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Xamiol® 50 micrograms/0.5 mg/g gel


The name of your medicine is Xamiol® 50 micrograms/0.5 mg/g gel but will be referred to as Xamiol®
throughout the leaflet.
Patient information leaflet
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 effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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

2. Before you use Xamiol®
Do not use Xamiol®
• If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of
• If you have problems with calcium levels in your body (ask your doctor)
• If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your
As Xamiol® contains a strong steroid do NOT use it on skin affected by
• infections caused by viruses (e.g. cold sores or chicken pox)
• infections caused by a fungus (e.g. athlete’s foot or ringworm)
• infections caused by bacteria
• infections caused by parasites (e.g. scabies)
• tuberculosis (TB) or syphilis
• perioral dermatitis (red rash around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne (pimples)
• rosacea (severe flushing or redness of the skin on the face)
• ulcers or broken skin
• itching of the anus (back passage) or genitals (sex organs).

Take special care with
Before using this medicine, tell your doctor/nurse/ pharmacist if
• you are using other medicines that contain corticosteroids as you may get side effects
• you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will
get worse or ‘flare up’ when steroids are stopped suddenly)
• you have diabetes mellitus (diabetes) as your blood sugar/glucose level may be affected by the
• your skin becomes infected as you may need to stop your treatment
• you have a certain type of psoriasis called guttate psoriasis
• you have serious liver or kidney disease.
Special precautions
• Avoid use on more than 30 % of your body or using more than 15 grams per day
• Avoid using under a bathing cap, bandages or dressings as it increases the absorption of the
• Avoid use on large areas of damaged skin or skin folds (groin, armpits, under breasts) as it
increases the absorption of the steroid
• Avoid use on your face or genitals (sex organs) as they are very sensitive to steroids
• Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.
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
• Use only on your psoriasis on the scalp and do not use on skin which does not have psoriasis
• Washing your hair before application of Xamiol® is not necessary
• Shake the bottle before use and remove the cap
• Before applying Xamiol® to the scalp, comb the hair to remove any loose scales. Tilt your head to
make sure Xamiol® does not run onto your face. It may help to part your hair before you use
Apply Xamiol® to the affected area with your fingertips, and rub it in gently
• Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g
corresponds to one teaspoon)
• Do not bandage, tightly cover or wrap the treated skin area
• Wash your hands well after using Xamiol®. This will avoid accidentally spreading the gel to other
parts of your body (especially the face, mouth and eyes)
• Do not worry if some gel accidentally gets on normal skin near your psoriasis, but wipe it off if it
spreads too far
• 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.
• After applying the gel, avoid contact with textiles which are easily stained by grease (e.g. silk).
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
Depending on the affected
area 1-4g (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 Washing your hair as usual.
scalp for a couple of minutes
before washing.

If necessary, repeat step 4-6 once or twice.
Duration of treatment
• Use the gel once a day. It may be more convenient to use the gel in the evening
• The normal initial treatment period is 4 weeks
• Your doctor may decide on a different treatment period
• Your doctor may decide on repeated treatment
• Do not use more than 15 grams in one day.
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.

Less serious side effects known to be caused by calcipotriol include the following
• Sensitivity of the skin to light resulting in a rash
• Eczema.
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®
• Keep out of the sight and reach of children.
• Do not use Xamiol® after the expiry date which is stated on the bottle after EXP. The expiry date
refers to the last day of that month
• Do not refrigerate. Keep the bottle in the outer carton in order to protect from light
• Discard the bottle with any remaining gel 3 months after first opening.

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.

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.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

6. Further information

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.

What Xamiol® contains
The active substances are:
Calcipotriol and betamethasone.
One gram of gel contains 50 microgram of calcipotriol (as monohydrate) and 0.5 mg of betamethasone
(as dipropionate).

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)
• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

The other ingredients are:
• paraffin, liquid
• polyoxypropylene-15 stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• α-tocopherol

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.

What Xamiol® looks like and the contents of the pack
Xamiol® is an almost clear, colourless to slightly off-white gel in high-density polyethylene bottles with
a low-density polyethylene nozzle and a highdensity polyethylene screw cap.

The side effects include the following:
• Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety.
• Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an
increase in pressure inside your eye (signs are eye pain, red eye, decreased or cloudy vision)
• Infections (because your immune system, which fights infections, may be suppressed or
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If you notice
this, stop taking Xamiol® and tell your doctor as soon as possible
• Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience
fluctuations in the blood glucose levels).

The bottles are placed in cartons.
Pack sizes: 30g and 2 x30g.

Serious side effects known to be caused by calcipotriol
• Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet.
Swelling of the mouth/throat and trouble breathing may occur. If you have an allergic reaction, stop
taking Xamiol®, tell your doctor immediately or go to the casualty department at your nearest
• Treatment with this gel may cause the level of calcium in your blood or urine to increase (usually
when too much gel has been used). Signs of increased calcium in blood are bone pain,
constipation, poor appetite, nausea and vomiting. This can be serious, and you should contact your
doctor immediately. However, when the treatment is stopped, the levels return to normal.

Manufacturer and Product Licence Holder
Xamiol® is manufactured by LEO Pharmaceutical Products Ltd. A/S, DK-2750 Ballerup Denmark. It is
procured from within the EU by the Product Licence Holder: Swinghope Limited, Brandon House,
Marlowe Way, Croydon CR0 4XS and repackaged by Interport Limited, Brandon house, Marlowe Way,
Croydon CR0 4XS.

PL No: 10380/1438

Leaflet revision date: 15/09/12
Xamiol® is a registered trademark of LEO Pharma A/S, Denmark.

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)
• Itching.
Uncommon (affect less than 1 in 100 people)
• Eye irritation
• Burning sensation of the skin
• Skin pain or irritation
• Inflammation or swelling of the hair root (folliculitis)
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular rash.
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
• Thinning of the skin
• Appearance of surface veins or stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Small white spots (colloid milia)
• Depigmentation (lightening of skin colour).


Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.