Hc45 Hydrocortisone 1% cream

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Hydrocortisone acetate

Հասանելի է:

Karo Healthcare UK Ltd

ATC կոդը:

D07AA02

INN (Միջազգային անվանումը):

Hydrocortisone acetate

Դոզան:

10mg/1gram

Դեղագործական ձեւ:

Cutaneous cream

Կառավարման երթուղին:

Cutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 13040000; GTIN: 5000167002010

Տեղեկատվական թերթիկ

15g
Pierce tube seal with
point in top of cap.
Pierce tube seal with
point in top of cap.
Pierce tube seal with
point in top of cap.
Pierce tube seal with
point in top of cap.
LOT
USE BY
HYDROCORTISONE
ACETATE
cream
HYDROCORTISONE
ACETATE
cream
HYDROCORTISONE
ACETATE
cream
Hydrocortisone Acetate 1% w/w
Treatment for Eczema, Dermatitis & Insect Bites
2002627_1
RBXXXXX
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. BEFORE YOU 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 restart using the cream/ointment
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
6. FURTHER INFORMATION: HC45 is a white cream containing
Hydrocortisone Acetate 1%
w/w as the active ingredient and white soft paraffin, liquid paraffin,
phenoxyethanol,
purified water, cetomacrogol emulsifying wax with cetostearyl alcohol.
PL holder: Karo Pharma AB, Stockholm, Sweden. PL 50567/0012
PA holder: Karo Pharma AB, Stockholm, Sweden. PA22650/008/001
Manufacturers: RB Healthcare (UK) Ltd, HU8 7DS, UK and RB NL Brands
B.V. Schiphol Blvd 207,
1118 BH Schiphol, NL.
Text revised: Aug 2022.
without consulting a pharmacist or doctor. If your condition has
resolved
and on recurrence the redness extends beyond the initial treatment
area,
and you experience a burning sensation please seek medical advice
before
restarting treatment. Do not cover with a dressing. Do not use if
allergic to
any of the ingredients. Contains Cetostearyl Alcohol which may cause
local skin reactions (e.g. contact dermatitis).
Do not use on the eyes, face, anal or genital areas, on broken skin or
infected skin, e.g impetigo,

Ապրանքի հատկությունները

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
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).
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.
Long term continuous or inappropriate use of topical s