possible side effects").
Fucicort can mask the symptoms of an infection.
Fucicort can increase the risk of infectious diseases, worsen existing infections, or reactivate latent infections.
Due to the content of betamethasone valerate, prolonged use of Fucicort can cause thinning of the skin (skin atrophy).
Children and adolescents
Fucicort should be used with caution in children as it may cause possible side effects (see "Possible additional side effects in children").
Avoid using large amounts of this medicine, prolonged treatments and covering the skin with clothing or bandages (occlusive dressing).
Interactions Which drugs or foods can modify the effect of Fucicort
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy: use Fucicort exactly as it has been prescribed for you.
Breastfeeding: You can use Fucicort if you are breastfeeding, but avoid applying it to your breasts.
Driving and using machines
Fucicort does not affect the ability to drive or use machines.
Fucicort contains cetostearyl alcohol and chlorocresol.
Fucicort contains cetostearyl alcohol: it can cause local skin reactions (eg contact dermatitis). Fucicort contains chlorocresol: it can cause allergic reactions.
Dose, Method and Time of Administration How to use Fucicort: Posology
Always use this medicine as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
How many
The recommended dose is one application 2 - 3 times a day.
Like
Apply a thin layer of the cream to the area to be treated. Wash your hands before using Fucicort, wash your hands after using this medicine even if you have not used it to treat your hands.
Overdose What to do if you have taken too much Fucicort
If you use more Fucicort than you should
In case of accidental ingestion / intake of an overdose of Fucicort, notify your doctor immediately or go to the nearest hospital.
If you forget to use Fucicort
If you forget to use Fucicort, talk to your doctor or pharmacist.
If you stop using Fucicort
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Fucicort
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed:
Uncommon (may affect up to 1 in 100 people)
- Allergic reaction,
- Localized inflammation of the skin (contact dermatitis),
- Worsening of pre-existing eczema,
- Burning sensation of the skin,
- Itching,
- Dry skin,
- Pain at the application site
- Application site irritation.
Rare (may affect up to 1 in 1000 people)
- Redness of the skin (erythema),
- Urticaria,
- Skin rash,
- Swelling at the application site,
- Blisters at the application site.
Other undesirable effects that have been reported following the use of betamethasone, which can therefore be potential undesirable effects also of Fucicort, are
- Thinning of the skin,
- Inflammation of the skin around the mouth,
- Stripes in the skin,
- Small blood vessels near the surface of the skin that become visible,
- Severe redness (rosacea),
- Increased hairiness,
- Excessive sweating,
- Skin discoloration,
- Bleeding in the skin (bruising) following prolonged use
Side effects if this medicine is applied close to the eyes (e.g. increased eye pressure and glaucoma),
- Malfunction of the adrenal gland, especially after prolonged use of the medicine.
Additional side effects in children and adolescents
- Cushing's syndrome (disease characterized by an excess of hormones in the blood which has full moon face symptoms, weight gain, fluid retention, reduced sugar tolerance and increased risk of diabetes, leg swelling, headache)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not store above 30 ° C.
Validity after first opening: 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP.
The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Fucicort contains
1 g of cream contains:
- the active ingredients are fusidic acid 20 mg, betamethasone valerate 1,214 mg (equal to betamethasone 1 mg).
- the other ingredients are macrogol cetostearyl ether, cetostearyl alcohol, chlorocresol (see section 2 "Fucicort contains cetostearyl alcohol and chlorocresol), monobasic sodium phosphate, liquid paraffin, white petroleum jelly, sodium hydroxide, all-rac-α-tocopherol, purified water.
Description of what Fucicort looks like and contents of the pack
Fucicort comes in cream form in a 30g 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
FUCICORT 20 MG / G + MG / G CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains:
Active principles: fusidic acid 20 mg,
betamethasone valerate 1,214 mg, equivalent to betamethasone 1 mg.
Excipient (s) with known effect: cetostearyl alcohol, chlorocresol.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
FUCICORT 20 mg / g + 1 mg / g Cream is indicated in the treatment of eczematous dermatitis with suspected or confirmed bacterial superinfection by microorganisms sensitive to fusidic acid.
04.2 Posology and method of administration
Adults and children: apply a thin layer of FUCICORT Cream 2 or 3 times a day.
04.3 Contraindications
Hypersensitivity to fusidic acid / sodium fusidate, betamethasone valerate or to any of the excipients listed in section 6.1.
Due to the presence of corticosteroid, Fucicort is contraindicated in the following conditions: Systemic fungal infections
Primary skin infections caused by fungi, viral or bacterial, whether untreated or not controlled with appropriate treatment (see section 4.4)
Skin manifestations related to tuberculosis, either untreated or not controlled with appropriate therapy
Perioral dermatitis and rosacea.
04.4 Special warnings and appropriate precautions for use
Long-term, uninterrupted topical therapies with Fucicort should be avoided.
