ELOCON

Main information

  • Trade name:
  • ELOCON ALCOHOL FREE mometasone furoate 1mg/g cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELOCON ALCOHOL FREE mometasone furoate 1mg/g cream
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212416
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212416

ELOCON ALCOHOL FREE 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. ELOCON ALCOHOL FREE mometasone furoate 1mg/g cream

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

ELOCON ALCOHOL FREE 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. ELOCON 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

(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 08:36:17 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 08:36:17 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

ELOCON

®

and

ELOCON ALCOHOL

FREE

Mometasone Furoate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Elocon and Elocon

Alcohol Free.

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 Elocon or

Elocon Alcohol Free 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 Elocon or

Elocon Alcohol Free is

used for

The name of your medicine is Elocon

or Elocon Alcohol Free. It contains

the active ingredient called

mometasone furoate.

It is a type of cortisone and belongs

to the group of medicines called

corticosteroids. Elocon or Elocon

Alcohol Free is classified as a high

potency topical corticosteroid.

There are three forms of this

medicine: cream, ointment and

lotion.

Elocon and Elocon Alcohol Free are

used on the skin to relieve the

redness, swelling, itching and

discomfort of many skin problems

such as:

psoriasis

eczema

other types of dermatitis.

Elocon Lotion is also used on the

scalp and hairy parts of the body.

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.

This medicine is available only with

a doctor's prescription.

Before you use

Elocon or Elocon

Alcohol Free

When you must not use it

Do not use Elocon or Elocon

Alcohol Free 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 Elocon or Elocon

Alcohol Free 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.

ELOCON

AND ELOCON ALCOHOL FREE

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 Elocon

or Elocon Alcohol Free .

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 get without a prescription

from your pharmacy, supermarket

or health food shop.

Some medicines and Elocon or

Elocon Alcohol Free may interfere

with each other.

How to use Elocon or

Elocon Alcohol Free

How to use it

Apply a thin film of Elocon Alcohol

Free Cream or Elocon Ointment or

a few drops of Elocon Lotion to the

affected skin or scalp once daily.

Massage gently until it disappears.

It is important to use Elocon or

Elocon Alcohol Free 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 Elocon or Elocon Alcohol

Free for more than four weeks at a

time unless your doctor tells you.

If you forget to use it

If you forget to use Elocon or Elocon

Alcohol Free, use it as soon as you

remember and then go back to your

normal time for applying Elocon or

Elocon Alcohol Free. 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 Australia 13 11 26 or

New Zealand 0800 POISON or

0800 764 766) for advice, or go to

Accident and Emergency at your

nearest hospital, if you think that

you or anyone else may have

swallowed Elocon or Elocon

Alcohol Free. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

Keep the telephone numbers of

these places handy.

While you are using

Elocon or Elocon

Alcohol Free

Things you must do

Tell all doctors and pharmacists

who are treating you that you are

using Elocon or Elocon Alcohol

Free .

Tell your doctor if you feel that

Elocon or Elocon Alcohol Free 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 Elocon or

Elocon Alcohol Free 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 Elocon or Elocon

Alcohol Free under dressings or on

large areas of skin unless your

doctor tells you.

Do not use plastic pants or tight

fitting nappies if Elocon or Elocon

Alcohol Free is to be used on the

nappy area of young children.

Do not use Elocon or Elocon

Alcohol Free in or near the eyes.

Do not give Elocon or Elocon

Alcohol Free to anyone else even if

their symptoms seem similar to

yours.

Do not use Elocon or Elocon

Alcohol Free to treat other

conditions unless your doctor tells

you.

Your doctor has prescribed Elocon or

Elocon Alcohol Free 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 Elocon or Elocon Alcohol

Free on skin areas that rub

together such as under the arm or

in the groin area if your doctor

tells you.

Only use Elocon or Elocon Alcohol

Free 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 Elocon or

Elocon Alcohol Free.

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.

ELOCON

AND ELOCON ALCOHOL FREE

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.

Elocon and Elocon Alcohol Free are

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.

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 Elocon or

Elocon Alcohol Free

Storage

Keep Elocon and Elocon Alcohol

Free in a cool dry place where the

temperature stays below 25°C.

Do not refrigerate Elocon and

Elocon Alcohol Free.

Do not store Elocon and Elocon

Alcohol Free 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 metres 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

Elocon Alcohol Free Cream is a

white to off-white cream. It is packed

in 5g, 15g, 45g and 50 g tubes.

Elocon Ointment is a white to off-

white ointment. It is packed in 5g,

15g, 45g and 50 g tubes.

Elocon Lotion is a colourless to light

yellow lotion. It is packed in 30mL

bottles.

Ingredients

Elocon Alcohol Free Cream contains:

mometasone furoate 1 mg/g

soft white paraffin

hexylene glycol

aluminium starch

octenylsuccinate

hydrogenated

phosphatidylcholine

white beeswax

purified water

titanium dioxide

phosphoric acid.

Elocon Alcohol Free Cream does not

contain any preservatives.

Elocon Ointment contains:

mometasone furoate 1 mg/g

soft white paraffin

hexylene glycol

white beeswax

purified water

propylene glycol monostearate

phosphoric acid.

Elocon Ointment does not contain

any preservatives.

Elocon Lotion contains:

mometasone furoate 1 mg/g

isopropyl alcohol

propylene glycol

hydroxypropylcellulose

sodium phosphate monobasic

dihydrate

phosphoric acid

purified water.

Elocon Lotion does not contain any

preservatives.

Supplier

In Australia:

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A,

26 Talavera Road,

Macquarie Park NSW 2113 Australia

In New Zealand:

Merck Sharp & Dohme (New

Zealand) Ltd

P O Box 99 851

Newmarket

Auckland 1149

New Zealand

Australian Registration

Numbers

Cream - AUST R 212416

Ointment - AUST R 43344

Lotion - AUST R 53472

ELOCON

AND ELOCON ALCOHOL FREE

Date of Preparation

7 July 2014

ELOCON

AND ELOCON ALCOHOL FREE

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