Diprosalic 0.05%/3% ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone dipropionate; Salicylic acid

Available from:

Organon Pharma (UK) Ltd

ATC code:

D07BC01

INN (International Name):

Betamethasone dipropionate; Salicylic acid

Dosage:

500microgram/1gram ; 30mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5012376011745 5012376011752

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPROSALIC® 0.05% W/W / 3% W/W OINTMENT
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 ointment is and what it is used for
2.
What you need to know before you use diprosalic ointment
3.
How to use diprosalic ointment
4.
Possible side effects
5.
How to store diprosalic ointment
6.
Contents of the pack and other information
1.
WHAT DIPROSALIC OINTMENT IS AND WHAT IT IS USED FOR
Diprosalic ointment 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 ointment is used to treat skin
conditions where the outer surface of the skin
is covered by a layer of scales. Your ointment 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 OINTMENT
DO NOT USE DIPROSALIC OINTMENT
•
if you are allergic to betamethasone dipropionate, salicylic acid or
any of the other ingredients in this

Summary of Product characteristics

OBJECT 1
DIPROSALIC OINTMENT
Summary of Product Characteristics Updated 08-Sep-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Diprosalic 0.05% w/w / 3% w/w Ointment
2. Qualitative and quantitative composition
Betamethasone Dipropionate 0.064% w/w*
(* equivalent to 0.05% Betamethasone)
Salicylic Acid 3.00% w/w
3. Pharmaceutical form
Ointment
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, 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.
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
cover the affected area twice daily.
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 viral lesions of the
skin, particularly herpes s