Mometasone Furoate 0.1% W/W Ointment
Package leaflet: Information for the user
Mometasone Furoate 0.1% w/w Ointment Mometasone Furoate
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 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 Ointmentis and what it is used for
2. What you need to know before you take Mometasone Furoate Ointment
3. How to use Mometasone Furoate Ointment
4. Possible side effects
5. How to store Mometasone Furoate Ointment
6. Contents of the pack and other information
1. What Mometasone Furoate Ointment is and what is used for
Mometasone Furoate 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 Ointment is classified as a “potent corticosteroid”.
In adults and children, aged 2 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 your symptoms.
2. What you need to know before you use Mometasone Furoate Ointment
Do not use Mometasone Furoate Ointment
• 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 Ointment 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 Ointment
If irritation or sensitisation develop with the use of Mometasone Furoate Ointment , 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 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.
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 Ointment
Tell your doctor or your pharmacist if you are taking, have recently taken or might take 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 breastfeeding treatment with Mometasone Furoate 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 breastfeeding, 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 breastfeeding.
Ask your doctor for advice before taking any medicine.
Mometasone Furoate Ointment contains propylene glycol, and butylated hydroxytoluene
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.
3. How to use Mometasone Furoate Ointment
Mometasone Furoate Ointment 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 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 it on your face for more than 5 days.
• Do not apply the ointment to children, on any part of the 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 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 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 ointment on your face without close supervision of your doctor.
Use in children and adolescents
Mometasone Furoate Ointment is not recommended for children under the age of 2.
Children 2 years of age and over:
Do not use the ointment for children over 2 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 use more Mometasone Furoate 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 affect their 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 or pharmacist.
If you forget to use Mometasone Furoate 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 stop using Mometasone Furoate Ointment
If you have been using Mometasone Furoate Ointment for a long time and your skin problems seems to have got better, you should not suddenly stop using the ointment. 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 ointment until you stop treatment altogether.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
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 skin 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 medicine.
5. How to store Mometasone Furoate Ointment
Keep out of the sight and reach of children.
Do not use Mometasone Furoate 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.
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 Ointment contains
• The active substance is mometasone furoate.
Each gram of Mometasone Furoate Ointment contains 1mg of mometasone furoate.
The other ingredients are hexylene glycol, , phosphoric acid 10% solution, propylene glycol monopalmitostearate, white beeswax, white soft paraffin (contains butylhydroxytoluene (E321)), purified water.
What Mometasone Furoate Ointment looks like and contents of the pack
Mometasone Furoate Ointment is a translucent white soft ointment.
The ointment 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 ointment
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited, Croxley Green Business Park, WD18 8YA Glenmark Pharmaceuticals S.R.O., Fibichova 143, 56617 Vysoke Myto Salutas Pharma GmbH, Otto- von- Guericke- Allee 1, 39179 Barleben, Germany