Solaraze 3% Gel
Solaraze™ 3% Gel
(Diclofenac Sodium)
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 nonsteroidal anti-inflammatory agents.
■ If you are in the final 3 months of your pregnancy.
Take special care with Solaraze 3% Gel
■ The possibility of systemic side effects from application of Solaraze 3% Gel 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 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 and do not swallow it. If Solaraze 3% Gel has accidentally been swallowed, consult a doctor immediately.
■ Discontinue Solaraze 3% Gel 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.
Pregnancy/Breast-feed ing
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.
Consult your doctor if you are breast-feeding. Solaraze 3% Gel can be used whilst breast-feeding with caution but should not be used on the breasts.
If you are pregnant, trying to get pregnant, or breast-feeding, 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.
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); swelling of the face; 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, 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.
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 SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C.
■ Do not use after the expiry date printed on the carton or blister strip. The date refers to the last date of that month.
■ If your doctor tells you to stop taking the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
■ If the medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.
■ 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
The active ingredient is diclofenac sodium. Each gram of gel contains the equivalent of 30mg 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 or pale yellow gel.
The gel is provided in tubes containing 25 grams of product in single cartons.
Manufacturer:
Manufactured by: Almirall Hermall GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany or
Bioglan AB, PO Box 50310, S-202 13 Malmo, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0258 POM
Leaflet issue and revision date: 26.09.12
Solaraze™ is a trademark or ALMIRALL S.A.
Page 2 of 2