XAMIOL 50 MCG/G / 0.5 MG/G Гель

Содержание инструкции

1. XAMIOL 50 micrograms/0.5 mg/g gel
   1. What is XAMIOL and what is it 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. Package contents and other information

XAMIOL 50 micrograms/0.5 mg/g gel

Calcipotriol/betamethasone

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is XAMIOL and what is it used for

XAMIOL is used for the topical treatment of scalp psoriasis in adults. Psoriasis is a condition in which the cells of your skin reproduce too quickly. This causes redness, scaling and thickening of your skin.
XAMIOL contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells while betamethasone works by reducing 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 this medicine (listed in section 6);
• if you have problems with calcium levels in your body (ask your doctor);
• if you have certain types of psoriasis, such as erythrodermic, exfoliative or pustular (ask your doctor).

Since Xamiol contains a potent corticosteroid, DO NOT use it on skin affected by:

• skin infections caused by viruses (such as herpes or chickenpox);
• skin infections caused by fungi (such as athlete's foot or ringworm);
• skin infections caused by bacteria;
• skin infections caused by parasites (such as scabies);
• tuberculosis (TB);
• perioral dermatitis (red skin rashes around the mouth);
• thin skin, easily damaged veins, stretch marks;
• ichthyosis (dry skin with scales similar to those of fish);
• acne (pimples);
• rosacea (severe flushing or redness of the face);
• ulcers or open wounds.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Xamiol if:

• you are using other medicines that contain corticosteroids, as side effects may occur;
• you have used this medicine for a long time and decide to stop treatment (there is a risk that your psoriasis may worsen or flare up if steroids are stopped suddenly);
• you have diabetes mellitus (diabetes), as the steroid contained in the product may affect blood sugar;
• skin lesions tend to become infected, as you may need to stop treatment;
• you have a certain type of psoriasis called guttate psoriasis:
• you experience blurred vision or other visual disturbances.

Special precautions

• Avoid applying the product to more than 30% of the body or using more than 15 g of product per day.
• Avoid using shower caps, bandages or clothing that may increase steroid absorption.
• Avoid use on large areas of damaged skin, on mucous membranes or in skin folds (e.g. groin, armpits or under the breasts), as this increases steroid absorption.
• Avoid applying the medicine to the skin of the face or genitals (sexual organs) which are very sensitive to steroids.
• Avoid excessive sunbathing, excessive use of the solarium or other forms of light treatment.

Children
Xamiol is not recommended for use in children under 18 years of age.

Other medicines and XAMIOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before using this medicine. If your doctor has established that you can breastfeed, use caution.

Driving and operating machinery
This medicine should not affect your ability to drive or operate machinery.

Xamiol contains butylhydroxytoluene (E321)
Xamiol contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.

3. How to use XAMIOL

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
How to use Xamiol: for external use.
Medicine for use only on the scalp.
Instructions for correct use

• Use Xamiol only for psoriasis of your scalp, and do not use it on skin not affected by psoriasis.
• It is not necessary to wash your hair before using Xamiol.
• Shake the bottle before use and remove the cap.
• Before applying Xamiol to the scalp, comb your hair to remove scales of skin. Tilt your head to prevent Xamiol from running down your face. It may be helpful to divide your hair into sections before using Xamiol. Apply the medicine to the affected areas with your fingertips and rub gently.
• Generally, an amount between 1 g and 4 g per day is sufficient for the treatment of the scalp (4 g corresponds to one teaspoon).
• Do not use bandages, do not wrap tightly or cover the treated areas.
• Wash your hands well after applying Xamiol. This will prevent accidental contact of the gel with other parts of the body (especially the face, mouth and eyes).
• Do not be alarmed if a small amount of gel accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medicine spreads too far from the psoriatic area.
• To obtain an optimal effect, it is recommended not to wash your hair immediately after applying Xamiol. Leave Xamiol on your head overnight or during the day.
• After applying the gel, avoid contact with fabrics that could easily stain with oil (for example, silk).

It is not necessary to wash your hair before applying Xamiol.

• 1. Shake the bottle before use.
• 2. Put a drop of Xamiol on your finger.

• 3. Apply directly to the areas of the scalp where plaques are felt to the touch and gently rub Xamiol gel onto the skin.

Usually 1-4 g (up to 1 teaspoon) is sufficient, depending on the affected areas.

To achieve an optimal effect, it is recommended not to wash your hair immediately
after applying Xamiol. Leave Xamiol on the scalp
overnight or during the day. When washing your hair after
application, it is useful to follow these instructions:

• 4. Use a mild shampoo on dry hair, especially on the areas where the gel has been applied.
• 5. Leave the shampoo on your hair for a couple of minutes before washing your hair.
• 6. Wash your hair as usual.

If necessary, repeat steps 4-6 a second time.
Duration of treatment

• Use the gel once a day. It may be more appropriate to use it in the evening.
• Normally the initial treatment period is 4 weeks.
• The doctor may decide on a different treatment period.
• The doctor may decide to have you repeat the treatment.
• Do not use more than 15 grams per day.

