Psotriol 50 micrograms/g + 0.5 mg/g gel

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Psotriol 50 micrograms/g + 0.5 mg/g gel

calcipotriol/betamethasone

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Psotriol is and what it is used for

This medicine is used as a topical treatment for scalp psoriasis in adults and for plaque psoriasis (psoriasis vulgaris) on the skin of other body areas, in mild to moderate cases in adults. Psoriasis is caused by excessively rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.

Psotriol contains calcipotriol and betametasona. Calcipotriol helps normalize the rate of skin cell growth, 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, or pustular psoriasis (consult your doctor).

Since Psotriol contains a potent corticosteroid, 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 blood vessels, or stretch marks
• Ichthyosis (dry, scaly skin)
• Acne (spots)
• Rosacea (redness or intense flushing of the facial skin)
• Ulcers or damaged skin

Warnings and precautions

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

• You are using other medicines containing corticosteroids, as you may experience adverse effects.
• You have used this medicine for a long time and plan to stop using it (since there is a risk that your psoriasis may worsen or 'rebound' when steroids are stopped suddenly).
• You have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid.
• A skin infection develops, as treatment may need to be interrupted.
• You have a type of psoriasis called guttate psoriasis.
• You experience blurred vision or other visual disturbances.

Special precautions

• Avoid use on more than 30% of your body surface or more than 15 grams per day.
• Avoid using shower caps, bandages, or dressings, as they increase steroid absorption.
• Avoid using bandages or dressings, as they increase steroid absorption.
• Avoid use on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases steroid absorption.
• Avoid use on the face or genital area (sex organs), as these areas are highly sensitive to steroids.
• Avoid excessive sun exposure, excessive use of artificial tanning, and other forms of light therapy.

Children and adolescents

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

Other medicines and Psotriol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If your doctor approves breastfeeding, take care not to apply Psotriol to the breast area.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

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

Butylated hydroxytoluene (E321) may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

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

3. How to use Psotriol

Follow exactly the administration instructions for this medicine given 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 apply it to skin without psoriasis.
• Shake the bottle before use and remove the cap.
• Apply the gel onto a clean fingertip or directly onto the area affected by psoriasis.
• Apply Psotriol to the affected area with the fingertip and gently rub until the psoriatic area is covered with a thin layer of gel.
• Do not apply a dressing, cover, or wrap the treated skin area.
• Wash your hands thoroughly after using Psotriol. This will help prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).
• Do not worry if a small amount of gel is accidentally applied to healthy skin near your psoriasis, but clean it off if it has spread too far.
• 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 can be easily stained by 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 ensure Psotriol does not run into your face. It may be helpful to part your hair before using Psotriol.

1. Shake the bottle before use.
2. Apply a drop of Psotriol 50 micrograms/g + 0.5 mg/g gel to the fingertip.
3. Apply directly to areas of the scalp where you can feel raised plaques and rub Psotriol into the skin.
   Depending on the affected area, 1 to 4 g (up to 1 teaspoon) is usually sufficient.
   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, the following instructions may be helpful:
4. Apply a mild shampoo to dry hair, especially on areas 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, repeat steps 4–6 one or two times.

Duration of treatment

• Use the gel once daily. It may be more convenient to apply the gel at night.
• The usual initial treatment period is 4 weeks for scalp areas and 8 weeks for non-scalp areas.
• Your doctor may decide on a different treatment duration.
• Your doctor may decide that you should repeat the treatment.
• Do not use more than 15 grams in one day.

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

What should I expect when using Psotriol?

Most patients notice obvious results within 2 weeks, even though the psoriasis may not have completely cleared at that time.

If you use more Psotriol than you should

Contact your doctor if you have used more than 15 grams in one day. Excessive use of Psotriol may cause a problem with calcium levels in your blood, which usually returns to normal once treatment is stopped. Your doctor may need to perform a blood test to check whether excessive use of the gel has caused any problems with your blood calcium levels. Prolonged and excessive use may also cause your adrenal glands to stop functioning properly (these glands are located near the kidneys and produce hormones).

Contact the Toxicology Information Service at telephone number 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 missed doses.

If you stop treatment with Psotriol

Treatment with Psotriol should be discontinued as directed by your doctor. You may need to stop using this medicine gradually, especially if you have been using it for a long time.

If you have any further questions about the use of this medicine, ask 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

Inform your doctor or nurse immediately or as soon as possible if you experience any of the following adverse 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, inform your doctor as soon as possible.

It is known that some serious adverse effects are caused by betamethasone (a potent steroid), one of the components of Psotriol. If you experience any of the following serious adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur after long-term use, when applied to skin folds (e.g. groin, armpits or under the breasts), when the treated area is covered, or when used over large skin areas.

The adverse effects include:

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

Serious adverse effects caused by calcipotriol

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

Less serious adverse effects

Frequent adverse 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
• Skin pain or irritation
• Inflammation or swelling at the hair root (folliculitis)
• Skin rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Changes in skin colour at the site where the gel has been applied
• Acne (spots)
• Dry skin
• Skin rash (rash)
• Pustular rash
• Skin infection

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

• Allergic reactions
• Stretch marks (striae)
• Skin peeling
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

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

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

Less serious adverse effects caused by the use of betamethasone, especially with prolonged use, include the following. If you notice any of these, inform your doctor or nurse as soon as possible.

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

Less serious adverse effects caused by calcipotriol include:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

The vial should be discarded, together with any remaining gel, 6 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

Liquid paraffin, polyoxyl stearate ether, hydrogenated castor oil, butylhydroxytoluene (E321).

Appearance of the product and contents of the container

Psotriol 50 micrograms/g + 0.5 mg/g gel is a nearly transparent, colourless to slightly whitish gel supplied in bottles with polyethylene screw caps.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 the most recent review of this leaflet: March 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es