PSOTRIOL 50 MICROGRAMMI/G + 0.5 MG/G Żel

Treść ulotki

1. PSOTRIOL 50 micrograms/g + 0.5 mg/g gel
   1. What is PSOTRIOL and what is it used for
   2. What you need to know before using PSOTRIOL
   3. How to use PSOTRIOL
   4. Possible side effects
   5. How to store PSOTRIOL
   6. Package Contents and Other Information

PSOTRIOL 50 micrograms/g + 0.5 mg/g gel

calcipotriol/betamethasone

Read this leaflet carefully before you start using 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 could 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 is PSOTRIOL and what it is used for
• 2. What you need to know before you use 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 as a topical treatment for scalp psoriasis in adults and of the skin
of other areas of the body to treat plaque psoriasis (psoriasis vulgaris) of mild to moderate severity
in adults. Psoriasis is caused by skin cells that reproduce too quickly. This
causes redness, scaling and thickening of the skin.
PSOTRIOL contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells
and betamethasone works by reducing inflammation.

2. What you need to know before using PSOTRIOL

Do not use PSOTRIOL

• 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 (consult your doctor)
• if you have certain types of psoriasis, such as erythrodermic, exfoliative and pustular psoriasis (consult your doctor) Because PSOTRIOL contains a potent steroid, DO NOT use it on skin affected by:
• skin infections caused by viruses (e.g. herpes labialis or chickenpox)
• skin infections caused by fungi (e.g. athlete's foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g. scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thinning of the skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)

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• rosacea (severe flushing or redness of the facial skin)
• skin ulcers or open wounds.

Warnings and precautions
Consult your doctor, pharmacist or nurse before and during the use of PSOTRIOL if

• you are using other medicines containing corticosteroids, as adverse effects may occur
• you have used this medicine for a long period and intend to stop treatment (because there is a risk of worsening or “flare-up” of psoriasis when treatment with steroids is stopped abruptly)
• you have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid
• you develop skin infections. Treatment may need to be discontinued
• you have certain types of psoriasis called guttate psoriasis
• you experience blurred vision or other vision problems

Special precautions

• avoid applying the product to more than 30% of the body or using more than 15 g per day
• avoid using swimming caps, bandages or dressings as they may increase steroid absorption
• avoid use under bandages or dressings as they increase steroid absorption
• avoid applying the medicine to large areas of damaged skin, mucous membranes or at the site of skin sores (groin, armpits, under the breasts) as this increases steroid absorption
• avoid use on the face or genitals (sexual organs) as these are areas very sensitive to steroids
• avoid excessive exposure to the sun, excessive use of the solarium or other forms of light treatment

Children and adolescents
The use of PSOTRIOL is not recommended in children and adolescents under the age of 18 years.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
If your doctor has established that you can breastfeed, make sure not to apply PSOTRIOL to the breast area.

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

PSOTRIOL contains butylhydroxytoluene (E321)
Butylhydroxytoluene (E321) may cause localized skin reactions (e.g. contact dermatitis) or
irritation to the eyes and mucous membranes.

3. How to use PSOTRIOL

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
How to apply PSOTRIOL: cutaneous use.
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Instructions for correct use

• Use the medicine only for psoriasis and not on skin that is not affected by psoriasis
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or directly onto the area affected by psoriasis
• Apply PSOTRIOL to the affected area with your fingertips and rub gently until the area affected by psoriasis is covered with a thin layer of gel.
• Do not bandage, tightly wrap or cover the treated skin areas
• Wash your hands thoroughly after applying PSOTRIOL. 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 achieve an optimal effect, it is recommended not to bathe or shower immediately after applying PSOTRIOL
• After applying the gel, avoid contact with fabrics that could easily stain with oil (for example, silk).

If you suffer from scalp psoriasis

• Before applying PSOTRIOL to the scalp, brush your hair to remove any scales. Tilt your head so that PSOTRIOL does not run down your face. It may be helpful to divide your hair into sections before using PSOTRIOL.
• 1.Shakethe bottle before use
• 2.Put a drop of PSOTRIOL on a finger
• 3.Apply directly to the areas of the scalp where you can feel the plaques and gently rub PSOTRIOL into the skin. Generally, 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
PSOTRIOL.
Leave PSOTRIOL 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 one or two times.
Duration of treatment

• Use the gel once a day. It may be more convenient to apply the gel in the evening.
• The normal initial treatment period is 4 weeks for scalp areas and 8 weeks for areas other than the scalp.
• The doctor may decide on a different treatment period.
• The doctor may decide to repeat the treatment
• Do not use more than 15 grams per day.

If you are using other medicines containing calcipotriol, the total amount of medicines containing
calcipotriol must not exceed 15 grams per day and the area must not exceed 30% of the total body
surface area.

