Mometasone Furoate 0.1% Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Elocon® Cream
(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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.
The name of your medicine is Elocon Cream but it will be referred as to Elocon throughout this leaflet.
What is in this leaflet:
1. What Elocon is and what it is used for
2. What you need to know before you use Elocon
3. How to use Elocon
4. Possible side effects
5. How to store Elocon
6. Contents of the pack and other information
1. What Elocon is and what it is used for
Elocon is one of a group of medicines called topical corticosteroids. It 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, Elocon 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 need to know before you use Elocon
Do not use Elocon if you have any of the following:
• if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of this medicine (listed in section 6) or to other similar medicines.
• 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
• genital itching
• nappy rash
• cold sores
• chickenpox
• shingles
• warts
• ulcerated skin
• wounds
• other skin infections
Ask your doctor or pharmacist if you are not sure.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Elocon:
• if your skin becomes irritated or sensitive after using Elocon, you should stop using it and tell your doctor Other medicines and Elocon
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility
You should tell your doctor if you are pregnant or breast-feeding, before you start using Elocon.
3. How to use Elocon
Always use Elocon exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Use in children
Elocon is not recommended for children under the age of 2.
How much to use
Usually for adults and children aged 2 and above, a thin layer of Elocon should be gently rubbed into the affected area of skin once a day.
Before using Elocon
You should always follow these instructions when using Elocon:
• Do not use the cream 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 check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.
• 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.
If you use more Elocon 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.
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.
If you forget to use Elocon
If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before.
If you stop using Elocon
If you have been using Elocon for a long time and your skin problem 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.
4. Possible side effects
Like all medicines, Elocon can cause side effects, although not everybody gets them.
A few people may find that they suffer from some of the following side effects after using Elocon:
• 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
• tingling
• excessive hair growth
• softening of the skin and stretch marks
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Elocon
• Keep out of the sight and reach of children.
• The cream should be stored between 2°and 30°C.
• Do not use Elocon after the expiry date which is stated on the carton and tube label after 'Exp'. The expiry date refers to the last day of that month.
• If the cream becomes discolored or shows any signs of deterioration, seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• 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 Elocon contains
• Each gram of cream contains 1mg of mometasone furoate.
• Other ingredients: hexylene glycol, phosphoric acid, propylene glycolstearate, stearyl alcohol and ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, white beeswax, white soft paraffin, and purified water.
What Elocon looks like and contents of the pack
Elocon cream is available in a sealed metal collapsible tube with white plastic screw-cap incorporating a device to break the seal on the tube. The tube contains a white, homogenous cream.
Elocon cream comes in a 30gram tube.
Manufactured by: Famar SA, 49th km. Road Athens-Lamia, Vlora-Pole, Greece.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Elocon® Cream, PL 18799/1222 POM
Leaflet date: 11.04.2016
Elocon is a registered trademark of Merck Sharp and Dohme group of companies.
Mometasone Furoate 0.1% 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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.
The name of your medicine is Mometasone Furoate 0.1% Cream but it will be referred as to Mometasone furoate throughout this leaflet.
What is in this leaflet:
1. What Mometasone furoate is and what it is used for
2. What you need to know before you use Mometasone furoate
3. How to use Mometasone furoate
4. Possible side effects
5. How to store Mometasone furoate
6. Contents of the pack and other information
1. What Mometasone furoate is and what it is used for
Mometasone furoate is one of a group of medicines called topical corticosteroids. It 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 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 need to know before you use Mometasone furoate
Do not use Mometasone furoate if you have any of the following:
• if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of this medicine (listed in section 6) or to other similar medicines.
• 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
• genital itching
• nappy rash
• cold sores
• chickenpox
• shingles
• warts
• ulcerated skin
• wounds
• other skin infections
Ask your doctor or pharmacist if you are not sure.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Mometasone furoate:
• if your skin becomes irritated or sensitive after using Mometasone furoate, you should stop using it and tell your doctor
Other medicines and Mometasone furoate
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility
You should tell your doctor if you are pregnant or breast-feeding, before you start using Mometasone furoate.
3. How to use Mometasone furoate
Always use Mometasone furoate exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Use in children
Mometasone furoate is not recommended for children under the age of 2.
How much to use
Usually for adults and children aged 2 and above, a thin layer of Mometasone furoate should be gently rubbed into the affected area of skin once a day.
Before using Mometasone furoate
You should always follow these instructions when using Mometasone furoate:
• Do not use the cream 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 check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.
• 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.
If you use more Mometasone furoate 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.
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.
If you forget to use Mometasone furoate
If you forget to use your cream at the right time, use it as soon as you remember, then carry on as before.
If you stop using Mometasone furoate
If you have been using Mometasone furoate for a long time and your skin problem 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.
4. Possible side effects
Like all medicines, Mometasone furoate can cause side effects, although not everybody gets them.
A few people may find that they suffer from some of the following side effects after using Mometasone furoate:
• 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
• tingling
• excessive hair growth
• softening of the skin and stretch marks
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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
• Keep out of the sight and reach of children.
• The cream should be stored between 2°and 30°C.
• Do not use Mometasone furoate after the expiry date which is stated on the carton and tube label after ‘Exp’. The expiry date refers to the last day of that month.
• If the cream becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• 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 contains
• Each gram of cream contains 1mg of mometasone furoate.
• Other ingredients: hexylene glycol, phosphoric acid, propylene glycolstearate, stearyl alcohol and ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, white beeswax, white soft paraffin, and purified water.
What Mometasone furoate looks like and contents of the pack
Mometasone furoate cream is available in a sealed metal collapsible tube with white plastic screw-cap incorporating a device to break the seal on the tube. The tube contains a white, homogenous cream.
Mometasone furoate cream comes in a 30gram tube.
Manufactured by: Famar SA, 49th km. Road Athens-Lamia, Vlora-Pole, Greece.
Procured from within the EU and repackaged by the Product Licence holder:
POM
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Mometasone Furoate 0.1% Cream, pL 18799/1222
Leaflet date: 11.04.2016