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SOLARAZE 3% W/W GEL

Active substance: DICLOFENAC SODIUM

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SOLARAZE® 3% GEL/DICLOFENAC SODIUM 3% w/w TOPICAL GEL
(diclofenac sodium)
Patient Information leaflet
27mm

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Solaraze is and what it is used for
2. Before you use Solaraze
3. How to use Solaraze
4. Possible side effects
5. How to store Solaraze
6. Further information

DATE:

Take special care with Solaraze
• 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.

DATE:

Pregnancy/Breastfeeding
Speak to your doctor if you are, or could be pregnant. Solaraze should be used with caution during the first
six months of pregnancy but must not be used during the last three months of pregnancy.
Consult your doctor if you are breastfeeding. Solaraze can be used whilst breastfeeding with caution but
should not be used on the breasts.

20/05/13

If you are pregnant, trying to get pregnant, or breastfeeding, and your doctor considers treatment appropriate,
Solaraze 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.
Ask your doctor or pharmacist for advice before taking or using any medicine.

UK PIL DATED JANUARY 2012
MULTIPLE MANUFACTURERS

6464 2155A






CODE:

DT
ARTWORKER:

2. Before you use Solaraze
Do not use Solaraze
• If you are allergic to diclofenac or any of the ingredients in Solaraze.
• 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.

DATE OF PROOF:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0440
PRE-PRESS NO.:

CUSTOMER: Waymade
PRODUCT: Solaraze 3% Gel

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.

WARNING!

Notes:

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.

PROOF HISTORY:
v.5 - waymade - 20/05/13

Leaflet Flat Size = 148 x 317

This product is known by the above names but will be referred to as Solaraze throughout this leaflet.





THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

By shahs at 2:37 pm, Jul 15, 2013

3. How to use Solaraze
Solaraze 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 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.

If you use more Solaraze than you should
Remove the excess gel by washing with water.
If you forget to use Solaraze
Continue to apply as directed but do not apply twice as much to make up for the missed application.

Colour
Swatch

Black

WARNING!

leaflet.

update the child safety warning on the

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

variation 10 - To

Previously assessed against UK PIL dated January
2012

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

4. Possible side effects
Like all medicines, Solaraze can have side effects although not everybody gets them.

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, dermatitis, eczema, 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,
excessive bleeding or oily skin, a measles-like rash.
Rare side effects: (occur in between 1 and 10 out of every 10,000 patients)
Dermatitis with large blisters.
Very rare side effects: (occur in fewer than 1 in 10,000 patients)
Bleeding from your stomach, problems with your kidneys, breathing difficulties (asthma), infected
skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping
treatment.



5. How to store Solaraze
Do not use after the expiry date printed on the carton or metal tube. The date refers to the last day of
that month.
Solaraze 3% Gel/Diclofenac sodium 3%w/w topical gel should be not be stored above 25°C
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop using the gel, please take it back to the pharmacist for safe disposal.
Only keep the gel if your doctor tells you to.
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
Your medicine is called Solaraze 3% Gel/Diclofenac sodium 3%w/w topical gel.
Each gram of gel contains 30 milligrams of diclofenac sodium. Solaraze 3% Gel/Diclofenac sodium 3%w/w
topical gel is a clear, transparent, colourless or pale yellow gel.

Solaraze 3% Gel/Diclofenac sodium 3%w/w topical gel is available as packs containing one 25 gram tube or
two 25 gram tubes.
DATE:

POM

PL No: 6464/2155

20/05/13

This product is manufactured by Almirall Hermal GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 17.05.2013

DATE OF PROOF:

DT

UK PIL DATED JANUARY 2012
MULTIPLE MANUFACTURERS

6464 2155A

Solaraze is a registered trademark of Shire Pharmaceuticals Group Plc.

CODE:

Solaraze 3% Gel

PRODUCT:

CUSTOMER:

Waymade

ARTWORKER:

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

Solaraze 3% Gel/Diclofenac sodium 3%w/w topical gel also contains sodium hyaluronate, benzyl alcohol,
macrogol monomethyl ether 350 and purified water.

Colour
Swatch

Black

WARNING!




DATE:

CUSTOMER
APPROVED:



WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

If any of the following common side effects are severe or last for more than a few days you should stop using
Solaraze and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain and
blistering.

PROOF HISTORY:
v.4 - waymade - 20/05/13

Leaflet Flat Size = 148 x 317

27mm

If you have any of the following side effects, stop using Solaraze and contact your doctor as soon as
possible:
Skin rash (nettle rash); breathing difficulties (wheezing); swelling of the face; runny nose (allergic rhinitis).
These symptoms indicate that you may be allergic to Solaraze.

Expand view ⇕

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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