Locoid Ointment Ointment 1mg/g

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

HYDROCORTISONE BUTYRATE

Dostopno od:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

Koda artikla:

D07AB02

INN (mednarodno ime):

HYDROCORTISONE BUTYRATE 1 mg/g

Farmacevtska oblika:

OINTMENT

Sestava:

HYDROCORTISONE BUTYRATE 1 mg/g

Tip zastaranja:

POM

Terapevtsko območje:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2005-09-23

Navodilo za uporabo

LOCOID
®
0.1 % ointment
Information for the user
We advise you to read this package insert, also if you have used
Locoid ointment before.
The information may have changed.
WHAT IS LOCOID OINTMENT AND HOW
DOES IT WORK?
_Composition_
Locoid ointment contains as active
ingredient 1 mg hydrocortisone
17-butyrate per gram.
The other ingredients are: liquid paraffin
and polyethylene.
_What does Locoid ointment look like and _
_how is it supplied?_
Locoid ointment is white and is packed
in tubes of 30 g. The tube is packed in a
yellow/grey/white box imprinted Locoid
ointment.
_How does Locoid ointment work?_
_ _
Locoid ointment contains an adrenal
cortex hormone (corticosteroid) and
decreases quickly the symptoms, such
as itching, redness or scaling of the skin,
which occur in certain skin disorders.
Corticosteroids in general do not cure
the underlying disease.
The ointment base provides for the skin
disorder to become less moist.
_Authorization holder and manufacturer_
_ _
Locoid ointment has been registered in
the name of LEO Pharma A/S,
Industriparken 55, 2750 Ballerup,
Denmark and is manufactured by
Astellas Pharma Europe B.V.
Leiden, The Netherlands
Locoid ointment is only available on
prescription.
WHAT CAN LOCOID OINTMENT BE USED
FOR?
Locoid ointment may be used for the
treatment of superficial skin diseases
in which itching, redness or scaling are
often present.
Locoid ointment contains much fat and is
therefore suitable for disorders with dry
and scaly skin.
WHAT YOU SHOULD KNOW BEFORE USING
LOCOID OINTMENT
_When should you not use Locoid _
_ointment?_
Locoid ointment should not be used for:
-
Skin disorders caused by bacterial,
viral, fungal, yeast or parasitic
infections. These disorders might
aggravate or be masked.
-
Acne, also with redness of the skin.
-
Wounds, fish skin (ichthyosis).
-
Skin disorders which might result from
previous treatment with corticosteroids,
such as inflammation of the skin
around the mouth, thin skin, possibly
with stripes, fragile blood vessels.
If you are hypersensitive to
hyd

Lastnosti izdelka

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Locoid
®
, ointment 1 mg/g Locoid
®
Lipocream, cream 1 mg/g
Locoid
®
cream, cream 1 mg/g Locoid
®
scalp
lotion, lotion 1 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid ointment, Locoid Lipocream and Locoid cream contain 1 mg/g and
Locoid scalp
lotion 1 mg/ml hydrocortisone 17-butyrate.
Locoid ointment is hydrophobic (greasy); Locoid Lipocream and cream
contain buffered
oil-in-water emulsions (Locoid Lipocream has a higher lipid content
and Locoid cream a
higher water content). The lotion, which is a buffered, slightly
viscous solution, is
prepared on the basis of an isopropanol/water mixture.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Locoid ointment is an ointment, Locoid Lipocream and Locoid cream are
creams and
Locoid scalp lotion is a solution for cutaneous use.
Locoid oleogel, Locoid Lipocream and Locoid cream are white. Locoid
scalp lotion is
clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Superficial, corticosteroid-responsive dermatoses that are not caused
by microorganisms
and that are expected to respond inadequately to weak products.
Follow-up or maintenance treatment of dermatoses that have been
suppressed previously
by a stronger corticosteroid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply a small amount of Locoid to the skin 1 - 3 times daily. Once the
disorder has
improved, application once daily or two to three times a week is
usually sufficient.
Generally, not more than 30-60 g per week should be used.
Page 2 of 7
Locoid should be applied evenly in a thin layer onto the affected
skin. It may carefully be
massaged lightly into the skin to promote penetration.
Occlusion may be necessary to obtain a better therapeutic result.
4.3
CONTRAINDICATIONS

Skin lesions caused by:
-
bacterial infections (e.g. pyodermias, luetic and tuberculous lesions)
-
viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares,
verrucae planae, condylomata, moll