Consumer medicine information

Eumovate

Clobetasone butyrate

BRAND INFORMATION

Brand name

Eumovate

Active ingredient

Clobetasone butyrate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Eumovate.

What is in this leaflet

Please read this leaflet carefully before you start using EUMOVATE Cream.

This leaflet answers some common questions about EUMOVATE. 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 or pharmacist has weighed the risks of you using EUMOVATE against the benefits they expect it will have for you.

Use EUMOVATE as instructed and follow the advice given in this leaflet.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What EUMOVATE is used for

EUMOVATE is used to treat eczema and dermatitis. It can help you to control patches of dry, red, itchy, flaky or inflamed skin caused by eczema and dermatitis.

EUMOVATE contains clobetasone butyrate. Clobetasone butyrate is a topical corticosteroid. It is used to control inflammation on the skin.

EUMOVATE works to stop the skin’s over-reaction to the triggers that cause skin flare ups. It suppresses the inflammation that causes eczema or dermatitis. EUMOVATE cream base also has moisturising properties.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Your doctor or pharmacist may have recommended it for another reason.

Before using EUMOVATE

When you must not use it

Do not use EUMOVATE if you have an allergy to:

  • any medicine containing clobetasone butyrate
  • any of the ingredients listed at the end of this leaflet.
  • any other similar medicines such as hydrocortisone.

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

Do not use EUMOVATE on:

  • cuts or open wounds
  • infected skin
  • inflamed skin near ulcers

Do not use EUMOVATE to treat:

  • rosacea (skin condition of the face where the nose and cheeks are unusually red)
  • acne, spots or pimples
  • pruritis (itching) with or without rash
  • perioral dermatitis
  • untreated bacterial infections such as cellulitis (infection of the skin), folliculitis (infection of the hair follicle), furunculosis (boils) or impetigo (blisters)
  • fungal infections such as athletes foot and jock itch
  • viral infections such as cold sores, chicken pox or shingles
  • parasitic infestations such as scabies
  • psoriasis unless recommended by your doctor

If you have any of these conditions, ask your doctor or pharmacist for advice.

Do not use on delicate skin areas such as the face, groin, genitals or between the toes.

Do not use EUMOVATE:

  • if you are pregnant or may be pregnant
  • if you are breastfeeding
  • to treat any other conditions other than eczema and dermatitis unless advised by your doctor.

Do not use EUMOVATE on children under the age of 12 years except on the advice of a doctor.

Do not use the cream on the wrong skin conditions. It could make it worse.

If you are not sure what is causing your skin problem, ask your pharmacist or doctor.

Do not give EUMOVATE to anyone else, even if they have similar symptoms to you.

Do not use EUMOVATE 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 or pharmacist.

Before you start to use EUMOVATE

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant or are breastfeeding. You should not use EUMOVATE if you are pregnant or may be pregnant or if you are breastfeeding unless advised by your doctor. Your doctor or pharmacist will discuss the possible risks and benefits of using EUMOVATE during pregnancy or breastfeeding.

Tell your doctor or pharmacist if you have kidney or liver problems.

If you have not told your doctor pharmacist about any of the above, tell him/her before you start using EUMOVATE.

Taking other medicines

Tell your doctor or pharmacist about any other medicines you are taking including medicines that you buy without a prescription, in a pharmacy, supermarket or health food shop.

Do not use other corticosteroids (like hydrocortisone) on the skin while you are using this cream. You would be doubling the dose.

Some medicines and EUMOVATE may interfere with each other. These include:

  • other corticosteroid medicines which may include some eczema creams, asthma inhalers, tablets, injections, nasal sprays, and eye or nose drops.
  • ritonavir (antiviral medicine) and itraconazole (antifungal agent)

These medicines may affect the way EUMOVATE works.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to Use EUMOVATE

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 on the carton or in this leaflet, ask your doctor or pharmacist for help.

How much to use

The minimum amount of cream should be used for the minimum amount of time. Do not use for more than 7 days.

  • Squeeze out the cream along the top of your index finger (see picture).
  • From the crease in the finger, squeeze the cream halfway to your fingertip. This will cover a patch of skin the same size as the palm of your hand.
  • Use the fingertip unit as a guide. For smaller areas, use a smaller amount. This cream is not meant to treat large areas.

