PSOTRIOL 50 micrograms/g + 0.5 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Psotriol 50 micrograms/g + 0.5 mg/g ointment

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 Psotriol 50 micrograms/g + 0.5 mg/g ointment is and what it is used for
2. What you need to know before you use 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 other information

1. What Psotriol 50 micrograms/g + 0.5 mg/g ointment is and what it is used for

Psotriol 50 micrograms/g + 0.5 mg/g ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by the skin cells growing too quickly. This leads to redness, scaling, and thickening of the skin.

Psotriol 50 micrograms/g + 0.5 mg/g ointment contains calcipotriol and betamethasone. Calcipotriol helps to normalise the growth of skin cells, and betamethasone acts to reduce inflammation.

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

Do not use Psotriol 50 micrograms/g + 0.5 mg/g ointment

• 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 your calcium levels (check with your doctor)
• If you have certain types of psoriasis, such as erythrodermic, exfoliative, or pustular (check with your doctor)

Since Psotriol 50 micrograms/g + 0.5 mg/g ointment contains a strong steroid, do not use it on skin affected by:

• skin infections caused by viruses (e.g. herpes or chicken pox)
• skin infections caused by fungi (e.g. athlete's foot or ringworm)
• bacterial skin infections
• parasitic skin infections (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 broken skin

Warnings and precautions

Consult your doctor or pharmacist before starting to use Psotriol 50 micrograms/g + 0.5 mg/g ointment if:

• you are using other medicines that contain corticosteroids, as you may experience 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 levels may be affected by the steroid
• a skin infection appears, as treatment may need to be interrupted
• 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 dressings or bandages as this increases the absorption of the steroid
• avoid using it on large areas of damaged skin, on mucous membranes, or on skin folds (e.g. groin, armpits, or under the breasts) as this increases the absorption of the steroid
• avoid using it on the face or genitals (sex organs) as these areas are very sensitive to steroids
• avoid excessive sunbathing, using sunlamps or other forms of light treatment

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

Children

Psotriol 50 micrograms/g + 0.5 mg/g ointment is not recommended for use in children under 18 years of age.

Using Psotriol 50 micrograms/g + 0.5 mg/g ointment with other medicines

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

Pregnancy, breastfeeding, and fertility

Do not use Psotriol 50 micrograms/g + 0.5 mg/g ointment if you are pregnant (or think you may be pregnant) or if you are breastfeeding, unless you have agreed this with your doctor. If your doctor agrees that you can breastfeed, be careful and do not apply Psotriol 50 micrograms/g + 0.5 mg/g ointment to the breast area.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

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

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

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How to apply Psotriol 50 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 seal on the tube is not broken
• To break the seal, use the point on the back of the cap
• Apply the ointment to a clean finger
• Gently rub it into 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 dressing on the treated area
• Wash your hands well after using Psotriol 50 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 healthy skin near your psoriasis, but wipe it off if it spreads too much
• In order to achieve the best effect, it is recommended not to shower or bathe immediately after applying Psotriol 50 micrograms/g + 0.5 mg/g ointment
• After applying the ointment, avoid contact with fabrics that may be easily stained by grease (e.g. silk).

Duration of treatment

• Use the ointment once a day. It may be more convenient to apply the ointment at night
• The initial treatment period is normally 4 weeks, but your doctor may decide on a different treatment period
• 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 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 50 micrograms/g + 0.5 mg/g ointment

Most patients see noticeable results after 2 weeks, even if the psoriasis has not completely cleared 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 in one day. Overuse of Psotriol 50 micrograms/g + 0.5 mg/g ointment can cause a problem with the calcium in your blood, which usually returns to normal when treatment is stopped. Your doctor may need to perform a blood test to check that using too much ointment 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 glands near the kidneys that produce hormones).

Contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount used.

If you forget to use Psotriol 50 micrograms/g + 0.5 mg/g ointment

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

If you stop using Psotriol 50 micrograms/g + 0.5 mg/g ointment

Use of Psotriol 50 micrograms/g + 0.5 mg/g ointment 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/nurse immediately or as soon as possible if you experience any of the following side effects. You may need to stop your treatment.

The following serious side effects have been reported for Psotriol 50 micrograms/g + 0.5 mg/g ointment:

Uncommon (may affect up to 1 in 100 people)

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

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

• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet) may occur. If this happens to you, stop using Psotriol 50 micrograms/g + 0.5 mg/g ointment and tell your doctor as soon as possible.

It is known that some serious side effects are caused by betamethasone (a strong steroid), one of the components of Psotriol 50 micrograms/g + 0.5 mg/g ointment. If you experience 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 on skin folds (e.g. groin, armpits, or under the breasts), when covered, or when used on large areas of skin. The side effects include:

• Your adrenal glands may stop working properly. The symptoms are tiredness, 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 suppressed or weakened)
• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If this happens to you, stop using Psotriol 50 micrograms/g + 0.5 mg/g ointment 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 your blood sugar/glucose levels).

Serious side effects caused by calcipotriol

• Allergic reactions with severe 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 using Psotriol 50 micrograms/g + 0.5 mg/g ointment, tell your doctor immediately or go to the emergency department of the nearest hospital.
• Treatment with this ointment may cause an increase in the level of calcium in your blood or urine (usually when too much ointment is used). The 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, the levels return to normal.

Less serious side effects

The following less serious side effects have been reported for Psotriol 50 micrograms/g + 0.5 mg/g ointment.

Common (may affect up to 1 in 10 people)

• Itching
• Scaling of the skin

Uncommon (may affect up to 1 in 100 people)

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

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

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

Less serious side effects caused by the use of betamethasone, especially during prolonged use, include:

• 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 follicle (folliculitis)
• Blurred vision

Less serious side effects caused by calcipotriol include:

• Dry skin
• Sensitivity of the skin 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
• Skin 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 to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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 tube after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Do not refrigerate.

The tube should be discarded 1 year after the first opening. Write the date of the first opening of the tube on the space provided on the carton.

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 ointment

The active substances 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 ingredients are:

Liquid paraffin, polyoxypropylene stearyl ether, white paraffin (contains all-rac-α-tocopherol), butylhydroxytoluene (E321)

Appearance of the product and pack size

Psotriol 50 micrograms/g + 0.5 mg/g ointment is a white to yellowish ointment, available in aluminum/epoxyphenol tubes with a polyethylene screw cap.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Mibe Pharma España S.L.U.

Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 - Brehna

Germany

Sun-Farm Sp. z. o. o.

Dolna 21

Lomianki, 05-092Mazowieckie

Poland

This medicine is authorised in the Member States of the European Economic Area under 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: Psotriol 50 microgramos/g + 0,5 mg/g pomada

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

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

Poland: Psotriol

Date of last revision of this leaflet: May 2019

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