Mometasone Furoate 0.1% W/W Cream
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Mometasone furoate 0.1% w/w Cream
Read all of this leaflet carefully before you start using this medicine.
- 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Mometasone furoate 0.1% w/w Cream is and what it is used for
2. 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. Further 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 (or steroids). Mometasone furoate 0.1% w/w Cream is classified as a “potent corticosteroid”.
Mometasone furoate 0.1% w/w Cream is used to reduce redness and itchiness caused by certain inflammatory skin problems such as psoriasis and some types of dermatitis. This preparation is not a cure for your condition, but should help to relieve your symptoms.
2. BEFORE YOU USE MOMETASONE FUROATE 0.1% W/W CREAM Do not use Mometasone furoate 0.1% w/w Cream
• If you, or your child, are allergic (hypersensitive) to the active substance, mometasone furoate, or to any of the other ingredients included in section 6 (please see Further information on what Mometasone furoate 0.1% w/w Cream contains.
• On any other skin problems as it could make them worse especially rosacea (a skin condition affecting the face), acne, 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, 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).
Take special care with Mometasone furoate 0.1% w/w Cream
• if you or your child are allergic (hypersensitive) to other corticosteroids
• if irritation or sensitization develop with the use of Mometasone furoate 0.1% w/w Cream, you should tell your doctor immediately.
• 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.
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.
Taking other medicines
Please 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.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, may be pregnant or are breast-feeding
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 breastfeeding, 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 breast-feeding.
Ask your doctor for advice before taking any medicine.
Important information about some of the ingredients of Mometasone furoate 0.1% w/w Cream
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
Mometasone furoate 0.1% w/w Cream is for use on the skin (cutaneous use).
This medicine is for external use only.
Always use Mometasone furoate 0.1% w/w Cream exactly as your doctor has told you. You should
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 6 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.
• 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.
• 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).
• Avoid getting the cream in your eyes.
• 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.
Children 6 years of age and over
Do not use the cream on any part of the child’s body, without close supervision of the doctor
• Do not use it for more than 5 days.
• Do not apply the cream to more than a maximum of 10% of the childs body surface area. Children under 6 years of age
Mometasone furoate 0.1% w/w Cream is not recommended for use in children below 6 years of age.
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 undesirable effects. 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 followed the dosage instructions or your doctor’s advice and have used the cream too frequently 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 twice as much or use twice in one day to make up for a missed application.
If you stop using Mometasone furoate 0.1% w/w Cream
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.
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.
The following frequencies are taken as a basis when evaluating side effects:
|
very common: |
affects more than 1 user in 10 |
|
common: |
affects 1 to 10 users in 100 |
|
uncommon: |
affects 1 to 10 users in 1,000 |
|
rare: |
affects 1 to 10 users in 10,000 |
|
very rare: |
affects less than 1 user in 10,000 |
|
not known: data |
frequency cannot be estimated from the available |
Side effects in children and adults that have been reported with the use of topical corticosteroids include:
|
Skin problems Common: |
Mild to moderate burning sensations at the application site, thinning of the skin tingling/stinging, itching, bacterial infections, paraesthesia (abnormal sensations on the skin) or unusual red marks on the skin |
|
Uncommon: |
Irregular skin marks or stripes, secondary infection, pus filled 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.) |
|
Infections Uncommon |
Secondary infection. |
|
Blood vessels Very rare |
Dilated blood vessels on the skin or spider |
|
veins. |
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).
If any of the above side effects gets serious, or if you notice any side effects not listed in the leaflet please tell your doctor or pharmacist.
5. HOW TO STORE MOMETASONE FUROATE 0.1% W/W CREAM
Keep out of the reach and sight 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.
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.
6. FURTHER 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
The manufacturers are:
Accord Healthcare, Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom
Glenmark Pharmaceuticals Europe Ltd, 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 September 2014
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