Psotriol 50 micrograms/g + 0.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Psotriol 50 micrograms/g + 0.5 mg/g ointment

calcipotriol/betamethasone

Read the 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 may 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.

Contents of the leaflet

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 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 adverse effects
5. How to store 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 excessively rapid production of your skin cells. This leads to redness, scaling, and thickening of the skin.

Psotriol 50 micrograms/g + 0.5 mg/g ointment 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 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 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 50 micrograms/g + 0.5 mg/g ointment 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 blood vessels, or stretch marks
• Ichthyosis (dry, scaly skin)
• Acne (spots)
• Rosacea (intense redness or flushing of the facial skin)
• Ulcers or damaged 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 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

Special precautions

• Avoid use on more than 30% of your body surface or more than 15 grams per day
• 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 genitals (genital organs), as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial tanning, or other forms of light therapy

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

Children

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

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 might be pregnant) or if you are breastfeeding, unless your doctor has previously approved it. If your doctor agrees that you may breastfeed, take care not to 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 operate machinery.

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 use of this medicine as given by your doctor. If in doubt, 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 areas affected by psoriasis; do not apply it to skin without psoriasis
• Before first use of the ointment, remove the cap and check that the seal on the tube is intact
• To break the seal, use the protrusion located on the back of the cap
• Apply the ointment to a clean fingertip
• Gently rub it into the skin to cover the psoriatic area, until most of the ointment has been absorbed
• Do not apply a dressing, or cover or wrap the treated skin area
• Wash your hands thoroughly after using Psotriol 50 micrograms/g + 0.5 mg/g ointment (unless you are treating your hands). This will help prevent accidental contact of the ointment with other parts of your body (especially the face, scalp, mouth, and eyes)
• Do not worry if a small amount of ointment is accidentally applied to healthy skin near the psoriasis, but wipe it off if it has spread excessively
• To achieve optimal 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 daily. It may be more convenient to apply the ointment at night
• The usual initial treatment period is 4 weeks, but your doctor may decide on a different 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 medicines 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 50 micrograms/g + 0.5 mg/g ointment?

Most patients notice obvious improvement within 2 weeks, even if the psoriasis has not yet completely cleared at that time.

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

Contact your doctor if you have used more than 15 grams in one day. Excessive use of Psotriol 50 micrograms/g + 0.5 mg/g ointment 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 ensure that overuse has not caused a problem 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 50 micrograms/g + 0.5 mg/g ointment

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

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

Use of Psotriol 50 micrograms/g + 0.5 mg/g ointment 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 how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

The following serious adverse 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, inform 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, stop using Psotriol 50 micrograms/g + 0.5 mg/g ointment and 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 50 micrograms/g + 0.5 mg/g ointment. If you experience any of these serious adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur with 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:

• Impaired function of your adrenal glands. Symptoms include fatigue, depression, and anxiety.
• Cataracts (symptoms include blurred or cloudy vision, reduced night vision, and light sensitivity) or increased pressure inside the eye (symptoms include 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 50 micrograms/g + 0.5 mg/g ointment and inform your doctor as soon as possible.
• Effects 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 parts of the body 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 50 micrograms/g + 0.5 mg/g ointment and contact your doctor immediately or go to the nearest hospital emergency department.
• 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 elevated blood calcium include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and you must contact your doctor immediately. However, calcium levels return to normal once treatment is stopped.

Less serious adverse effects

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

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

• Itching
• Skin peeling

Uncommon (may affect up to 1 in 100 people)

• Skin pain or irritation
• Skin rash with inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin color at the site of ointment application
• Skin rash (rash)
• Burning sensation
• Skin infection
• Thinning of the skin
• Appearance of 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 (striae)
• Skin sensitivity to light leading to a skin rash
• Acne (spots)
• Dry skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

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)
• Colloid milium (golden-yellow papules)
• Skin discoloration (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)
• Blurred vision

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 inflammation of the skin (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 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 stated on the tube and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Do not refrigerate.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines 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 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 components are:

Liquid paraffin, polyoxyl stearate ether, white paraffin (containing all-rac-α-tocopherol), butylhydroxytoluene (E321)

Appearance of the medicinal product and contents of the pack

Psotriol 50 micrograms/g + 0.5 mg/g ointment is a whitish to yellow ointment supplied in aluminium/epoxyphenolic 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).

Only certain 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

Sun-Farm Sp. z o.o.

Ul. Dolna 21

Lomianki, 05-092 Mazowieckie

Poland

This medicinal product is authorized in the European Economic Area member states 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 the most recent revision of this leaflet: May 2019

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