Informations for option: Mometasone Furoate 0.1% W/W Cream, show other option

Select option:

1. Mometasone Furoate 0.1% W/W Cream
2. Mometasone Furoate 0.1% W/W Cream

Document: leaflet MAH GENERIC_PL 04416-1421 change

• leaflet MAH BRAND_PL 00025-0577
• leaflet MAH BRAND_PLPI 18799-2191
• leaflet MAH BRAND_PLPI 20636-2397
• leaflet MAH BRAND_PLPI 39352-0229
• leaflet MAH BRAND_PLPI 39352-0230
• leaflet MAH GENERIC_PL 04416-1421
• leaflet MAH GENERIC_PL 17507-0111
• leaflet MAH GENERIC_PL 25258-0009
• leaflet MAH GENERIC_PL 25258-0118
• leaflet MAH GENERIC_PL 33016-0002

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mometasone Furoate

What is in this leaflet:

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

2.    What you need to know before you take Mometasone Furoate Cream

3.    How to use Mometasone Furoate Cream

4.    Possible side effects

5.    How to store Mometasone Furoate Cream

6.    Contents of the pack and other information

Mometasone Furoate Cream contains the active substance mometasone furoate, which belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids can be divided into four degrees of strength or potency: mild, moderate, potent and very potent. Mometasone Furoate Cream is classified as a “potent corticosteroid”.

In adults and children, aged 2 years and over, Mometasone Furoate Cream 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 your symptoms.

Do not use Mometasone Furoate Cream

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

•    if you have any other skin problems as Mometasone Furoate Cream could make them worse especially:

-    rosacea (a skin condition affecting the face),

-    acne,

-    skin atrophy (thinning of the skin)

-    dermatitis around the mouth,

-    perianal and genital itching,

-    nappy rash,

-    bacterial infections such as impetigo, tuberculosis (infection of the lung), syphilis ( a sexually transmitted disease),

-    viral infections such as cold sores, shingles, and chickenpox,

-    warts

-    fungal infections such as athlete’s foot (red, itchy, flaky skin on the feet), or thrush (an infection affecting the vagina that can cause discharge and itching or other skin infections.

-    ulcerated skin, wounds

•    If you have recently had a reaction to a vaccination (e.g. for flu) Warnings and precautions

Talk to your doctor or pharmacist before using Mometasone Furoate Cream

If irritation or sensitisation develop with the use of Mometasone Furoate Cream , you should stop using it and tell your doctor immediately.

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.

Mometasone Furoate Cream should not be applied to broken skin.

The cream should not be put on the eyelids. Take care not to get any cream in the eye.

High blood sugar (hyperglycaemia) and high levels of glucose in the urine (glucosuria) can occur in some patients after topical application due to systemic absorption

Other medicines and Mometasone Furoate Cream

Tell your doctor or your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and any other remedies or dietary supplements such as vitamins. Ask your doctor for advice before taking any medicine.

Pregnancy, breast-feeding and fertility

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.

During pregnancy or while you are breast-feeding treatment with Mometasone Furoate Cream should only be started following instructions from your doctor.

However, if your doctor does prescribe the cream 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 Cream should not be applied to the breast area immediately before breastfeeding.

Ask your doctor for advice before taking any medicine.

Mometasone Furoate Cream contains propylene glycol, stearyl alcohol and butylated hydroxytoluene

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

Mometasone Furoate Cream is for cutaneous use (use on the skin).

This medicinal product is for external use only.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor should review your treatment at regular intervals.

Adults, including elderly patients and children 2 years of age and older:

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

You only need to use a small amount of this preparation.

If you have been prescribed the cream, 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.

Special care should be used:

•    Do not use it on your face for more than 5 days.

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

•    Do not put the cream 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 not use the cream on large areas of the body (over 20%

of body surface area) or for a long time (for example every day for over 3 weeks).

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

•    Unless directed by your doctor, do not apply a bandage or dressing to the area being treated. This will increase absorption of the preparation and increase possible side effects. Treated areas on the face or in children should not be covered with a bandage or plaster.

•    Do not use the cream on your face without close supervision of your doctor.

Use in children and adolescents

Mometasone Furoate Cream is not recommended for children under the age of 2.

Children 2 years of age and over:

Do not use the cream for children over 2 years of age, on any part of their body, without close supervision of the doctor. Do not apply the cream to more than a maximum of 10% of the child’s body surface area.

If you use more Mometasone Furoate Cream than you should

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

If you use the cream 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 as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist.

If you forget to use Mometasone Furoate Cream

If you forget to apply the cream 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 up for a missed application.

If you stop using Mometasone Furoate Cream

If you have been using Mometasone Furoate Cream for a long time and your skin problems seems to have got better, you should not suddenly stop using the cream. 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 until you stop treatment altogether.

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

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

If your symptoms do not begin to improve after using this preparation as instructed by your doctor or if they get worse, check with your doctor.

Side effects in children and adults that have been reported with the use of topical corticosteroids include the following (which may occur at the site of application):

Uncommon (may affect up to 1 in 100 people)

•    skin dryness

•    inflamed skin (dermatitis)

•    softening and whitening of the skin (maceration)

•    heat rash/prickly heat (miliaria)

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

•    inflammation of hair follicles (folliculitis)

•    a burning sensations

•    Itching

•    fine red lines under the skin (thread veins or telangiectasia)

Not known (frequency cannot be estimated from the available data):

•    allergic skin reactions (contact dermatitis)

•    irritation and/or pain

•    skin infections (including boils)

•    acne-like rashes

•    tingling or stinging (paraesthesia)

•    stretch marks (striae)

•    thinning of the skin

•    changes in skin colour

•    abnormal hair growth (hypertrichosis)

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

Intracranial hypertension has been reported in paediatric patients receiving topical corticosteroids.

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 corticosteroids ointments and creams can absorb product through the skin and this can lead to a disorder called Cushing’s syndrome which include many symptoms, such as a fat, round face and weakness. Children on long term treatment may grow more slowly than others. Your doctor will help prevent this happening by prescribing the lowest dose of steroid at which your symptoms are well-controlled.

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 via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicinal product.

Keep this medicine out of the reach and sight of children.

Do not use Mometasone Furoate Cream 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.

Do not store above 25°C. Do not refrigerate or freeze

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

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

What Mometasone Furoate Cream contains

• The active substance is mometasone furoate.

Each gram of Mometasone Furoate Cream contains 1mg of mometasone furoate.

The other ingredients are hexylene glycol; purified water; white beeswax, propylene glycol monopalmitostearate, stearyl alcohol, macrogol 20 cetostearyl ether, titanium dioxide (E171), aluminium starch octenylsuccinate, phosphoric acid 10% solution, white soft paraffin (contains butylhydroxytoluene (E321)).

What Mometasone Furoate Cream looks like and contents of the pack

Mometasone Furoate Cream is a white to off-white smooth cream.

The cream is filled in a latex-lined aluminium collapsible tube, lacquered with an epoxy phenolic resin, fitted with a white polyethylene piercing screw cap.

Tube containing 10g, 15g, 20g, 30g, 50g, 60g or 100g of cream

Not all packs sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR United Kingdom

Manufacturer

Glenmark Pharmaceuticals Europe Limited, Croxley Green Business Park, WD 8YA or

Glenmark Pharmaceuticals S.R.O., FiMchova 143, 56617 Vysok6 Myto or

Salutas Pharma GmbH, Otto- von- Guericke- Allee 1,39179 Barleben, Germany

This leaflet was last revised in 05/2015.

SZ00000LT000