Reckitt Benckiser Ireland Limited
Summary of Product Characteristics last updated on medicines.ie: 3/12/2015
Hc45 Hydrocortisone Acetate 1% w/w Cream
Hc45 Hydrocortisone Acetate Cream
(Hydrocortisone acetate 1% w/w)
Hydrocortisone acetate 1% w/w
Cetostearyl alcohol 7.2% w/w
For full list of excipients, see section 6.1.
White, odourless or almost odourless cream
4.1 Therapeutic indications
Allergic contact dermatitis
Irritant contact dermatitis
Insect bite reactions
Mild to moderate eczema
4.2 Posology and method of administration
Adults and children over 10 years: Once or twice a day, for a maximum of 7 days.
Medical advice should be sought if the condition does not improve.
Dosage adjustments are not considered necessary in the elderly.
Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age unless recommended by a health care professional.
Method of administration
For topical administration.
Apply sparingly to a small area. Massage gently into the skin.
Hypersensitivity to hydrocortisone acetate or to any of the excipients listed in section 6.1
Do not use 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 or athlete's foot or infected bites or stings).
Use 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).
Prolonged use of the product is not recommended (see section 4.2) as continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation, particularly of the face.
Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings may suppress adrenocortical function.
This product contains ceteostearly alcohol which my cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
Should not be used in pregnancy unless considered essential by the physician. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity.
The product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. A risk to new-borns/infants cannot be excluded.
No known effects.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
As hydrocortisone acetate is a weak corticosteroid, topical preparations are usually well tolerated, especially under recommended use, where treatment exposure and duration is restricted (see section 4.2).
Undesirable effects from topical corticosteroids are more commonly associated with potent corticosteroids compared with weak agents like hydrocortisone acetate. Adverse effects are very uncommon and typically linked with prolonged therapy or misuse (see section 4.9). 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
Skin and Subcutaneous Tissue Disorders
Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis
Musculoskeletal and Connective Tissue Disorders
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:firstname.lastname@example.org.
No special antidotes are likely to be required.
Acute overdose is highly unlikely. 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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Corticosteroids, dermatological preparations; corticosteroids, weak (group I); ATC Code: D07AA02
Hydrocortisone is a corticosteroid which has anti-inflammatory activity.
5.2 Pharmacokinetic properties
Hydrocortisone acetate is a well characterised corticosteroid which has anti-inflammatory activity resulting at least in part, from binding with a steroid receptor.
Hydrocortisone acetate reduces inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.
5.3 Preclinical safety data
Whilst there is inadequate evidence on safety in human pregnancy, animal studies have demonstrated a possible association between topical corticosteroids and foetal abnormalities, including cleft palate and intra-uterine growth retardation.
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 layers and can be increased by inflammation or diseases of the epidermal barrier.
Hydrocortisone is absorbed to a greater degree from scrotum, axilla, eyelid, face and scalp than from the forearm, knee, palm and sole.
6.1 List of excipients
White soft paraffin
Cetomacrogol emulsifying wax (includes cetostearyl alcohol)
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Internally lacquered, membrane-sealed, collapsible aluminium tube with polypropylene or high density polythene cap containing 15g cream..
6.6 Special precautions for disposal and other handling
No special requirements
Reckitt Benckiser Ireland Ltd.,
Citywest Business Campus,
Date of first authorisation: 24th September 1996
Date of last renewal: 24th September 2006