Elocon Scalp Lotion 0.1% W/W
PACKAGE LEAFLET: INFORMATION FOR THE USER
Elocon® Scalp Lotion 0.1% w/w
(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 Scalp Lotion 0.1% w/w but will be referred to as Elocon throughout the remainder of the 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 Scalp Lotion 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 Scalp Lotion is used to reduce redness and itchiness caused by certain conditions affecting the scalp, 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:
• Allergies (hypersensitivity) to mometasone furoate, or any of the other ingredients of this medicine (listed in section 6) or to other similar medicines
• Scalp problems as it could make them worse
• Chickenpox
• Shingles
• Warts
• Other skin infections
• Ulcerated skin
• Wounds
• Skin atrophy (thinning of the skin)
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 scalp becomes irritated or sensitive after using Elocon, you should stop using it and tell your doctor
• If you think that you have developed an infection on your scalp whilst using Elocon, you should tell your doctor as he may need to give you another type of medicine to use.
Children
Elocon is not recommended for children under the age of 2.
Other medicines and Elocon Scalp Lotion
Tell your doctor, pharmacist or nurse 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 using this medicine.
Elocon Scalp Lotion contains propylene glycol, which can cause skin irritation.
3. How to use Elocon
Always use Elocon exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Use in Children
• Elocon is not recommended for children under the age of 2.
• Do not use the lotion on your child’s scalp for more than 5 days.
• Treated areas in children should not be covered with a bandage or plaster.
• If you use the lotion on your child more often than you should, or on large areas of the body, it can affect some of their hormones, and this may affect their growth and development.
Before using Elocon
You should always follow these instructions when using Elocon:
• This medicine should only be used on the scalp. Do not use it on any other part of your body.
• You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face should not be covered with a bandage or plaster.
• You should not use a large amount of lotion 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 the eyes, including eye-lids.
How to use Elocon
• Usually for adults and children, a few drops of Elocon Scalp Lotion should be applied to the affected area of the scalp once a day and gently massage until the lotion disappears.
• The hair can be wet or dry when applying the lotion to the scalp.
If you use more Elocon than you should
• If you (or somebody else) accidentally swallows the lotion, it should not produce any problems. However, if you are worried, you should see your doctor.
• If you use the lotion 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 lotion 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 lotion 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 the lotion for a long time and your scalp problem seems to have got better, you should not suddenly stop using the lotion. If you do, you may find that your scalp becomes red and you may notice stinging and burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the lotion 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 associate 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
Do not store above 25°C.
Keep out of the sight and reach of children.
Do not use Elocon after the expiry date which is stamped on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
6. Contents of the pack and other information
Each ml contains the active ingredient mometasone furoate 0.1 %w/w.
Also contains isopropanol, propylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic monohydrate, phosphoric acid and purified water.
Clear colourless lotion in white plastic bottle with a dropper, white screw cap and tamper evident ring.
The lotion is available in a bottle containing 30 ml.
Manufactured by Famar A.B.E. 49th km Athens-Lamia Motorway, Aulona Attiki, Greece. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton,
BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
Elocon Scalp Lotion 0.1% w/w PL 20774/1249
POM
Date of preparation 19th April 2016
Elocon is a registered trademark of Schering Corporation
PP3/1249/V2