SUMMARY CMI

SOLARAZE^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using SOLARAZE?

SOLARAZE contains the active ingredient diclofenac sodium. SOLARAZE is used to treat a skin condition known as actinic keratosis, also called solar keratosis.

For more information, see Section 1. Why am I using SOLARAZE? in the full CMI.

2. What should I know before I use SOLARAZE?

Do not use if you have ever had an allergic reaction to SOLARAZE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use SOLARAZE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SOLARAZE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SOLARAZE?

• Use SOLARAZE twice daily unless your doctor tells you differently.
• 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. Do not use more than 8 g daily.
• Gently smooth a small amount of gel onto the skin over the area to be treated. You may notice a slight cooling effect when you smooth the gel onto your skin.

More instructions can be found in Section 4. How do I use SOLARAZE? in the full CMI.

5. What should I know while using SOLARAZE?

For more information, see Section 5. What should I know while using SOLARAZE? in the full CMI.

6. Are there any side effects?

Common side effects include inflammation, irritation, pain, itching, tingling and blistering at the site of treatment, hypersensitivity or painful sensation when the skin is touched, pins and needles, contact dermatitis, eczema, dry skin, redness, swelling, rash, scaly rash, thickening of the skin, skin ulcer, raised scar, exfoliation, conjunctivitis.

Serious side effects include muscle pain, swelling of the body, swelling of the face, lips, mouth, throat or lymph nodes/glands, which may cause difficulty in swallowing or breathing, bleeding of the stomach (may have dark stools or blood in stools).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

SOLARAZE^®

Active ingredient(s): diclofenac sodium

Consumer Medicine Information (CMI)

This leaflet provides important information about using SOLARAZE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SOLARAZE.

Where to find information in this leaflet:

1. Why am I using SOLARAZE?
2. What should I know before I use SOLARAZE?
3. What if I am taking other medicines?
4. How do I use SOLARAZE?
5. What should I know while using SOLARAZE?
6. Are there any side effects?
7. Product details

1. Why am I using SOLARAZE?

SOLARAZE contains the active ingredient diclofenac sodium. SOLARAZE belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which are used to relieve pain and inflammation.

SOLARAZE is used to treat a skin condition known as actinic keratosis, also called solar keratosis, that results in scaly or crusted patches of skin caused by too much sun exposure.

2. What should I know before I use SOLARAZE?

Warnings

Do not use SOLARAZE if:

• you are allergic to diclofenac, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you are allergic to aspirin or any other NSAID medicine.
• you are in the third trimester of pregnancy.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• are allergic to any foods, preservatives, medicines or dyes.
• have any other medical conditions, in particular a 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.
• have previously had any allergic reactions which may be fever, rash and/or swelling of the face, lips, mouth, throat or lymph nodes/glands, (which may cause difficulty in swallowing or breathing), shortness of breath or fainting.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known whether SOLARAZE passes into breast milk. Your doctor will decide whether or not you should use SOLARAZE.

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 if you are in the third trimester of pregnancy.

It may affect your developing baby if you use it during pregnancy.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy 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.

4. How do I use SOLARAZE?

How much to use

• 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.
• Do not use more than 8 g daily.
• Follow the instructions provided and use SOLARAZE until your doctor tells you to stop.

When to use SOLARAZE

• Use SOLARAZE twice daily unless your doctor tells you differently.
• 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.

How to use SOLARAZE

• 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. You may notice a slight cooling effect when you smooth the gel onto your skin.
• Wash your hands after applying the gel unless your hands are being treated.

SOLARAZE is for external use only.

If you forget to use SOLARAZE

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 SOLARAZE

If you think that you have used too much SOLARAZE, remove the excess gel by washing with water.

If someone swallows SOLARAZE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using SOLARAZE?

Things you should do

Call your doctor straight away if you become pregnant.

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.

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.

Remind any doctor, dentist or pharmacist you visit that you are using SOLARAZE.

Things you should not do

• Do not apply to skin wounds, infected skin or dermatitis.
• Do not use an airtight occlusive bandage.
• Do not allow SOLARAZE to come into contact with your eyes, or the inside of your nose or mouth
• Do not ingest SOLARAZE.
• 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.

Looking after your medicine

• Keep SOLARAZE in a cool dry place where the temperature stays below 25°C. Do not freeze.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SOLARAZE contains

Do not use this medicine if you are allergic to any of these ingredients.

What SOLARAZE looks like

SOLARAZE is a clear, transparent, colourless to pale yellow gel in a 25 g tube (Aust R 116785).

