Pso triol

Package leaflet: Information for the user

Psotriol, (50 micrograms + 0.5 mg)/g, ointment
Calcipotriolum + Betamethasonum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Psotriol is and what it is 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 Psotriol is and what it is used for

Psotriol ointment is applied to the skin for the treatment of psoriasis vulgaris in adults. Psoriasis
is caused by excessive production of skin cells. This leads to redness, scaling, and thickening of the skin.
Psotriol ointment contains calcipotriol and betamethasone. Calcipotriol helps slow down the rate of
skin cell growth to normal levels, 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 disorders of calcium levels in the body (should be discussed with a doctor),
• if the patient has been diagnosed with certain types of psoriasis: erythrodermic psoriasis, pustular psoriasis, or guttate psoriasis (should be discussed with a doctor).

Due to the fact that Psotriol contains a potent steroid, DO NOT use this medicine in the course of
skin conditions such as:

• viral skin infections (e.g. herpes simplex or varicella),
• fungal skin infections (e.g. athlete's foot or dermatophytosis),
• bacterial skin infections,
• parasitic skin infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin with easy bruising, fragile blood vessels, or stretch marks,
• ichthyosis (dry, scaly skin resembling fish scales),
• acne,
• rosacea (severe sudden redness or flushing of the facial skin),
• skin ulcers or breaks in skin integrity.

Warnings and precautions
Before starting treatment with Psotriol, consult your doctor or pharmacist if:

• the patient is using other medicines containing corticosteroids that may cause adverse effects,
• the patient has been using this medicine for a long time and plans to discontinue treatment (as there is a risk of worsening or rebound of psoriasis upon sudden discontinuation of steroids),
• the patient has been diagnosed with diabetes, as steroids may affect blood glucose levels,
• the patient has a skin infection that may require discontinuation of treatment,
• the patient has a specific type of psoriasis called guttate psoriasis.

Special precautions
Avoid using the medicine on more than 30% of the body surface or using more than 15 g of the medicine per day.
Avoid using the medicine under bandages or dressings, as this increases steroid absorption.
Avoid using the medicine on large areas of damaged skin, mucous membranes, or in skin folds (groin, armpits, under the breasts), as this increases steroid absorption.
Avoid using the medicine on the face or genital organs (genital areas), as these areas are particularly sensitive to the effects of steroids.
Avoid excessive sun exposure, excessive use of sunbeds, and other forms of phototherapy.
Contact your doctor if the patient experiences blurred vision or other visual disturbances.
Children and adolescents
Psotriol is not recommended for use in children under 18 years of age.
Psotriol with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Pregnancy, breastfeeding and fertility
Do not use Psotriol if the patient is pregnant (or suspects she may be pregnant) or breastfeeding, unless previously agreed with the doctor. If the doctor has approved breastfeeding during treatment, exercise caution and do not apply Psotriol to the surface of the breasts.
Before using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
This medicine is not expected to have any effect on the ability to drive or operate machinery.
Psotriol contains butylated hydroxytoluene (E 321)
Butylated hydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Psotriol

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Instructions for correct use

• Apply only to skin affected by psoriasis. Do not apply to unaffected skin.
• Before first use of the ointment, remove the cap from the tube and check whether the seal inside the tube is intact.
• To break the seal, use the tip of the cap's reverse side.
• Squeeze the ointment onto a clean fingertip.
• Gently rub the ointment into the affected skin until most of the ointment has disappeared from the skin surface.
• Do not apply bandages, occlusive dressings, or wraps to the treated area.
• After applying Psotriol ointment, wash your hands thoroughly (unless you are treating the skin of the hands). This helps prevent accidental transfer of the ointment to other parts of the body (especially the face, hairy scalp, mouth, or eyes).
• There is no need to worry if a small amount of ointment accidentally spreads to healthy skin near the psoriatic lesions. If the ointment spreads too far, wipe it off.
• For optimal effectiveness, avoid taking a shower or bath immediately after applying Psotriol ointment.
• After application, avoid contact with textiles that are easily stained by greasy substances (e.g. silk).

Duration of treatment

• The ointment should be applied once daily. Evening application may be more convenient.
• The initial treatment period is usually 4 weeks, but your doctor may decide on a different duration.
• Your doctor may decide to repeat the treatment course.
• Do not apply more than 15 grams of the medicine per day.

When using other medicines containing calcipotriol, the total daily amount of calcipotriol-containing products must not exceed 15 grams, and the treated skin area should not exceed 30% of the total body surface area.

