Consumer medicine information

Solaraze

Diclofenac sodium

BRAND INFORMATION

Brand name

Solaraze

Active ingredient

Diclofenac sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Solaraze.

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

[vA07-0]

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Solaraze

Active ingredient

Diclofenac sodium

Schedule

S4

 

1 Name of Medicine

Diclofenac sodium.

2 Qualitative and Quantitative Composition

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

Excipients with known effect.

Benzyl alcohol.
For the full list of excipients, see Section 6.1 List of Excipients.

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.

The usual adult dose may be used.

Paediatric use.

Dosage recommendations and indications for the use of Solaraze have not been established for use in children.

Effects on laboratory tests.

No data available.

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.

Diclofenac inhibited ovulation in rabbits and impaired implantation and early embryonic development in rats. Diclofenac had no obvious effects on fertility in male rats dosed at up to 4 mg/kg/day.
(Category C)
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with the dose and duration of therapy.
Animal studies have shown reproductive toxicity. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Solaraze is contraindicated during the last trimester of pregnancy and should not be used during the first two trimesters of pregnancy unless clearly necessary.
If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low (< 30% of the body surface) and duration of treatment as short as possible (not longer than 3 weeks).
There are no adequate data from use of diclofenac in pregnant women. In embryofoetal toxicity studies in mice, rats and rabbits, foetal death and growth retardation occurred at maternal toxic doses, although on the basis of the available data, diclofenac is not considered teratogenic. The gestation period and the duration of parturition were prolonged by diclofenac treatment. Doses lower than maternal toxic level did not affect postnatal development. The potential risk for humans is unknown.
The use of prostaglandin synthetase inhibitors in the second and third trimesters of pregnancy may result in:
Functional renal injury in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment), or anamnios (particularly with prolonged exposure). After birth: kidney failure may persist (particularly with late and prolonged exposure).
Pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with preterm closing of the ductus arteriosus). This risk exists from the beginning of the 6th month and increases if administration is close to full term.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to:
Increased risk of bleeding in the mother and child.
Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
Inhibition of uterine contractions resulting in delayed or prolonged labour.
Increased risk of oedema formation for the mother.
 Diclofenac sodium is excreted in breast milk after oral administration. The extent to which diclofenac sodium is excreted into the milk after topical administration of the Solaraze gel is unknown. Since no experience has been acquired with Solaraze, it is not recommended for use in breastfeeding women.

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.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

Diclofenac is a nonsteroidal anti-inflammatory drug. The mechanism of action of diclofenac in actinic keratoses is not known but may be related to the inhibition of the cyclooxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. Efficacy of the treatment has only been demonstrated in placebo controlled studies. Comparative studies with topical 5-fluorouracil have not been conducted. The long-term beneficial effects of Solaraze have not been proven.

Clinical trials.

The efficacy of Solaraze was established in two placebo controlled trials involving a total of 231 patients with actinic keratoses.
Study 1 comprised a total of 112 subjects of which 111 subjects were treated with study medication and 93 subjects completed the study. Of the 111 subjects, 56 were enrolled in the Solaraze group and 55 in the vehicle group. Patients were treated with 0.5 g Solaraze or placebo twice a day for 90 days followed by a 30 days follow-up. The primary efficacy endpoint of the study was to evaluate the changes in CLNS (cumulative lesion number score) and TLNS (target lesion number score) between baseline and follow-up, and proportion of patients with CLNS = 0 and TLNS = 0. The percentage of patients with CLNS = 0 at follow-up was 34% of patients treated with Solaraze and 18% of patients treated with placebo, the percentage of patients with TLNS = 0 at follow-up was 34% of patients treated with Solaraze and 20% of patients treated with placebo. The percentage of patients treated with diclofenac with CLNS = 0 at follow up was significantly greater (p = 0.061) than in the vehicle group. The percentage of patients treated with diclofenac group with TLNS = 0 at follow up was greater than in vehicle group, but statistical significance could not be shown (p = 0.102).
In study 2, a total of 120 subjects were enrolled and treated with study medication, with 113 patients completing the study. Of the 120 subjects, 61 were treated with Solaraze and 59 with placebo; 0.5 g of Solaraze or placebo was applied twice a day for 12 weeks followed by a follow-up period of 12 weeks. The primary efficacy endpoint of the study was to assess the clearance of actinic keratoses lesions after 12 weeks of treatment and 12 weeks of follow-up, calculating the percentage of subjects with CLNS = 0 at week 24. The percentage was higher in the diclofenac group (10%) compared with the vehicle group (4%), although this difference was not statistically significant. Histopathological assessments were also carried out in this study with ratings from 0 = normal to 3 = severe, biopsies were performed at screening and week 24. At week 24, there was a mean decrease in screening lesions of -0.7 in the Solaraze group and -0.4 in the placebo group. Thirteen Solaraze treated subjects (23%) demonstrated a resolved target lesion biopsy (grade = 0) at week 24 compared with six vehicle control subjects (11%) (p = 0.679). There was a significant correlation (p = 0.0004) between the histopathological data and the efficacy data.
Additionally, two studies were performed in healthy subjects, all treated with Solaraze.
Study 1 assessed the photosensitisation and sensitisation potentials of Solaraze combined or not with sunscreen. Thirty-two subjects were enrolled in the study of which 30 subjects completed the study. Photosensitisation and sensitisation reactions were assessed using a 5 point scale. No such reactions were observed at irradiated or nonirradiated sites combined or not with sunscreen.
Study 2 evaluated the phototoxicity potential of Solaraze alone or in combination with sunscreen. Thirty-two subjects were enrolled in the study and all 32 completed the study. Phototoxicity was assessed using a 6-point scale. No phototoxicity reactions were observed for Solaraze alone or in combination with sunscreen products.

