SOLARAZE 3 %w/w Gel

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

DICLOFENAC SODIUM

Tilgjengelig fra:

PCO Manufacturing

ATC-kode:

D11AX18

INN (International Name):

DICLOFENAC SODIUM

Dosering :

3 %w/w

Legemiddelform:

Gel

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other dermatologicals

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-08-12

Informasjon til brukeren

_ _
_ _
PACKAGE LEAFLET: INFORMATION
FOR THE USER
SOLARAZE
®
3%, GEL
Diclofenac Sodium 3% w/w
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 further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for
you personally and you should 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 get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist. IN THIS LEAFLET:
1.
What Solaraze is and what it is used for
2.
Before you use Solaraze
3.
How to use Solaraze
4.
Possible side effects
5.
How to store Solaraze
6.
Further 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.
BEFORE YOU USE SOLARAZE
DO NOT USE SOLARAZE
•
If you are allergic to diclofenac or any of
the ingredients in Solaraze.
•
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.
TAKE SPECIAL CARE WITH SOLARAZE
•
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 type of bleeding disorder or
bruise 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.
•
Do not allow Solaraze to

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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product Imported from Italy and the UK:_
A clear, transparent, colourless or pale yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of actinic keratoses
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_USE IN ADULTS_: Solaraze is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount
needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 5 cm x 5 cm
lesion site. The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment
duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be
evident for up to 30 days following cessation of therapy. A maximum of 8 grams daily should not be exceeded. Long
term efficacy has not been established.
_USE IN THE ELDERLY: _The usual adult dose may be used.
_USE IN CHILDREN: _Dosage recommendations and indications for the use of Solaraze have not been established for use in
children.
4.3 CONTRAINDICATIONS
Solaraze is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, macrogol
monomethyl ether 350 and/ or sodium hyaluronate.
Because of cross-reactions, the gel should not be used by patients who have experienced hypersensitivity reactions such
as symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic acid or other non-steroidal anti-inflammatory
agents.
The use of Solaraze is contraindicated during the third trimester of pr