XAMIOL 50 MICROGRAMS/G + 0.5MG/G GEL

Active substance: CALCIPOTRIOL MONOHYDRATE

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Xamiol® 50 micrograms/g + 0.5mg/g Gel
(calcipotriol/betamethasone dipropionate)
Your medicine is known by the above name, but will be referred to as Xamiol
throughout this:
Patient Information Leaflet

Driving and using machines
This medicine should not have any effect on your ability to drive or use
machines.

Read all of this leaflet carefully before you start taking 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 gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Important information about some of the ingredients of Xamiol
Xamiol contains butylhydroxytoluene (E321), which may cause local skin
reactions (e.g. contact dermatitis), or irritation to the eyes and mucous
membranes.

In this leaflet:
1) What Xamiol is and what it is used for
2) Before you take 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 take Xamiol
Do not use Xamiol
• If you are allergic (hypersensitive) to calcipotriol, betamethasone or any
of the other ingredients of Xamiol
• 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 doctor).
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 Xamiol
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 steroid
• 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 steroid
• 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.
Children
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.

3) How to take 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 Xamiol. 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 skin.
Depending on the affected
area 1-4g (up to one
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 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.
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)
• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor
as soon as possible.
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:
• 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 weakened)
• 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).

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).
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 all medicines out of the reach and sight of children.
• Do not use Xamiol after the expiry date printed on the carton, and bottle
label 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 the first opening.
• If your doctor stops your treatment, return unused medicine to a
pharmacist.
• If your medicine appears discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
• 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 dipropionate.
Each gram of gel contains 50 micrograms of calcipotriol (as monohydrate)
and 0.5mg of betamethasone (as dipropionate).
The other ingredients are:
• liquid paraffin
• polyoxypropylene-15 stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E321)
• α-tocopherol.
What Xamiol looks like and content of the pack
Xamiol is an almost clear, colourless to slightly off-white gel filled in highdensity polyethylene bottles with low-density polyethylene nozzle and a
highdensity polyethylene screw cap.
The bottles are placed in cartons.
Xamiol comes in packs containing 30g or 60g (2 x 30g) of gel.

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 hospital
• 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 is 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.
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.

PL 10383/2021

POM

Who makes and repackages your medicine
Your medicine is manufactured by LEO Pharmaceutical Products Ltd. A/S, 55
Industriparken – 2750 Ballerup, Denmark. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading
Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 19.05.2012
Xamiol® is a registered trademark of LEO Pharma A/S, Denmark.

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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.

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