Hydrocortisone 1% cream

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Hydrocortisone

Предлага се от:

Strides Pharma UK Ltd

АТС код:

D07AA02

INN (Международно Name):

Hydrocortisone

дозиране:

10mg/1gram

Лекарствена форма:

Cutaneous cream

Начин на приложение:

Cutaneous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 13040000; GTIN: 5031676000754 8902501008139

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCORTISONE CREAM 1%
HYDROCORTISONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Hydrocortisone Cream is and what it is used for
2. What you need to know before you use Hydrocortisone Cream
3. How to use Hydrocortisone Cream
4. Possible side effects
5. How to store Hydrocortisone Cream
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR
Hydrocortisone belongs to a group of medicines called topical
corticosteroids. These
work by calming the inflammation that occurs during certain skin
conditions or reactions.
Hydrocortisone Cream may be used for treating various skin conditions
including:
•
Eczema
•
Dermatitis, including intertrigo (irritation between skin folds)
•
Insect bite reactions
•
Inflammation of the external ear (otitis externa)
•
Prurigo nodularis- a long term skin condition where very itchy lumps
appear
•
Neurodermatoses- a long term skin condition where itchy skin becomes
thick due to
scratching
•
Nappy rash, if infection exists it is being treated with appropriate
antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE CREAM
DO NOT USE HYDROCORTISONE CREAM IF YOU:
•
Are allergic to hydrocortisone or any of the other ingredients of this
medicine
(listed in section 6)
•
Have any other skin infection such as athlete’s foot (tinea paedis),
chickenpox (varicella) or
shingles (Herpes zoster), coldsores (Herpes simplex), impetigo,
ringworm o

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Cream 1%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream containing 1% micronised hydrocortisone
Excipient(s) with known effect
Chlorocresol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone has topical anti-inflammatory activity of value in the
treatment
of irritant dermatitis, contact allergic dermatitis, insect bite
reactions and mild
to moderate eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To be applied evenly and sparingly once or twice daily for a maximum
period
of one week. Wash hands after application unless these are the
intended site of
treatment.
If the condition is not improved, consult a doctor.
_Adults and the elderly _
The same dose is used for adults and the elderly, as clinical evidence
would
indicate that no special dosage regimen is necessary in the elderly.
_Children _
Long term therapy should be avoided where possible.
_Infants _
Therapy should be limited if possible to a maximum of seven days.
Do not use for children under 10 years of age without medical advice.
Method of administration
For topical application.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients
listed in section 6.1.
•
Use on the eyes, face or ano-genital region
•
Use on broken or infected skin, including skin lesions caused by
infections
with viruses (e.g. herpes infections such as cold sores, chicken pox),
fungi
(e.g. athlete’s foot, ringworm, thrush) or bacteria (e.g. impetigo)
•
Acne
The product is not recommended for use on children under 10 years of
age
without medical supervision.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient presents with symptoms such as
blurred
vision or other visual disturbances, the patient should be considered
for
referral to an o