SUMMARY CMI

NOVASONE^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using NOVASONE?

NOVASONE contains the active ingredient mometasone furoate. NOVASONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as psoriasis, eczema, and other types of dermatitis.

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

For more information, see Section 1. Why am I using NOVASONE? in the full CMI.

2. What should I know before I use NOVASONE?

Do not use if you have ever had an allergic reaction to mometasone furoate, any other corticosteroid, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use NOVASONE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NOVASONE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NOVASONE?

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. More instructions can be found in Section 4. How do I use NOVASONE? in the full CMI.

5. What should I know while using NOVASONE?

For more information, see Section 5. What should I know while using NOVASONE? in the full CMI.

6. Are there any side effects?

Common side effects include itching, burning, tingling/stinging of the skin, thinning of the skin, and acne.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

NOVASONE^®

Active ingredient(s): [mometasone furoate]

Consumer Medicine Information (CMI)

This leaflet provides important information about using NOVASONE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NOVASONE.

Where to find information in this leaflet:

1. Why am I using NOVASONE?
2. What should I know before I use NOVASONE?
3. What if I am taking other medicines?
4. How do I use NOVASONE?
5. What should I know while using NOVASONE?
6. Are there any side effects?
7. Product details

1. Why am I using NOVASONE?

NOVASONE contains the active ingredient mometasone furoate. NOVASONE is 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, and other types of dermatitis.

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

All NOVASONE pack sizes 15 g/ 15 mL or less are available from your pharmacist behind the counter without a doctors prescription.

All other pack sizes remain prescription only presentations.

2. What should I know before I use NOVASONE?

Warnings

Do not use NOVASONE if:

• you are allergic to mometasone furoate, any other corticosteroid, or 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.
• Always check the ingredients to make sure you can use this medicine.

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.

Check with your doctor if you:

• have allergies to any other medicines or any other substances, such as foods, dyes or preservatives.
• have any other medical conditions especially if you have an infection.
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor or pharmacist can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines and NOVASONE may interfere with each other.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NOVASONE.

4. How do I use NOVASONE?

How much to use

• 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 or pharmacist 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 NOVASONE

• NOVASONE should not be used for more than four weeks at a time unless your doctor or pharmacist tells you..

If you forget to use NOVASONE

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 NOVASONE

If you think that you have swallowed NOVASONE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using NOVASONE?

Things you should do

Tell your doctor or pharmacist if:

• you feel that NOVASONE is not helping your condition or if your skin condition worsens or appear to be infected.
• for any reason, you have not used NOVASONE exactly as prescribed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.

Remind any doctor, dentist or pharmacist you visit that you are using NOVASONE.

Things you should not do

• Do not use NOVASONE under dressings or on large areas of skin unless your doctor or pharmacist 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 or pharmacist tells you. Your doctor has prescribed NOVASONE 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 NOVASONE on skin areas that rub together such as under the arm or in the groin area if your doctor or pharmacist tells you.

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

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

Looking after your medicine

• Keep NOVASONE where the temperature stays below 25°C. Do not refrigerate NOVASONE.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

NOVASONE is generally well tolerated.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What NOVASONE contains

NOVASONE Cream

NOVASONE Ointment

NOVASONE Lotion

Do not take this medicine if you are allergic to any of these ingredients.

What NOVASONE looks like

NOVASONE Cream is a white to off-white cream. It is packed in 15g (S3-Pharmacist Only) tubes.(Aust R 212417).

NOVASONE Ointment is a white to off-white ointment. It is packed in 15g (S3-Pharmacist Only) tubes.(Aust R 58613).

NOVASONE Lotion is a colourless to light yellow lotion. It is packed in 30mL bottles. (Aust R 58614).

Who distributes NOVASONE

Organon Pharma Pty Limited
Level 5, 66 King St
Sydney NSW 2000
Australia

This leaflet was prepared in February 2025.

Published by MIMS April 2025

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.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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.

4.9 Overdose

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

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

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* (S3), 15 g (S3), 45 g* and 50 g* tubes.
Novasone Cream: 15 g (S3), 45 g and 50 g* tubes.
Novasone Lotion: 5 mL* (S3), 10 mL* (S3), 15 mL* (S3), 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.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicines.
Schedule 3 - Pharmacist Only Medicines (Pack Sizes 15 g or 15 mL or less).

Summary Table of Changes