CORTCAL 50 micrograms/g + 0.5 mg/g OINTMENT

2. What you need to know before you use Cortcal

Do not use Cortcal:

• if you are allergic 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 suffer from certain types of psoriasis: such as erythrodermic, exfoliative and pustular (consult your doctor)

Since this medicine 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
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile veins, stretch marks
• ichthyosis (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 treatment with calcipotriol/betamethasone ointment if:

• you are using other medicines that contain corticosteroids, as you may suffer from 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 it may be necessary to interrupt treatment
• you suffer from 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 dressings as this increases the absorption of the steroid
• avoid using it on large areas of damaged skin, on mucous membranes or in skin folds (e.g. groin, armpits, under the breasts) as this increases the absorption of the steroid
• avoid using it on the face or genitals (sex organs) as these are highly sensitive areas to steroids
• avoid excessive sunbathing, excessive use of sunlamps and other light treatments

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

Children

Cortcal is not recommended for use in children under 18 years of age.

Using Cortcal with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility

Do not use calcipotriol/betamethasone ointment if you are pregnant (or think you may be pregnant) or if you are breastfeeding, unless you have previously agreed this with your doctor. If your doctor agrees that you can breastfeed, be careful and do not apply calcipotriol/betamethasone ointment to the breast area.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

3. How to use Cortcal

Follow your doctor's instructions for using this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

How to apply this medicine: For 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 psoriasis area, 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 calcipotriol/betamethasone 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 clean it off if it spreads too much
• in order to achieve an optimal effect, it is recommended not to shower or bathe immediately after applying calcipotriol/betamethasone ointment
• after applying the ointment, avoid contact with fabrics that may be easily stained by the 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 to 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 Cortcal

Most patients notice obvious results after 2 weeks, even if the psoriasis has not completely cleared up at that time.

If you use more Cortcal than you should

Consult your doctor if you have used more than 15 grams in one day.

Excessive use of calcipotriol/betamethasone ointment may cause a problem with the calcium in your blood, which usually returns to normal when treatment is stopped.

Your doctor may need to perform blood tests to check that using too much ointment has not caused a problem with the calcium in your blood.

Prolonged and excessive use may also cause your adrenal glands to stop working properly (these are located near the kidneys and produce hormones).

If you have used more calcipotriol/betamethasone ointment than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

If you forget to use Cortcal

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

If you stop treatment with Cortcal

Use of this medicine should be stopped as indicated by your doctor. It may be necessary to gradually stop using this medicine, especially if you have been using it for a long time.

If you have any further questions on 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 suffer from any of the following side effects. You may need to stop your treatment.

The following serious side effects have been reported for calcipotriol/betamethasone:

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)

• psoriasis pustular (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using calcipotriol/betamethasone and tell your doctor as soon as possible.

It is known that some serious side effects are caused by betamethasone (a potent steroid), one of the components of this medicine. If you suffer from 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 in skin folds (e.g. groin, armpits, or under the breasts), when covered, or when used on large areas of skin.

Side effects include the following:

• your adrenal glands may stop working properly. Symptoms are tiredness, depression, and anxiety
• cataracts (symptoms are cloudy or blurred vision, difficulty seeing at night, 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 weakened or suppressed)
• psoriasis pustular (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using Cortcal 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 blood sugar levels)

Serious side effects caused by calcipotriol

• allergic reactions with severe swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop using calcipotriol/betamethasone, 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). Symptoms of high calcium levels 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, levels return to normal

Less serious side effects

The following less serious side effects have been reported for calcipotriol/betamethasone:

Common (may affect up to 1 in 10 people)

• itching
• skin exfoliation

Uncommon (may affect up to 1 in 100 people)

• skin pain or irritation
• skin rash with inflammation of the skin (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 in the area where the ointment has been applied
• skin rash (rash)
• burning sensation
• skin infection
• thinning of the skin
• appearance of purple or red discoloration on 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 stopping treatment

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

• blurred vision

Less serious side effects caused by the use of betamethasone, especially during prolonged use, include the following. If you notice any of these, tell 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)
• skin rash with inflammation or swelling (allergic contact dermatitis)
• yellowish bumps (miliary colloid)
• skin discoloration (depigmentation)
• inflammation or swelling of the hair root (folliculitis)

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 dilation of small blood vessels (erythema)
• skin rash (rash)
• skin rash (rash) with inflammation of the skin (dermatitis)
• worsening of psoriasis

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Medicines Monitoring System https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cortcal

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 or freeze.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cortcal

• 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 (excipients) are: all-rac-α-tocopherol (E307), oleyl alcohol, light liquid paraffin, and white vaseline.

Appearance and packaging

Cortcal is a white ointment.

The ointment is available in aluminum/epoxyphenol tubes with a screw cap made of polyethylene or polypropylene.

Package sizes: tubes containing 15 g, 30 g, 60 g, or 120 g of ointment.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Galenicum Derma, S.L.

Crta N-1, Km 36,

28750 San Agustin de Guadalix (Madrid)

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova ulica, 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Lange Goehren 3

D-39171, Suelzetal

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben Germany

Date of last revision of this leaflet: November 2021

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