Diprosalic 0.05%/2% scalp application

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Salicylic acid; Betamethasone dipropionate

Dostupné z:

Organon Pharma (UK) Ltd

ATC kód:

D07BC01

INN (Medzinárodný Name):

Salicylic acid; Betamethasone dipropionate

Dávkovanie:

20mg/1ml ; 500microgram/1ml

Forma lieku:

Cutaneous solution

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13040000; GTIN: 5012376011776

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPROSALIC® SCALP APPLICATION 0.05% W/W / 2% W/W, CUTANEOUS SOLUTION
Betamethasone dipropionate/salicylic acid
_ _
READ ALL OF THIS LEAFLET 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 only. 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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What diprosalic scalp application is and what it is used for
2.
What you need to know 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.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIPROSALIC SCALP APPLICATION
DO NOT USE DIPROSALIC SCALP APPLICATION

Súhrn charakteristických

OBJECT 1
DIPROSALIC SCALP APPLICATION
Summary of Product Characteristics Updated 08-Sep-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Diprosalic
®
Scalp Application 0.05% w/w / 2% w/w, cutaneous solution
2. Qualitative and quantitative composition
Betamethasone Dipropionate 0.064% w/w*
(* equivalent to 0.05% Betamethasone)
Salicylic Acid 2.00% w/w
3. Pharmaceutical form
Cutaneous solution
A colourless, translucent, viscous solution.
4. Clinical particulars
4.1 Therapeutic indications
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
It is active topically and produces a
rapid and sustained response in those inflammatory dermatoses that are
normally responsive to topical
corticosteroid therapy, and it is also effective in the less
responsive conditions, such as psoriasis of the
scalp.
Topical salicylic acid softens keratin, loosens cornified epithelium
and desquamates the epidermis.
Diprosalic presentations are therefore indicated for the treatment of
hyperkeratotic and dry corticosteroid-
responsive dermatoses where the cornified epithelium may resist
penetration of the steroid. The salicylic
acid constituent of Diprosalic preparations, as a result of its
descaling action, allows access of the dermis
more rapidly than by applying steroid alone.
4.2 Posology and method of administration
Adults:
Once to twice daily. In most cases a thin film should be applied to
the affected areas 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 presentations contra-indicates their use as does
tuberculous and most