SOLARAZE diclofenac sodium 3 % gel tube

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

diclofenac sodium, Quantity: 3 % w/w

Disponibil de la:

Mayne Pharma International Pty Ltd

INN (nume internaţional):

Diclofenac sodium

Forma farmaceutică:

Gel

Compoziție:

Excipient Ingredients: polyethylene glycol monomethyl ether; benzyl alcohol; sodium hyaluronate; purified water

Calea de administrare:

Topical

Unități în pachet:

1 x 50g tube, 1 x 25g tube

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Management of actinic keratosis.

Rezumat produs:

Visual Identification: Clear, transperant, colourless or pale yellow gel.; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2007-05-15

Prospect

SOLARAZE®
1
SOLARAZE®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SOLARAZE?
SOLARAZE contains the active ingredient diclofenac sodium. SOLARAZE is
used to treat a skin condition known as actinic
keratosis, also called solar keratosis.
For more information, see Section 1. Why am I using SOLARAZE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SOLARAZE?
Do not use if you have ever had an allergic reaction to SOLARAZE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SOLARAZE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SOLARAZE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE SOLARAZE?
•
Use SOLARAZE twice daily unless your doctor tells you differently.
•
The amount of gel needed will vary depending on the size of the area
to be treated. Usually 0.5 g of gel (about the size of a
pea) will be sufficient for one area. Do not use more than 8 g daily.
•
Gently smooth a small amount of gel onto the skin over the area to be
treated. You may notice a slight cooling effect when
you smooth the gel onto your skin.
More instructions can be found in Section 4. How do I use SOLARAZE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SOLARAZE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
SOLARAZE.
•
Call your doctor straight away if you become pregnant.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are using this medicine.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
Avoid sun exposure, in

Caracteristicilor produsului

v 6.0
1
AUSTRALIAN PRODUCT INFORMATION
SOLARAZE
®
(DICLOFENAC SODIUM) GEL
1.
NAME OF THE MEDICINE
Diclofenac sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLARAZE gel contains diclofenac sodium 3% (w/w).
Excipients with known effect: benzyl alcohol.
For the full list of excipients, see
_section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
A clear, transparent, colourless to pale yellow gel.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Management of actinic keratoses.
4.2.
DOSE AND METHOD OF ADMINISTRATION
SOLARAZE is applied locally to the skin twice daily and smoothed into
the skin gently. The
amount needed depends on the size of the lesion. Normally 0.5 g (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 g daily
should not be
exceeded. Long-term efficacy has not been established.
4.3.
CONTRAINDICATIONS
SOLARAZE is contraindicated in patients with a known hypersensitivity
to diclofenac,
benzyl alcohol, polyethylene glycol monomethyl ether and/ or sodium
hyaluronate.
Because of cross-reactions, patients who have experienced
hypersensitivity reactions such as
symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic
acid or other non-
steroidal anti-inflammatory drugs (NSAIDs), should not use the gel.
The use of SOLARAZE is contraindicated during the third trimester of
pregnancy (see
_section 4.6 Fertility, Pregnancy and Lactation – Use in Pregnancy_
).
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2
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The likelihood of systemic side effects occurring following the
topical application of
SOLARAZE is small compared to the frequency of side effects with oral
diclofenac, owing
to low systemic absorption with SOLARAZE. However, the possibility of
systemic adverse
events