Solaraze 3% gel

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

DICLOFENAC SODIUM

Tilgjengelig fra:

Lexon (UK) Ltd

ATC-kode:

D11AX18

INN (International Name):

DICLOFENAC SODIUM

Dosering :

3 percent weight/weight

Legemiddelform:

Gel

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

diclofenac

Autorisasjon dato:

2018-07-06

Informasjon til brukeren

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:
What Solaraze is and what it is used for
What you need to know before you use
Solaraze
How to use Solaraze
Possible side effects
How to store Solaraze
Contents of the pack and other information
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.
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 using Solaraze. If skin reactions occur,
discontinue use.
•
Do not apply to skin wounds, infected skin or
dermatitis.
•
D

Preparatomtale

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)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Portugal_
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 for 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
The product is supplied in a sealed tube with a white screw on cap
with a pierced tip.
Pack size: 50 g
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/052/001
9 DATE OF FIRST AUTHORISATION/R