DiproSalic 0.05% w/w + 2% w/w Scalp Application

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone; Salicylic acid

Available from:

LTT Pharma Limited

ATC code:

D07XC; D07XC01

INN (International Name):

Betamethasone; Salicylic acid

Dosage:

0.05 %w/w + 2 percent weight/weight

Pharmaceutical form:

Cutaneous solution

Administration route:

topic use

Units in package:

100 ml of product

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Schering-Plough Labo NV

Therapeutic group:

Corticosteroids, potent, other combinations

Therapeutic area:

Corticosteroids, potent, other combinations; betamethasone

Therapeutic indications:

It 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.

Authorization status:

Authorised

Authorization date:

2015-03-06

Patient Information leaflet

DIPROSALIC 0.05% W/W + 2% W/W SCALP APPLICATION
betamethasone /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:
What DiproSalic Scalp Application is and what it is used for
Before you use DiproSalic Scalp Application
How to use DiproSalic Scalp Application
Possible side effects
How to store DiproSalic Scalp Application
Further information
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.
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 any other skin problem as it could make it worse especially rosacea
(a
skin condition affec

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2019
CRN008MRN
Page 1 of 2
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
_Product imported from Portugal_
A colourless, translucent viscous cutaneous solution.
4 CLINICAL PARTICULARS
As per PA1286/029/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/029/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
hydroxypropyl methylcellulose
disodium edetate
sodium hydroxide
isopropyl alcohol
purified water
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
24 January 2019
CRN008MRN
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and
outer package of the product on the market in the country of origin.
The shelf life after opening the bottle is 6 weeks.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Polyethylene container with high density polyethylene closures,
containing 100 ml of
product.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch, Worcestershire B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/151/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
March 2015
10 DATE OF REVISION OF THE TEXT
January 2019