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XAMIOL 50 MICROGRAM/G + 0.5 MG/G GEL

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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Previously assessed against UK PIL dated October 2014
By rajeevkumarj at 2:01 pm, Aug 10, 2016

Driving and using machines

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Xamiol® 50 micrograms/g + 0.5mg/g Gel
(calcipotriol / betamethasone dipropionate)

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.

Your medicine is available using the name Xamiol 50 micrograms/g + 0.5mg/g gel but will be
referred to as Xamiol throughout this leaflet.

3.

Instructions for proper use





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
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.

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.

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.

1.

MOCK-UP




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.

WHAT YOU NEED TO KNOW BEFORE YOU USE XAMIOL

Do not use Xamiol




As












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).

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.

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:

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.

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.
Page 1 of 2

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)

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).

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

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

Reporting of side effects

Like all medicines, Xamiol can cause side effects, although not everybody gets them.

Serious 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.

Uncommon (may affect up to 1 in 100 people)

5.

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





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).







6.

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 your doctor stops your treatment, return unused medicine to a pharmacist.
If your medicine appears to be discoloured or show any other signs of deterioration, please
return it to your pharmacist who will advise you.
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.

CONTENTS OF THE PACK AND OTHER 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-11 stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E321)
• α-tocopherol.

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.

Xamiol is an almost clear, colourless to slightly off-white gel filled in high-density polyethylene
bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap.
The bottles are placed in cartons.

Less serious side effects

Xamiol comes in packs containing 30g or 60g (2 x 30g) of gel.

Common side effects (may affect up to 1 in 10 people)

Manufacturer

The following less serious side effects have been reported for Xamiol


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)






What Xamiol looks like and the contents of the pack

Manufactured by:
LEO Pharma A/S, 55 Industriparken – 2750 Ballerup, Denmark.
Or
LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0476

POM

Leaflet issue and revision date: 09.08.16
Xamiol® is a registered trademark of LEO Pharma A/S

Allergic reactions
Stretch marks
Skin exfoliation
Rebound effect: A worsening of symptoms/psoriasis after ended treatment.

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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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