Who distributes SOLARAZE

Mayne Pharma International Pty Ltd
1538 Main North Road
Salisbury South, SA 5106
solaraze.com.au

® Registered Trademark of Almirall

This leaflet was prepared in September 2021.

CMI Version: 8.0

Published by MIMS November 2021

1 Name of Medicine

Diclofenac sodium.

2 Qualitative and Quantitative Composition

Solaraze gel contains diclofenac sodium 3% (w/w).

Excipients with known effect.

3 Pharmaceutical Form

A clear, transparent, colourless to pale yellow gel.

4 Clinical Particulars

4.1 Therapeutic Indications

Management of actinic keratoses.

4.2 Dose and Method of Administration

Solaraze is applied locally to the skin twice daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 g (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. A maximum of 8 g daily should not be exceeded. Long-term efficacy has not been established.

4.3 Contraindications

Solaraze is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether and/or sodium hyaluronate.
Because of cross reactions, patients who have experienced hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), should not use the gel.
The use of Solaraze is contraindicated during the third trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in Pregnancy).

4.4 Special Warnings and Precautions for Use

The likelihood of systemic side effects occurring following the topical application of Solaraze is small compared to the frequency of side effects with oral diclofenac, owing to low systemic absorption with Solaraze. However, the possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see product information on systemic forms of diclofenac).
This product should be used with caution in patients with a history of and/or active gastrointestinal ulceration or bleeding, or reduced heart, liver or renal function, since isolated cases of systemic adverse reactions consisting of renal affection have been reported with topically administered antiphlogistics.
It is known that NSAIDs can interfere with platelet function. Although the likelihood of systemic side effects is very low, caution should be used in patients with intracranial haemorrhage and bleeding diathesis.
Direct sunlight, including solarium, should be avoided during treatment. If sensitivity skin reactions occur, discontinue use.
Solaraze should not be applied to skin wounds, infections or exfoliative dermatitis. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
Discontinue the treatment if a generalised skin rash develops after applying the product.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients using NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue the NSAID and evaluate the patient immediately.
Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Drug interactions of topical application of Solaraze have not been studied but since systemic absorption of diclofenac is low, drug interactions applied to orally administered NSAIDs are unlikely (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Concomitant oral administration of other NSAIDs should be minimised.
No data are available on the recurrence of actinic keratoses after cessation of treatment with Solaraze.
No studies evaluating the long-term efficacy of Solaraze have been conducted.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No drug interactions during treatment with Solaraze have been reported. After topical administration, systemic absorption is limited. Drug interactions applied to orally administered NSAIDs are improbable.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In studies examining a total of 229 subjects of which 112 were treated with Solaraze, no serious adverse events related to Solaraze were reported.
Adverse events related to Solaraze (> 1%) are summarised in Table 1.
Most frequently reported reactions include localised skin reactions, such as contact dermatitis, erythema and rash, or application site reactions, such as inflammation, irritation, pain and blistering. In studies there appeared to be no age specific increase or pattern of reactions.
Adverse reactions (see Table 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (> 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known: cannot be estimated from the available data.
Patch testing of previously treated patients indicate a 2.18% probability of allergic contact dermatitis sensitisation (type IV) to diclofenac with as yet unknown clinical relevance. Cross reactivity to other NSAIDs is not likely. Serum testing more than 100 patients indicated no presence of type I antidiclofenac antibodies.

Reporting suspected adverse effects.

4.9 Overdose

Due to the low systemic absorption of Solaraze, overdosage is extremely unlikely as a result of topical use. However, the skin should be rinsed with water. There have been no clinical cases of ingestion of Solaraze inducing overdosage.
In the event of accidental ingestion (25 g Solaraze gel contains the equivalent of 750 mg diclofenac sodium) resulting in significant systemic side effects, general therapeutic measures normally adopted to treat poisoning with NSAIDs should be used.
Supporting and symptomatic treatment should be given for complications, such as renal failure, convulsions, gastrointestinal irritation and respiratory depression. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion. Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Specific therapies such as forced diuresis and dialysis will probably not be therapeutic in eliminating NSAIDs due to their high rate of protein binding.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Pharmacokinetics in special patient groups.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Do not freeze.

6.5 Nature and Contents of Container

The product is supplied in an epoxy-phenolic lined sealed aluminium tube with a white polypropylene screw on cap with a pierced tip, in a 25 g or 50 g size.
Not all presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in acetone, and partially insoluble in ether.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes