Psotriol

Leaflet attached to the packaging: information for the user

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

Calcipotriol+ Betamethasone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

1. What is Psotriol and what is it used for

Psotriol ointment is used on the skin to treat psoriasis in adults. Psoriasis is caused by the skin cells being produced too quickly. This leads to redness, scaling, and thickening of the skin. Psotriol ointment contains calcipotriol and betamethasone. Calcipotriol helps to slow down the growth of skin cells to normal values, while betamethasone reduces inflammation.

2. Important information before using Psotriol

When not to use Psotriol

• if the patient is allergic (hypersensitive) to calcipotriol, betamethasone, or any of the other ingredients of Psotriol (listed in section 6),
• if the patient has disturbances in calcium levels in the body (should be consulted with a doctor),
• if the patient has certain types of psoriasis: erythrodermic psoriasis, pustular psoriasis, and guttate psoriasis (should be consulted with a doctor).

Since Psotriol contains a strong steroid, it should NOT be used in the course of skin diseases such as:

• viral skin infections (e.g., herpes or chickenpox),
• fungal skin infections (e.g., athlete's foot or dermatophyte infections),
• 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 to use Psotriol, the patient should discuss it with their doctor or pharmacist if:

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

Special precautions: The patient should avoid using the medicine on more than 30% of the body surface or using more than 15g of the medicine per day. The patient should avoid using the medicine under bandages or dressings, as this increases the absorption of steroids. The patient should avoid using 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. The patient should avoid using the medicine on the face or genital areas, as they are very sensitive to the effects of steroids. The patient should avoid excessive sunbathing, excessive use of sunbeds, and other forms of light therapy. The patient should contact their doctor if they experience blurred vision or other vision disturbances.

Children and adolescents

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

Psotriol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

Psotriol should not be used if the patient is pregnant (or thinks they may be pregnant) or breastfeeding, unless agreed with the doctor. If the doctor has agreed to breastfeeding during treatment, the patient should be cautious and not use Psotriol on the breast area. Before using any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

This medicine should not affect the patient's 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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The way to use Psotriol: apply to the skin. Instructions for proper use:

• Use only on skin affected by psoriasis, do not use on skin that is not affected by psoriasis.
• Before first use, remove the cap from the tube and check if the seal in the tube is not damaged.
• To break the seal, use the tip of the back of the cap.
• Squeeze the ointment onto a clean finger.
• Gently rub the ointment into the skin, so as to cover the surface of the skin affected by psoriasis, until most of the ointment has disappeared from the skin surface.
• Do not apply bandages, tight dressings, or tourniquets to the treated area on the skin.
• After using Psotriol ointment, wash hands thoroughly (if the patient is not using the ointment to treat skin on the hands). This will prevent accidental transfer of the ointment to other parts of the body (especially the face, hairy scalp, mouth, or eyes).
• Do not worry if a small amount of ointment accidentally gets on healthy skin near the skin affected by psoriasis. If the ointment spreads too far, wipe it off.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately after applying Psotriol ointment.
• After applying the ointment, avoid contact with fabrics that can easily stain due to fat (e.g., silk).

Duration of treatment

• The ointment should be used once a day. Using the ointment in the evening may be more convenient.
• Usually, the initial treatment period is 4 weeks, but the doctor may decide on a different treatment duration.
• The 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 obvious treatment results after 2 weeks, even if the symptoms of psoriasis have not yet disappeared in the treated area.

Using more than the recommended dose of Psotriol

A patient who has used more than 15 grams of ointment in a 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. The doctor may recommend a blood test to check if the use of too much ointment has caused a disturbance in calcium levels in the blood. Prolonged, excessive use of the medicine may also suppress the normal functioning 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 the use of Psotriol

The use of Psotriol should be stopped according to the doctor's instructions. It may be necessary to gradually stop using the medicine, especially if it has been used for a long time. In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Psotriol can cause side effects, although not everybody gets them. Severe side effects: If any of the following symptoms occur, the patient should inform their doctor or nurse immediately or as soon as possible. It may be necessary to stop the treatment. There have been reports of the following severe side effects of Psotriol: Not very common (may affect up to 1 in 100 people)

• Exacerbation of psoriasis. In case of exacerbation of psoriasis, the patient should inform their doctor as soon as possible.

Rare (may affect up to 1 in 1000 people)

• Pustular psoriasis (red area of skin with yellowish pustules, usually on the hands or feet) may occur. If this is noticed, the patient should stop using Psotriol and inform their 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 any of the following severe side effects occur, the patient should inform their doctor as soon as possible. They are likely to occur after prolonged use, use in skin folds (e.g., in the groin, under the arms, or under the breasts), under occlusive dressings, or on large areas of skin. These side effects include:

• 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 intraocular pressure (symptoms include eye pain, redness of the eyes, blurred vision).
• Infections (related to the suppression or weakening of the immune system's ability to fight infections).
• Pustular psoriasis (red area with yellowish pustules, usually on the hands or feet). If such symptoms are observed, the patient should stop using Psotriol and inform their doctor as soon as possible.
• Effect on blood sugar control in diabetes (if the patient has diabetes, fluctuations in blood glucose levels may occur).

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 an allergic reaction is observed, the patient should stop using Psotriol and inform their doctor immediately or go to the nearest hospital emergency department.
• Using this ointment may cause an increase in calcium levels in the blood or urine (usually in case of using too much ointment). Signs of increased calcium levels in the blood include excessive urination, constipation, muscle weakness, confusion, and coma. These can be severe, so the patient should contact their doctor immediately. However, after discontinuation of treatment, these levels return to normal.

Less severe side effects: The following less severe side effects of Psotriol have been reported. Common side effects (may affect up to 1 in 10 people)

• Itching
• Scaling of the skin

Uncommon (may affect up to 1 in 100 people)

• Pain or irritation of the skin
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair follicle (folliculitis)
• Changes in skin pigmentation at the site of application
• Rash
• Burning sensation
• Skin infections
• Thinning of the skin
• Appearance of red or purple skin discolorations (petechiae or purpura).

Rare (may affect up to 1 in 1000 people)

• Bacterial or fungal infections of the hair follicle (furuncles)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Photosensitive skin reaction with rash
• Acne
• Dry skin
• Rebound effect: exacerbation of psoriasis symptoms after treatment discontinuation.

Less severe side effects caused by betamethasone, especially when used for a long time, are listed below. If any of these occur, the patient should inform their 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)
• Blurred vision

Less severe side effects caused by calcipotriol include

• Dry skin
• Sensitivity of the skin to light, causing rash
• Pruritus
• Irritation of the skin
• Burning or stinging sensation
• Redness of the skin due to dilation of small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin
• Worsening of psoriasis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Psotriol

This medicine should be stored out of 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 that month. Do not store above 25°C. Do not store in the refrigerator. Shelf life after first opening the tube: 1 year. The patient should write the date of first opening the tube in the space provided on the carton. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Psotriol contains

The active substances of Psotriol are: calcipotriol and betamethasone. One gram of ointment 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)], white petrolatum (containing all-rac-α-tocopherol)

What Psotriol looks like and contents of the pack

Psotriol is a nearly white to yellow ointment, in an aluminum tube with an inner epoxy coating and a PE cap, in a cardboard box. Pack sizes: 30 g, 60 g. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: