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XAMIOL 50 MICROGRAM/G + 0.5 MG/G GEL

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Xamiol® gel
calcipotriol/betamethasone
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. 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.
What is in this leaflet
1.
What Xamiol is and what it is used for
2.
What you need to know before you use Xamiol
3.
How to use Xamiol
4.
Possible side effects
5.
How to store Xamiol
6.
Contents of the pack and other 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.

WHAT YOU NEED TO KNOW BEFORE YOU USE XAMIOL

Do not use Xamiol

If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients
of Xamiol (listed in section 6)

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

skin infections caused by viruses (e.g. cold sores or chicken pox)

skin infections caused by a fungus (e.g. athlete’s foot or ringworm)

skin infections caused by bacteria

skin 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
Warnings and precautions
Talk to your doctor/nurse/pharmacist before using Xamiol 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
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, mucous membranes or in 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.

Other medicines and Xamiol
Please tell your doctor, pharmacist or nurse 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
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 1-4 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

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 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.
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 (may affect up to 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, use in skin folds (e.g. groin,
armpits or under breasts), use under occlusion or use on large areas of skin.
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 the 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 using 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).

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 using 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 are excessive secretion of
urine, constipation, muscle weakness, confusion and coma. 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 (may affect up to 1 in 10 people)

Itching.
Uncommon (may affect up to 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

Infection of the skin.
Rare (may affect up to 1 in 1,000 people)

Allergic reactions

Stretch marks

Skin exfoliation

Rebound effect: A worsening of symptoms/psoriasis after ended treatment.
Less serious side effects caused by using betamethasone, especially for a long time, include the following.
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)

Golden coloured gel-filled bumps (colloid milia)

Lightening of skin colour (depigmentation)

Inflammation or swelling of the hair root (folliculitis)
Less serious side effects known to be caused by calcipotriol include the following

Dry skin

Sensitivity of the skin to light resulting in a rash

Eczema

Itching

Skin irritation

Burning and stinging sensation

Redness of the skin due to widening of the small blood vessels (erythema)

Rash

Rash with inflammation of the skin (dermatitis)

Worsening of psoriasis
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 XAMIOL


Keep out of the reach and sight 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.

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 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:

paraffin, liquid

polyoxypropylene-11 stearyl ether

castor oil, hydrogenated

butylhydroxytoluene (E321)

all-rac-α-tocopherol.
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:
LEO Pharma A/S
DK-2750 Ballerup
Denmark.
The manufacturer is:
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road
Dublin
Ireland.
For further information about this medicine, contact the local representative of the Marketing
Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK.
Tel: (01844) 347333
e-mail: medical-info.uk@leo-pharma.com
This medicine is authorised in the Member States of the EEA under the following names:
Xamiol gel: UK
This leaflet was last revised in October 2014.
For further information about psoriasis, you can contact:
The Psoriasis Association.
mail@psoriasis-association.org.uk
® Registered Trade Mark

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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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