XAMIOL 50MICROGRAMS/G + 0.5 MG/G GEL

Active substance: CALCIPOTRIOL

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CUSTOMER: Waymade
PRODUCT:
CODE:

PRE-PRESS NO.:

06464/2907E

02-1808

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE OF PROOF:

Xamiol 0.5mg gel 30g

06/03/13

DATE:

PROOF HISTORY:
v.2 - waymade -06/03/13

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2012

Pg 1

Pg 4

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
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:
• paraffin liquid
• polyoxypropylene-15 stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol

XAMIOL® 50 micrograms/g + 0.5mg/g GEL
(calcipotriol / betamethasone)
Patient Information Leaflet

Your medicine is known by the name above but will be referred to as Xamiol throughout this 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

What Xamiol looks like and the contents of the pack
Xamiol is an almost clear, colourless to slightly off-white gel in a white plastic bottle with a red plastic screw
cap.

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 is available in 30g bottles.

Xamiol contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back
to normal and betamethasone acts to reduce inflammation.

POM

PL No: 06464/2907

This product is manufactured by LEO Pharmaceutical Products Ltd. A/S, 55 Industriparken, 2750 Ballerup,
Denmark and procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon Essex SS14 3FR.
Leaflet Rev date: (ref.) 28.2.2013
Xamiol is a registered trademark of LEO Pharma A/S
For further information about psoriasis, you can contact:
The Psoriasis Association.
mail@psoriasis-association.org.uk

2. Before you use 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.
Driving and using machines
This medicine should not have any effect on your ability to drive or use machines.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PRE-PRESS NO.:

02-1808

PRODUCT:

Xamiol 0.5mg gel 30g

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/2907E

DATE OF PROOF:

06/03/13

DATE:

PROOF HISTORY:
v.2 - waymade -06/03/13

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2012

Pg 2

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.

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 1g and 4g per day is sufficient for treatment of the scalp (4g
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.

io
Xam

Gel

1

Shake bottle before use

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l® G

®

iol

Xam

3

2

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 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:

5

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.

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If you forget to use Xamiol
Do not take a double dose to make up for forgotten individual doses.

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.

6

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.

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 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 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 with 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).
Less serious side effects known to be caused by calcipotriol include the following

Sensitivity of the skin to light resulting in a rash

Eczema.

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 notice the above or any other changes in your health while using 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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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