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PACKAGE LEAFLET: INFORMATION FOR THE USER (Mometasone Furoate 0.1%w/w Ointment)

PACKAGE LEAFLET: INFORMATION FOR THE USER (Mometasone Furoate 0.1%w/w Ointment)

Read all of this leaflet carefully before you start using this medicine

because it contains important information for you:

-    Keep this leaflet. You may need to read itagain.

-    If you have any further questions, askyour doctor or pharmacist.

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

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Mometasone Furoate 0.1% w/w Ointment is and what it is used for

2.    What you need to know before you use Mometasone Furoate 0.1% w/w Ointment

3.    Howto use Mometasone Furoate 0.1% w/w Ointment

4.    Possible side effects

5.    Howto store Mometasone Furoate 0.1% w/w Ointment

6.    Contents of the pack and other information

1.WHAT MOMETASONE FUROATE 0.1% W/W OINTMENT IS AND WHAT IT IS USED FOR

When this medicine is used on psoriasis, it may make the condition worse (e.g. a pustular form of the disease may occur). You should let your doctor review your progress at regular intervals, as such treatment needs careful supervision.

Other medicines and Mometasone Furoate 0.1% w/w Ointment

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

However, if your doctor does prescribe the ointment to you during pregnancy or while you are breast-feeding, you should avoid using large doses and use only for a short period. Mometasone Furoate Ointment should not be applied to the breast area whilst breast-feeding.

Mometasone Furoate 0.1% w/w Ointment contains propylene glycol and butylated hydroxytoluene (E321)

Mometasone Furoate Ointment contains propylene glycol which may cause skin irritations and butylated hydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

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Mometasone Furoate 0.1% w/w Ointment contains the active substance mometasone furoate, which belongs to a group of medicines called topical corticosteroids (or steroids).

It is classified as a “potent corticosteroid”

In adults and children, aged 6 years and over, Mometasone Furoate Ointment is used to reduce symptoms caused by certain inflammatory skin disorders such as psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis. This preparation is generally used to treat very dry, scaly and cracked skin complaints. It is not a cure for your condition, but should help to relieve yoursymptoms.

3. HOWTO USE MOMETASONE FUROATEQ.1%W/WOINTMENT

2.BEFOREYOU USE MOMETASONE FUROATE 0.1% W/W OINTMENT

Do not use Mometasone Furoate 0.1% w/w Ointment

•    If you are allergic to mometasone or any of the other ingredients of this medicine (listed in section 6)..

•    On any other skin problems as it could make them worse especially rosacea (a skin condition affecting theface), acne, skin atrophy (thinning of the skin), dermatitis around the mouth, perianal and genital itching, nappy rash, bacterial infections such as impetigo and pyodermas, tuberculosis (infection of the lung), syphilis (a sexually transmitted disease), viral infections such as warts, cold sores, shingles, and chickenpox, fungal infections such as athlete's foot (red, itchy, flaky skin onthefeet), orthrush (an infection affecting the vagina that can cause discharge and itching) or other skin infections.

•    On wounds or on skin which is ulcerated

•    If you have recently had a reaction to a vaccination (e.g. forflu)

Warnings and precautions

Talk to your doctor or pharmacist before using Mometasone Furoate

Ointment.

If irritation or sensitisation develop with the use of Mometasone Furoate

Ointment, you should tell your doctor immediately.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Mometasone Furoate Ointment is not recommended for children under the age of 6. Usually for adults and children, a thin layer of Mometasone Furoate Ointment should be gently rubbed into the affected area of skin once a day.

If you have been prescribed the ointment, 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.

Your doctor should reviewyour treatment at regular intervals.

You should always follow these instructions when using Mometasone Furoate Ointment:

•    do not use the ointment on yourfacefor more than 5 days

•    do not apply the ointmentto children, on any part of their body, for more than 5 days

•    do not put the 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 checkwith your doctorbefore covering thetreated 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 ointment on large areas of the body fora long time (for example every day for many weeks or months)

•    do not use in or around your eyes, including eye-lids

•    do not use on broken skin

Use in children and adolescents Do not use the ointment for children over 6 years of age, on any part of their body, without close supervision of the doctor. Do not apply the ointmentto more than a maximum of 10% of the child's body surface area.

