Leaflet: information for the user

Psotriol 50 micrograms/g + 0.5 mg/g ointment

calcipotriol/betamethasone

Read this leaflet carefully before starting to use this medicine, as 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 is Psotriol 50 micrograms/g + 0.5 mg/g ointment and what it is used for

2. What you need to know before using Psotriol 50 micrograms/g + 0.5 mg/g ointment

3. How to use Psotriol 50 micrograms/g + 0.5 mg/g ointment

4. Possible side effects

5. Storage of Psotriol 50 micrograms/g + 0.5 mg/g ointment

6. Contents of the pack and additional information

Psotriol50 microgramos/g + 0,5 mg/g ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by the excessively rapid production of skin cells. This causes redness, scaling, and thickening of the skin.

Psotriol50 microgramos/g + 0,5 mg/g ointment contains calcipotriol and betamethasone. Calcipotriol helps to normalize the growth rate of skin cells and betamethasone acts by reducing inflammation.

Do not use Psotriol 50 microgramos/g + 0,5 mg/g ointment

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

SincePsotriol50 microgramos/g + 0,5 mg/g ointment contains a potent steroid, DO NOT use it on the 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
• Icthyosis (dry skin with scales)
• Acne (pimples)
• Rosacea (intense redness or flushing of the face)
• Ulcers or damaged skin

Warnings and precautions

Consult your doctor or pharmacist before starting to usePsotriol50 microgramos/g + 0,5 mg/g ointment if:

• You are using other medicines that contain corticosteroids, as you may experience adverse 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 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 have a type of psoriasis called guttate psoriasis

Special precautions

• Avoid using it on more than 30% of your body or more than 15 grams per day
• Avoid using bandages or gauze as it increases steroid absorption
• Avoid using it on large areas of damaged skin, mucous membranes or skin folds (e.g. groin, armpits, under breasts) as it increases steroid absorption
• 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

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Psotriol 50 microgramos/g + 0,5 mg/g ointment is not recommended for use in children under 18 years old.

Use of Psotriol 50 microgramos/g + 0,5 mg/g ointment with other medicines

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

Pregnancy, breastfeeding and fertility

Do not usePsotriol50 microgramos/g + 0,5 mg/g ointment if you are pregnant (or think you may be) or breastfeeding, unless previously agreed with your doctor. If your doctor agrees that you can breastfeed, be careful and do not applyPsotriol50 microgramos/g + 0,5 mg/g ointment to the breast area.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

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

Psotriol 50 microgramos/g + 0,5 mg/g ointment contains butylhydroxytoluene (E321)

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

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

How to applyPsotriol50 micrograms/g + 0.5 mg/g ointment: Cutaneous use.

Instructions for proper use:

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Before the first use of the ointment, remove the cap and check that the tube seal is not broken
• To break the seal, use the point that appears on the back of the cap
• Apply the ointment to a clean finger
• Gently rub it onto your skin to cover the affected area of psoriasis, until most of the ointment has disappeared from the skin
• Do not put a bandage, or cover or wrap the treated skin area
• Wash your hands thoroughly after usingPsotriol50 micrograms/g + 0.5 mg/g ointment (unless you are using the ointment to treat your hands). This will prevent accidental contact of the ointment with other parts of your body (especially the face, scalp, mouth, and eyes)
• Do not worry if you accidentally apply a little ointment to the healthy skin near your psoriasis, but clean it if it has spread too much
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applyingPsotriol50 micrograms/g + 0.5 mg/g ointment
• After applying the ointment, avoid contact with fabrics that can easily stain with grease (for example, silk).

Treatment duration

• Use the ointment once a day. It may be more comfortable to apply the ointment at night
• The initial treatment period is usually 4 weeks, but 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 50 micrograms/g + 0.5 mg/g ointment?

Most patients observe obvious results in 2 weeks, even if the psoriasis has not yet faded at that time.

