It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 3/12/2015

Hc45 Hydrocortisone Acetate 1% w/w Cream

1. NAME OF THE MEDICINAL PRODUCT

Hc45 Hydrocortisone Acetate Cream

(Hydrocortisone acetate 1% w/w)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone acetate 1% w/w

Excipients:

Cetostearyl alcohol 7.2% w/w

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream.

White, odourless or almost odourless cream

4. CLINICAL PARTICULARS

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.

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 unless recommended by a health care professional.

Method of administration

For topical administration.

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

4.3 Contraindications

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

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy:

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.

Breast-feeding

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.

Fertility

No known effects.

4.7 Effects on ability to drive and use machines

None known.

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

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

4.9 Overdose

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. PHARMACOLOGICAL PROPERTIES

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. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

Liquid Paraffin

Cetomacrogol emulsifying wax (includes cetostearyl alcohol)

Phenoxyethanol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

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

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/45/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24th September 1996

Date of last renewal: 24th September 2006

10. DATE OF REVISION OF THE TEXT

July 2015

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.