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 among staphylococcus aureus has been reported to occur with the use of topical Zeta. 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 Cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes. Zeta cream should therefore be used with care when applied in the proximity of the eyes.

Fertility

There are no clinical studies with topical Zeta regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical Zeta can be used during pregnancy.

Breast-feeding

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Zeta can be used during breast-feeding but it is recommended to avoid applying topical Zeta on the breast.

Zeta administered topically 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 trials and from spontaneous reporting.

Based on pooled data from clinical studies including 4724 patients who received Zeta cream or Zeta ointment, the frequency of undesirable effects is 2.3%.

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by application site conditions such as pain and irritation, which all occurred in less than 1% of patients.

Hypersensitivity and angioedema have been reported.

Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in 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

Rare

(≥1/10,000 and <1/1,000)

Hypersensitivity

Eye disorders

Rare

(≥1/10,000 and <1/1,000)

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon

(≥1/1,000 and <1/100)

Dermatitis (incl. dermatitis contact, eczema)

Rash^*

Pruritus

Erythema

*Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.

Rare

(≥1/10,000 and <1/1,000)

Angioedema

Urticaria

Blister

General disorders and administration site conditions

Uncommon

(≥1/1,000 and <1/100)

Application site pain (incl. skin burning sensation)

Application site irritation

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

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.

ATC code: D06AX01

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.

Propylene Glycol

Monobasic Sodium Phosphate

Potassium Sorbate

Light Mineral Oil

Cetostearyl Alcohol

Cetomacrogol 1000

White Soft Paraffin

Not applicable

Store below 30 °C

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