NOVASONE

Main information

  • Trade name:
  • NOVASONE mometasone furoate 1mg/g cream tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOVASONE mometasone furoate 1mg/g cream tube
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212417
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212417

NOVASONE mometasone furoate 1mg/g cream tube

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

11/09/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 11.

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. NOVASONE mometasone furoate 1mg/g cream tube

Product Type

Single Medicine Product

Effective date

27/01/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

2g, 5g - sample

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

A white to off-white smooth homogenous cream free from foreign matter.

Active Ingredients

mometasone furoate

1 mg/g

Public Summary

Page 1 of

Produced at 23.11.2017 at 08:35:40 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 23.11.2017 at 08:35:40 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

NOVASONE

Mometasone furoate

Consumer Medicine Information

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

NOVASONE

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.

NOVASONE

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

soft white paraffin

hexylene glycol

aluminium starch

octenylsuccinate

soy phosphatidylcholine -

hydrogenated

white beeswax

purified water

titanium dioxide

phosphoric acid

Novasone Cream does not contain

any preservatives.

Novasone Ointment contains:

mometasone furoate 1 mg/g

soft white 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

hydroxypropylcellulose

sodium phosphate monobasic

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

7 July 2014

NOVASONE

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