Each gram of Hydrocortisone, 1% topical ointment, contains:

active ingredient: hydrocortisone acetate – 10 mg;

For a full list of excipients, see section List of excipients.

Ointment for topical use.

White homogenous ointment with weak odor.

Therapeutic indications

For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.

Children under 10 years of age: Not recommended except under medical supervision. For topical application.

The product should not be used if allergic to any of the ingredients or on the eyes or face, the anogenital area or on broken or infected skin including impetigo, cold sores, acne or athlete’s foot.

Medical advice should be sought if the condition does not improve.

Visual impairment:

Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.

Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

This product should not be used in pregnancy without medical advice. There is no information about effects during lactation.

No adverse effects known.

Hydrocortisone Ointment 1% is usually well tolerated but if hypersensitivity occurs discontinue use.

Eye disorders:

Frequency not known: blurred vision (see also section Special warnings and precautions for use)

Skin and subcutaneous tissue disorders:

Not known (cannot be estimated from available data): Withdrawal reactions – redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section Special warnings and precautions for use)

No special precautions or antidotes are likely to be needed.

ATC code: D07AA02.

Pharmacological group: Hydrocortisone is a corticosteroid which has antiinflammatory activity.

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelid, face and scalp than from the forearm, knee, elbow, palm and sole.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

List of excipients

Paraffin liquid,

Propylparaben (E216),

Petrolatum (vaseline) white,

Ethanol.

Not applicable.

3 years.

Shelf life 6 months from date of first opening.

Store in a dry place, out of the reach of children. At temperature not higher than 15^oC.

Hydrocortisone 1% topical ointment is supplied in an aluminum tube (10 g), inserted with leaflet in cardboard box.

Hydrocortisone 1% topical ointment is supplied in an aluminum tube (15 g), inserted with leaflet in cardboard box.

No special requirements.