If you use more Psotriol 50 micrograms/g + 0.5 mg/g ointment than you should

Consult your doctor if you have used more than 15 grams per day. Excessive use ofPsotriol50 micrograms/g + 0.5 mg/g ointment can cause a problem with your blood calcium, which usually normalizes when you stop treatment. Your doctor may need to perform a blood test to evaluate whether excessive use of the ointment has caused a problem with your blood calcium. Prolonged and excessive use can 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 forgot to use Psotriol 50 micrograms/g + 0.5 mg/g ointment

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

If you interrupt treatment with Psotriol 50 micrograms/g + 0.5 mg/g ointment

The use ofPsotriol50 micrograms/g + 0.5 mg/g ointment should be discontinued as indicated by your doctor. It may be necessary to discontinue the use of this medication gradually, especially if you have been using it for a long time.

If you have any other questions 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/nurse immediately or as soon as possible if you experience any of the following severe side effects. You may need to stop treatment.

The following severe side effects have been reported forPsotriol50 micrograms/g + 0.5 mg/g ointment:

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

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

Very rare (may affect up to 1 in 10,000 people)

• Psoriasis pustular (a red area with yellowish pustules usually on the hands or feet) may occur. If this happens, stop applyingPsotriol50 micrograms/g + 0.5 mg/g ointment and inform your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a powerful steroid), one of the components ofPsotriol50 micrograms/g + 0.5 mg/g ointment. 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 vision, decreased night vision and sensitivity to light) or increased pressure in 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)
• Psoriasis pustular (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applyingPsotriol50 micrograms/g + 0.5 mg/g ointment and inform your doctor as soon as possible
• Effect on blood sugar control in diabetes mellitus (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. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop applyingPsotriol50 micrograms/g + 0.5 mg/g ointment,inform your doctor immediately or go to the nearest hospital emergency department.
• The treatment with this ointment may cause an increase in calcium levels in your blood or urine (usually when too much ointment 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

The following mild side effects have been reported forPsotriol50 micrograms/g + 0.5 mg/g ointment:

Common (may affect up to 1 in 10 people)

• Itching
• Skin peeling

Rare (may affect up to 1 in 100 people)

• Skin pain or irritation
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair follicle (folliculitis)
• Changes in skin color in the area where the ointment has been applied
• Rash
• Burning sensation
• Skin infection
• Thinning of the skin
• Purple or red discoloration of the skin (purpura or ecchymosis).

Very rare (may affect up to 1 in 1,000 people)

• Folliculitis caused by bacteria or fungi
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Sensitivity of the skin to light resulting in a skin rash
• Acne (pimples)
• Dry skin
• Rebound effect: Worsening of symptoms/psoriasis after treatment is stopped.

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 (allergic contact dermatitis)
• Yellowish papules (milia coloide)
• Decoloration of the skin (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)
• Blurred vision.

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
• Burning sensation and itching
• Redness of the skin due to dilation of small blood vessels (erythema)
• Rash
• 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 Vigilance 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 tube after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Do not refrigerate.

The tube must be disposed of 1 year after the first opening. Write the date of the first opening of the tube in the space provided on the box.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

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

The active principles are:

Calcipotriol and betamethasone.

One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other components are:

Liquid paraffin, polioxypropylene ester, white paraffin (contains all-rac-α-tocopherol), butylhydroxytoluene (E321)

Appearance of the product and contents of the package

Psotriol 50 micrograms/g + 0.5 mg/g ointment is a white to light yellowish paste that is presented in aluminum/epoxyphenol tubes with a polyethylene screw cap.

Package sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g, 100 g (in a package of 2 x 50 g), 120 g, 120 g (in a package of 2 x 60 g).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mibe Pharma España S.L.U.

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

28045, Madrid

Spain

Responsible for manufacturing

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 - Brehna

Germany

Sun-Farm Sp. z. o. o.

Ul. Dolna 21

Lomianki, 05-092Mazowieckie

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Psotriol 50 Mikrogramm/g + 0.5 mg/g Salbe

Belgium:Calcipotriol/betamethason Dermapharm 50 microgram/g + 0.5 mg/g zalf/pommade/Salbe

Germany:Calcipotriderm comp. 50 Mikrogramm/g + 0.5 mg/g Salbe

Spain:Psotriol50 micrograms/g + 0.5 mg/g ointment

Croatia:Psotriol 50 μg/g + 500 μg/g mast

Italy:Calcipotriol/Betamethasone Dermapharm 50 micrograms/g + 0.5 mg/g ointment

Poland:Psotriol

Last review date of this leaflet: May 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es