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If you use more Mometasone Furoate 0.1% w/w Ointment than you should

If you (or somebody else) accidentally swallow the ointment, it should not produce any problems. However, if you are worried, you should see your doctor or pharmacist. If you use the ointment more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affecttheir growth and development.

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

If you forget to apply Mometasone Furoate 0.1% w/w Ointment

If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then carry on as before. Do not apply twice as much or use twice in one day to make upfor a missed application.

If you stop using Mometasone Furoate 0.1% w/w Ointment

Do not stop treatment suddenly if you have used it for a long time since this may be harmful. Treatment should be stopped gradually, as advised by your doctor.

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

prescribing the lowest dose of steroid at which your symptoms are well-controlled.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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5. HOW TO STORE YOUR MOMETASONE FUROATE 0.1% W/W OINTMENT

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them

The following side effects have been observed after using Mometasone Furoate 0.1% w/w Ointment:

Common may affect upto 1 in 10 people

•    mild to moderate burning sensations atthe application site

•    thinning oftheskin

•    tingling/stinging, itching

•    bacterial infections

•    paraesthesia (abnormal sensations on the skin)

•    unusual red marks on the skin.

Uncommon may affect up to 1 in 100 people

•    irregular skin marks or stripes

•    secondary infection

•    pusfilled blisters on facial skin

•    purple or dark blue discoloration of the skin

•    inflammation of skin follicles

•    unusual hair growth

•    sensitisation

•    dryness

•    changes in skin colour

•    maceration of the skin (softening and whitening of the skin)

•    inflammation (including acne type reactions)

•    miliaria (prickly heat, a very itchy rash)

•    secondary infection

Very rare may affect up to 1 in 10,000 people

•    dilated blood vessels on the skin or spider veins

Increased usage, treatment of large areas of skin, long term use and use undera dressing may increase the risk of side effects.

Corticosteroids may affect the normal production of steroids in the body. This is more likely to happen if high doses are being used over a long period of time.

Children in particular, treated with corticosteroid ointments and creams can absorb product through the skin and this can lead to a disorder called Cushing's syndrome which includes many symptoms, suchasafat, round face and weakness. Children on long term treatment may grow more slowly than others. Your doctor will help prevent this happening by

Keepthis medicine out of the sight and reach of children Do not use Mometasone Furoate 0.1% w/w Ointment after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of the month.

Discard the opened tube with any remaining ointment after 12 weeks.

Do not store above 30^oC.

Do notthrow away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAND OTHER INFORMATION

What Mometasone Furoate 0.1% w/w Ointment contains

•    The active substance is mometasone furoate

Each gram of Mometasone Furoate 0.1% w/w Ointment contains 1mg of mometasonefuroate.

•    The other ingredients are hexylene glycol; phosphoric acid, concentrated (for pH adjustment); propylene glycol monopalmitostearate; beeswax white; paraffin, white soft; butylated hydroxytoluene (E321) (as an antioxidant) and water, purified.

What Mometasone Furoate 0.1% w/w Ointment looks like and the contents of the pack

Mometasone Furoate Ointment is a translucent white soft ointment. The ointment is filled in aluminium tubes fitted with a white polyethylene piercing screw cap in a cardboard carton.

Pack sizes: Tubes with 15g, 30g, 50g or 100g of ointment.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Ltd,

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow.

Middx, HA30BU,

United Kingdom

Manufacturer

Glenmark Pharmaceuticals s.r.o, Fibichova 143, 566 17 Vysoke Myto, Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom

This leaflet was last revised in September2014

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Font: 9 pt, HelveticaCondensed Date: 26-09-2014 Version: 02 (UK) - Icon