Locoid Scalp Lotion 0.1% w/v Cutaneous Solution

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/volume

Pharmaceutical form:

Cutaneous solution

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

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 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 effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFL ET:
1.
What Locoid
®
Scalp Lotion is and what it is used for
2.
What you need to know before you use Locoid
®
Scalp Lotion
3.
How to use Locoid
®
Scalp Lotion
4.
Possible side eff ects
5.
How to store Locoid
®
Scalp Lotion
6.
Contents of the pack and other information
1. WHAT LOCOID
® SCALP LOTION IS AND WHAT IT IS USED FOR
The active substance in Locoid Scalp Lotion (hydrocortisone butyrate)
is a corticosteroid which when made
up as a lotion 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
Scalp Lotion 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 Scalp Lotion is used to treat a variety of skin conditions such
as eczema and dermatitis (itching) of
all types, but it is used in particular in the treatment of psoriasis
of the scalp. This is a condition resulting in
thickening of areas of the scalp. It can also be used for the
treatment of seborrhoea capitis, a condition
causing redness and infl ammation of the scalp, and scaling of the
scalp with crusted patches, often with
severe dandruff. It is not suitable for treating large areas of
psoriasis of the scalp.You should let your doctor
review your progress regularly as treatment of psoriasis needs care

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid Scalp Lotion 0.1% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The lotion contains Hydrocortisone butyrate 0.1 % w/v.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
Clear, colourless to faintly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for clinical use on treatment of scalp
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 to the scalp.
Dosage: to be applied evenly and sparingly one or three times daily.
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.
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 effects
if over used in infancy.
Extreme caution is required in dermatoses of infancy. In such patients
courses of treatment
should not normally exceed 7 days.
As with all corticosteroids, applicati