  • Don’t cover the treated patch of skin with anything (bandages, dressings, gloves or plastic wrap). It can cause more of the medicine to pass through the skin.

How to use it

Adults or children over 12 years of age:

  • Use the cream twice a day for up to 7 days
  • Wash your hands and dry them
  • Squeeze out the correct amount of cream to cover the affected area onto your index finger. The picture above gives you an idea of how much to use.
  • Gently rub cream onto the patch of skin you are treating.
  • Wash your hands again (unless it is your hands you are treating).

Be especially careful not to get the cream in your eyes.

Use in children under 12 years of age only on the advice of a doctor.

Don’t cover the treated patch of skin with anything (bandages, dressings, gloves or plastic wrap). It can cause more of the medicine to pass through the skin.

When to use it

Use your medicine at about the same time each day. Using it at the same time each day will have the best effect. It will also help you remember when to use it.

How long to use it

Use EUMOVATE twice a day for up to 7 days. Do not use for more than 7 days except on the advice of a doctor.

If you forget to use it

If you forget to use EUMOVATE or miss an application, use it when you remember.

Do not try to make up for missed applications by using the cream more often as this may increase the chance of you getting a side effect.

If you have any questions about this, ask your doctor or pharmacist.

If you have trouble remembering when to use your medicine, ask your doctor or pharmacist for some hints.

If you use too much (overdose)

If you use a bit too much of the cream by mistake, don’t worry but try to keep to the fingertip unit. Using corticosteroids on the skin continuously over many weeks or months can cause skin thinning and permanent skin damage.

If you or anyone swallow EUMOVATE; Immediately telephone your doctor or Poisons Information Centre for advice (in Australia telephone 13 11 26, in New Zealand telephone 0800 764 766) or go to Accident & Emergency at your nearest hospital, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using EUMOVATE

Things you must do

Inform any other doctors, dentists or pharmacists who are treating you that you are using EUMOVATE.

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are using EUMOVATE.

If you become pregnant while using this medicine, tell your doctor or pharmacist immediately.

If you experience blurred vision or other visual disturbances, speak to your doctor.

If your rash/irritation gets better but then comes back tell your doctor or pharmacist. Don’t treat the same patch more than twice without taking advice from your doctor.

It is possible that you are treating the wrong skin condition or that your skin may still be reacting to something that it is coming in contact with. Some of the common triggers are:

  • Ear rings or studs - especially gold-plated ear rings
  • Other jewellery
  • Coins
  • Watch buckles, metal straps or the metal back of a watch
  • Metal studs or fastenings on jeans, bras or underwear

All of these may have a metal in them called nickel that is a very common trigger. If you react badly to nickel, all of the triggers in the list could be a problem.

Other common triggers include rubber and pine tree sap, which are used in things we touch every day. You might find triggers:

  • In the home: such as plasters, furniture polish, varnishes, rubber gloves or elastic in clothes.
  • In substances you use at work: like glues, oils, lubricants or cement.
  • In the garden: certain plants and weeds, gardening gloves.

Even if it is not practical to avoid triggers, there are often practical steps you can take to minimise possible irritation.

EUMOVATE is meant to control skin conditions that improve within a week of treating yourself. If you think you need further treatment after that, see a doctor for advice. Do not keep on using it.

If your skin gets worse or it does not improve within a week, stop using the cream and see your doctor.

If your skin condition clears up in less than a week, stop using the cream. Think about emollient (moisturising) products to help stop it coming back.

Skin specialists often advise people with eczema or dermatitis to use emollient (or moisturising) skin products, including creams and bath oils, to keep moisture in the skin. This can make your skin more resistant to flare ups. Avoid using soap and heavily scented products. Ask your doctor or pharmacist for further information.

Things you must not do

Do not use EUMOVATE 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 EUMOVATE. This medicine helps most people with eczema and dermatitis, but it may have unwanted side effects in a few people. This cream is very unlikely to cause any problems as long as you follow the advice in this leaflet.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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.

If your skin gets worse during treatment, you may have a skin infection or a trigger you have not recognised or even an allergy to the cream.

Stop using the cream and see your doctor as soon as possible.

Tell your doctor or pharmacist if you notice any of the following:

  • rash
  • itch
  • local skin burning
  • skin thinning
  • skin bleaching or increased skin pigmentation and hair disorders

Worsening of eczema or dermatitis symptoms has also been reported.

