Solaraze gel
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
SOLARAZE®
diclofenac sodium 3% w/w
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about SOLARAZE.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using SOLARAZE against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What SOLARAZE is used for
This medicine is used to treat the skin condition known as actinic keratosis or solar keratosis.
It contains the active ingredient diclofenac sodium. Diclofenac sodium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Before you use SOLARAZE
When you must not use it
Do not use SOLARAZE if you have an allergy to:
any medicine containing diclofenac sodium
any of the ingredients listed at the end of this leaflet
aspirin or any other NSAID medicine
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
fainting
Do not use this medicine if you are in the third trimester of pregnancy.
It may affect your developing baby if you use it during pregnancy.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
stomach ulcer, or bleeding from the stomach
heart disease
liver disease
kidney disease
blood disorder
skin problems, such as skin wounds, infections or conditions, such as contact dermatitis and exfoliative dermatitis
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Like most NSAID medicines, SOLARAZE is not recommended for use during pregnancy. If there is a need to consider its use during the first or second trimester of pregnancy, your doctor will discuss with you the benefits and risks of using it. If you are pregnant or attempting to conceive, the dose of SOLARAZE should be applied to an area of the skin as small as possible (less than about a third of your body) and must not be used for longer than three weeks.
Do not use SOLARAZE during the third trimester of pregnancy.
Tell your doctor if you are breast-feeding.
It is not known whether SOLARAZE passes into breast milk. Your doctor will decide whether or not you should use SOLARAZE.
If you have not told your doctor about any of the above, tell them before you start using SOLARAZE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
At the recommended dose of SOLARAZE, it is unlikely that it will interfere with other medicines.
How to use SOLARAZE
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How to use it
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.
Wash your hands after applying the gel unless your hands are being treated.
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.
SOLARAZE is for external use only.
When to use it
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.
How long to use it
Continue using your medicine for as long as your doctor tells you.
The usual treatment period 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.
If you forget to use it
If you forget to use SOLARAZE, continue to apply the next dose as directed. Do not apply twice as much gel to make up for the missed application.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some hints.
If you use too much (overdose)
If you use more SOLARAZE than you should, remove the excess gel by washing with water.
If someone swallows SOLARAZE
Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) for advice, or go to Accident and Emergency at the nearest hospital, if you or anyone else may have swallowed SOLARAZE. Do this even if there are no signs of discomfort or poisoning.
You or that person may need urgent medical attention.
While you are using SOLARAZE
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using SOLARAZE.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Avoid sun exposure, including tanning salons. If skin reactions occur, discontinue use.
After applying SOLARAZE to the skin, you can use a permeable (non-occlusive) bandage at the area. Do not use an airtight occlusive bandage.
Things you must not do
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.
SOLARAZE is not suitable for children.
Do not use SOLARAZE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using SOLARAZE.
This medicine helps most people but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are mild and short lived.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you experience any of the following and they worry you:
burning, dryness, redness, inflammation, irritation, pain, itching, rash, swelling, tingling, blistering or hair loss at the site of treatment
conjunctivitis, eye pain or weeping/dry eyes
contact dermatitis, eczema, dry or red skin, itching
hypersensitivity or painful sensation when the skin is touched
pins and needles
rash, sometimes blistering or scaly
skin reaction to sunlight
skin ulcer
raised scar
pain in the abdomen, feeling sick (nausea), diarrhoea
hair loss
facial swelling
bleeding
asthma
Tell your doctor as soon as possible if you notice any of the following:
muscle pain
swelling of the body or facial swelling
The above list includes serious side effects that may require medical attention.
If any of the following happen, stop using SOLARAZE and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
bleeding of the stomach (may have dark stools or blood in stools)
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using SOLARAZE
Storage
Keep SOLARAZE in a cool dry place where the temperature stays below 25°C. Do not freeze.
Do not store it in the bathroom or near a sink. Do not leave it on a window sill or in a car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
SOLARAZE is a clear, transparent, colourless to pale yellow gel in a 25g or 50g tube.
Not all pack sizes may be available.
Ingredients
SOLARAZE contains 3% w/w of diclofenac sodium as the active ingredient.
Other ingredients are:
sodium hyaluronate
benzyl alcohol
polyethylene glycol monomethyl ether
purified water
Supplier
SOLARAZE is supplied in Australia by:
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Ave
Chatswood NSW 2067
Medical Information: 1800 644 542
® = Registered Trademark of Almirall S.A.
Australian Registration Number: AUST R 116785
This leaflet was revised in January 2020.
For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi
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