DiproSalic 0.05% w/w + 2% w/w scalp application

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Betamethasone dipropionate; Salicylic acid

Предлага се от:

Organon Pharma (Ireland) Limited

АТС код:

D07XC; D07XC01

INN (Международно Name):

Betamethasone dipropionate; Salicylic acid

дозиране:

0.05 %w/w+2 percent weight/weight

Лекарствена форма:

Cutaneous solution

Терапевтична област:

Corticosteroids, potent, other combinations; betamethasone

Статус Оторизация:

Marketed

Дата Оторизация:

1983-10-27

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPROSALIC® 0.05% W/W + 2% W/W SCALP APPLICATION
Betamethasone (as dipropionate)/Salicylic acid
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Diprosalic Scalp Application is and what it is used for
2.
Before you use Diprosalic Scalp Application
3.
How to use Diprosalic Scalp Application
4.
Possible side effects
5.
How to store Diprosalic Scalp Application
6.
Further information
1.
WHAT DIPROSALIC SCALP APPLICATION IS AND WHAT IT IS USED FOR
Diprosalic Scalp Application contains two active ingredients,
betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate is one of a group of medicines called
topical corticosteroids. It is classified as a
“potent corticosteroid”. These medicines are put on the surface of
the skin to reduce the redness and itchiness
caused by certain skin problems. Salicylic acid softens the top layer
of scales on the surface of the skin,
which are caused by your skin problem. This allows the betamethasone
dipropionate to reach the diseased
skin underneath to help heal it.
In adults and children, Diprosalic Scalp Application is used to treat
skin conditions where the outer surface
of the skin is covered by a layer of scales. Your scalp application
will remove the layer of scales and reduce
the redness and itchiness caused by your skin problem.
2.
BEFORE YOU USE DIPROSALIC SCALP APPLICATION
DO NOT USE DIPROSALIC SCALP APPLICATION
-
if you are allergic (hypersensitive) to betamethasone dipropionate,
salicylic acid or any of the other
ingredients in Diprosalic Scalp Application.
-
on a

Данни за продукта

Health Products Regulatory Authority
30 July 2021
CRN00C803
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DiproSalic 0.05% w/w + 2% w/w Scalp Application
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05
% w/w
Betamethasone (as dipropionate)
2.00
% w/w
Salicylic Acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A colourless, translucent viscous cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
In combination with salicylic acid it is indicated for the
treatment of chronic lichenified eczema, lichen planus, lichen simplex
and non bullous ichthyosiform erythroderma. It is also
effective in the less responsive conditions such as psoriasis of the
scalp and chronic plaque psoriasis of the hands and feet but
excluding widespread plaque psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium
and desquamates the epidermis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
In most cases a few drops should be applied to the affected areas once
or twice daily and massaged gently and thoroughly
into the skin.
For some patients adequate maintenance therapy may be achieved with
less frequent application.
It is recommended that DiproSalic preparations are prescribed for two
weeks, and that treatment is reviewed at that time. The
maximum weekly dose should not exceed 60g.
Children:
Dosage in children should be limited to 5 days.
4.3 CONTRAINDICATIONS
Rosacea, acne, perioral dermatitis, perianal and genital pruritus.
Hypersensitivity to any of the ingredients of the DiproSalic
preparations contra-indicates their use as does tuberculous and most
viral lesions of the skin, particularly herpes simplex,
vaccinia, varicella. DiproSalic should not be used in napkin
eruptions, fungal or bacterial skin infections without suitable
concomitant anti-infective therapy.
Health Products Regulatory Authority
30 July 2021
CRN00C803
Page 2 of 5
4.4 SPECIAL WA