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

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

BETAMETHASONE DIPROPIONATE; Salicylic acid

Dostupné z:

PCO Manufacturing Ltd.

ATC kód:

D07XC; D07XC01

INN (Medzinárodný Name):

BETAMETHASONE DIPROPIONATE; Salicylic acid

Forma lieku:

Cutaneous solution

Terapeutické oblasti:

Corticosteroids, potent, other combinations; betamethasone

Dátum Autorizácia:

2022-01-07

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE
USER
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:
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 any other s

Súhrn charakteristických

Health Products Regulatory Authority
11 January 2022
CRN00CPQC
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 sourced from Portugal_
A colourless, translucent viscous cutaneous solution.
4 CLINICAL PARTICULARS
As per PA23198/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Hydroxypropyl methylcellulose (Methocel E 4M Premium EP)
Sodium hydroxide
Isopropyl alcohol
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of 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
Health Products Regulatory Authority
11 January 2022
CRN00CPQC
Page 2 of 2
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.,
Unit 10,
Ashbourne Business Park,
Rath,
Ashbourne,
Co. Meath,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/487/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
January 2022
10 DATE OF REVISION OF THE TEXT
January 2022