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Xamiol gel

Xamiol gel

calcipotriol/betamethasone

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:

There is information on the following

  • 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

What Xamiol Is And What It Is Used For

Xamiol is used as topical treatment of scalp psoriasis. 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.

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 other types of psoriasis: these are guttate, erythrodermic, exfoliative and pustular (ask your doctor)
  • If you have serious liver or kidney disease.

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.

Take special care with Xamiol:

Before using this product, 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.

Special precautions

  • Avoid using more than 100 grams per week
  • 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 as it increases the absorption of the steroid
  • Avoid use on your face as the face is very sensitive to steroids
  • Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.

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.

Driving and using machines

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

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.

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.

Xamiol is not recommended for the use in children and adolescents below the age of 18 years.

Instructions for proper use

  • Use only on your psoriasis on the scalp and do not use on skin which does not have psoriasis
  • Shake the bottle before use and remove the cap
  • Apply Xamiol to the areas of your scalp affected by psoriasis. Comb the hair first 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
  • 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.

1. It may help to part your hair before you use Xamiol.

2. Apply Xamiol to the areas of your scalp affected by psoriasis.

3. Gently rub in Xamiol using your fingertips.

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:

4. Apply a mild shampoo to the dry hair, especially to those areas where the gel was applied.

5. Leave the shampoo on the scalp for a couple of minutes before washing.

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 or
    • 100 grams in one week.

All the affected scalp areas may be treated with Xamiol. However, if you also use calcipotriol containing products on your body psoriasis, then the total amount of calcipotriol products must not exceed 15 grams per day or 100 grams per week 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 or 100 grams in one week. Excessive prolonged use of Xamiol may 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 use 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 product, ask your doctor or pharmacist.

Xamiol gel 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:

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 occur rarely but 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.

Uncommon (affect less than 1 in 100 people):

  • Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

Very rare (affect less than 1 in 10,000 people):

  • 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 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 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).

The following less serious side effects have also 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.

Do not stop Xamiol unless your doctor tells you to, as it may be necessary for you to stop this medicine gradually.

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.

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.

Further Information

What Xamiol contains

The active substances are:

Calcipotriol and betamethasone.

One gram of gel contains 50 microgram of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other ingredients are:

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

What Xamiol looks like and the contents of the pack

Xamiol is an almost clear, colourless to slightly off-white gel 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 Pharmaceutical Products Ltd. A/S
DK-2750 Ballerup
Denmark

The manufacturer is:

LEO Pharmaceutical Products Ltd. A/S
DK-2750 Ballerup
Denmark

For further information about this product, contact the local representative of the Marketing Authorisation Holder:

LEO Laboratories Limited
Princes Risborough
Bucks
HP27 9RR
U.K.
Tel:(01844) 347333
e-mail:medical-info.uk@leo-pharma.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Xamiol gel: UK

This leaflet was last approved in: 09/2008

Registered Trade Mark

LEO

023946-00





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