Hc45 Hydrocortisone Cream

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients:

Hydrocortisone Acetate BP 1.0% w/w Excipients:

Also contains Cetomacrogol emulsifying wax (with Cetostearyl Alcohol)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

A smooth, white cream

4 CLINICAL PARTICULARS

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 orgin.

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.

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

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
Musculoskeletal and Connective Tissue Disorders	Not known	Collagen disorder

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.

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Corticosteroids, dermatological preparations; corticosteroids, weak (group I); ATC Code: D07AA02

Hydrocortisone acetate is a well characterised corticosteroid which has antiinflammatory 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.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin Liquid paraffin Phenoxyethanol Purified water

Cetomacrogol emulsifying wax (includes cetostearyl alcohol)

6.2 Incompatibilities

None known

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 15g.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0647

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/11/1986 / 12/11/1998

10 DATE OF REVISION OF THE TEXT

29/07/2015