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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Betamethasone dipropionate; Salicylic acid

Tillgänglig från:

IMED Healthcare Ltd.

ATC-kod:

D07XC; D07XC01

INN (International namn):

Betamethasone dipropionate; Salicylic acid

Läkemedelsform:

Cutaneous solution

Terapiområde:

Corticosteroids, potent, other combinations; betamethasone

Tillstånd datum:

2023-08-25

Bipacksedel

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 any o

Produktens egenskaper

Health Products Regulatory Authority
25 August 2023
CRN00DFR5
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 a 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 PA23198/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Hypromellose (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
Low Density Polyethylene (LDPE) counter-drip bottle. Each bottle
contains 100 ml of product."
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Health Products Regulatory Authority
25 August 2023
CRN00DFR5
Page 2 of 2
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland.
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/206/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
August 2023
10 DATE OF REVISION OF THE TEXT