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HC45 HYDROCORTISONE CREAM

Active substance(s): HYDROCORTISONE ACETATE / HYDROCORTISONE ACETATE / HYDROCORTISONE ACETATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Hc45 Hydrocortisone Cream

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
Skin and
Subcutaneous
Tissue Disorders
Musculoskeletal
and Connective
Tissue Disorders

Frequency

Adverse Events

Not known

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

Not known

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 25ºC

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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