Fucidin H Cream

Addition of manufacturing site Segrate Italy to section 6 and revision date changed to Jan 2022

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains fusidic acid, anhydrous (as hemihydrate) 20 mg and hydrocortisone acetate 10 mg.

Excipients with known effect:

Each each gram contains butylhydroxyanisole (E320) 0.04 mg, cetyl alcohol 111 mg and potassium sorbate 2.7 mg.

For the a full list of excipients, see section 6.1

4.3. Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or any of the excipients.

Due to the presence of corticosteroid, Fucidin® H is contraindicated in the following conditions: Skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the
excipients listed in section 6.1.

Due to the content of corticosteroid, Fucidin® H is contraindicated in the following
conditions:

Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by
appropriate treatment (see section 4.4).

Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate
therapy.

Perioral dermatitis and rosacea. 


4.4. Special Warnings and Precautions for Use

Long-term continuous topical therapy with Fucidin® H should be avoided. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids.

Depending on the application site, possible systemic absorption of hydrocortisone acetate
should always be considered during treatment with Fucidin® H.

Due to the content of corticosteroid, Fucidin® H should be used with care near the eyes.
Avoid getting Fucidin® H into the eyes (see section 4.8).

Raised intra-ocular pressure and glaucoma can also be caused by topical use of corticosteroids on the face, particularly with prolonged use near the eyes.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following
systemic absorption of topical corticosteroids.

Fucidin® H should be used with care in children as paediatric patients may be more
susceptible to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome
than adult patients (see section 4.8).

Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all
antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing
antibiotic resistance. Limiting therapy with topical fusidic acid and hydrocortisone acetate to
no more than 14 days at a time will minimise the risk of developing resistance.

This also prevents the risk that the immunosuppressive action of corticosteroid might mask
any potential symptoms of infections due to antibiotic-resistant bacteria.

Due to the immunosuppressant effect of corticosteroids, Fucidin® H may be associated with
increased susceptibility to infection, aggravation of existing infection, and activation of latent
infection. It is advised to switch to systemic therapy if infection cannot be controlled with
topical treatment (see section 4.3).

Long-term continuous topical therapy should be avoided, particularly in infants and children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Fucidin® H cream is used near the eye. Glaucoma might result if the preparation enters the eye.
Systemic chemotherapy is required if bacterial infection persists.

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. The use of steroid-antibiotic combinations should be limited to 2 weeks as steroids may mask infections or hypersensitivity reactions.

As Fucidin® H cream contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus. Contact with open wounds and mucous membranes should be avoided. As with all corticosteroids, prolonged use especially on the face should be avoided.

Fucidin® H cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes. 
 

4.5. Interaction with other Medicinal products and other forms of Interaction

None known.

No interaction studies have been performed. Interactions with systemically administered
medicinal products are considered minimal.

4.6. Fertility, Pregnancy and Lactation

Pregnancy
For fusidic acid no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/ foetal development, parturition or postnatal development. Absorption of hydrocortisone acetate following topical application is limited and data from exposed pregnancies indicate no adverse effects on the foetus/newborn child. Caution should be exercised when prescribing to pregnant women.




Pregnancy:

Fusidic acid:
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is
negligible.

Hydrocortisone acetate:
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates
no malformative nor feto/neonatal toxicity of corticosteroids.

Fucidin® H can be used during pregnancy if clinically needed. However, based on a general
knowledge about systemic corticosteroids, caution should be exercised when using Fucidin®
H during pregnancy.

Breastfeeding
No effects on the breastfed new-born/infant are anticipated since the systemic exposure of
topically applied fusidic acid/hydrocortisone acetate to a limited area of skin of the
breastfeeding woman is negligible.
Fucidin® H can be used during breastfeeding but it is recommended to avoid applying
Fucidin® H on the breast.

Fertility
There are no clinical studies with Fucidin® H regarding fertility.