All affected areas can be treated with Xamiol. However, if you are also using other medicines
containing calcipotriol, the total amount of medicines containing calcipotriol must not exceed 15
grams per day and the treated areas must not exceed 30% of the entire body surface.

What can you expect with the use of Xamiol?
Most patients experience noticeable improvements after 2 weeks, even if psoriasis is not
completely gone.

If you use more Xamiol than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Xamiol can also cause problems with calcium levels in your blood, which usually normalize when treatment is stopped.
The doctor may consider it necessary to subject you to some blood tests to check if the use of
excessive amounts of gel may have caused a problem with calcium levels in the blood.
Excessive and prolonged use can also cause malfunction of the adrenal glands (the
adrenal glands are located near the kidneys and produce hormones).

If you forget to use Xamiol
Do not use a double dose to make up for a missed dose.

If you stop treatment with Xamiol
The use of Xamiol must be discontinued as directed by your doctor. It may be necessary
to discontinue the use of the drug gradually, especially after using it for a long time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor or nurse immediately or as soon as possible if any of the following side effects occur, you may need to stop treatment.
The following serious side effects have been reported with the use of Xamiol
Not common (may affect up to 1 in 100 people)

• Worsening of psoriasis. Tell your doctor as soon as possible if your psoriasis gets worse.

Some serious side effects are known to be caused by betamethasone (a strong steroid), one
of the ingredients of Xamiol. You should tell your doctor as soon as possible if you experience a
serious side effect. The frequency of these side effects may increase after a long period of
treatment, use in skin folds (e.g. groin, armpits or under the breasts) or with the use of an occlusive bandage
or use in large areas of skin.
Side effects include:

• The adrenal glands may not function properly. Symptoms are fatigue, depression and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty seeing at night and sensitivity to light) or increased pressure inside the eyes (symptoms are: eye pain, red eyes, decreased vision or blurred vision).
• Infections (because your immune system, which fights infections, may be suppressed or weakened).
• Pustular psoriasis (red areas with yellow pustules, usually on the hands or feet). In this case, stop treatment with Xamiol and tell your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic you may experience fluctuations in blood sugar).

Serious side effects reported with the use of calcipotriol:

• Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and difficulty breathing may occur. If you experience an allergic reaction, stop treatment with Xamiol, tell your doctor immediately or go to theemergency room of the nearest hospital.
• Treatment with this gel can increase calcium levels in the blood or urine (usually when using excessive amounts of gel). Symptoms of increased calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion and coma. Thiscan be serious and therefore you should contact your doctor immediately. In any case, levels return to normal when treatment is stopped.

Less serious side effects
The following less serious side effects have been reported with Xamiol:

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

• Itching.

Not common side effects (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 dilation of capillaries (erythema).
• Acne (pimples).
• Dry skin.
• Rash.
• Pustular rash.
• Skin infection.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions.
• Stretch marks.
• Skin exfoliation.
• Rebound effect: a worsening of symptoms/psoriasis after the end of treatment.

Frequency not known (frequency cannot be estimated based on available data)

• When used on the scalp, white or gray hair may temporarily turn yellowish in the application site.
• Blurred vision.

Less serious side effects due to the use of betamethasone, especially for a long period,
include those listed below. If any of these effects occur, tell your doctor or
nurse as soon as possible:

• Thinning of the skin.
• Appearance of superficial veins or stretch marks.
• Changes in hair growth.
• Red rashes around the mouth (perioral dermatitis).
• Rashes, with inflammation or swelling (allergic contact dermatitis).
• Small golden-colored cysts (milia colloid).
• Skin discoloration (depigmentation).
• Inflammation or swelling at the hair root (folliculitis).

Less serious side effects known to be caused by calcipotriol include:

• Dry skin.
• Skin sensitivity to light, causing rash.
• Eczema.
• Itching.
• Skin irritation.
• Burning and stinging sensation.
• Redness of the skin due to dilation of capillaries (erythema).
• Rash.
• Rash with inflammation of the skin (dermatitis).
• Worsening of psoriasis.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store XAMIOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial after Exp.
The expiry date refers to the last day of that month.
Do not store in a refrigerator. Keep the vial in the carton to protect it from light.
Dispose of the vial with any remaining gel within 6 months of first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What XAMIOL contains
The active ingredients 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:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylated hydroxytoluene (E321)
• all-rac-α-tocopherol

Description of the appearance of XAMIOL and package contents
Xamiol is presented as a rather clear, colourless or whitish gel, contained in a bottle made of
high-density polyethylene with a low-density polyethylene nozzle and a high-density polyethylene cap.
The bottle is contained in a cardboard box.
Pack sizes: 1 tube of 15 g, 30 g, 60 g and 2 tubes of 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Distributor in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini, 129
00144 Roma

Manufacturer
LEO Pharma A/S,
Industriparken 55
2750 Ballerup
Denmark
LEO Laboratories Ltd (LEO Pharma)
285 Cashel Road
12 Dublin
Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Xamiol: Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Slovenia