Product Information for the User

Daivobet 50micrograms/0.5mg/g Cream

calcipotriol/betamethasone

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

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

1.What is Daivobet and how is it used

2.What you need to know before starting to use Daivobet

3.How to use Daivobet

4.Possible adverse effects

5.Storage of Daivobet

6.Contents of the package and additional information

Daivobet cream 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.

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

Do not use Daivobet

-If you are allergic (hypersensitive) 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 have certain types of psoriasis: erythrodermic, exfoliative, and pustular (consult your doctor).

Since Daivobet contains 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)

-Fine skin, fragile veins, striae

-Icthyosis (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/nurse/pharmacist before and during the use of Daivobet if

-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/glucose levels may be affected by the steroid

-You appear to have a skin infection, as you may need to interrupt treatment

-You have a type of psoriasis called guttate psoriasis

-You experience blurred vision or other visual disturbances.

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 (wrinkles, armpits, 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.

Children

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

Use of Daivobet with other medications

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. If your doctor agrees that you can breastfeed, be careful and do not apply Daivobetin the breast area.

Driving and operating machinery

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

Daivobet cream contains butylhydroxytoluene (E321)

Daivobet cream may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes due to the presence of butylhydroxytoluene (E321).

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 use Daivobet: 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 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 apply a bandage, or cover or wrap the treated skin area

-Wash your hands thoroughly after using Daivobet (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 results, it is recommended not to shower or bathe immediately after applying Daivobet ointment

-After applying the ointment, avoid contact with fabrics that can easily stain with grease (e.g., silk).

Treatment duration

-Use the ointment once a day. It may be more convenient 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 in a 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 Daivobet?

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

If you use more Daivobet than you should

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

Excessive use of Daivobet may 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).

Contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Daivobet

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

If you interrupt treatment with Daivobet

Daivobet use should be discontinued as indicated by your doctor. It may be necessary to discontinue this medication gradually, especially if you have been using it for a long time.

If you have any other doubts about using 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 Daivobet:

Less common (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 applying Daivobet and inform your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a potent steroid), one of the components of Daivobet. 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. armpits, groin, 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 light sensitivity) 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)

-Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet).If this happens, stop applying Daivobet and inform your doctor as soon as possible

-Effects 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 respiratory problems may occur. If you experience an allergic reaction, stop applying Daivobet,inform your doctor immediately or go to the nearest hospital emergency room

-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 Daivobet:

Common (may affect up to 1 in 10 people)

• Itching

-Skin exfoliation.

Less common (may affect up to 1 in 100 people)

-Skin pain or irritation

-Dermatitis (skin inflammation)

-Redness of the skin due to dilation of small blood vessels (erythema)

-Folliculitis (inflammation or swelling of the hair follicle)

-Changes in skin color in the area where the cream has been applied

-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)

• Folliculitis caused by bacteria or fungi
• Allergic reactions
• Hypocalcemia
• Striae
• 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.

Frequency not known (cannot be estimated from available data):

• Blurred vision.

The mild side effects caused by the use of betamethasone, especially over a prolonged period, include the following. If you experience any of them, inform your doctor or nurse as soon as possible.

-Thinning of the skin

-Appearance of superficial veins or striae

-Changes in hair growth

-Redness around the mouth (perioral dermatitis)

-Dermatitis (skin inflammation or swelling)

-Yellowish papules (miliar colloid)

-Decoloration of the skin (depigmentation)

-Folliculitis (inflammation or swelling of the hair follicle).

The mild 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)

-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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: 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 label after CAD. The expiration date is the last day of the month indicated

-Do not storethe medication at a temperature above 25°C

-The tube must be discarded one year after the first opening. Write the date when you first open the tube in the space provided for this on the box.

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

Composition of Daivobet

The active principles are:

Calcipotriol and betamethasone.

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

Theother components are:

-liquid paraffin

-all-rac-α-tocopherol

-polyoxipropylene stearyl ether

-white vaseline

-butilhydroxytoluene (E321).

Appearance of Daivobet and content of the container

Daivobet ointment is a whitish to yellowish ointment that is presented in aluminium/epoxyphenol tubeswith a polyethylene screw cap.

Container sizes: 15, 30, 60, 100 and 120g.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder is:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Theresponsible manufactureris:

LEO Laboratories Ltd.

Cashel Road, Dublin 12, Ireland.

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

Daivobet: Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden

Dovobet: Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, Netherlands, United Kingdom

Last review date of this leaflet: August 2018

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