Hydrocortisone 1% ointment

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Ladda ner Bipacksedel (PIL)
20-04-2020
Ladda ner Produktens egenskaper (SPC)
20-01-2018

Aktiva substanser:

Hydrocortisone

Tillgänglig från:

Sigma Pharmaceuticals Plc

ATC-kod:

D07AA02

INN (International namn):

Hydrocortisone

Dos:

10mg/1gram

Läkemedelsform:

Cutaneous ointment

Administreringssätt:

Cutaneous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 13040000

Produktens egenskaper

                                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

                                
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