Psotriol

Package Leaflet: Information for the User

Psotriol, (50 micrograms + 0.5 mg)/g, gel

Calcipotriol+ Betamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet

• 1. What is Psotriol and what is it used for
• 2. Important information before using Psotriol
• 3. How to use Psotriol
• 4. Possible side effects
• 5. How to store Psotriol
• 6. Contents of the pack and other information

1. What is Psotriol and what is it used for

Psotriol is used for the local treatment of scalp psoriasis in adults and mild to moderate plaque psoriasis (psoriasis vulgaris) in adults, located on the skin of the body, other than the scalp. Psoriasis is caused by the skin cells being produced too quickly. This leads to redness, scaling, and thickening of the skin. Psotriol contains calcipotriol and betamethasone. Calcipotriol helps to slow down the rate of skin cell growth to normal, while betamethasone reduces inflammation.

2. Important information before using Psotriol

When not to use Psotriol

Since Psotriol contains a strong steroid, DO NOT use this medicine in the treatment of skin diseases such as:

• viral skin infections (e.g. herpes or chickenpox),
• fungal skin infections (e.g. athlete's foot or fungal infections caused by dermatophytes),
• bacterial skin infections,
• parasitic skin infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin, with easy bruising, stretch marks,
• ichthyosis (dry skin with scaling similar to fish scales),
• acne,
• rosacea (severe redness or redness of the skin on the face),
• ulcers or skin integrity disorders.

Warnings and precautions

Before starting treatment with Psotriol, discuss with your doctor or pharmacist if:

• you are using other medicines containing corticosteroids, which may cause side effects,
• you have been using this medicine for a long time and plan to stop using it (as there is a risk of worsening or exacerbation of psoriasis in case of sudden discontinuation of steroids),
• you have diabetes, as steroids may affect blood sugar (glucose) levels,
• you have a skin infection that may require discontinuation of treatment,
• you have a certain type of psoriasis called guttate psoriasis,
• you experience blurred vision or other vision disturbances.

Special precautions
Do not use the medicine on more than 30% of the body surface or use more than 15 g of the medicine per day.
Do not use the medicine under bathing caps, bandages or dressings, as this increases the absorption of steroids.
Do not use the medicine on large areas of damaged skin, mucous membranes or skin folds (groin, armpits, under the breasts), as this increases the absorption of steroids.
Do not use the medicine on the face or genital areas, as they are very sensitive to the effects of steroids.
Do not expose yourself to excessive sunlight, excessive use of sunbeds and other forms of light therapy.

Children and adolescents

Psotriol is not recommended for use in children and adolescents under 18 years of age.

Psotriol and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
If your doctor has agreed to breastfeeding during treatment, be careful and do not apply Psotriol to the breast area.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Psotriol contains butylhydroxytoluene (E 321)

Butylhydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.

3. How to use Psotriol

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Method of administration: topical use.
Instructions for proper use:

• Use only on psoriatic skin, do not use on unaffected skin.
• Shake the bottle before use and remove the cap.
• Squeeze the gel onto a clean finger or directly onto the affected area.
• Apply Psotriol to the affected areas using your fingertips and gently rub it into the skin until a thin layer of gel is formed.
• Do not cover the treated area with bandages, tight dressings or bandages.
• After using Psotriol, wash your hands thoroughly to avoid accidentally transferring the gel to other parts of your body (especially the face, mouth or eyes).
• Do not worry if a small amount of gel accidentally gets on healthy skin near the psoriatic skin. If the gel spreads too far, wipe it off.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately after applying Psotriol.
• After applying the gel, avoid contact with fabrics that may stain easily due to the fat content (e.g. silk).

In case of use on the scalp:
Before applying Psotriol to the scalp, comb your hair to remove any loose skin scales. Tilt your head to prevent the medicine from running onto your face.
Before applying Psotriol, it may be helpful to part your hair.

• 1. Shakethe bottle before use.
• 2. Apply a drop of Psotriol to the fingertip.
• 3. Apply the medicine directly to the skin in areas where you can feel a raised plaque and rub Psotriol into the skin. Depending on the size of the affected area, a quantity of 1-4 g of gel (up to 1 teaspoon) isusually sufficient.

To achieve optimal effect, it is not recommended to wash your hair immediately after using Psotriol. Leave the medicine on the skin for the whole night or day. When washing your hair after application, the following instructions may be helpful:

• 4. Apply a mild shampoo to dry hair, especially on the surfaces where the gel was applied.
• 5. Leave the shampoo on the scalp for a few minutes before rinsing.
• 6. Wash your hair as usual.

