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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

HYDROCORTISONE ACETATE

Inapatikana kutoka:

KARO PHARMA AB

ATC kanuni:

D07AA; D07AA02

INN (Jina la Kimataifa):

HYDROCORTISONE ACETATE

Dawa fomu:

Cream

Eneo la matibabu:

Corticosteroids, weak (group I); hydrocortisone

Idhini hali ya:

Marketed

Idhini ya tarehe:

1996-09-24

Tabia za bidhaa

Health Products Regulatory Authority
30 September 2022
CRN00CVFH
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.
Not for use with an occlusive dressing or on large areas of the body.
Health Products Regulatory Authority
30 September 2022
CRN00CVFH
Page 2 of 5
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 int