Consumer medicine information

Elocon

Mometasone furoate

BRAND INFORMATION

Brand name

Elocon Alcohol Free Cream

Active ingredient

Mometasone furoate

Schedule

S4 | S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Elocon.

What is in this leaflet

This leaflet answers some common questions about ELOCON.

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 ELOCON against the benefits it is expected to 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 ELOCON is used for

The name of your medicine is ELOCON. It contains the active ingredient called mometasone furoate.

It is a type of cortisone and belongs to the group of medicines called corticosteroids. ELOCON is classified as a high potency topical corticosteroid.

There are three forms of ELOCON: Alcohol Free cream, ointment and lotion.

ELOCON is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as:

  • psoriasis
  • eczema
  • other types of dermatitis.

ELOCON Lotion is also used on the scalp and hairy parts of the body.

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.

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

Before you use ELOCON

When you must not use it

Do not use ELOCON if you have an allergy to:

  • any medicine containing mometasone furoate
  • any other corticosteroid
  • any of the ingredients listed at the end of this leaflet.

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 ELOCON if you have:

  • a viral skin infection (such as cold sores, shingles or chicken pox)
  • a fungal skin infection (such as thrush, tinea or ringworm)
  • tuberculosis of the skin
  • acne rosacea
  • inflammation around the mouth
  • skin conditions with ulcers.

Ask your doctor if you are not sure whether you have any of these conditions.

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 or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you have any other medical conditions, especially if you have an infection.

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

Using other medicines

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any other medicines. This includes any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and ELOCON may interfere with each other.

How to use ELOCON

How to use it

Apply a thin film of ELOCON Alcohol Free Cream or Ointment or a few drops of ELOCON Lotion to the affected skin or scalp once daily. Massage gently until it disappears.

It is important to use ELOCON exactly as your doctor has told you. If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

Do not use ELOCON for more than four weeks at a time unless your doctor tells you.

If you forget to use it

If you forget to use ELOCON, use it as soon as you remember and then go back to your normal time for applying ELOCON. Do not try to make up for the amount you missed by using more than you would normally.

If you swallow it

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have swallowed ELOCON. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep the telephone numbers of these places handy.

While you are using ELOCON

Things you must do

Tell all doctors and pharmacists who are treating you that you are using ELOCON.

Tell your doctor if you feel that ELOCON is not helping your condition or if your skin condition worsens or appear to be infected.

Tell your doctor if, for any reason, you have not used ELOCON exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Things you must not do

Do not use ELOCON under dressings or on large areas of skin unless your doctor tells you.

Do not use plastic pants or tight fitting nappies if ELOCON is to be used on the nappy area of young children.

Do not use ELOCON in or near the eyes.

Do not give ELOCON to anyone else even if their symptoms seem similar to yours.

Do not use ELOCON to treat other conditions unless your doctor tells you. Your doctor has prescribed ELOCON especially for you and your condition. If you use it for another condition, it may not work or make the condition worse.

Things to be careful of

Do not use large amounts for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Only use ELOCON on skin areas that rub together such as under the arm or in the groin area if your doctor tells you.

Only use ELOCON on the face if your doctor tells you.

If improvement does not occur within one week, tell your doctor.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using ELOCON.

This medicine helps most people with skin problems, 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 not. You may need medical attention if you get some 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.

ELOCON is generally well tolerated.

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

  • itching
  • burning
  • tingling/stinging
  • thinning of the skin
  • appearance of small blood vessels on the surface on the skin
  • stretch marks or streaks on the skin
  • acne/pimples/lumps on the skin/blisters containing pus
  • redness
  • boils/abscesses
  • dermatitis
  • increased size of affected area/worsening of disease
  • numbness
  • dry skin
  • inflamed hair roots
  • vision disturbances or blurred vision

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.

Side effects that may happen with oral or injectables corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.

After using ELOCON

Storage

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

Do not refrigerate ELOCON.

Do not store ELOCON or any other medicine 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 it where children cannot reach it. Keep the medicine away from pets. 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 using 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

ELOCON Alcohol Free Cream is a white to off-white cream. It is packed in 15g, 45g* and 50 g tubes.

ELOCON Ointment is a white to off-white ointment. It is packed in 5g*, 15g, 45 g* and 50 g* tubes.

