Consumer medicine information

Momasone Cream and Lotion

Mometasone furoate

BRAND INFORMATION

Brand name

Momasone

Active ingredient

Mometasone furoate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Momasone Cream and Lotion.

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 this medicine, ask your doctor or pharmacist. Keep this leaflet with your 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 available as a cream or lotion. 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

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

Your doctor, however, may have prescribed Momasone for another purpose.

Ask your doctor if you have any questions about why Momasone has been prescribed for you.

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

Before you use Momasone

When you must not use it

Do not use Momasone if you have had an allergic reaction to:

  • 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 if you have any of the above conditions.

Do not use Momasone after the expiry date. An expiry date is shown on the tube and carton of Momasone.

If you use it after the expiry date has passed, it may not work as well.

Do not use Momasone if the packaging shows signs of tampering.

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 breast feeding. Your doctor will tell you if you can use Momasone during pregnancy or while you are breast feeding.
  • 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 creams, ointments, lotions or taking any other medicines. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Momasone may interfere with each other.

How to use Momasone

How to use it

Apply a thin film of Momasone Cream or a few drops of Momasone Lotion to the affected skin or scalp once 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 Poisons Information Centre (telephone 13 11 26 - Australia) for advice or go to the Accident and Emergency centre 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 Momasone

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 seem 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 to be like yours.

Do not use Momasone to treat other conditions unless your doctor tells you. Your doctor has prescribed Momasone 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.

Momasone 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

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 Momasone

Storage

Keep Momasone in a cool dry place.

Momasone Cream should be stored where the temperature stays below 25°C.

Do not refrigerate Momasone.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Momasone 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 Momasone or it has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What it looks like

Momasone Cream is a white to off-white cream. It is available in 15g, 30g or 45g tubes.

Momasone Lotion is a clear liquid, free of particulate matter. It is available in bottles of 30mL, 60mL or 75mL.

Not all presentations are available in Australia.

Ingredients

Momasone Cream contains:

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

Momasone Cream does not contain any preservatives.

Momasone Lotion contains:

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

Supplier

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

Australian Registration Numbers

Cream - AUST R 171795

Lotion – AUST R 226990

Date of Preparation:

June 2016

Published by MIMS November 2017

BRAND INFORMATION

Brand name

Momasone

Active ingredient

Mometasone furoate

Schedule

S4

 

1 Name of Medicine

Mometasone furoate.

2 Qualitative and Quantitative Composition

Momasone cream and lotion contain mometasone furoate 0.1% w/w (1 mg/g).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Momasone lotion.

A clear topical lotion.

Momasone cream.

An off-white topical cream.

4 Clinical Particulars

4.1 Therapeutic Indications

Momasone cream and lotion are indicated for short-term (up to 4 continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.
Momasone 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 mometasone furoate cream should be applied to the affected skin areas once daily. Mometasone furoate cream is suitable for moist lesions.
A few drops of mometasone furoate lotion should be applied to affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.

4.3 Contraindications

Momasone cream and lotion are contraindicated in patients who are hypersensitive to mometasone furoate or to other corticosteroids. Like other topical corticosteroids, mometasone furoate 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 mometasone furoate cream 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.
Mometasone furoate cream 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)
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 furoate cream 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)

Mometasone furoate cream 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 www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

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 hypothalamic pituitary adrenal (HPA) 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.

The efficacy of Momasone cream was studied in trial ZPS 386. The efficacy of Momasone lotion was studied in trial ZPS 469.

Cream - ZPS 386.

The clinical equivalence of Momasone 0.1% w/w cream versus Elocon 0.1% w/w cream was conducted in a parallel, 3 arm placebo controlled randomized clinical efficacy study, in 66 participants with steroid responsive dermatitis.
The efficacy of the treatment was determined using the objective SCORing Atopic Dermatitis (SCORAD) scoring system. Assessments were made prior to the test, at 7, 14 and 21 days after treatment.
The percent improvement in SCORAD scores are presented in Table 1.
No significant difference in the percent improvement in SCORAD scores was detected between Momasone and Elocon.

The efficacy of momasone lotion was studied in trial ZPS 469.

The clinical equivalence of Momasone 0.1% lotion versus Elocon 0.1% lotion was conducted in a parallel, 3 arm placebo controlled randomized clinical efficacy study, in 66 participants with steroid responsive scalp dermatitis; 62 participants completed the study.
The efficacy of the treatment was determined using the objective SCORing Atopic Dermatitis (SCORAD) scoring system. Assessments were made prior to the test, at 7, 14 and 21 days after treatment.
The percent improvement in SCORAD scores are presented in Table 2.
No significant difference in the percent improvement in SCORAD scores was detected between Momasone and Elocon.

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 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. As mometasone furoate is applied topically and only low concentrations of radioactivity are detected in plasma, specific bioavailability studies have not been conducted for mometasone furoate. Since plasma levels of radio-labelled product are very low, metabolism in humans has not been studied.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Momasone cream contains soft white paraffin, propylene glycol, aluminium starch octenylsuccinate, propylene glycol monostearate, stearyl alcohol, ceteareth-20, white beeswax, purified water, titanium dioxide and phosphoric acid.
Momasone lotion contains monobasic sodium phosphate, phosphoric acid, propylene glycol, hyprolose, isopropyl alcohol 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 Australia 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

Cream 1 mg/g (0.1% w/w).

15 g, 30 g, and 45 g (Al tube).

Lotion 1 mg/g (0.1% w/w).

30 mL, 60 mL and 75 mL (HDPE bottle).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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.
The chemical name for mometasone furoate is 9α, 21-dichloro-11β, 17-dihydroxy-16α-methylpregna-1, 4-diene-3, 20-dione 17-(2-furoate).

Chemical structure.


Molecular formula: C27H30Cl2O6.
Molecular weight: 521.4.

CAS number.

83919-23-7.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes