HC45 Hydrocortisone Acetate Cream (Hydrocortisone Acetate 1% w/w)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE ACETATE

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

D07AA; D07AA02

INN (International Name):

HYDROCORTISONE ACETATE

Dosage:

1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Corticosteroids, weak (group I); hydrocortisone

Authorization status:

Marketed

Authorization date:

1996-09-24

Patient Information leaflet

Hc945
H yd ro c o r t i s o n e
Cream
T B R 1 9 6 5 - D 0 1 2 1 0 8 7 – E n g l i s h
15g
HYDROCORTISONE
ACETATE cream
HYDROCORTISONE
ACETATE cream
HYDROCORTISONE
ACETATE
cream
Hydrocortisone Acetate 1% w/w
Treatment for Eczema, Dermatitis & Insect Bites
without medical advice.
Contact your doctor if you experience blurred vision or other visual
disturbances.
Check tube seal is intact before first use, then remove it.
3.HOWTO USE HC45: Use sparingly on small skin areas, once or twice a
day for a maximum of 7 days. If the condition does not improve,
consult
your doctor.
4.POSSIBLE SIDE EFFECTS: May cause local skin reactions and blurred
vision. Steroid withdrawal reaction: If used continuously for
prolonged
periods a withdrawal reaction may occur on stopping treatment with
some or all of the following features: redness of the skin which can
extend
beyond the initial area treated, a burning or stinging sensation,
intense
itching, peeling of the skin, oozing open sores. If anything unusual
happens,
stop using the product. If you get any side effects, talk to your
doctor,
pharmacist or nurse.This includes any possible side effects not listed
above.
You can also report side effects directly via the Yellow Card Scheme
at:
http://www.mhra.gov.uk/yellowcard (UK) or via http://www.hpra.ie
(Ireland). By reporting side effects, you can help provide more
information
on the safety of this medicine.
5.HOWTO STORETHIS MEDICINE: Store below 25°C.
1.WHAT HC45 IS USED FOR: HC45 works by altering the body’s
responses to inflammatory reactions due to irritant contact
dermatitis,
allergic contact dermatitis, insect bites and mild to moderate eczema.
2.BEFOREYOU USE HC45: Use this medicine only on your skin to cover
the affected area. If your condition worsens during use consult a
pharmacist or doctor – you may be experiencing an allergic reaction,
have
an infection or your condition requires a different treatment.
If you experience a recurrence of your condition shortly after
stopping
treatment, within 2 weeks, do not restar

Summary of Product characteristics

Health Products Regulatory Authority
08 April 2022
CRN00CT2C
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Health Products Regulatory Authority
08 April 2022
CRN00CT2C
Page 2 of 5
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 interruptio