ELOCON Lotion is a colourless to light yellow lotion. It is packed in 5 g*, 10 mL*, 15 mL*, 20 mL*, 30mL, 50 mL* and 100 mL* bottles.

* Not currently available in the market

Ingredients

ELOCON Alcohol Free Cream contains:

  • mometasone furoate 1 mg/g
  • white soft paraffin
  • hexylene glycol
  • aluminium starch octenylsuccinate
  • propylene glycol monostearate
  • stearyl alcohol
  • ceteareth-20
  • white beeswax
  • purified water
  • titanium dioxide
  • phosphoric acid.

ELOCON Alcohol Free Cream does not contain any preservatives.

ELOCON Ointment contains:

  • mometasone furoate 1 mg/g
  • white soft paraffin
  • hexylene glycol
  • white beeswax
  • purified water
  • propylene glycol monostearate
  • phosphoric acid.

ELOCON Ointment does not contain any preservatives.

ELOCON Lotion contains:

  • mometasone furoate 1 mg/g
  • isopropyl alcohol
  • propylene glycol
  • hyprolose
  • monobasic sodium phosphate dihydrate
  • phosphoric acid
  • purified water.

ELOCON Lotion does not contain any preservatives.

Supplier

In Australia:

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A,
26 Talavera Road,
Macquarie Park, NSW 2113 Australia

In New Zealand:

Merck Sharp & Dohme (New Zealand) Ltd
P O Box 99 851
Newmarket
Auckland 1149
New Zealand

Australian Registration Numbers

Alcohol Free Cream - AUST R 212416

Ointment - AUST R 43344

Lotion - AUST R 53472

Date of Preparation

July 2020

S-CCDS-MK0887-MTL-082017 RCN -

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Elocon Alcohol Free Cream

Active ingredient

Mometasone furoate

Schedule

S4 | S3

 

1 Name of Medicine

Mometasone furoate.

2 Qualitative and Quantitative Composition

Mometasone furoate 0.1% (1 mg/g).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Elocon (mometasone furoate) 0.1% (1 mg/g) is available as ointment, alcohol free cream, and lotion.

4 Clinical Particulars

4.1 Therapeutic Indications

Elocon Alcohol Free Cream, Elocon Ointment and Lotion are indicated for short-term (up to four (4) continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.
Elocon Lotion is also suitable for short-term use for scalp psoriasis and seborrhoeic dermatitis.

4.2 Dose and Method of Administration

A thin film of Elocon Alcohol Free Cream or Elocon Ointment should be applied to the affected skin areas once daily. Elocon Alcohol Free Cream is suitable for moist lesions; the ointment should be used for dry, scaling and fissured lesions.
A few drops of Elocon Lotion should be applied to affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.

4.3 Contraindications

Elocon Alcohol Free Cream, Ointment and Lotion are contraindicated in patients who are hypersensitive to mometasone furoate or to other corticosteroids. Like other topical corticosteroids, Elocon is contraindicated in most viral infections of the skin, tuberculosis, acne rosacea, perioral dermatitis, fungal skin infections and ulcerative conditions.

4.4 Special Warnings and Precautions for Use

If irritation or sensitisation develops with the use of Elocon Alcohol Free Cream, Elocon Ointment or Lotion treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is controlled adequately.
Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated, if the occlusive technique is used, if used in areas where the epidermal barrier is disrupted or if used long-term. Suitable precautions should be taken to ensure application sites are not occluded, particularly in infants and children (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. 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 of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Elocon Alcohol Free Cream, Elocon Ointment and Lotion are not for ophthalmic use.

Use in the elderly.

No data available.

Paediatric use.

In infants, plastic pants and napkins may act as occlusive dressings and increase absorption. Paediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than adults because of a larger skin surface area to body weight ratio. Use of topical corticosteroids in children should be limited to the least amount required for a therapeutic effect. Chronic corticosteroid therapy may interfere with growth and development of children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Similarly mometasone furoate has been shown to be teratogenic after dermal application to animals. At doses greater than 0.3 mg/kg in rats and at all dose levels tested in rabbits (0.15 mg/kg and 0.3 mg/kg), sequelae typical of other topical corticosteroids resulted. There are no adequate and well controlled studies of the teratogenic effects of corticosteroids in pregnant women. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Drugs of this class should not be used on pregnant patients in large amounts or for prolonged periods of time.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether breast-feeding should be discontinued or Elocon Alcohol Free Cream, Elocon Ointment or Lotion be discontinued, taking into account the importance of the drug to the mother.

