Fusibact B Cream is indicated for the treatment of eczematous dermatoses including atopic eczema,
infantile eczema (children of 1 year and over), discoid eczema, stasis eczema, contact eczema and
seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology
A single treatment course should not normally exceed 2 weeks.
Method of administration
For cutaneous use
A small quantity should be applied to the affected area twice daily until a satisfactory response is
obtained. In the more resistant lesions the effect of Fusibact B Cream can be enhanced by occlusion
with polyethylene film. Overnight occlusion is usually adequate.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Due to the content of corticosteroid preparations, fusidic acid/betamethasone cream is contraindicated in the following conditions: Infants under one year of age with infected dermatitis. Systemic fungal infections. 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 or syphilis, either untreated or uncontrolled by appropriate therapy. Acne vulgaris. Perioral dermatitis and rosacea.

Long-term continuous topical therapy should be avoided, particularly in infants and children.
Depending on the application site, possible systemic absorption of betamethasone valerate should
always be considered during treatment with fusidic acid/betamethasone.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents
with symptoms such as blurred vision or other visual disturbances, the patient should be considered
for referral to an ophthalmologist for evaluation of possible causes which may include cataract,
glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been
reported after use of systemic and topical corticosteroids.
Due to the content of corticosteroid, fusidic acid/betamethasone should be used with care near the
eyes. Avoid getting fusidic acid/betamethasone into the eyes (see section 4.8).
Glaucoma might result if the preparation enters the eye. Raised intra-ocular pressure and glaucoma
may also occur after topical use of steroids near the eyes, particularly with prolonged use in patients
predisposed to developing glaucoma.
Reversible hypothalamic pituitary adrenal (HPA) axis suppression may occur following systemic
absorption of topical corticosteroids.
Fusidic acid/betamethasone should be used with care in children as paediatric patients may
demonstrate greater susceptibility to topical corticosteroids induced HPA axis suppression and
Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment
(see section 4.8).
Adrenal suppression can occur even without occlusion. Cushing syndrome may occur as a potential
risk in line with adrenal suppression. 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.
Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with
all antibiotics, extended or recurrent application may increase the risk of developing antibiotic
resistance. . Limiting therapy with topical fusidic acid and betamethasone valerate 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 content of corticosteroid having immunosuppressant effect, fusidic acid/ betamethasone
may be associated with increased susceptibility to infection, aggravation of existing infection, and
activation of latent infection. It is advised to switch to systemic treatment if infection cannot be
controlled with topical treatment (see section 4.3).
Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any
clinical improvement since in this situation occult extension of the infection may occur due to the
masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.
Fusibact B Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact
dermatitis) and chlorocresol which may cause allergic reactions.

None known.

Pregnancy
Fusidic acid:
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible
Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals
have shown negligible systemic absorption of topical fusidic acid.
Betamethasone valerate:
There are no or limited amount of data from the use of topical betamethasone valerate in pregnant
women. Studies in animals have shown reproductive toxicity/foetal abnormalities (see section 5.3).
Fusibact B Cream should not be used during pregnancy unless clearly necessary.
Breast-feeding
No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the
topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breastfeeding
woman is negligible. Fusibact B Cream can be used during breast-feeding but should not be
applied on the breasts to avoid accidental ingestion by the infant
Fertility
There are no clinical studies with fusidic acid/betamethasone regarding fertility.

Fusibact B Cream has no or negligible influence on the ability to drive or to use machines

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from
clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritis
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects 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
Not known (cannot be estimated from the available data)

Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal
suppression especially during prolonged topical administration (see section 4.4).
Raised intraocular pressure, glaucoma and cataract may also occur after topical use of corticosteroids
near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma
and cataract (see section 4.4).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis
(including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae,
telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation. Ecchymosis
may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for fusidic acid/betamethasone
cream described in the frequency table above.
Paediatric population
The observed safety profile is similar in children and adults (see section 4.4).

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

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 3 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 Fusidic acid/Betamethasone 20 mg/g + 1
mg/g cream does not exceed the oral daily dose of systemic treatment. A single oral overdose of
corticosteroids is rarely a clinical problem.

Pharmacotherapeutic group: Corticosteroids, potent, combinations with antibiotic,
ATC code: D07C-C01,
Fusibact B Cream combines the well-known anti-inflammatory and antipruritic effects of
betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone is a topical
steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of
therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic
acid is effective against Staphyloccus aureus, Streptococci, Corynebacteria, Neisseria and certain
Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains
of S. aureus. The antibacterial activity of fusidic acid is not diminished in the presence of
betamethasone.

There are no data which define the pharmacokinetics of fusidic acid/betamethasone cream, following
topical administration in man.
However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of
penetration depends on factors such as the duration of exposure to fusidic acid and the condition of
the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.
Betamethasone is absorbed following topical administration. The degree of absorption is dependent
on various factors including skin condition and site of application. Betamethasone is metabolised
largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are
excreted with the urine.

Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal
malformations, and low birth weight).

Chlorocresol
Vitamin E Acetate (alpha-Tocopherol)
Cetomacrogol 1000
Cetostearyl Alcohol
White Soft Paraffin
Liquid Paraffin
Sodium Dihydrogen Phosphate Anhydrous
Sodium hydroxide
Purified Water

Not applicable.

24 months After first opening: 3 month(s)

Do not store above 30°C.

Aluminum tube of 15g and 30 g
Not all pack sizes may be marketed

No special requirements.

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