What to expect when using Psotriol
Most patients notice clear improvement within 2 weeks, even if psoriasis symptoms have not yet completely resolved at the treated site.

Use of more than the recommended dose of Psotriol
A patient who has applied more than 15 grams of ointment in one day should contact their doctor. Excessive use of Psotriol may cause disturbances in blood calcium levels, which usually return to normal after stopping treatment. Your doctor may recommend a blood test to check whether excessive use has caused abnormal calcium levels. Prolonged, excessive use may also suppress normal adrenal gland function (the glands located near the kidneys that produce hormones).

Missed dose of Psotriol
Do not apply a double dose to make up for a missed dose.

Stopping Psotriol treatment
Psotriol treatment should be discontinued according to your doctor’s instructions. Gradual discontinuation may be necessary, especially if the medicine has been used for a prolonged period.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If any of the following symptoms occur, inform your doctor or nurse immediately or as soon as possible. It may be necessary to discontinue treatment.

There have been reports of the following serious adverse effects with Psotriol:

Uncommon (may affect up to 1 in 100 people)

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

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

• Pustular psoriasis (red areas of skin with yellowish pustules, usually on the hands or feet). If this occurs, stop using Psotriol and inform your doctor immediately.

It is known that some serious adverse effects are due to betamethasone (a potent steroid), one of the components of Psotriol. If any of the following serious adverse effects occur, inform your doctor as soon as possible. These are likely to occur after long-term use, use in skin folds (e.g. groin, underarms, or under the breasts), under occlusive dressings, or over large skin areas.

These adverse effects include:

• Suppression of normal adrenal gland function. Symptoms include fatigue, depression, and anxiety.
• Cataract (symptoms include blurred or hazy vision, difficulty seeing at night, and sensitivity to light) or increased pressure inside the eye (symptoms include eye pain, redness of the eyes, and reduced or blurred vision).
• Infections (due to suppression or weakening of the immune system's ability to fight infections).
• Pustular psoriasis (red areas with yellowish pustules, usually on the hands or feet). If such symptoms are observed, discontinue use of Psotriol and inform your doctor immediately.
• Effect on metabolic control of diabetes (if the patient has diabetes, fluctuations in blood glucose levels may occur).

Serious adverse effects caused by calcipotriol

• Allergic reactions with deep swelling of the face or other body parts such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If an allergic reaction occurs, stop using Psotriol and inform your doctor immediately or go to the nearest hospital emergency department.
• Use of this ointment may lead to increased calcium levels in the blood or urine

(typically when excessive amounts of ointment are used). Signs of elevated calcium levels in the blood include excessive urination, constipation, muscle weakness, confusion, and coma. These may be serious and therefore you should contact your doctor immediately. However, calcium levels return to normal after discontinuation of treatment.

Less serious adverse effects

The following less serious adverse effects have been reported with Psotriol.

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

• Itching
• Skin peeling

Uncommon (may affect up to 1 in 100 people)

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

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

• Bacterial or fungal infections of hair follicles (boils)
• Allergic reactions
• Hypercalcemia
• Striae (stretch marks)
• Photosensitivity reaction manifesting as a rash
• Acne
• Dry skin
• Rebound effect: worsening of psoriasis symptoms after stopping treatment

Less serious adverse effects caused by betamethasone, especially when used for prolonged periods, include:

• Skin thinning
• Appearance of superficial blood vessels and striae
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Rash with inflammation or swelling (allergic contact dermatitis)
• Golden-colored gel-filled elevations (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of hair follicles (folliculitis)
• Blurred vision

Less serious adverse effects caused by calcipotriol include:

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

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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]

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Psotriol

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Do not store in the refrigerator.
Period of validity after first opening of the tube: 1 year
The date of first opening of the tube should be written in the space provided for this purpose on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Psotriol contains
The active substances in this medicine are:
calcipotriene and betamethasone.
One gram of ointment contains 50 micrograms of calcipotriene (as calcipotriol monohydrate)
and 0.5 mg of betamethasone (as betamethasone dipropionate).
Other ingredients are:
liquid paraffin, stearyl alcohol polyoxyl ether [containing butylhydroxytoluene (E 321)],
white soft paraffin (containing all-rac-α-Tocopherol).

What Psotriol looks like and contents of the pack
Psotriol is an ointment of almost white to yellow appearance, contained in an aluminum tube internally coated with epoxy lacquer and fitted with a polyethylene cap, packed in a cardboard box.
Pack sizes: 30 g, 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

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