Lactation
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid and hydrocortisone acetate is negligible following topical application. Fucidin® H can be used during breast-feeding. If used on the nipples, any cream on the nipples should be cleaned off before breast-feeding.

4.7. Effects on Ability to Drive and Use Machines

Fucidin® H has no or negligible influence on the ability to drive and to use machines

Fucidin® H has no or negligible influence on the ability to drive or to use machines.

4.8. Undesirable Effects

Based on combined clinical data for Fucidin® H approximately 5% of patients can be expected to experience an undesirable effect.
The most frequently reported undesirable effects of Fucidin® H are various skin reactions and in particular application site reactions.

Allergic reactions and contact dermatitis have been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

The estimation of the frequency of adverse reactions is based on a pooled analysis of data
from clinical studies and spontaneous reporting.

The most frequently reported adverse reactions during treatment are application site reactions
including pruritus, burning and irritation.

Adverse reactions are listed by MedDRA system organ class (SOC) and the individual
adverse reactions are listed starting with the most frequently reported. Within each frequency
grouping, adverse reactions are presented in the order of decreasing seriousness.

Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000

• Immune system disorders
Frequency Unknown:
Allergic reaction

• Skin and subcutaneous tissue disorders
Uncommon:
Eczema aggravated
Pruritus
Skin irritation
Skin burning sensation
Skin stinging sensation

Frequency Unknown
Rash
Allergic contact dermatitis
Depigmentation

Immune system disorders
Uncommon (≥1/1,000 and <1/100):
Hypersensitivity

Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 and <1/100):
Contact Ddermatitis contact
Eczema (condition aggravated)
Rash

General disorders and administration site conditions
Common (≥1/1,00 and <1/10):
Application site reaction (incl. pruritus, burning and
irritation)

Undesirable effects observed for corticosteroids include:
Skin atrophy, telangiectasia and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and adrenocortical suppression.

Systemic undesirable class effects of mild corticosteroids, like hydrocortisone acetate, include
adrenal suppression especially during prolonged topical administration (see section 4.4).

Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids
near the eyes, particularly with prolonged use and in patients predisposed to developing
glaucoma (see section 4.4).

Dermatological undesirable class effects of mild corticosteroids like hydrocortisone acetate include:
Atrophy, dermatitis (incl. dermatitis contact contact dermatitis, dermatitis acneiform dermatitis and perioral dermatitis),
skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and
hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.

Class effects for corticosteroids have been uncommonly reported for Fucidin® H as described
in the frequency table above.

Paediatric population
The observed safety profile is similar in children and adults (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL- Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie  


4.9. Overdose

Overdose is unlikely to occur.

For topically applied fusidic acid, no information concerning potential symptoms and signs
due to overdose administration is available. Cushing's syndrome and adrenocortical
insufficiency may develop following topical application of corticosteroids in large amounts
and for more than three weeks.
Systemic consequences of an overdose of the active substances after accidental oral intake are
unlikely to occur. The amount of fusidic acid in one tube of Fucidin® H does not exceed the
oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a
clinical problem.


6.6. Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


10. DATE OF (PARTIAL) REVISION OF THE TEXT

July 2011

February 2014

Section 6.1 List of Excipients. The following excipient has been added:

all-rac-α-tocopherol

Section 10. Date of (Partial) Revision of the Text: Update to:

July 2011

The following sentence has been added to this section: 'Systemic chemotherapy is required if bacterial infection persists'.

Section 4.8:
Under the sub-heading of 'Immune System reactions', 'allergic reaction', is now listed as a frequency of 'Unknown', it previously came under the heading of 'very rare'.

Under the subheading of 'Skin and subcutaneous tissue disorders', 'rash' is now listed under the frequency of 'Frequency Unknown', it previously came under the heading of 'Very rare'.

Allergic contact dermatitis and skin depigmentation are also listed as an undesirable effect resulting from the use of corticosteroids.

Section 6.5:
The following sentence has been added: 'Not all pack sizes may be marketed'.