Consumer medicine information

Momasone Ointment

Mometasone furoate

BRAND INFORMATION

Brand name

Momasone Ointment

Active ingredient

Mometasone furoate

Schedule

S4 | S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Momasone Ointment.

What is in this leaflet

This leaflet answers some common questions about MOMASONE.

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 MOMASONE 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 MOMASONE is used for

The name of your medicine is MOMASONE. It contains the active ingredient called mometasone furoate. It is a type of cortisone and belongs to the group of medicines called corticosteroids. MOMASONE is classified as a high potency topical corticosteroid.

MOMASONE 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.

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.

A doctor’s prescription is required for the 50 g tube of MOMASONE ointment.

The 15 g tube can be purchased without a doctor’s prescription.

Before you use it

When you must not use it

Do not use MOMASONE 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 MOMASONE 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 MOMASONE.

Using other medicines

Tell your doctor or pharmacist if you are using other ointments 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 MOMASONE may interfere with each other.

How to use it

How to use it

Apply a thin film of MOMASONE ointment to the affected skin daily. Massage gently until it disappears.

It is important to use MOMASONE 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 MOMASONE for more than four weeks at a time unless your doctor tells you.

If you forget to use it

If you forget to use MOMASONE, use it as soon as you remember and then go back to your normal time for applying MOMASONE.

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 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have swallowed MOMASONE. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using it

Things you must do

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

Tell your doctor if you feel that MOMASONE 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 MOMASONE 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 MOMASONE under dressings or on large areas of skin unless your doctor tells you.

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

Do not use MOMASONE in or near the eyes.

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

Do not use MOMASONE to treat other conditions unless your doctor tells you. Your doctor has prescribed MOMASONE 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 MOMASONE on skin areas that rub together such as under the arm or in the groin area if your doctor tells you.

Only use MOMASONE 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 MOMASONE.

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.

MOMASONE 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
  • eye problems e.g. cataracts, glaucoma and 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 it

Storage

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

Do not refrigerate MOMASONE.

Do not store MOMASONE 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 meters 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

MOMASONE is a translucent, white, soft, uniform and smooth ointment. It is available in 15 g or 50 g aluminium tubes with a white piercing cap.

Ingredients

MOMASONE ointment contains mometasone furoate 1 mg/g as the active ingredient.

Inactive ingredients

  • white soft paraffin
  • hexylene glycol
  • white beeswax
  • purified water
  • propylene glycol monostearate
  • phosphoric acid.

MOMASONE ointment does not contain any preservatives.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian registration number:
AUST R 266268

Date of revision: September 2020

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Momasone Ointment

Active ingredient

Mometasone furoate

Schedule

S4 | S3

 

1 Name of Medicine

Mometasone furoate.

2 Qualitative and Quantitative Composition

Each gram of Momasone ointment contains mometasone furoate 1 mg in an ointment base of soft white paraffin, hexylene glycol, white beeswax, purified water, propylene glycol monostearate and phosphoric acid.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

Momasone ointment is 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.

4.2 Dose and Method of Administration

A thin film of Momasone ointment should be applied to the affected skin areas once daily. Momasone ointment should be used for dry, scaling and fissured lesions.

Note.

1. There are other registered mometasone furoate dosage forms, such as creams and lotions. Mometasone furoate creams are suitable for moist lesions. Mometasone furoate lotions are suitable for hairy areas, such as scalp sites.
2. Avoid using mometasone on open skin (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Momasone ointment is contraindicated in patients who are hypersensitive to mometasone furoate or to other corticosteroids. Like other topical corticosteroids, Momasone 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

Momasone ointment is not for ophthalmic use.
If irritation or sensitisation develops with the use of Momasone ointment, 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, due to the larger skin surface to bodyweight ratio and the possibility of occlusive napkins and plastic pants being used.

Visual disturbance.

Visual disturbance may be reported with systemic and topical 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 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.

Use in the elderly.

No data available.

Paediatric use.

The use of mometasone furoate 0.1% once daily has been documented in a number of studies in children from 7 months to 12 years old, with moderate to severe dermatitis involving at least 15% of the body surface area. Duration of treatment was usually only for 3 weeks, with up to 6 weeks in one study. No skin thinning was observed in any of these studies or change in plasma cortisol levels, where this was monitored. In general, mometasone furoate was well tolerated. Local reactions were minor, e.g. stinging, and occurred in few patients.
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. Chronic corticosteroid therapy may interfere with growth and development of children. Care should be taken that application sites in infants and young children are not occluded with tightly fitting napkins or plastic pants.
Use of topical corticosteroids in children should be limited to the least amount required for a therapeutic effect.

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 mometasone ointment 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)

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.
Momasone ointment is 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.

Post marketing.

Eye disorders.

Blurred vision.

4.9 Overdose

Excessive, prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency. Infants and young children are likely to be particularly susceptible to HPA axis suppression, Cushing's syndrome and growth suppression under these conditions.

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.
If a large amount of Momasone ointment is accidentally ingested, particularly by a child, contact the Poisons Information Centre on 131126 (Australia) for advice on overdose treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mometasone furoate is a synthetic corticosteroid, exhibiting anti-inflammatory, antipruritic and vasoconstrictive properties.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The percutaneous absorption of mometasone furoate 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.

Distribution.

As mometasone furoate ointment is applied topically and only low concentrations of radioactivity are detected in plasma, specific bioavailability studies have not been conducted.

Metabolism.

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

Excretion.

No data available.

5.3 Preclinical Safety Data

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.
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.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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

Momasone ointment is a translucent, white, uniform and smooth ointment in an aluminium tube with a white HDPE piercing cap. Available in 15 g and 50 g tube pack sizes*.
*Note: Not all tube pack sizes may be 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 a white to off-white powder practically insoluble in water, slightly soluble in octanol and moderately soluble in ethyl alcohol.

Chemical structure.


Mometasone furoate is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna- 1,4-diene-3,20-dione 17-(2-furoate). The empirical formula is C27H30Cl2O6. MW: 521.4.

CAS number.

83919-23-7.

7 Medicine Schedule (Poisons Standard)

50 g: Schedule 4 - Prescription Only Medicine.
15 g: Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes