Solaraze 3% Gel
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. What Solaraze 3% Gel is and what it is used for
2. Before you use Solaraze 3% Gel
3. How to use Solaraze 3% Gel
4. Possible side effects
5. How to store Solaraze 3% Gel
6. 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.
Pregnancy/Breastfeeding
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.
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.
Solaraze 3% Gel can be used whilst breastfeeding but should not be used on the breasts.
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.
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
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.
What Solaraze 3% Gel looks like and contents of the pack
Solaraze 3% Gel is a clear, transparent, colourless gel packed in tubes containing 25grams.
Manufacturer
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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