Hydrocortisone 1% ointment

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Hydrocortisone

זמין מ:

DE Pharmaceuticals

קוד ATC:

D07AA02

INN (שם בינלאומי):

Hydrocortisone

כמות:

10mg/1gram

טופס פרצבטיות:

Cutaneous ointment

מסלול נתינה (של תרופות):

Cutaneous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 13040000

עלון מידע

148
148
210
210
PATIENT INFORMATION LEAFLET
HYDROCORTISONE 1% W/W OINTMENT
1% HYDROCORTISONE
READ ALL OF THIS LEAFLET BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
This medicine is available without a prescription. However, you still
need to use this product carefully to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve
after 7 days
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Hydrocortisone Ointment is and what it is used for
2.
Before you use Hydrocortisone Ointment
3.
How to use Hydrocortisone Ointment
4.
Possible side effects
5.
How to store Hydrocortisone Ointment
6.
Further information
1.
WHAT HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR
Hydrocortisone Ointment is a smooth off-white ointment for application
to the skin only. It contains hydrocortisone which belongs
to a group of medicines called corticosteroids. Hydrocortisone
Ointment is used to reduce inflammation in a variety of
inflammatory skin conditions, such as:
•
mild to moderate eczema
•
dermatitis caused by irritants or allergens
•
insect bite reactions
Hydrocortisone should not be confused with anabolic steroids, used by
some body builders and taken as tablets or injections.
2.
BEFORE YOU USE HYDROCORTISONE OINTMENT
DO NOT USE HYDROCORTISONE OINTMENT:
•
if you are allergic to hydrocortisone or to any of the other
ingredients of Hydrocortisone Ointment
_(see Section 6 _
_ _
_and end of Section 2)._
•
if you have a bacterial infection (e.g. impetigo), viral infection
(e.g. cold sores ‘herpes simplex’, chicken pox) or
fungal infection (e.g. tinea, also called ‘athlete’s foot’,
ringworm or thrush) of the skin.
•
on your face or near your eyes, on the anal or genital region, or on
broken skin.
TAKE SPECIAL CARE WITH HYDROCORTIS

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Ointment 1 %
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ointment containing 1% micronised hydrocortisone
Excipient(s) of known effect
Wool Fat Liquid
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
Smooth off white translucent ointment
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
_Adults and elderly:_ A small amount to be applied to the affected
area evenly
and sparingly once or twice a day for a maximum period of one week.
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 and infants: _As for adults and the elderly_. _Long term
therapy
should be avoided and where possible limited to five to seven days.
This product is not recommended for use on children under 10 years of
age
without medical supervision.
Method of administration
For cutaneous use only.
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 untreated bacterial (e.g. impetigo), fungal (e.g. candida or
dermatophyte) or viral (e.g. herpes simplex) infections of the skin,
infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis
or
acne.
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
ophthalmologist for evaluation of possible causes which may include
cataract,
glaucoma or rare diseases such as central serous chorioretinopathy