If necessary, steps 4-6 can be repeated once or twice.

Duration of treatment

• The gel should be used once a day. Using the gel in the evening may be more convenient.
• Typically, the initial treatment period is 4 weeks for the scalp and 8 weeks for other skin areas.
• Your doctor may decide on a different treatment duration.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams of the medicine per day.

In case of using other medicines containing calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated skin area should not exceed 30% of the total body surface.

What to expect when using Psotriol

Most patients observe noticeable treatment results after 2 weeks, even if the symptoms of psoriasis have not yet subsided in the treated area.

Using more than the recommended dose of Psotriol

A patient who has used more than 15 grams of the medicine in one day should contact their doctor. Excessive use of Psotriol may cause disturbances in calcium levels in the blood, which usually return to normal after discontinuation of treatment. Your doctor may recommend a blood test to check if the use of too much gel has caused a disturbance in calcium levels in the blood. Prolonged, excessive use of the medicine may also suppress the normal function of the adrenal glands (located near the kidneys and producing hormones).

Missing a dose of Psotriol

Do not use a double dose to make up for a missed dose.

Stopping treatment with Psotriol

Treatment with Psotriol should be stopped as directed by your doctor. It may be necessary to gradually stop using the medicine, especially if it has been used for a long time.
If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Psotriol can cause side effects, although not everybody gets them.
Severe side effects
If you experience any of the following symptoms, inform your doctor or nurse immediately or as soon as possible. It may be necessary to stop treatment.
Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. If your psoriasis worsens, inform your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a strong steroid), one of the ingredients of Psotriol. If you experience any of the following severe side effects, inform your doctor as soon as possible.

• Suppression of normal adrenal gland function. Symptoms include fatigue, depression and anxiety.
• Cataract (symptoms include blurred vision, difficulty seeing at night and sensitivity to light) or increased pressure in the eye (symptoms include eye pain, redness of the eyes, decreased or blurred vision).
• Infections (related to the suppression or weakening of the immune system that fights infections).
• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If you notice such symptoms, stop using Psotriol and inform your doctor as soon as possible.
• Effect on metabolic control in diabetes (if you have diabetes, you may experience fluctuations in blood glucose levels).

Severe side effects caused by calcipotriol.

• Allergic reactions with deep swelling of the face or other parts of the body, such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If you experience an allergic reaction, stop using Psotriol and immediately inform your doctor or go to the nearest hospital emergency department.
• Using this gel may cause an increase in calcium levels in the blood or urine (usually when using too much gel). Signs of elevated calcium levels in the blood include excessive urination, constipation, muscle weakness, confusion and coma. These can be severe and therefore you should contact your doctor immediately.However, after stopping treatment, these levels usually return to normal.

Mild side effects
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
• Pain or irritation of the skin
• Inflammation or swelling of the hair follicle (folliculitis)
• Rash with skin inflammation (dermatitis)
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Acne
• Dry skin
• Rash
• Pustular rash
• Skin infections

Rare (may affect up to 1 in 1000 people)

• Allergic reactions
• Stretch marks
• Peeling of the skin
• Rebound effect: worsening of psoriasis symptoms after stopping treatment.

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

• White or gray hair may temporarily change color to yellowish at the application site when using the medicine on the scalp.
• Blurred vision

Mild side effects caused by betamethasone, especially when used for a long time, are listed below. If you experience any of these, inform your doctor or nurse as soon as possible.

• Thinning of the skin
• Appearance of superficial blood vessels and stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Rash with inflammation or swelling (allergic contact dermatitis)
• Yellowish gel-filled bumps (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Mild side effects caused by calcipotriol include:

• Dry skin
• Skin sensitivity to light, causing a rash
• Rash
• Itching
• Skin irritation
• Burning or stinging sensation
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Rash
• Rash with skin inflammation
• Worsening of psoriasis

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices and Biocides of the Office for Registration of Medicinal Products, Medical Devices and Biocides:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Psotriol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Shelf life after first opening the bottle: 6 months
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Psotriol contains

The active substances are calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of calcipotriol (as calcipotriol monohydrate) and 0.5 mg of betamethasone (as betamethasone dipropionate).
The other ingredients are:
liquid paraffin, polyoxypropylene stearyl ether [contains butylhydroxytoluene (E 321)], hydrogenated castor oil.

What Psotriol looks like and contents of the pack

Psotriol is a nearly transparent gel, colorless or almost white, in a bottle with a polyethylene cap, in a cardboard box.
Pack size: 60 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki
Poland

Date of last revision of the leaflet: