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

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    Apply a drop of    Apply directly to scalp areas

use    Xamiol to fingertip.    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._

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 all medicines out of the sight and reach 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) 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-15 stearyl ether

•    hydrogenated castor oil

•    butylhydroxytoluene (E321)

•    a-tocopherol.

What Xamiol looks like and content of the pack

Xamiol is an almost clear, colourless to slightly off-white gel filled in high-density 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.

PL 10383/2021

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: 30.08.2016

For further information about psoriasis, you can contact@ The Psoriasis Association. mail@psoriasis-association.org.uk

Xamiol® is a registered trademark of LEO Pharma A/S, Denmark.