Solaraze 3% gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Diclofenac sodium

Tilgjengelig fra:

Waymade Healthcare Plc

ATC-kode:

M02AA15

INN (International Name):

Diclofenac sodium

Dosering :

30mg/1gram

Legemiddelform:

Cutaneous gel

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13080100

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLARAZE
TM
3%, GEL
Diclofenac Sodium 3% w/w
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 diclofenac on the skin you can use
a permeable
(non-occlusive) bandage. Do not use an airtight occlusive dressing.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solaraze
TM
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
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 systemic side effects occurring following t