4.1. Therapeutic indications

Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.

4.2. Posology and method of administration

Posology

Once or twice a day, for a maximum of 7 days. If the condition is not improved, consult your doctor.

Elderly population

Dosage adjustments are not considered necessary in the elderly.

Paediatric population

Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.

Method of administration

For topical administration.

Apply accurately and sparingly to a small area. Massage gently into the skin.

4.3. Contraindications

Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1

The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne athlete's foot, or infected bites and stings.

In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

Not for use with an occlusive dressing or on large areas of the body.

4.4. Special warnings and precautions for use

The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).

If the condition does not improve consult your doctor. Prolonged use of the product is not recommended (see section 4.2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation.

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 advise is recommended in these cases or other treatment options should be considered.

Contains: Cetomacrogol emulsifying wax with Cetostearyl Alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

The label will state mild steroid.

4.5. Interaction with other medicinal products and other forms of interaction

None known

4.6. Fertility, pregnancy and lactation

Pregnancy

This product should not be used in pregnancy without medical advice. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Breast-feeding

This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.

Fertility

No known effects.

4.7. Effects on ability to drive and use machines

None known

4.8. Undesirable effects

If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued.

Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Skin and Subcutaneous Tissue Disorders

Not known

Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis

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 4.4)

Musculoskeletal and Connective Tissue Disorders

Not known

Collagen disorder

Eye Disorders

Uncommon

Vision, blurred (see also section 4.4)

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google or Apple App Store.

4.9. Overdose

Acute overdose is highly unlikely. No special precautions or antidotes are likely to be needed. Chronic overdose or misuse may increase the risk of topical or systemic steroid-related adverse effects, including hypothalamic pituitary adrenal (HPA) axis suppression and Cushing's syndrome.

Management of overdose with topical corticosteroids includes gradual discontinuation under medical supervision.