5.2 Pharmacokinetic Properties

Absorption.

When Solaraze is applied topically, diclofenac is absorbed into the epidermis. In a study in patients with compromised skin (mainly atopic dermatitis and other dermatitic conditions) of the hands, arms or face, approximately 10% of the applied dose (2 g of 3% gel over 100 cm2) of diclofenac was absorbed systemically in both normal and compromised epidermis after seven days, with four times daily applications.
After topical application of 2 g Solaraze three times daily for six days to the calf of the leg in healthy subjects, diclofenac could be detected in plasma. Mean bioavailability parameters were AUC0-t 9 ± 19 nanogram.hour/mL (mean ± SD) with a Cmax of 4 ± 5 nanogram/mL and a Tmax of 4.5 ± 8 hours.
In comparison, a single oral 75 mg dose of diclofenac (Voltaren) produced an AUC of 1600 nanogram.hour/mL. Therefore, the systemic bioavailability after topical application of Solaraze is lower than after oral dosing.
Blood drawn at the end of treatment from 60 patients with AK lesions treated with Solaraze in three adequate and well controlled clinical trials were assayed for diclofenac levels. Each patient was administered 0.5 g of Solaraze gel twice a day for up to 105 days. There were up to three 5 cm x 5 cm treatment sites/patient on the face, forehead, hands, forearm, and scalp. Serum concentrations of diclofenac were, on average, at or below 20 nanogram/mL. These data indicate that systemic absorption of diclofenac in patients treated topically with Solaraze is much lower than that occurring after oral daily dosing of diclofenac sodium.
No information is available on the absorption of diclofenac when Solaraze is used under occlusion.

Distribution.

Diclofenac binds highly to serum albumin. The volume of distribution of diclofenac following oral administration is approximately 550 mL/kg.

Metabolism.

Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, however, to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration. The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise.

Excretion.

Diclofenac and its metabolites are excreted mainly in the urine after oral dosing. Systemic clearance of diclofenac from plasma is 263 ± 56 mL/minute (mean value ± SD). The terminal plasma half-life is 1-2 hours. Four of the metabolites also have short terminal half-lives of 1-3 hours.

Pharmacokinetics in special patient groups.

After topical application, the absorption of diclofenac in normal and compromised epidermis are comparable although there is a large interindividual variation. Systemic absorption of diclofenac is approximately 12% of the administered dose for compromised skin and 9% for intact skin.

5.3 Preclinical Safety Data

Genotoxicity.

Diclofenac showed no genotoxic effects in an adequate battery of studies.

Carcinogenicity.

Dietary administration of diclofenac to mice and rats at doses up to 0.5 mg/kg/day revealed no carcinogenic activity. However, the plasma concentration of diclofenac at this dose level was only 1-5% of that observed in humans. Administration of higher doses to the animals resulted in increased mortality due to gastrointestinal ulceration.
Diclofenac applied topically to the skin of mice was not tumourigenic at doses up to 2 mg/kg/day, which resulted in plasma diclofenac levels 1 to 8 times (males) and 4 to 13 times (females) the human concentration. When applied topically to the skin of hairless mice, diclofenac at 2.8 mg/kg/day has been shown to slightly reduce the median onset time of UV induced skin tumours. Caution should be exercised to avoid sun exposure of the application site(s).

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.


Chemical name: Sodium [o-(2,6-dichloranilino)phenyl]acetate.
Molecular mass: 318.13.

CAS number.

CAS-15307-79-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes