Solaraze 3% gel

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Diclofenac sodium

Boleh didapati daripada:

Almirall Ltd

Kod ATC:

M02AA15

INN (Nama Antarabangsa):

Diclofenac sodium

Dos:

30mg/1gram

Borang farmaseutikal:

Cutaneous gel

Laluan pentadbiran:

Cutaneous

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 13080100; GTIN: 4042762053944 4042762055177

Risalah maklumat

PACKAGE INFORMATION LEAFLET
SOLARAZE
® 3% GEL
(diclofenac sodium)
The name of your medicine is Solaraze 3% Gel but will be
referred to as Solaraze throughout the remainder of the
leaflet.
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
using Solaraze. If skin reactions occur, discontinue
use.
•
Do not apply to skin wounds, infected skin or
dermatitis.
•
Do not allow Solaraze to come into contact with your
eyes or the inside of your nose or mouth and do not
swallow it. If Solaraze has accidentally been
swallowed, consult a doctor immediately.
•
Discontinue Solaraze and consult your doctor if you
develop a wide-spread skin rash.
•
After applying products containing diclof

Ciri produk

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
1 g of gel contains 10 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel
A clear, transparent, colourless or pale yellow gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of actinic keratosis (AK).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_USE IN ADULTS: _Solaraze is applied locally to the affected area
twice daily, with the gel smoothed
into the skin gently. The amount needed depends on the size of the
affected area. Normally 0.5
grams (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion
site. The maximum daily
amount of 8 grams of product allows simultaneous treatment of up to
200 cm² skin surface area.
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.
_ _
_USE IN THE ELDERLY:_ The usual adult dose may be used.
_PAEDIATRIC POPULATION:_ AK is a condition not generally seen within
the paediatric population and
was not studied. Therefore, 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
pregnancy (see Section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The likelihood of syst