Indicated either alone or in combination with systemic therapy, in the treatment of primary and
secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus
spp and Corynebacterium minutissimum. Primary skin infections that may be expected to
respond to treatment with Fusidic acid applied topically include: impetigo contagiosa, superficial
folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as
infected eczematoid dermatitis, infected contact dermatitis and infected cuts/abrasions.

Adults and Children:
Uncovered lesions - apply gently three or four times daily.
Covered lesions - less frequent applications may be adequate.

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.
Extended or recurrent use may increase the risk of developing contact sensitisation.

Fusidic acid does not appear to cause conjunctival irritation in experimental animals. Caution
should still be exercised, however, when Fusibact Cream is used near the eyes.

Fusibact Cream contains Butylated Hydroxianisole, 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.

None known

There is inadequate evidence of safety in human pregnancy. Animal studies and many years of
clinical experience have suggested that fusidic acid is devoid of teratogenic effect. There is
evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier.
The use of topical Fusibact Cream in pregnancy requires that the potential benefits be weighed
against the possible hazards to the foetus. Safety in nursing mothers has not been established.
When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in
breast milk, but with topical use the possible amount of drug present is unlikely to affect the
infant.

Fusibact Cream administered topically has no or negligible influence on the ability to drive or
to use machines.

Based on combined clinical data for Fusibact Cream and Fusibact ointment, less than 5% of
patients can be expected to experience an undesirable effect. The most frequently reported adverse
drug reactions are various skin reactions and in particular application site reactions. Undesirable
effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with
the most frequently reported.

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)

Immune system disorders
Rare
Hypersensitivity
Eye disorders
Rare
Conjunctivitis

Skin and subcutaneous tissue disorders
Uncommon
Pruritus
Rash including erythematous, maculo-papular and pustular reactions
Contact Dermatitis
Irritation at site of application (including pain, stinging, burning and erythema)
Not known
Urticaria
Angioedema
Eczema
Periorbital oedema

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

Overdose is unlikely to occur
Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of
Fusibact cream is unlikely to cause any harm. The total quantity of Fusidic acid (30 g Fusibact
cream contains 600 mg Fusidic acid) will usually not exceed the approved total daily oral dose of
Fusidic acid containing products except in children aged less than 1 year and weighing ≤ 10 kg.
Although in this instance a child of this particular age group is unlikely to ingest a whole tube of
Fusibact cream. The concentration of the excipients is too low to constitute a safety risk.

Fusidic acid is a potent antibacterial agent. Fusidic acid and its salts show fat and water solubility
and strong surface activity and exhibit unusual ability to penetrate intact skin. Concentrations of
0.03 - 0.12 mcg Fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical
application of Fusidic acid is also effective against streptococci, corynebacteria, neisseria and
certain clostridia.

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.

There are no pre-clinical data of relevance to the prescriber which are additional to that
already included in other sections of the SPC.

1. Butylated Hydroxyanisole
2. Cetyl Alcohol
3. Glycerol (Glycerine 100%)
4. Propylene Glycol
5. Liquid Paraffin
6. Simethicone Emulsion (Antifoam)
7. Potassium Sorbate
8. Polysorbate 60 (Tween 60)
9. Polysorbate 80 (Tween 80)
10. White Petroleum Jelly (White soft paraffin)
11. Purified Water q.s. to add

Not applicable

Do not store above 30°C.

Immediate Container: collapsible aluminum tubes, internally lacquered, latex
end seal, membrane nozzle, white full dia HDPE cap with spike for piercing.
Cap: High density (HDPE) with piercing end.
Outer Individual Carton
Leaflet (PIL)

Use as directed by the physician
For external use only
Keep out of the reach of children.
Caution: Avoid contact with eye and mouth