Leaflet: information for the user

Psotriol 50 micrograms/g + 0.5 mg/g gel

calcipotriol/betamethasone

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Psotriol is and what it is used for

2. What you need to know before you start using Psotriol

3. How to use Psotriol

4. Possible side effects

5. Storage of Psotriol

6. Contents of the pack and additional information

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

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

No use Psotriol

• If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other components of this medication (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: erythrodermic, exfoliative and pustular (consult your doctor).

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

• Skin infections caused by viruses (for example, herpes or chickenpox)
• Skin infections caused by fungi (for example, athlete's foot or ringworm)
• Skin infections caused by bacteria
• Skin infections caused by parasites (for example, scabies)
• Tuberculosis (TB)
• Perioral dermatitis (red rash around the mouth)
• Fine skin, fragile veins, stretch marks
• Icthyosis (dry skin with scales)
• Acne (pimples)
• Rosacea (intense redness or 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 medications that contain corticosteroids, as you may experience adverse effects
• You have used this medication for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or 'flare up' when steroids are suddenly stopped)
• You have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
• You notice a skin infection, as you may need 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 hats, bandages or gauze as it increases the absorption of the steroid
• Avoid using bandages or gauze as it increases the absorption of the steroid
• Avoid using it on large areas of damaged skin, mucous membranes or skin folds (groins, armpits, under the breasts) as it increases the absorption of the steroid
• Avoid using it on the face or genitals (sexual organs) as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial sunlight and other forms of light treatment

Children and adolescents

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

Other medications and Psotriol

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

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

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

This medication may cause skin reactions because it contains hydrogenated ricin oil.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to apply Psotriol gel: Topical 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 using and remove the cap.
• Apply the gel to a clean finger or directly to the affected area by psoriasis.
• Apply Psotriol to the affected area with the tip of your fingers and gently rub until the affected area by psoriasis is covered with a thin layer of gel.
• Do not put a bandage, cover or wrap the treated skin area.
• Wash your hands thoroughly after using Psotriol. This way, accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes) will be avoided.
• Do not worry if accidentally some gel is applied to healthy skin near your psoriasis, but clean it if it has spread too much.
• To achieve an optimal effect, it is recommended not to shower or bathe immediately after applying Psotriol.
• Avoid contact with fabrics that can be easily stained with grease (for example, silk).

If you have scalp psoriasis:
• Before applying Psotriol to the scalp, brush your hair to remove loose scales. Tilt your head to ensure that Psotriol does not fall on your face. It may be helpful to separate your hair before using Psotriol.

1.Shakethe bottle before using.
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 scalp areas where you can feel the raised plaque and rub Psotriol on the skin.
Depending on the affected area, usually 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.
Leave Psotriol on the scalp for the night or during the day. When washing your hair after application, the following instructions may be helpful:

4. Apply a mild shampoo to thedry hair, especially in areas where the gel was applied.
5. Leave the shampoo on the scalp for a couple of minutes before washing it.
6. Wash your hair as usual.

If necessary, repeat steps 4-6 once or twice.

Treatment duration

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

If you use other medications containing calcipotriol, the total amount of medications containing calcipotriol 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 observe obvious results in 2 weeks, even if the psoriasis has not yet faded at that time.

If you use more Psotriol than you should

Consult your doctor if you have used more than 15 grams per day. Excessive use of Psotriol may cause a problem with your blood calcium, which usually normalizes when the treatment is interrupted. Your doctor may need to perform a blood test to evaluate whether excessive use of the gel has caused a problem with your blood calcium. Prolonged and excessive use may also cause your adrenal glands to malfunction (located near the kidneys and produce hormones).

Contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Psotriol

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Psotriol

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects

Inform your doctor or nurse immediately or as soon as possible if you experience any of the following severe side effects. You may need to stop treatment.

Rare (may affect up to 1 in 100 people)

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

We know that some severe side effects are caused by betamethasone (a potent steroid), one of the components of Psotriol. If you experience any of the severe side effects, inform 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. elbows, armpits or under the breasts), when the area is covered or when used on large areas of skin.

The side effects include the following:

• Your adrenal glands may not function properly. Symptoms are fatigue, depression and anxiety.
• Cataracts (symptoms are blurred or hazy vision, decreased night vision and light sensitivity) 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 depressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applying Psotriol and inform your doctor as soon as possible.
• Effect on diabetes mellitus metabolic control (if you have diabetes you may experience changes in blood glucose levels).

Severe side effects caused by calcipotriol

• Allergic reactions with intense swelling of the face or other parts of the body such as the hands or feet. It may cause swelling of the mouth/throat and respiratory problems. If you experience an allergic reaction, stop applying Psotriol,inform your doctor immediately or go to the nearest hospital emergency room.
• The treatment with this gel may cause an increase in the level of calcium in your blood or urine (usually when too much gel is used). Symptoms of high calcium levels 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.

Mild side effects

Frequent side effects (may affect up to 1 in 10 people)

• Itching

Rare (may affect up to 1 in 100 people)

• Eye irritation
• Sensation of burning on the skin
• Pain or skin irritation
• Inflammation or swelling of the hair follicle (folliculitis)
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to 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
• Pustular rash
• Skin infection

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

• Allergic reactions
• Stretch marks
• Skin exfoliation
• Rebound effect: A worsening of symptoms/psoriasis after treatment is stopped.

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

• The hair may turn temporarily yellowish in color at the application site when used on the scalp.

• Blurred vision.

Mild side effects caused by the use of betamethasone, especially over a prolonged period, include the following. If you notice any of them, inform 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)
• Red rash with inflammation or swelling of the skin (allergic contact dermatitis)
• Yellowish papules with gel (milia coloide)
• Decoloration of the skin (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Mild side effects caused by calcipotriol include the following:

• Dry skin
• Sensitivity of the skin to light resulting in a skin rash
• Eczema
• Itching
• Skin irritation
• Sensation of burning and itching
• Redness of the skin due to dilation of small blood vessels (erythema)
• Skin rash
• Skin rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

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

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

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

The active principles 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, polioxypropylene ester, hydrogenated ricin oil, butylhydroxytoluene (E321).

Appearance of the product and contents of the package

Psotriol 50 micrograms/g + 0.5 mg/g gel is a nearly transparent, colorless to slightly white gel that is presented in screw-top polyethylene bottles.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Mibe Pharma España S.L.U.

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

28045, Madrid

Spain

Manufacturer responsible

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 with 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

Last review date of this leaflet: March 2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es