Patient Leaflet Updated 16-Apr-2012 | Leo Laboratories Limited
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Xamiol® is and what it is used for
2. Before you use Xamiol®
3. How to use Xamiol®
4. Possible side effects
5. How to store Xamiol®
6. Further information
1. WHAT XAMIOL® IS AND WHAT IT IS USED FOR
Xamiol® is used as topical treatment of scalp psoriasis in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin.
Xamiol® contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.
2. BEFORE YOU USE XAMIOL®
Do not use Xamiol®
As Xamiol® contains a strong steroid do NOT use it on skin affected by
Take special care with Xamiol®
Before using this medicine, tell your doctor/nurse/pharmacist if
Xamiol® is not recommended for the use in children below the age of 18 years.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not use Xamiol® if you are pregnant (or might be pregnant) or if you are breast-feeding, unless you have agreed it with your doctor first. If your doctor has agreed that you can breast-feed, take care.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine should not have any effect on your ability to drive or use machines.
Important information about some of the ingredients of Xamiol®
Xamiol® contains 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 XAMIOL®
Always use Xamiol® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to put on Xamiol®: Cutaneous use. Medicine only to be used on scalp.
Instructions for proper use
Washing your hair before application of Xamiol® is not necessary.
Shake bottle before use
Apply a drop of Xamiol® to fingertip
Apply directly to scalp areas where you can feel the raised plaque and rub the Xamiol® gel on to the skin.
Depending on the affected area 1-4 g (up to 1 teaspoon) is normally enough.
In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Xamiol®. Let Xamiol® remain on the scalp during the night or during the day. When washing hair after application the following instructions might be useful:
Apply a mild shampoo to the dry hair, especially to those areas where the gel was applied.
Leave the shampoo on the scalp for a couple of minutes before washing.
Wash your hair as usual.
If necessary, repeat steps 4-6 once or twice.
Duration of treatment
All the affected areas may be treated with Xamiol®. However, if you also use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day and the area treated should not exceed 30 % of the total body surface.
What should I expect when I use Xamiol®?
Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.
If you have used more Xamiol® than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive prolonged use of Xamiol® may also cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.
Your doctor may need to carry out blood tests to check that using too much gel has not caused a problem with calcium in your blood.
Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones).
If you forget to use Xamiol®
Do not take a double dose to make up for forgotten individual doses.
If you stop using Xamiol®
The use of Xamiol® should be stopped as indicated by your doctor. It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xamiol® can cause side effects, although not everybody gets them.
Approximately 1 in 12 people may experience side effects, but most of these are reactions at the site where the gel has been applied.
Serious side effects
Tell your doctor/nurse immediately or as soon as possible if any of the following happens. You may have to stop your treatment.
The following serious side effects have been reported for Xamiol®
Uncommon (affect less than 1 in 100 people)
Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Xamiol®. You should tell your doctor as soon as possible if any of the serious side effects occur. These side effects are more likely to happen after long-term use, or use under occlusion.
The side effects include the following:
Serious side effects known to be caused by calcipotriol
Less serious side effects
The following less serious side effects have been reported for Xamiol®
Common side effects (affect less than 1 in 10 people)
Uncommon (affect less than 1 in 100 people)
Less serious side effects caused by using betamethasone for a long time, include the following, and you should tell your doctor or nurse as soon as possible if you notice any of them
Less serious side effects known to be caused by calcipotriol include the following
If you notice the above or any other changes in your health while taking this medicine, tell your doctor.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE XAMIOL®
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 Xamiol® contains
The active substances are:
Calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
The other ingredients are:
What Xamiol® looks like and the contents of the pack
Xamiol® is an almost clear, colourless to slightly off-white gel filled in high-density polyethylene bottles with a low-density polyethylene nozzle and a high-density polyethylene screw cap.
The bottles are placed in cartons.
Pack sizes: 15, 30, 60 and 2 x 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
The manufacturer is:
For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
This medicine is authorised in the Member States of the EEA under the following names:
Xamiol® gel: UK
This leaflet was last revised in January 2012.
For further information about psoriasis, you can contact:
The Psoriasis Association.
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