Package Insert: Information for the Patient

Cortcal 50 micrograms/g + 0.5 mg/g Ointment

calcipotriol/betamethasone

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Cortcal is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. The cause of psoriasis is the excessively rapid production of skin cells. This causes redness, scaling, and thickening of the skin.

Cortcal contains calcipotriol and betamethasone. Calcipotriol helps to normalize the rate of growth of skin cells and betamethasone reduces inflammation.

Do not use Cortcal:

• if you are allergic 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)

Sincethis medicationcontains 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
• 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 of the face)
• ulcers or injured skin

Warnings and precautions

Consult your doctor or pharmacist before starting to usecalcipotriol/betamethasone ointmentif:

• 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 level 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

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 the absorption of the steroid
• avoid using it on large areas of damaged skin, mucous membranes or skin folds (joints, axillae, 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

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

Children

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

Use of Cortcal with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including over-the-counter medications.

Pregnancy, breastfeeding and fertility

Do not usecalcipotriol/betamethasone ointmentif you are pregnant (or think you may be) or breastfeeding, unless your doctor has previously agreed to it. If your doctor agrees that you can breastfeed, be careful and do not applycalcipotriol/betamethasone ointmentto the breast area.

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.

Driving and operating machinery

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

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 this medication: Topical 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 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 usingcalcipotriol/betametasona ointment(unless you are using the ointment to treat your hands). This will prevent accidental contact with other parts of your body (especially your face, scalp, mouth, and eyes)
• Do not worry if you accidentally apply a little ointment to healthy skin near your psoriasis, but clean it up if it has spread too much
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applyingcalcipotriol/betametasona ointment
• After applying the ointment, avoid contact with fabrics that can easily stain with grease (such as 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 to expect when using Cortcal?

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

If you use more Cortcal than you should

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

Excessive use ofcalcipotriol/betametasona ointmentmay cause a problem with your blood calcium levels, which usually normalize when you stop treatment.

Your doctor may need to perform blood tests to evaluate whether excessive use of the ointment has caused a problem with your blood calcium levels.

Prolonged and excessive use may also cause your adrenal glands to malfunction (located near the kidneys and produce hormones).

If you have used morecalcipotriol/betametasona ointmentthan you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Cortcal

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

If you interrupt treatment with Cortcal

The use of this medication should be discontinued as indicated by your doctor. It may be necessary to gradually discontinue the use of this medication, 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 for calcipotriol/betametasona:

Rare (may affect up to 1 in 100 people)

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

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

• You may develop pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applying calcipotriol/betametasona and inform your doctor as soon as possible.

It is known that some severe side effects are caused by betametasona (a powerful steroid), one of the components of this medicine. 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 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, difficulty seeing at night 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 depressed or weakened)
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applying Betcal 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. You may experience swelling of the mouth/throat and breathing problems. If you experience an allergic reaction, stop applying calcipotriol/betametasona,inform your doctor immediately or go to the nearest hospital emergency department
• The treatment with this cream may cause an increase in calcium levels in your blood or urine (usually when too much cream 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 for calcipotriol/betametasona:

Mild side effects 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
• Dermatitis (skin inflammation or rash)
• 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 cream has been applied
• Rash
• Burning sensation
• Skin infection
• Skin thinning
• 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,
• Striae,
• 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.

Frequency unknown (frequency cannot be estimated from available data)

• Blurred vision

Mild side effects caused by the use of betametasona, especially over a long period, include the following. If you notice any of them, inform your doctor or nurse as soon as possible.

• Skin thinning
• Appearance of superficial veins or striae
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Dermatitis (skin inflammation or rash)
• Yellowish papules (miliar colloid)
• Decoloration of the skin (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Mild side effects caused by calcipotriol include

• 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 skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Medicines for Human Use Pharmacovigilance System https://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 tube after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze.

The tube mustbe discarded after 1 year after its first opening. Write the date of the first tube opening in the space indicated for this on the box.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you do not need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Betcal

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

Appearance of the product and content of the container

Betcal is a whiteish-colored ointment.

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

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Galenicum Derma, S.L.

Crta N-1, Km 36,

28750 San Agustin de Guadalix (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: November 2021

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