PSOTRIOL 50 micrograms/g + 0.5 mg/g GEL

Introduction

Package Leaflet: Information for the User

Psotriol 50 micrograms/g + 0.5 mg/g gel

calcipotriol/betamethasone

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Psotriol and what is it used for
2. What you need to know before you use Psotriol
3. How to use Psotriol
4. Possible side effects
5. Storage of Psotriol
6. Contents of the pack and other information

1. What is Psotriol and what is it used for

This medicine is used for the topical treatment of scalp psoriasis in adults and for the treatment of psoriasis on other areas of the body to treat plaque psoriasis (psoriasis vulgaris) of mild to moderate severity in adults. Psoriasis is caused by the skin cells growing too quickly. This leads to redness, scaling, and thickening of the skin.

Psotriol contains calcipotriol and betamethasone. Calcipotriol helps to normalize the growth of skin cells and betamethasone acts by reducing inflammation.

2. What you need to know before you use 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 suffer from certain types of psoriasis: such as erythrodermic, exfoliative, and pustular (consult your doctor).

Since Psotriol contains a potent steroid, DO NOT use it on skin affected by:

• skin infections caused by viruses (e.g., herpes 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)
• thin skin, fragile veins, stretch marks
• ichthyosis (dry skin with scales)
• acne (pimples)
• rosacea (redness or intense flushing of the skin on the face)
• ulcers or damaged skin

Warnings and precautions

Consult your doctor or pharmacist before starting to use Psotriol if:

• you are using other medicines that contain corticosteroids, as you may suffer from side effects
• you have used this medicine for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or 'flare' when the steroids are stopped suddenly)
• you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid
• a skin infection appears, as it may be necessary to interrupt treatment
• you suffer from a type of psoriasis called guttate psoriasis
• you experience blurred vision or other visual disturbances

Special precautions

• avoid using it on more than 30% of your body or more than 15 grams per day
• avoid using shower caps, bandages, or dressings as they increase the absorption of the steroid
• avoid using bandages or dressings as they increase the absorption of the steroid
• avoid using it on large areas of damaged skin, on mucous membranes, or in skin folds (e.g., groin, armpits, or under the breasts) as it increases the absorption of the steroid
• avoid using it on the face or genitals (sex organs) as they are highly sensitive to steroids
• avoid excessive sunbathing, excessive use of sunlamps, and other light treatments

Children and adolescents

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

Other medicines and Psotriol

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 or pharmacist for advice before using this medicine.

If your doctor agrees that you can breastfeed, be careful and do not apply Psotriol to the breast area.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Psotriol 50 micrograms/g + 0.5 mg/g gel contains butylhydroxytoluene (E321)

Butylhydroxytoluene (E321) may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

This medicine may cause skin reactions because it contains hydrogenated castor oil.

3. How to use Psotriol

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How to apply Psotriol gel: Cutaneous use.

Instructions for proper use:

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis.
• Shake the bottle before use and remove the cap.
• Apply the gel to a clean finger or directly to the affected area.
• Apply Psotriol to the affected area with your fingertips and gently rub until the affected area is covered with a thin layer of gel.
• Do not cover the treated skin with a bandage or dressing.
• Wash your hands well after using Psotriol. This will prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).
• Do not worry if you accidentally apply a little gel to the healthy skin near your psoriasis, but clean it if it has spread too much.
• In order to achieve an optimal effect, it is recommended not to shower or bathe immediately after applying Psotriol.
• After applying the gel, avoid contact with fabrics that may be easily stained with grease (e.g., silk).

If you have scalp psoriasis: • Before applying Psotriol to the scalp, comb your hair to remove loose scales. Tilt your head to make sure Psotriol does not get on your face. It may be helpful to separate your hair before using Psotriol. 1. Shakethe bottle before use. 2. Apply one drop of Psotriol 50 micrograms/g + 0.5 mg/g gel to the tip of your finger. 3. Apply directly to the areas of the scalp where you can feel the raised plaque and rub Psotriol onto the skin. Depending on the affected area, normally 1 to 4 grams (up to 1 teaspoon) are sufficient.To achieve an optimal effect, it is recommended not to wash your hair immediately after applying Psotriol.Let Psotriol stay on the scalp for the night or during the day. When washing your hair after application, the following instructions may be useful: 4. Apply a mild shampoo to dry hair, especially in areas where the gel was applied. 5. Leave the shampoo on the scalp for a couple of minutes before rinsing. 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 at night.
• The initial treatment period is normally 4 weeks for scalp areas and 8 weeks for non-scalp areas.
• Your doctor may decide on a different treatment period.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams in one day.

