Locoid Crelo 0.1% topical emulsion

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone butyrate

Available from:

Neon Healthcare Ltd

ATC code:

D07AB02

INN (International Name):

Hydrocortisone butyrate

Dosage:

1mg/1gram

Pharmaceutical form:

Cutaneous emulsion

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5013346028015

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCOID
®
CRELO
Hydrocortisone butyrate 0.1% w/w
READ ALL OF THIS LEAFL ET 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. 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 LEAFL ET:
1.
What Locoid Crelo is and what it is used for
2. What you need to know before you use Locoid Crelo
3. How to use Locoid Crelo
4. Possible side effects
5. How to store Locoid Crelo
6. Contents of the pack and other information
1. WHAT LOCOID CRELO IS AND WHAT IT IS USED FOR
Locoid Crelo contains the active substance hydrocortisone butyrate.
This is a
corticosteroid which when made up as an emulsion is for use on the
skin. This is
known as topical application. Topical corticosteroids are ranked as
mildly potent,
moderately potent, potent and very potent; Locoid Crelo is classed as
potent.
Topical corticosteroids are able to reduce the inflammation caused by
a variety of
skin conditions, and so allow it to get better. They can also affect
the cause of the
condition, which can lead to its healing.
Locoid Crelo is indicated in adults, children and infants. It is used
to treat a variety
of skin conditions especially those affecting the scalp, hairy or
facial skin, such as
eczema and dermatitis (itching) of all types including atopic
(childhood) eczema,
photodermatitis (itching caused by exposure to light) and dermatitis
caused by skin
irritants and allergies.
It can also be used in the treatment of psoriasis, a condition
resulting in thickening
of areas of the skin. It is important that you follow your doctor’s
instructions
particularly in psoriasis,

Summary of Product characteristics

OBJECT 1
LOCOID CRELO
Summary of Product Characteristics Updated 15-Sep-2016 | Leo
Laboratories Limited
1. Name of the medicinal product
Locoid Crelo
2. Qualitative and quantitative composition
Locoid Crelo contains 0.1% w/w hydrocortisone butyrate.
Excipient(s) with known effect:
Cetostearyl alcohol (2% w/w)
Butylhydroxytoluene (0.02% w/w)
Propylene glycol (5% w/w)
Propyl parahydroxybenzoate (0.3% w/w)
Butyl parahydroxybenzoate (0.15% w/w)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Topical emulsion.
The product is a white emulsion.
4. Clinical particulars
4.1 Therapeutic indications
Locoid Crelo is indicated in adults, children and infants. The product
is recommended for clinical use in
the treatment of conditions responsive to topical corticosteroids,
e.g. eczema, dermatitis and psoriasis.
The product is intended for topical application especially to the
scalp or hirsute skin.
Topical corticosteroids are not generally indicated in psoriasis but
may be acceptable in psoriasis
excluding widespread plaque psoriasis provided warnings are given, see
section 4.4 Special warnings and
precautions for use.
4.2 Posology and method of administration
Posology
_Adults and older people_
The same dose is used for adults and older people, as clinical
evidence would indicate that no special
dosage regimen is necessary in older people.
_Paediatric population_
Long term treatment should be avoided where possible.
_Infants_
Therapy should be limited if possible to a maximum of seven days.
Method of administration
For cutaneous use.
Dosage: To be applied evenly and sparingly no more than twice daily.
The formulation of the product makes it suitable for use in both scaly
lesions and for moist, weeping
lesions.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
This preparation is contraindicated in the presence of untreated viral
or fungal infections, tubercular or
syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea
and in bact