Depending on the application site, the possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucicort.
Due to the corticosteroid content, Fucicort should be used with caution near the eyes. Avoid contact of Fucicort with eyes (see section 4.8).
Reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following systemic absorption of topical corticosteroids.
Fucicort should be used with caution in children as pediatric patients may show greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatments (see section 4.8). ).
Due to the content of betamethasone valerate, prolonged topical use of Fucicort can cause skin atrophy.
Bacterial resistance has been found with topical use of fusidic acid. As with all antibiotics, prolonged or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.Limiting topical fusidic acid and betamethasone valerate therapy to no more than 14 days at a time minimizes the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroids could mask the potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroids with an immunosuppressive effect, Fucicort may be associated with an increased susceptibility to infection, aggravation of an already existing infection, and the activation of a latent infection. Switching to systemic treatment is recommended if infection cannot be controlled with topical treatment (see section 4.3).
Fucicort cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol can cause local skin reactions (eg contact dermatitis) and chlorocresol can cause allergic reactions.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.
04.6 Pregnancy and lactation
Pregnancy:
Fusidic acid:
No effects are expected during pregnancy as systemic exposure to fusidic acid is negligible.
Betamethasone valerate:
There are no or limited data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Fucicort should not be used during pregnancy unless the clinical condition of the woman requires treatment with fusidic acid and betamethasone valerate.
Feeding time:
No effects on the breastfed newborn / infant are expected as systemic exposure following topically applied fusidic acid and betamethasone valerate to a limited area of the breastfeeding woman's skin is negligible.
Fucicort can be used during breastfeeding, but it is recommended that you avoid applying Fucicort to the breasts.
Fertility:
There are no clinical studies with Fucicort regarding fertility.
04.7 Effects on ability to drive and use machines
Fucicort has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
The estimate of the frequency of undesirable effects is based on a "combined analysis of data from clinical trials and spontaneous reports.
The most frequently reported side effect during treatment is itching.
Undesirable effects are classified using MedDRA system organ class (SOC) and individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are listed in order of decreasing severity.
Very common ≥ 1/10
Common: ≥ 1/100,
Uncommon: ≥ 1 / 1,000,
Rare: ≥ 1 / 10,000,
Very rare:
Systemic corticosteroid class undesirable effects such as betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4).
Increased intraocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, especially with prolonged use and in patients predisposed to developing glaucoma (see section 4.4).
Dermatological side effects of the most potent corticosteroid class include: atrophy, dermatitis (including contact dermatitis and acneiform dermatitis), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation.
Bruising can also occur with prolonged use of topical corticosteroids.
Corticosteroid class effects have been reported uncommonly for Fucicort as described in the frequency table above.
Pediatric population
The observed safety profile is similar in children and adults (see section 4.4).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows for continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemwww. Agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
For topically applied fusidic acid, no information is available regarding potential symptoms and signs of overdose in administration. Cushing's syndrome and adrenal insufficiency may develop following topical application of corticosteroids in large quantities and for more than three weeks.
Systemic consequences of an overdose of the active substances are unlikely to occur after accidental oral intake. The amount of fusidic acid in one tube of Fucicort does not exceed the daily oral dose of a systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Active corticosteroids, combinations with antibiotics
ATC code: D07CC01
FUCICORT Cream combines the well-known anti-inflammatory and anti-itching activity of betamethasone with the topical antibacterial activity of fusidic acid.
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 of Corynebacteria.
Fusidic acid exerts its antibacterial activity by inhibiting protein synthesis in bacteria. After 30 years of use in therapy, resistance to fusidic acid was rare (1 - 2%).
Penicillin-resistant bacteria are very often sensitive to fusidic acid.
Betamethasone valerate is a topical steroid that acts quickly in those forms of inflammatory dermatosis, which normally respond to this type of therapy.
05.2 Pharmacokinetic properties
Systemic absorption of fusidic acid is negligible. Betamethasone can have significant systemic absorption, greater than 5% of the administered dose. The amount of betamethasone absorbed is metabolised in the liver and excreted via the kidney.
05.3 Preclinical safety data
Studies with corticosteroids in animals have shown reproductive toxicity (eg cleft palate, skeletal malformations, low birth weight).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white petroleum jelly, liquid paraffin, monobasic sodium phosphate, sodium hydroxide, all-rac-α-tocopherol, purified water.
06.2 Incompatibility
Nothing to report.
06.3 Period of validity
3 years in intact packaging.
After first opening: 3 months
06.4 Special precautions for storage
Do not store above 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube.
Pack containing a 30 g tube Pack containing a 15 g tube
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
15 g cream - A.I.C. n. 033402013
30 g cream - A.I.C. n. 033402025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 20 May 2000
Renewal date: 1 August 2014
10.0 DATE OF REVISION OF THE TEXT
7 July 2015