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)

Elocon Alcohol Free Cream, Ointment and Lotion are generally well tolerated. Pruritus, burning, tingling/stinging, signs of skin atrophy and acneiform reaction have been reported in less than 5% of patients.
Other local adverse reactions reported in less than 1% of patients include erythema, furunculosis, dermatitis, abscess, aggravated allergy, increased lesion size, disease exacerbation, paraesthesia, dry skin, pimples, folliculitis and papular and pustular formation.
The following local adverse reactions have been reported infrequently with the use of other topical corticosteroids: irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Excessive, prolonged use of topical corticosteroids can suppress pituitary adrenal function resulting in secondary adrenal insufficiency.

Treatment.

Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mometasone furoate is a synthetic corticosteroid, exhibiting anti inflammatory, antipruritic and vasoconstrictive properties.
In laboratory animals, mometasone furoate exhibits potent topical anti-inflammatory activity but approximately half of the suppressive effect on the HPA (hypothalamic pituitary adrenal) axis when compared with equivalent doses of betamethasone valerate. The topical to systemic potency ratio of mometasone furoate is approximately 3 to 10 times that of betamethasone valerate in animal studies.

Clinical trials.

A single-blind, randomised, single exposure study was conducted in 165 healthy subjects to assess the relative vasoconstrictive potency of the new reformulated Elocon Alcohol Free Cream containing hydrogenated phosphatidylcholine in comparison to an initially marketed formulation. The primary objective of this study was to assess the relative vasoconstrictive potency as determined by skin blanching as measured by a chromameter. Results from the study show the new formulated Elocon cream is bioequivalent to the initially marketed formulation.

5.2 Pharmacokinetic Properties

Absorption.

Following topical application of radio labelled mometasone furoate in animals, systemic absorption was minimal in all species studied, ranging from approximately 2% in dogs to 11% in rabbits over a 5 to 7 day period.
The percutaneous absorption of Elocon was evaluated in healthy volunteers receiving a single application of radio-labelled mometasone furoate cream 0.1% which remained on intact skin for eight hours. Based on the radioactivity excreted in the urine and faeces during the five day study period, approximately 0.4% of the applied dose was absorbed systemically. In a similar study conducted using the ointment formulation, approximately 0.7% of the applied dose was absorbed systemically.
Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. As Elocon is applied topically and only low concentrations of radioactivity are detected in plasma, specific bioavailability studies have not been conducted for mometasone furoate.
No pharmacokinetic studies were conducted with the new Elocon Alcohol Free Cream formulation.

Distribution.

No data available.

Metabolism.

Since plasma levels of radio-labelled product are very low, metabolism in humans has not been studied.

Excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each gram of Elocon Alcohol Free Cream contains mometasone furoate 1 mg in a cream base of: white soft paraffin, hexylene glycol, hydrogenated soy phosphatidylcholine, aluminium starch octenylsuccinate, white beeswax, purified water, titanium dioxide, phosphoric acid.
Each gram of Elocon Ointment contains mometasone furoate 1 mg in an ointment base of: white soft paraffin, hexylene glycol, white beeswax, purified water, propylene glycol monostearate, phosphoric acid.
Each gram of Elocon Lotion contains mometasone furoate 1 mg in a lotion base of: isopropyl alcohol, propylene glycol, hyprolose, monobasic sodium phosphate dihydrate, phosphoric acid, 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

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

6.4 Special Precautions for Storage

Alcohol Free Cream, Ointment and Lotion: Store below 25°C.

6.5 Nature and Contents of Container

Elocon Ointment: 5 g*, 15 g, 45 g* and 50 g tubes.
Elocon Alcohol Free Cream: 15 g, 45 g* and 50 g tubes.
Elocon Lotion: 5 mL*, 10 mL*, 15 mL*, 20 mL*, 30 mL, 50 mL* and 100 mL* bottles.
* Not currently available 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.

6.7 Physicochemical Properties

Mometasone furoate is 9α,21-dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4 diene-3,20-dione-17-(2-furoate). The empirical formula is C27H30Cl2O6. MW: 521.4.
Mometasone furoate is a white to off white powder practically insoluble in water, slightly soluble in octanol and moderately soluble in ethyl alcohol.

Chemical structure.


CAS number.

83919-23-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicines.

Summary Table of Changes