Locoid Ointment 0.1% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE BUTYRATE

Available from:

LEO Pharma A/S

ATC code:

D07AB; D07AB02

INN (International Name):

HYDROCORTISONE BUTYRATE

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, moderately potent (group II); hydrocortisone butyrate

Authorization status:

Marketed

Authorization date:

1977-10-14

Patient Information leaflet

PATIENT LEAFL ET: INFORMATION FOR THE USER
LOCOID
® OINTMENT 0.1% W/W
Hydrocortisone butyrate
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leafl et. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If you get any of the side eff ects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leafl et. See section 4.
IN THIS LEAFL ET:
1. What Locoid
®
Ointment is and what it is used for
2. What you need to know before you use Locoid
®
Ointment
3. How to use Locoid
®
Ointment
4. Possible side eff ects
5. How to store Locoid
®
Ointment
6. Contents of the pack and other information
1. WHAT LOCOID
® OINTMENT IS AND WHAT IT IS USED FOR
The active substance in Locoid Ointment (hydrocortisone butyrate) is a
corticosteroid which
when made up as an ointment is f
or use on the skin. This is known as topical application.
Topical corticosteroids are ranked as mildly potent, moderately
potent, potent and very
potent; Locoid Ointment is classed as potent. Topical corticosteroids
are able to reduce
the infl ammation 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 Ointment is used to treat a variety of skin conditions that
respond to topical
corticosteroids. Among these are 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, and use it only on small areas on the sc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid Ointment 0.1% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ointment contains Hydrocortisone butyrate 0.1% w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Translucent, light grey to whitish, soft fatty ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for clinical use in the treatment of
conditions responsive to topical corticosteroids e.g.
eczema, dermatitis and psoriasis not caused by micro-organisms.
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 special precautions for use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical application.
Dosage: to be applied evenly and sparingly one to three times daily.
Application may be made under occlusion in the more resistant lesions
such as thickened psoriatic plaques on elbows
and knees. Overnight occlusion is usually sufficient to give a
satisfactory response.
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.
Children and infants: long term treatment should be avoided and
occlusion should not be used.
Courses should be
limited to seven days where possible.
4.3 CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the excipients listed
in section 6.1.
This preparation is contraindicated in the presence of untreated viral
or fungal infections (mycotic yeast) or parasitic
infections, tubercular or syphilitic lesions, ulcerous skin lesions
peri-oral dermatitis, acne vulgaris and rosacea and in
bacterial infections unless used in connection with appropriate
chemotherapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Although generally regarded as safe, even for long-term administration
in adults, there is a potential for adverse