Xamiol

Package leaflet: Information for the user

XAMIOL 50 micrograms/0.5 mg/g gel

Calcipotriol/betamethasone
Please 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 only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including 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 using 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 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 using XAMIOL

Do not use XAMIOL:

• if you are allergic (hypersensitive) to calcipotriol, betamethasone, or to 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 psoriasis (ask your doctor).

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

• viral skin infections (such as herpes or chickenpox);
• fungal skin infections (such as athlete’s foot or ringworm);
• bacterial skin infections;
• parasitic skin infections (such as scabies);
• tuberculosis (TB);
• perioral dermatitis (red skin eruptions around the mouth);
• thin skin, fragile blood vessels, or stretch marks;
• ichthyosis (dry, fish-scale-like skin);
• acne (pimples);
• rosacea (intense facial flushing or redness);
• open ulcers or wounds.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Xamiol if:

• you are using other medicines containing corticosteroids, as adverse 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), since the steroid contained in this product may affect blood glucose levels;
• your skin lesions tend to become infected, as you may need to discontinue treatment;
• you have a 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 your body surface or using more than 15 g of the product per day.
• Avoid using shower caps, bandages, or clothing that may increase steroid absorption.
• Avoid use on large areas of damaged skin, mucous membranes, or skin folds (e.g. groin, armpits, or under the breasts), as this increases steroid absorption.
• Avoid applying the medicine to facial skin or genitals (sexual organs), which are highly sensitive to steroids.
• Avoid excessive sun exposure, overuse of sunbeds, or other forms of light therapy.

Children
Xamiol is not recommended for use in children under 18 years of age.
Other medicines and XAMIOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine. If your doctor has determined that you may breastfeed, use with caution.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery.
Xamiol contains butylated hydroxytoluene (E321)
Xamiol contains butylated hydroxytoluene (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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How to use Xamiol: for topical use only.
This medicine is intended for use only on the scalp.

Instructions for correct use

• Use Xamiol only for psoriasis affecting your scalp. Do not use it on unaffected skin.
• It is not necessary to wash your hair before applying Xamiol.
• Shake the bottle well before use and remove the cap.
• Before applying Xamiol to the scalp, comb your hair to loosen skin scales. Tilt your head to prevent Xamiol from running down your face. It may be helpful to part your hair into sections before applying Xamiol. Apply the medicine directly to affected areas using your fingertips, and gently massage it in.
• Generally, a daily amount between 1 g and 4 g is sufficient for treating the scalp (4 g corresponds to one teaspoon).
• Do not use bandages, tight dressings, or cover the treated areas.
• Wash your hands thoroughly after applying Xamiol. This helps 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 near the psoriatic plaque, but clean the skin if the medicine spreads too far from the affected area.
• For optimal effect, it is recommended not to wash your hair immediately after applying Xamiol. Leave Xamiol on the scalp overnight or during the day.
• After applying the gel, avoid contact with fabrics that may be easily soiled or stained (e.g. silk).

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

1. Shake the bottle before use.
2. Place a drop of Xamiol on a fingertip.
3. Apply directly to areas of the scalp where plaques can be felt by touch, and gently rub the Xamiol gel into the skin.

Typically, 1–4 g (up to one teaspoon) is sufficient, depending on the affected areas.
For optimal results, 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, follow these instructions:

4. Use a mild shampoo on dry hair, especially on areas where the gel was applied.
5. Allow the shampoo to remain on the hair for a few minutes before rinsing.
6. Wash your hair as usual.

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

• Apply the gel once daily. It may be more convenient to use it in the evening.
• The usual initial treatment period is 4 weeks.
• Your doctor may decide on a different treatment duration.
• Your doctor may recommend repeating the treatment.
• Do not use more than 15 grams per day.

All affected areas may be treated with Xamiol. However, if you are also using other medications containing calcipotriol, the total daily amount of calcipotriol-containing medicines must not exceed 15 grams, and the treated areas must not exceed 30% of the total body surface area.

What to expect when using Xamiol
Most patients experience noticeable improvement after 2 weeks, although psoriasis may not have completely cleared.

If you use more Xamiol than you should
Contact your doctor if you have used more than 15 grams in one day.
Overuse of Xamiol may lead to disturbances in blood calcium levels, which usually return to normal once treatment is stopped.
Your doctor may consider it necessary to perform blood tests to check whether excessive use of the gel has caused any changes in blood calcium levels.
Prolonged and excessive use may also lead to impaired adrenal gland function (the adrenal glands are located near the kidneys and produce hormones).

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

If you stop using Xamiol
Treatment with Xamiol should be discontinued as directed by your doctor. You may need to stop using the medicine gradually, especially if it has been used for a long time.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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:

Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. Inform your doctor as soon as possible if your psoriasis worsens.

Some serious side effects are known to be caused by betamethasone (a potent corticosteroid), one of the components of Xamiol. You must inform your doctor as soon as possible if you experience a serious side effect. The frequency of these side effects may increase after long-term treatment, use in skin folds (e.g. groin, armpits or under the breasts), use under occlusive dressings, or application over large skin areas.

These side effects include:

• Adrenal glands may not function properly. Symptoms include fatigue, depression, and anxiety.
• Cataract (symptoms include blurred or cloudy vision, difficulty seeing at night, and light sensitivity) or increased intraocular pressure (symptoms include 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 inform your doctor immediately.
• Interference with metabolic control of diabetes mellitus (if you are diabetic, you may experience fluctuations in blood glucose levels).

Serious side effects reported with 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 and contact your doctor immediately or go to the nearest hospital emergency department.
• Treatment with this gel may increase calcium levels in the blood or urine (usually when excessive amounts of the gel are used). Symptoms of elevated calcium levels in the blood include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and therefore you must contact your doctor immediately. In any case, calcium 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.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye irritation.
• Skin burning sensation.
• Skin pain or irritation.
• Inflammation or swelling at the hair root (folliculitis).
• Skin rash with skin inflammation (dermatitis).
• Redness of the skin due to capillary dilation (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 peeling.
• Rebound effect: worsening of symptoms/psoriasis after stopping treatment.

Frequency not known (frequency cannot be estimated from the available data)

• When used on the scalp, white or grey hair may temporarily turn yellowish at the site of application.
• Blurred vision.

Less serious side effects due to the use of betamethasone, especially with long-term use, include the following. If any of these occur, inform your doctor or nurse as soon as possible:

• Skin thinning.
• Appearance of visible veins or stretch marks.
• Changes in hair growth.
• Red rashes around the mouth (perioral dermatitis).
• Skin rashes, with inflammation or swelling (contact allergic dermatitis).
• Small golden-colored cysts (colloid milia).
• 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 a rash.
• Eczema.
• Itching.
• Skin irritation.
• Burning and stinging sensation.
• Redness of the skin due to capillary dilation (erythema).
• Rash.
• Rash with skin inflammation (dermatitis).
• Worsening of psoriasis.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: 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 stated on the tube after "Exp".
The expiry date refers to the last day of that month.
Do not store in the refrigerator. Keep the tube in its carton to protect it from light.
Dispose of the tube with any remaining gel after 6 months from first opening.
Do not dispose of medicines via 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 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 components are:

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

Description of the appearance of XAMIOL and contents of the pack
Xamiol is a fairly clear, colourless or whitish gel, contained in a high-density polyethylene bottle with a low-density polyethylene nozzle and a high-density polyethylene cap.
The bottle is contained in a cardboard box.
Pack sizes: 1 bottle of 15 g, 30 g, 60 g and 2 bottles 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

Local representative in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini, 129
00144 Rome
Italy

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

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