EGERIAN 0.1% + 0.1% Cream

PACKAGE LEAFLET
Egerian 0.1%+0.1% cream
Gentamicin sulfate
and Betamethasone valerate

COMPOSITION
100 g of cream contain:

Active ingredients:Gentamicin 0.1 g(as gentamicin sulfate)

Betamethasone 0.1 g(as betamethasone valerate)

Excipients: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white petrolatum,
liquid paraffin, sodium phosphate monobasic, phosphoric acid, purified water.

PHARMACEUTICAL FORM AND CONTENT
Cream. Tube containing 30 grams.

PHARMACOTHERAPEUTIC CATEGORY
Active corticosteroids, associations with antibiotics.

MARKETING AUTHORISATION HOLDER
AGIPS Farmaceutici Srl – Via Amendola, 4 – 16035 Rapallo (GE)

MANUFACTURER AND FINAL CONTROLLER
IDI Farmaceutici S.r.l. – via dei Castelli Romani, 83/85 – 00040 Pomezia (Rome)

THERAPEUTIC INDICATIONS
Topical treatment of allergic or inflammatory dermatoses secondarily infected or
when there is a threat of infection. These include: eczema (atopic,
infantile, nummular), anogenital and senile pruritus, contact dermatitis, seborrheic
dermatitis, neurodermatitis, intertrigo, solar erythema, exfoliative dermatitis, dermatitis
from radiation, stasis dermatitis and psoriasis.

CONTRAINDICATIONS
Cutaneous tuberculosis, herpes simplex, as well as in the presence of viral diseases with
skin involvement.
The product is also contraindicated in patients with hypersensitivity to the active
ingredients (gentamicin sulfate; betamethasone valerate) or to any of the excipients.

PRECAUTIONS FOR USE
In case of irritation or sensitization related to the use of the product, treatment
should be discontinued and appropriate therapy instituted. Each of the undesirable effects
described for systemic corticosteroids, including hypoadrenalism, can also occur with
topical corticosteroids, especially in pediatric patients (see also “Special warnings”).
Systemic absorption of topical corticosteroids increases with treatment of large
skin areas or with the use of occlusive dressings. In such cases, or when
prolonged treatment is expected, appropriate precautions are required,
particularly in pediatric patients.
The use of topical antibiotics can sometimes allow the proliferation of non-sensitive organisms
including fungi.
In this case or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and specific therapy should be started.

INTERACTIONS
None known.

SPECIAL WARNINGS
The medicine contains chlorocresol which may cause allergic reactions. The medicine
also contains cetostearyl alcohol which may cause local skin reactions (e.g.
contact dermatitis).
The product must not be used for ophthalmic use.

Use in paediatrics:pediatric patients may be more sensitive than adults to
depression of the hypothalamic-pituitary-adrenal axis induced by topical corticosteroids and to the effects
of exogenous corticosteroids, due to the greater absorption due to the high ratio between
skin surface area and body weight. Depression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation and intracranial hypertension have been described in children treated with topical corticosteroids.
In children, manifestations of hypoadrenalism include low cortisol levels and
lack of response to ACTH stimulation. Manifestations of intracranial hypertension include tension of the fontanelles, headache and bilateral papilledema.

Use during pregnancy and breastfeeding:the safety of topical corticosteroids has not
been established in pregnant women; therefore, during pregnancy the use of drugs
belonging to this class should be limited to cases where the expected benefit justifies
the potential risk to the fetus. In pregnant patients, these drugs should not be used
intensively, at high doses or for long periods of time. It is not known whether
topical administration of corticosteroids can cause sufficient systemic absorption to produce measurable concentrations in breast milk. Therefore, it is
necessary to decide whether to discontinue breastfeeding or to discontinue therapy, taking
into account the importance of the drug for the mother.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Apply a small amount of cream to the affected area 2-3 times daily.
Refractory psoriatic lesions and deeply infected dermatoses may
respond better to therapy with local corticosteroids and antibiotics when these are
used with the occlusive bandage technique, described below.

Occlusive bandage technique:

• 1) apply a thick layer of cream to the entire surface of the lesion under a light gauze and cover with transparent, waterproof and flexible plastic material, beyond the edges of the treated area;
• 2) seal the edges to healthy skin with a bandage or other means;
• 3) leave the dressing “in situ” for 1-3 days and repeat the procedure 3-4 times as needed. With this method, a noticeable improvement is often observed within a few days. Rarely, miliaria or folliculitis develops on the skin under the dressing, requiring removal of the plastic covering.

OVERDOSE
Symptoms: excessive or prolonged use of topical corticosteroids can depress
hypophyseal-surrenal function, causing secondary hypoadrenalism and manifestations of
hypercortisolism including Cushing's syndrome. A single episode of gentamicin overdose should not produce any symptoms. Excessive and prolonged use of
topical gentamicin can lead to the formation of lesions due to fungi and bacteria not
sensitive. Treatment: appropriate symptomatic treatment is indicated.
Symptoms of acute hypercortisolism are generally reversible. If necessary, treat the
electrolyte imbalance. In the case of chronic toxicity, slow withdrawal of the
corticosteroid is recommended. In the case of proliferation of fungi and bacteria, appropriate
antifungal or antibacterial therapy is indicated.

UNDESIRABLE EFFECTS
The following undesirable effects, related to the use of topical corticosteroids, have been described:
burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis. When using
occlusive dressings, undesirable effects such as skin maceration, secondary infection, skin atrophy, striae and
miliaria may occur more frequently.
Treatment with gentamicin may produce temporary irritation (erythema and itching) that
usually does not require discontinuation of treatment.

side effects.

The patient should inform the attending physician or pharmacist of any adverse

effect encountered.

SHELF LIFE AND STORAGE
Shelf life: see the expiry date indicated on the packaging.
Caution: do not use the medicine after the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging
correctly stored.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN