DICLOFENAC SODIUM 3% GEL

Active substance: DICLOFENAC SODIUM

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Var. 04: To change the manufacturer from (Bioglan AB, Malmo, Sweden)
to (Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany).
PACKAGE LEAFLET: INFORMATION FOR THE USER

SOLARAZE™ 3% GEL
DICLOFENAC SODIUM 3% GEL
(Diclofenac Sodium)

Your medicine is available using the above names, but will be referred
to as Solaraze 3% Gel throughout this leaflet.
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.
2.
3.
4.
5.
6.

What Solaraze 3% Gel is and what it is used for
Before you use Solaraze 3% Gel
How to use Solaraze 3% Gel
Possible side effects
How to store Solaraze 3% Gel
Further information

1. What Solaraze 3% Gel is and what it is used
for

Solaraze 3% Gel is a non-steroidal anti-inflammatory dermatological
gel. When applied to the skin, Solaraze 3% 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 3% Gel
Do not use Solaraze 3% Gel:

If you are allergic to diclofenac or any of the ingredients in
Solaraze 3% Gel.
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 3% Gel:

You should 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
3% Gel. If skin reactions occur, discontinue use.
Do not apply to skin wounds, infected skin or dermatitis.
Do not allow Solaraze 3% Gel to come into contact with your eyes
or the inside of your nose or mouth.

If you use more Solaraze 3% Gel than you should
Remove the excess gel by washing with water.

If you forget to use Solaraze 3% Gel

Continue to apply as directed but do not apply twice as much to make
up for the missed application.

4. Possible side effects

Like all medicines, Solaraze 3% Gel can have side effects although not
everybody gets them.

If you have any of the following side effects, stop using
Solaraze 3% Gel and contact your doctor as soon as
possible:
skin rash (nettle rash); breathing difficulties (wheezing); runny nose
(allergic rhinitis). These symptoms indicate that you may be allergic to
Solaraze 3% Gel.
If any of the following common side effects are severe or last for more
than a few days you should stop using Solaraze 3% Gel and contact
your doctor: itching, rash, skin redness, inflammation, contact
dermatitis, pain and blistering.

Other Common side effects: (occur in between 1 and 10 out of
every 100 patients)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a
painful sensation when the skin is touched, pins and needles, muscle
stiffness, dry skin, swelling, rash (including scaly or blistering), sagging
of the skin, and skin ulcer.
Uncommon side effects: (occur in between 1 and 10 out of every
1,000 patients)
Eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling
sick, hair loss, facial swelling, a skin sensitivity to sunlight, excessive
bleeding or oily skin, a measles-like rash.

Very rare side effects (occur in fewer than 1 in 10,000 patients)
Bleeding from your stomach or problems with your kidneys.
Temporary hair discolouration at the application site has been reported.
This is usually reversed on stopping treatment.
If any of the side effects becomes serious or you notice any side effects
not mentioned in this leaflet please inform your doctor or pharmacist.

5. How to store Solaraze 3% Gel

Keep all medicines out of the reach and sight of children.
Do not store above 25°C.
Use by date: Do not use Solaraze 3% Gel after the expiry date on
the carton and tube label. The date refers to the last date of the
month.
If your gel appears discoloured, or shows any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further information

What Solaraze 3% Gel contains

Pregnancy/Breastfeeding

Each gram of Solaraze 3% Gel contains 30mg of the active ingredient
diclofenac sodium.
The gel also contains sodium hyaluronate, benzyl alcohol, macrogol
monomethyl ether 350 and purified water.

If you are pregnant, and your doctor considers treatment appropriate,
Solaraze 3% Gel must not be applied to an area of the skin larger than
about a third of your body and must not be used for longer than three
weeks.

What Solaraze 3% Gel looks like and contents of the
pack

Solaraze 3% Gel can be used whilst breastfeeding but should not be
used on the breasts.

Manufacturer

Speak to your doctor if you are, or could be pregnant. Solaraze 3% Gel
should be used with caution during the first six months of pregnancy
but must not be used during the last three months of pregnancy.

Ask your doctor or pharmacist for advice before taking or using any
medicine.

3. How to use Solaraze 3% Gel

Solaraze 3% Gel is not suitable for children.
Use the gel as directed by your doctor.
Pierce the aluminium membrane across the tube opening with the
cap before using.
Gently smooth a small amount of gel onto the skin over the area to
be treated. The amount of gel needed will vary depending upon the
size of the area to be treated. Usually 0.5 grams of gel (about the
size of a pea) will be enough for one area (5cm x 5cm) but not
more than 8 grams should be used per day.
You can apply Solaraze 3% Gel twice daily unless your doctor tells
you differently. You may notice a slight cooling effect when you
smooth the gel onto your skin.
The usual period of treatment is 60-90 days. Maximum effect has
been seen with treatment times closer to 90 days. Complete
healing may not occur for up to a month after treatment has
stopped.
Wash your hands after applying the gel, unless your hands are
being treated.

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Solaraze 3% Gel is a clear, transparent, colourless gel packed in tubes
containing 25grams.
Manufactured by: Almirall Hermal GmbH, Scholtzstrasse 3, 21465
Reinbek, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 08929/0341

POM

Leaflet issue and revision date (Ref): 03.05.12
Solaraze™ is a trademark of Almirall S.A.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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