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:
- 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 effect gets seriouss, 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 Ointment is and what it is used for
2. Before you use Mometasone Furoate 0.1% w/w Ointment
3. How to use Mometasone Furoate 0.1% w/w Ointment
4. Possible side effects
5. How to store Mometasone Furoate 0.1% w/w Ointment
6. Further information
1. WHAT MOMETASONE FUROATE 0.1% W/W OINTMENT IS AND WHAT IT IS USED FOR
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).
Topical corticosteroids can be divided into four degrees of strength or potency: mild, moderate, potent and very potent. Mometasone Furoate 0.1% w/w Ointment is classified as a “potent corticosteroid”.
In adults and children, aged 6 years and over, Mometasone Furoate 0.1% w/w 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 your symptoms._
2. BEFORE YOU USE MOMETASONE FUROATE 0.1% W/W OINTMENT
Do not use Mometasone Furoate 0.1% w/w Ointment
If you, or your child are allergic (hypersensitive) to the active substance, mometasone, or other corticosteroids or to any of the other ingredients included in section 6: Further information on what Mometasone Furoate 0.1% w/w Ointment 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 Ointment
Tell your doctor if you are pregnant, may be pregnant or are breast-feeding.
If irritation or sensitisation develop with the use of Mometasone Furoate 0.1% w/w Ointment, you should 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 0.1% w/w Ointment should not be applied to broken skin.
The ointment should not be put on the eyelids. Take care not to get any ointment 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. Ask your doctor for advice before taking any medicine.
Pregnancy and breast-feeding
During pregnancy or while you are breast-feeding, treatment with Mometasone Furoate 0.1% w/w Ointment should only be started following instructions from your doctor.
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 0.1% w/w Ointment should not be applied to the breast area whilst 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 Ointment
Mometasone Furoate 0.1% w/w 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.
3. HOW TO USE MOMETASONE FUROATE 0.1% W/W OINTMENT
Type of administration
Mometasone Furoate Ointment is for cutaneous use (use on the skin).
This medicinal product is for external use only.
Always use Mometasone Furoate 0.1% w/w Ointment 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 ointment 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 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.
Special Care should be used:
• Do not use the ointment on your face without close supervision of your doctor.
• You should not use the ointment on large areas of the body (over 20% of body surface area) or for a long time (for example every day for over three weeks)
• Avoid getting the ointment 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
• Mometasone Furoate 0.1% w/w Ointment is not recommended to be used in children under 6 years of age.
Children 6 years of age and over:
• 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 ointment to more than a maximum of 10% of the child’s body surface area.
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 up for a missed application.
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 undesirable effects. 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 affect their growth and development.
If you have not followed the dosage instructions or your doctor’s advice and have used the ointment too frequently and/or for a long time, you should tell your doctor or pharmacist.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mometasone Furoate 0.1% w/w Ointment can cause unwanted 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 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: |
frequency cannot be estimated from the available data |
|
Table 1: Treatment-related adverse reactions reported by body system and frequency | |
|
Skin and subcutaneous tissue disorders | |
|
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 and infestations | |
|
Uncommon: |
Secondary infection. |
|
Vascular disorders | |
|
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 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, 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.
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.
5. HOW TO STORE YOUR MOMETASONE FUROATE 0.1% W/W OINTMENT
Keep out of the reach and sight 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.
Do not store above 30°C.
Discard the opened tube with any remaining ointment 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. CONTENTS OF THE PACK AND 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 mometasone furoate
• 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 0.1% w/w 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 10 g, 15 g, 20 g, 30 g, 50 g, 60 g or 100 g of ointment. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmacuticals Europe Ltd,
Laxmi House, 2-B Draycott Avenue, Kenton, Harrow. Middx, HA3 0BU,
United Kingdom
Manufacturer
Accord Healthcare Limited 319 Pinner Road, Harrow,
Middlesex, HA1 4HF, UK
Distributor
TEVA UK Limited, Eastbourne, BN22 9AG.