What to expect with the use of PSOTRIOL
Most patients notice noticeable improvements after 2 weeks, even if the psoriasis has not yet
disappeared.
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If you use more PSOTRIOL than you should
Contact your doctor if you use more than 15 g of medicine in one day. Excessive use of PSOTRIOL can
cause a problem with calcium levels in the blood, which usually normalizes when treatment is stopped. The doctor may consider it necessary to perform some blood tests to ensure that
excessive use of the gel has not caused an alteration in calcium levels in the blood. Prolonged excessive
use can also cause the adrenal glands to malfunction (the adrenal glands are located near the kidneys and produce hormones).

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

If you stop treatment with PSOTRIOL
The use of PSOTRIOL must be discontinued according to the doctor's instructions. A
gradual discontinuation of treatment may be necessary, especially if you have used the medicine for a prolonged period.
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
Seek medical or nurse assistance immediately or as soon as possible if any of the following
side effects occur. In this case, you should stop treatment.
Uncommon (may affect up to 1 in 100 people)

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

Some serious side effects are known to be caused by betamethasone (a potent steroid), one
of the active ingredients of PSOTRIOL. Inform your doctor as soon as possible if a
serious side effect occurs. These side effects are more frequent after prolonged use, use in
skin folds (e.g. groin, armpits or under the breasts), use with occlusive dressing or use on a large
skin area. Side effects include:

• The adrenal glands may not function properly. Symptoms are fatigue, depression and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty with night vision and photosensitivity) or an increase in intraocular pressure (symptoms are eye pain, redness of the eyes, reduced or blurred vision).
• Infections (because the immune system, which fights infections, may be suppressed or weakened)
• Pustular psoriasis (a reddened area with yellowish pustules that usually appears on the hands or feet). If you notice this, stop using PSOTRIOL and inform your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic you may experience fluctuations in blood sugar).

Some serious side effects are known to be caused by calcipotriol

• Allergic reactions characterized by severe swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop using PSOTRIOL, report it immediately to your doctor or goto the nearest hospital emergency room.
• Treatment with this gel can cause an increase in calcium levels in the blood or urine (usually when an excessive amount of gel is used). Signs of an increase in the amount

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of calcium in the blood are excessive urination, constipation, muscle weakness, confusion and coma. This can be serious and therefore you should contact your doctor immediately.
However, calcium levels will return to normal once treatment is stopped.
Less serious side effects
Common (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
• Skin pain or irritation
• Inflammation or swelling of the hair root (folliculitis)
• Skin rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of capillaries (erythema)
• Acne (pimples)
• Dry skin
• Skin rash
• Pustular rash
• Skin infection.

Rare (may affect up to 1 in 1000)

• Allergic reactions
• Stretch marks
• Skin peeling
• Rebound effect: a worsening of symptoms/psoriasis once treatment is finished.

Not known (frequency cannot be estimated from 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 caused by the use of betamethasone, especially for a long period of
time, include those listed below. You should inform your doctor or nurse as soon as
possible if you notice any of the following side effects.

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Alteration of hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Small golden nodules filled with gelatinous substance (milia colloide)
• Skin discoloration (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)

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

• Dry skin
• Skin photosensitivity with resulting rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to dilation of capillaries (erythema) Page 5of 7
• Skin rash
• Skin rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or 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 PSOTRIOL

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 label after Scad. The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
Discard the bottle containing residual gel after 6 months from first opening.
Do not dispose of any medicine in waste water 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 PSOTRIOL 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, butylhydroxytoluene (E321).

Description of the appearance of PSOTRIOL and package contents
PSOTRIOL is a nearly transparent gel, from colorless to slightly dirty white contained in bottles with
a screw cap made of polyethylene.
Package sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g (as a pack of 2 x 50 g), 120 g (as a pack of 2 x 60 g).
Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mibe Pharma Italia S.r.l.
Via Leonardo Da Vinci 20/b

• 39100 - Bolzano

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Manufacturers responsible for batch release
Mibe GmbH Arzneimittel
Münchener Str. 15
06796 Brehna
Germany
Sun-Farm Sp. z o.o.
Ul. Dolna 21
Mazowieckie
05-092 Lomianki
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria: Calcidermetha 50 Micrograms/g + 0.5 mg/g Gel
Belgium: Calcipotriol/Betamethasone Dermapharm 50 micrograms/g + 0.5 mg/g gel
Calcipotriol/Betamethasone Dermapharm 50 microgrammes/g + 0.5 mg/g gel
Calcipotriol/Betamethasone Dermapharm 50 Mikrogramm/g + 0.5 mg/g Gel
Germany: Calcipotriderm comp. 50 Mikrogramm/g + 0.5 mg/g Gel
Spain: Calcipotriol/Betamethasone Dermapharm 50 micrograms/g + 0.5 mg/g gel
Croatia: PSOTRIOL 50 micrograms/g + 0.5 mg/g gel
Italy: PSOTRIOL
Poland: PSOTRIOL
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