Other side effects not listed above may also occur in some people.

Using more than the correct amount of cream may cause changes to your skin e.g. thinning or allow the active ingredient to pass through the skin and affect other parts of the body.

This is not a problem if you use the right amount of cream and for the correct period of time.

The following are very rare side effects and may occur if you use more than the correct amount of cream or for longer than recommended:

If you use more than the correct amount of cream or for longer than recommended you may experience:

  • increased weight
  • moon face or rounding of the face
  • obesity
  • changes to the colour of your skin
  • increased body hair

The following symptoms may occur with use in children:

  • delayed weight gain
  • slow growth

Other side effects that may show up in blood tests or when your doctor gives you a medical examination:

  • a decrease in the level of the hormone cortisol in your blood
  • high blood pressure
  • cloudy lens in the eye (cataract)
  • increased pressure in the eye (glaucoma)
  • weakening of the bones through gradual loss of mineral (osteoporosis). Additional tests may be needed after your medical examination to confirm if you have this condition
  • increased blood sugar levels
  • glucose in the urine.

After using EUMOVATE

Storage

Keep your cream in the pack until it is time to use it.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store EUMOVATE or any other medicine in the bathroom or near a sink.

Do not leave EUMOVATE or any other medicines in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep EUMOVATE 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.

Do not use the medicine after the expiry date on the tube end or carton.

Disposal

If your doctor or pharmacist tells you to stop using EUMOVATE or the medicine has passed the expiry date, ask your pharmacist what to do with any medicine that is left over.

Product Description

What EUMOVATE looks like

EUMOVATE is a smooth white cream for topical use.

EUMOVATE is available in tubes containing 15 g* and 30 g of cream.

* This pack size is marketed in New Zealand only.

Australia only: A 5 g sample tube is also available from your physician only.

Ingredients

The active ingredient in EUMOVATE is clobetasone butyrate. It is present at a concentration of 0.05%w/w.

The inactive ingredients are:

  • Glycerol
  • Glyceryl monostearate
  • Cetostearyl alcohol
  • Beeswax substitute 6621
  • Arlacel 165
  • Dimethicone 20
  • Chlorocresol
  • Sodium citrate
  • Citric acid monohydrate
  • Water-purified

Where to go for more information

If you have any questions about your treatment with EUMOVATE, ask your doctor or pharmacist.

Or you may call the toll-free INFOLINE:

In Australia: 1800 033 109

In New Zealand: 0800 808 500

Manufacturer and supplier

EUMOVATE is made in the UK and supplied:

In Australia by:

GlaxoSmithKline Australia Pty Ltd
Level 4
436 Johnston Street
Abbotsford
Victoria 3067

In New Zealand by:

GlaxoSmithKline NZ Ltd
Downtown Auckland

Trade marks are owned by or licensed to the GSK group of companies.

© 2018 GSK group of companies or its licensor.

This leaflet was prepared on 19 September 2018.

AUST R 178288

Version 9.0

Published by MIMS January 2019

BRAND INFORMATION

Brand name

Eumovate

Active ingredient

Clobetasone butyrate

Schedule

S3

 

1 Name of Medicine

Clobetasone butyrate.

6.7 Physicochemical Properties

Clobetasone butyrate is a corticosteroid used topically for its glucocorticoid effects. Its chemical name is 21-chloro-9α- fluoro-17α-hydroxy-16β- methylpregna-1,4-diene- 3,11,20-trione 17-butyrate.
Molecular formula: C26H32CIFO5.
Molecular weight: 479.0.

Chemical structure.


CAS number.

25122-57-0.

2 Qualitative and Quantitative Composition

Eumovate cream contains 0.05% w/w clobetasone butyrate as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cream.
White cream for topical use

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacological studies in man and animals have shown that clobetasone butyrate has a relatively high level of topical activity accompanied by a low level of systemic activity.
The anti-inflammatory properties of clobetasone butyrate reduce the erythema and itchiness associated with eczema and dermatitis.
The cream base in Eumovate cream has moisturising properties.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Data are lacking on the systemic distribution, metabolism and excretion of clobetasone butyrate in humans.
Although pharmacokinetic studies were not carried out with the cream formulation, plasma clobetasone butyrate levels would be expected to be no greater or even lower, with the cream formulation, as creams are less occlusive than ointments.

