Solaraze 3% gel

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Diclofenac sodium

Tilgjengelig fra:

PCO Manufacturing Ltd.

ATC-kode:

D11AX18

INN (International Name):

Diclofenac sodium

Dosering :

3 percent

Legemiddelform:

Gel

Terapeutisk område:

diclofenac

Autorisasjon dato:

2021-12-17

Informasjon til brukeren

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLARAZE
® 3% GEL
diclofenac sodium
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 Solaraze is and what it is used for
2.
What you need to know before you use Solaraze
3.
How to use Solaraze
4.
Possible side effects
5.
How to store Solaraze
6.
Contents of the pack and other information
1.
WHAT SOLARAZE IS AND WHAT IT IS USED FOR
Solaraze is a non-steroidal anti-inflammatory
dermatological gel. When applied to the skin, Solaraze
gel is used to treat a skin problem known as actinic or
solar keratosis that is caused by long-term sun exposure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SOLARAZE
DO NOT USE SOLARAZE

If you are allergic to diclofenac or any of the
ingredients of this medicine (listed in section 6).

If you have had an allergic reaction such as skin rash
(nettle rash), breathing difficulties (wheezing) or runny
nose (allergic rhinitis) after taking aspirin or any other
non-steroidal anti-inflammatory agents.

If you are in the final 3 months of your pregnancy.
WARNINGS AND PRECAUTIONS

The possibility of systemic side effects from
application of Solaraze cannot be excluded if the
product is used on large areas of skin and over a
prolonged period. Consult your doctor if:

you have, or have had in the past, a stomach
ulcer or bleeding from the stomach.

you have heart, liver or kidney problems.

you have any type of bleeding disorder or bruise
very easily.

Avoid sun exposure, including tanning salons, when
usin

Preparatomtale

Health Products Regulatory Authority
17 December 2021
CRN00CPQP
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solaraze 3% gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 30 mg diclofenac sodium (3% w/w).
Excipient(s) with known effect: benzyl alcohol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Austria_
A clear, transparent, colourless or pale yellow gel.
4 CLINICAL PARTICULARS
As per PA0968/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0968/004/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium hyaluronate
benzyl alcohol
macrogol monomethyl ether 350
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 tube and outer package of the product on the market
in the country of origin.
Shelf life after opening: 6 months.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 ˚C.
6.5 NATURE AND CONTENTS OF CONTAINER
The product is supplied in an epoxy-phenolic lined sealed aluminium
tube with a white
polypropylene screw on cap with a pierced tip, in 50 g (2 x 25 g)
size.
Health Products Regulatory Authority
17 December 2021
CRN00CPQP
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
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
PPA0465/488/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17
th
December 2021
10 DATE OF REVISION OF THE TEXT
December 2021