Consumer medicine information

Novasone

Mometasone furoate

BRAND INFORMATION

Brand name

Novasone

Active ingredient

Mometasone furoate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Novasone.

What is in this leaflet

This leaflet answers some common questions about NOVASONE.

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 NOVASONE 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 NOVASONE is used for

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

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

There are three forms of NOVASONE: cream, ointment and lotion.

NOVASONE 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

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

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

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

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

Before you use NOVASONE

When you must not use it

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

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

Do not use NOVASONE 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

unless your doctor tells you.

Ask your doctor if you are unsure whether you have any of these conditions.

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

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

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 NOVASONE during pregnancy or while you are breast feeding.
  • you have any other medical conditions, especially if you have an infection.

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 buy without a prescription from a pharmacy, supermarket or health food shop.

How to use NOVASONE

How to use it

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

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

If you forget to use it

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

If you swallow it

Telephone your doctor or Poisons Information Centre (Phone 13 11 26) or go to the accident and emergency centre at your nearest hospital immediately if you think that you or anyone else may have swallowed NOVASONE.

Keep the telephone numbers of these places handy.

While you are using NOVASONE

Things you must do

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

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

Tell your doctor if, for any reason, you have not used NOVASONE 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 NOVASONE under dressings or on large areas of skin unless your doctor tells you.

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

Do not use NOVASONE in or near the eyes.

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

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

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

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

Side Effects

Tell your doctor if you do not feel well while you are using NOVASONE.

NOVASONE helps most people with skin problems but it may have unwanted side effects in a few people.

NOVASONE is generally well tolerated. However, unwanted effects that have been reported by some people using NOVASONE include:

  • 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

NOVASONE may cause other side effects.

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

If you have any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using NOVASONE

Storage

Keep NOVASONE in a cool dry place. NOVASONE Cream, Ointment and Lotion should be stored where the temperature stays below 25°C.

Do not refrigerate NOVASONE.

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

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

Product Description

What it looks like

NOVASONE Cream is a white to off-white cream. It is packed in 15 g tubes.

NOVASONE Ointment is a white to off-white ointment. It is packed in 15 g tubes.

NOVASONE Lotion is a colourless to light yellow lotion. It is packed in 30 mL bottles.

Ingredients

NOVASONE Cream contains:

  • mometasone furoate 1 mg/g
  • white soft paraffin
  • hexylene glycol
  • aluminium starch octenylsuccinate
  • hydrogenated soy phosphatidylcholine
  • white beeswax
  • purified water
  • titanium dioxide
  • phosphoric acid

NOVASONE Cream does not contain any preservatives.

NOVASONE Ointment contains:

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

NOVASONE Ointment does not contain any preservatives.

NOVASONE Lotion contains:

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

NOVASONE Lotion does not contain any preservatives.

Supplier

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

Australian Registration Numbers

Cream - AUST R 212417

Ointment - AUST R 58613

Lotion - AUST R 58614

Date of Preparation

July 2020

S-CCDS-MK0887-MTL-082017

RCN -

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Novasone

Active ingredient

Mometasone furoate

Schedule

S4

 

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

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

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.3 Contraindications

Novasone Cream, Ointment and Lotion are contraindicated in patients who are hypersensitive to mometasone furoate or to other corticosteroids. Like other topical corticosteroids, Novasone 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 Novasone Cream, 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.
Novasone Cream, 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 Novasone Cream, 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)

Novasone 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 Novasone 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 Novasone 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 Novasone 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 Novasone 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 Novasone 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 Novasone 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 Novasone 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 Novasone 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

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

6.5 Nature and Contents of Container

Novasone Ointment: 5 g*, 15 g, 45 g* and 50 g* tubes.
Novasone Cream: 15 g, 45 g and 50 g* tubes.
Novasone 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-11β,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