Absorption.

A single application of 30 g clobetasone butyrate 0.05% ointment to eight patients (3 with eczema and 5 with psoriasis) resulted in a small rise in plasma clobetasone butyrate levels during the first three hours not exceeding 0.6 nanogram/mL then the levels gradually decreased. The maximum plasma level reached in the first three hours was 0.6 nanogram/mL. This rise in levels was followed by a more gradual decline with plasma levels of clobetasone butyrate falling below 0.1 nanogram/mL (the lower limit of the assay) after 72 hours. The normal diurnal variation in plasma cortisol levels was not affected by the application of clobetasone butyrate ointment.

5.3 Preclinical Safety Data

In studies conducted in rats and dogs, histological changes induced by clobetasone butyrate were typical of corticosteroids (thymic involution, adrenal cortex atrophy, fatty replacement of bone marrow, lympholysis of the spleen and lymph nodes, and a reduction or disappearance of eosinophils from the endometrium). However, on a dose for dose basis, these findings were of a lesser severity than those associated with other corticosteroids.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Short-term (up to 7 days) treatment of milder forms of eczema, dermatitis and other steroid responsive skin conditions.

4.3 Contraindications

Eumovate cream should not be used in patients with a history of hypersensitivity to clobetasone butyrate or to any of the excipients in the product.
The following conditions should not be treated with Eumovate cream: rosacea, acne, pruritus without rash, perioral dermatitis; untreated bacterial infections such as cellulitis, folliculitis, furunculosis or impetigo; fungal infections such as those associated with tinea (e.g. athletes foot, jock itch); viral infections including cold sores (herpes simplex), chicken pox or shingles (varicella zoster) or vaccinia; parasitic infestations such as scabies.
Do not use on broken or infected skin or on inflamed skin near chronic ulcers.
Topical corticosteroids inhibit wound healing processes and are contraindicated in skin ulcers, cuts and abrasions.

4.4 Special Warnings and Precautions for Use

Manifestations of hypercortisolism (Cushing's syndrome) can occur in some individuals, due to prolonged duration of use, extensive application to the skin, or because of increased systemic absorption due to use of occlusive dressings or application to broken or thin skin.
The management of eczema and dermatitis in adults and children usually requires the supervision of a doctor.
Visual disturbances have been reported with the use of systemic and topical corticosteroids as a result of increased systemic availability and direct contact with the eyes.
Consequently, if a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation as possible causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
Eumovate cream should not be used for the treatment of psoriasis as this condition needs to be managed by a doctor.
Eumovate cream should not be used concomitantly with other corticosteroids (by systemic or topical routes), as this may increase the risk of unwanted effects.
For external use only. This and all medication should be kept out of the reach of children. In the case of accidental ingestion, professional assistance should be sought or the Poisons Information Centre contacted immediately (see Section 4.9 Overdose).

Systemic absorption.

Eumovate cream treatment for more than a few days may lead to significant systemic absorption.
The systemic absorption of clobetasone would be expected to increase if: large amounts of Eumovate cream are used; large areas of skin are treated; treated skin is damaged or diseased; thin skin (such as on the face) or skin in intertrigenous regions is treated; the treated area is occluded.
In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.

Infection.

Topical corticosteroid therapy may predispose to local infection. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

Skin damage.

Topical corticosteroids cause atrophy of the epidermis and damage to the dermis. This may produce atrophic striae and discolouration, which are usually permanent. These are more likely to occur with prolonged therapy, occlusive dressings, application to intertrigenous areas, application to the face, and in children.
Eumovate cream should not be used on the face, groin, genitals or between the toes. As with other topical corticosteroids, it should not be used on skin with impaired circulation, such as stasis ulcers, since it may cause prolonged vasoconstriction.

Occlusive dressings.

Do not use with occlusive dressings, as occlusion increases the possibility of local and systemic side effects. Infants and children are at greater risk than adults.

Use near eyes.

Care should be taken to ensure that the cream does not enter the eye, as cataracts and glaucoma might result from repeated exposure.

Use in renal/hepatic impairment.

In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity).

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

In infants and children, long term continuous topical therapy should be avoided, since skin damage and adrenal suppression can occur even without occlusion. The least potent corticosteroid that will control the disease should be selected. In infants, the napkin may act as an occlusive dressing, and increase absorption. Corticosteroids may inhibit linear bone growth and inhibit epiphyseal maturation. Treatment should be minimised and supervised closely.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None reported. Eumovate cream should not be used concomitantly with other topical or systemic corticosteroids, either prescribed or obtained over the counter (such as hydrocortisone) as this may increase the likelihood of drug interactions.
Coadministered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.
(Category A)
There are limited data from the use of Eumovate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. Studies in mice, rats and rabbits revealed similar findings following administration of clobetasone butyrate. The relevance of this finding to humans has not been established.
Administration of clobetasone during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
Women who are pregnant should consult a doctor before use.
The safe use of topical corticosteroids during lactation has not been established. It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of clobetasone during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
Women who are breastfeeding should seek medical advice before using this product.
If used during lactation, clobetasone should not be applied to the breasts to avoid accidental ingestion by the infant.

4.8 Adverse Effects (Undesirable Effects)

Systemic side effects are more likely in children, if large areas of the skin are treated or if large amounts are used, if treatment is prolonged or if treated areas are occluded.
The use of corticosteroids by multiple routes of administration (e.g. topical and oral or inhaled) may increase the likelihood of adverse reactions occurring.
Adverse events drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10,000 and < 1/1000) and very rare (< 1/10,000) including isolated reports.

Infections and infestations.

Very rare: opportunistic infection.

Immune system disorders.

Very rare: hypersensitivity; local hypersensitivity reactions such as erythema, rash, pruritus, urticaria, local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment.
Patients should be advised to stop treatment if signs of hypersensitivity appear.

Endocrine disorders.

Very rare: hypothalamic pituitary adrenal (HPA) axis suppression (cushingoid features (e.g. moon face, central obesity), delayed weight gain/ growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/ glucosuria, cataract, hypertension, increased weight/ obesity, decreased endogenous cortisol levels).

Skin and subcutaneous tissue disorders.

Rare: hypersensitivity, allergic contact dermatitis, urticaria, skin atrophy*, pigmentation changes*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritus, erythema, hair disorders, bruising, rosacea; exacerbation of eczema and dermatitis has also been reported.
With prolonged treatment, permanent damage (including development of stria and telangiectases) to the dermis may occur.
Patients should be advised to stop treatment if signs of hypersensitivity appear.

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.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

Apply a thin film and gently rub in, using only enough to cover the affected area twice daily for up to 7 days.
If the condition resolves within 7 days, treatment with Eumovate cream should be stopped.
If the condition does not improve within the first 7 days or becomes worse, the patient should see a doctor.
If after 7 days of treatment, improvement is seen but further treatment is required, the patient should see a doctor.
After application, the hands should be washed unless they are the site being treated.
Patients advised by their doctors to use this cream for prolonged periods should be advised to tell subsequent doctors about this use.
All patients should be warned against prolonged used on one area of skin, or use of excessive quantities.
All patients should also be informed that the preparation is prescribed only for a specific condition occurring in a specific individual.

Children.

Use in children under 12 years only on the advice of a doctor. Children are more likely to develop local and systemic adverse reactions of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using Eumovate cream to ensure the amount applied is the minimum that provided therapeutic benefit.

Elderly.

Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal/ hepatic impairment.

In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

4.7 Effects on Ability to Drive and Use Machines

There have been no studies to investigate the effect of clobetasone on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasone.

4.9 Overdose

Symptoms and signs.

Topically applied clobetasone may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur (see Section 4.8 Adverse Effects (Undesirable Effects)). There is also a risk of skin atrophy with the chronic use of topical steroids.

Treatment.

In the event of overdose, clobetasone should be withdrawn gradually under medical supervision because of the risk of glucocorticosteroid insufficiency.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S3.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients are glycerol, glycerol monostearate, cetostearyl alcohol, beeswax substitute 6621, arlacel 165, dimethicone 20, chlorocresol, sodium citrate dihydrate, citric acid monohydrate, water-purified.

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.

6.5 Nature and Contents of Container

Aluminium tubes containing 15 g and 30 g.
A 5 g physician’s sample pack is also available.
Not all pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

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

Summary Table of Changes