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PATIENT INFORMATION LEAFLET

What Mometasone Furoate contains:

The active substance is mometasone furoate. Each gram of Mometasone Furoate Cream or Ointment contains 1 mg of mometasone furoate (0.1% w/w).

The other ingredients are:

Cream: hexylene glycol, stearyl alcohol & macrogol cetostearyl ether, white beeswax, propylene glycol monopalmitostearate, titanium dioxide (E171), aluminium starch octenylsuccinate, dilute phosphoric acid, white soft paraffin and purified water.

Ointment: hexylene glycol, white beeswax, propylene glycol monopalmitostearate, dilute phosphoric acid, white soft paraffin and purified water.

What Mometasone Furoate looks like and contents of the pack:

Mometasone Furoate Cream is a white or almost white cream with no visible particles or phase separation. Mometasone Furoate Ointment is an opaque ointment.

Within each carton is a tube with a plastic screw cap, which contains either 30 g, 60 g or 100 g of cream or ointment.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK. Manufacturer:

Tiofarma B.V., Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, The Netherlands.

These medicinal products are authorised in the Member States of the EEA under the following names:

United Kingdom:

Mometasone Furoate 0.1% w/w Cream Mometasone Furoate 0.1% w/w Ointment

Ireland:

Mometasone Furoate 0.1% w/w Cream Mometasone Furoate 0.1% w/w Ointment

This leaflet was last revised in February 2015.

For information in large print, on tape, on CD or in Braille, phone +44 (0) 1895 627 420.

O

Auden Mckenzie

Mometasone Furoate 0.1% w/w Cream & Mometasone Furoate 0.1% w/w Ointment

Read all of this leaflet carefully because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What is Mometasone Furoate and what is it used for?

2. Before you use Mometasone Furoate

3. How to use Mometasone Furoate

4. Possible side effects 5.Storing Mometasone Furoate 6. Further information

Do not use Mometasone Furoate:

•    if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of Mometasone Furoate (listed in Section 6), or to similar medicines.

•    on any other skin problems as it could make them worse especially

►    rosacea (a skin condition affecting the face)

►    acne

►    skin atrophy (thinning of the skin)

►    dermatitis around the mouth

►    genital itching

►    nappy rash

►    cold sores

►    chickenpox

►    shingles

►    warts

►    ulcerated skin

►    wounds

►    other skin infections.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Mometasone Furoate.

continued on the other side

Take special care with Mometasone Furoate:

• if your skin becomes irritated or sensitive after using Mometasone Furoate, you should stop using it and tell your doctor.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy and breast feeding:

You should tell your doctor if you are pregnant or breast-feeding, before you start using Mometasone Furoate.

Important information about some of the ingredients of Mometasone Furoate:

Mometasone Furoate Cream contains stearyl alcohol, which can cause local skin reactions (e.g. contact dermatitis) and propylene glycol monopalmitostearate, which can cause skin irritation.

Mometasone Furoate Ointment contains propylene glycol monopalmitostearate, which can cause skin irritation.

3. How to use Mometasone Furoate

Always use Mometasone Furoate exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Mometasone Furoate is not recommended for children under the age of 6.

Adults, including elderly patients and children 6 years of age and older

A thin layer of cream or ointment should be gently applied to the affected area of skin once daily.

You only need to use a small amount of this preparation

One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand. Never apply more than this quantity or more often than advised by your doctor or pharmacist.

You should always follow these instructions when using Mometasone Furoate:

Do not use the cream or ointment on your face for more than 5 days

Do not apply the cream or ointment to children, on any part of their body, for more than 5 days.

Do not put the cream or ointment under your child's nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted effects.

You should check with your doctor before covering the treated areas with a bandage or plaster.

Treated areas on the face or in children should not be covered with a bandage or plaster.

You should not use a large amount of cream or ointment on large areas of the body (over 20% of body surface area) for a long time (for example every day for many weeks or months).

Do not use in or around your eyes, including eye-lids.

Children 6 years of age and over

Do not use the cream or ointment on any part of the child's body, without close supervision of the doctor Do not use for more than 5 days

Do not apply the cream or ointment to more than a maximum of 10% of the child's body surface area. Children below 6 years of age

Mometasone Furoate 0.1% Cream and Ointment is not recommended for use in children below 6 years of age.

If you use more Mometasone Furoate than you should

If you (or somebody else) accidentally swallows the cream or ointment, it should not produce any problems. However, if you are worried, you should see your doctor.

If you use the cream or ointment more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.

If you have not used the cream or ointment as you were told to do and have used it too often and/or for a ong time, you should tell your doctor.

If you forget to use Mometasone Furoate

If you forget to use your cream or ointment at the right time, use it as soon as you remember, then carry on as instructed by your doctor.

If you stop using Mometasone Furoate

If you have been using Mometasone Furoate for a long time and your skin problem seems to have got better, you should not suddenly stop using the cream or ointment. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the cream or ointment until you stop treatment altogether.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mometasone Furoate can cause side effects, although not everybody gets them.

A few people may find that they suffer from some of the following side effects after using Mometasone Furoate:

allergic skin reactions

bacterial and secondary skin infections

acne

inflammation and/or infection of the hair follicles thinning of the skin

red marks with associated prickly heat

loss of skin colour

burning

stinging

itching

tingling

excessive hair growth

softening of the skin and stretch marks.

Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth and small dilated blood vessels.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via -UK:    the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard:

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing Mometasone Furoate

Keep all medicines out of the reach and sight of children.

Do not store above 30 °C.

Do not use Mometasone Furoate after the expiry date (Exp xx/yyyy) which is shown on the tube or carton. The expiry date refers to the last day of that month.

This medicine should be disposed of 3 months after first opening.

Do not use the cream or ointment if any visible signs of deterioration, such as noticeable changes in colour, are observed. If you are not sure please check with your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.