Mometasone Furoate 0.1% W/W Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mometasone furoate 0.1% w/w Cream
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 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 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.
In this leaflet:
1. What Mometasone furoate 0.1% w/w Cream is and what it is used for
2. What you need to know before you use Mometasone furoate 0.1% w/w Cream
3. How to use Mometasone furoate 0.1% w/w Cream
4. Possible side effects
5. How to store Mometasone furoate 0.1% w/w Cream
6. Contents of the information
1. WHAT MOMETASONE FUROATE 0.1% W/W CREAM IS AND WHAT IT IS USED FOR
Mometasone furoate 0.1% w/w Cream belongs to a group of medicines called topical corticosteroids . Mometasone furoate 0.1% w/w Cream is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.
In adults and children Mometasone furoate 0.1% w/w Cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis.
Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.
2. WHAT YOU NNED TO KNOW BEFORE YOU USE MOMETASONE FUROATE 0.1% w/w CREAM
Do not use Mometasone furoate 0.1% w/w Cream
If you, are allergic to mometasone furoate, or to similar medicines, or to 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 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, warts, ulcerated skin, wounds, chickenpox, 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.
• If you have recently had a reaction to a vaccination (e.g. for flu).
Warnings and precautions
Talk to your doctor or phamacist before using Mometasone furoate 0.1% w/w Cream
• when this medicine is used on psoriasis, as 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.
• if you notice a change in the appearance of the affected skin. Please tell your doctor immediately.
• If your skin becomes irritated or sensitive after using Mometasone furoate 0.1% w/w Cream, you should stop using it and tell your doctor
Mometasone furoate 0.1% w/w 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.
Other medicines and Mometasone furoate 0.1% w/w Cream
Tell your doctor or Pharmacist if you are using, have recently used or might use any other medicines
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 0.1% w/w 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 0.1% w/w Cream should not be applied to the breast area immediately before breastfeeding.
Ask your doctor for advice before taking any medicine.
Mometasone furoate 0.1% w/w 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.
3. HOW TO USE MOMETASONE FUROATE 0.1% W/W CREAM
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Mometasone furoate 0.1% w/w Cream is for use on the skin (cutaneous use).
This medicine is for external use only.
Mometasone furoate 0.1% w/w Cream is not recommended for children under the age of 2.
Your doctor should review your treatment at regular intervals.
Usually for adults and children:
• 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.
• 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 the cream on your face without close supervision of your doctor. Do not use it on your face for more than 5 days.
• Do not apply the cream to children, on any part of their 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 a large amount of cream on large areas of the body for a long time (for example every day for many weeks or months).
• 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.
If you use more Mometasone furoate 0.1% w/w 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 and have used it too often and/or for a long time, you should tell your doctor or pharmacist.
If you forget to apply Mometasone furoate 0.1% w/w 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 a double dose to make up for a forgotten dose.
If you stop using Mometasone furoate 0.1% w/w Cream
If you have been using Mometasone Furoate 0.1% w/w 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mometasone furoate 0.1% w/w Cream can cause side effects, although not everybody gets them.
If your symptoms do not begin to improve after using this preparation for 2-3 weeks or if they get worse, check with your pharmacist or doctor.
A few people may find that they suffer from some of the following side effects after using Mometasone furoate 0.1% w/w Cream:
• 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
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.
Increased usage, treatment of large areas of skin, long term use and use under a 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 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.
Raised pressure in the skull (intracranial hypertension) has been reported in children receiving topical corticosteroids. Symptoms may include headache, bulging of the skull (bulging fontanelles) and visual problems including blurred vision, “blind” spots and double vision (bilateral papilloedema).
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MOMETASONE FUROATE 0.1% W/W CREAM
Keep this medicine out of the sight and reach of children.
Do not use Mometasone furoate 0.1% w/w Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not refrigerate or freeze.
Discard the opened tube with any remaining cream after 12 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mometasone furoate 0.1% w/w Cream contains
• The active substance is mometasone furoate. Each gram of Mometasone furoate 0.1% w/w Cream contains 1mg of mometasone furoate.
• The other ingredients are hexylene glycol, water, white beeswax (E901), propylene glycol monopamitostearate, stearyl alcohol, ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, phosphoric acid, and white soft paraffin which contains traces of butylated hydroxytoluene (E321).
What Mometasone furoate 0.1% w/w Cream looks like and contents of the pack
Mometasone furoate 0.1% w/w Cream is a white to off-white smooth cream.
It is available in tubes containing 15g, 20g or 30g, of cream.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue, Kenton,
Middlesex, HA3 0BU,
United Kingdom
Manufacturer(s)
Accord Healthcare, Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom
Glenmark Pharmaceuticals s.r.o,
Fibichova 143,
566 17 Vysoke Myto,
Czech Republic
This leaflet was last revised in November 2015
U K/H/2276/001/IB/007