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.

The sodium salt of fusidic acid has been shown to cause conjunctival irritation. The

ointment should not be used in or near the eye. 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.

Zeta® Ointment contains cetyl alcohol and lanolin, which may cause allergic reactions

(possibly delayed).

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 effects.

There is evidence to suggest that when given systemically, fusidic acid can penetrate the

placental barrier. The use of topical Zeta® 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.

Zeta® administered topically has no or negligible influence on the ability to drive and to use machines.

Based on combined clinical data for Zeta® cream and Zeta® 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:

National Pharmacovigilance and Drug Safety Center (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

• Other GCC States:

Please contact the relevant competent authority.

Overdose is unlikely to occur.

Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion

of Zeta® ointment is unlikely to cause any harm. The total quantity of fusidic acid (30g

Zeta® ointment contains 576mg 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 ≤ 10kg. Although in this instance a child of this particular age group is unlikely to

ingest a whole tube of Zeta® ointment. The concentration of the excipients is too low to

constitute a safety risk.

ATC code: D06AX01

Fusidic acid is a potent topical 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 microgram/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.

White soften paraffin

Mineral oil

Wool fat

Cetyl alcohol

Not applicable.

Store below 30 °C

One printed Aluminum Collapsible Tube of 15 g ointment packed in a printed carton with folded leaflet.

None.