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

What to expect when using Psotriol

Most patients notice obvious results after 2 weeks, even if the psoriasis has not completely cleared at that time.

If you use more Psotriol than you should

Consult your doctor if you have used more than 15 grams in one day. Excessive use of Psotriol can cause a problem with the calcium in your blood, which usually normalizes when treatment is stopped. Your doctor may need to perform a blood test to check that the use of too much gel has not caused a problem with the calcium in your blood. Prolonged and excessive use can also cause your adrenal glands to stop working properly (these are located near the kidneys and produce hormones).

Contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Psotriol

Do not apply a double dose to make up for forgotten doses.

If you stop treatment with Psotriol

The use of Psotriol should be stopped as indicated by your doctor. It may be necessary to stop using this medicine gradually, especially if you have been using it for a long time.

If you have any other questions 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

Tell your doctor or nurse immediately or as soon as possible if you suffer from any of the following side effects. You may need to stop your treatment.

Uncommon (may affect up to 1 in 100 people)

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

It is known that some serious side effects are caused by betamethasone (a potent steroid), one of the components of Psotriol. If you suffer from any of these serious side effects, tell your doctor as soon as possible. These side effects are more likely to occur after long-term use, when used in skin folds (e.g., groin, armpits, or under the breasts), when covered, or when used on large areas of skin.

Side effects include the following:

• Your adrenal glands may stop working properly. Symptoms are fatigue, depression, and anxiety.
• Cataracts (symptoms are cloudy or blurred vision, decreased night vision, and sensitivity to light) or increased pressure inside the eye (symptoms are eye pain, red eye, blurred vision, or decreased vision).
• Infections (because your immune system, which fights infections, may be weakened).
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using Psotriol and tell your doctor as soon as possible.
• Effect on the metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood sugar levels).

Serious side effects caused by calcipotriol

• Allergic reactions with severe swelling of the face or other parts of the body such as hands or feet. It can cause swelling of the mouth/throat and breathing problems. If you experience an allergic reaction, stop using Psotriol, tell your doctor immediately or go to the emergency department of the nearest hospital.
• Treatment with this gel can cause an increase in the level of calcium in your blood or urine (usually when too much gel is used). Symptoms of high calcium in the blood are excessive urine production, constipation, muscle weakness, confusion, and coma. This can be serious and you should contact your doctor immediately. However, when treatment is stopped, levels return to normal.

Less serious 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 on the skin
• Pain or irritation of the skin
• Inflammation or swelling of the hair root (folliculitis)
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Changes in skin color in the area where the gel has been applied
• Acne (pimples)
• Dry skin
• Skin rash (rash)
• Pustular rash
• Skin infection

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

• Allergic reactions
• Stretch marks
• Exfoliation of the skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

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

• White or gray hair may temporarily turn yellow at the application site when used on the scalp.
• Blurred vision.

Less serious side effects caused by the use of betamethasone, especially during prolonged use, include the following. If you notice any of them, tell your doctor or nurse as soon as possible.

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Golden-colored papules (colloid milium)
• Discoloration of the skin (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)

Less serious side effects caused by calcipotriol include the following:

• Dry skin
• Skin sensitivity to light leading to a skin rash
• Eczema
• Itching
• Skin irritation
• Burning sensation and itching
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Skin rash (rash)
• Skin rash (rash) with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and bottle after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

The bottle should be discarded with the remaining gel 6 months after the first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Psotriol 50 micrograms/g + 0.5 mg/g gel

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 ingredients are:

Liquid paraffin, polyoxypropylene stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321).

Appearance of the product and pack size

Psotriol 50 micrograms/g + 0.5 mg/g gel is a nearly transparent, colorless to slightly whitish gel that comes in bottles with a screw cap made of polyethylene.

Bottle sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g, and 120 g.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 - Brehna

Germany

Or

Sun-Farm Sp. z o.o.

Ul. Dolna 21

Mazowieckie

05-092 Lomianki

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Calcidermetha 50 Mikrogramm/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: Psotriol 50 micrograms/g + 0.5 mg/g gel

Croatia: Psotriol 50 mikrograma/g + 0,5 mg/g gel

Italy: Psotriol

Poland: Psotriol

Date of last revision of this leaflet: March 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es