Solaraze 3% gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

Primecrown 2010 Limited

ATC code:

D11AX18

INN (International Name):

DICLOFENAC SODIUM

Dosage:

3 percent weight/weight

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

diclofenac

Authorization status:

Authorised

Authorization date:

2011-09-30

Summary of Product characteristics

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 the United Kingdom:_
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 last trimester of
pregnancy_ (see Section 4.6)._
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The likelihood of systemic side effects occurring following the
topical application of Solaraze is very small compared
to the frequency of side effects with oral diclofenac, owing to