DAIVOBET 50 micrograms / 0.5 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Daivobet 50micrograms/0.5mg/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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Daivobet and what is it used for
2. What you need to know before you use Daivobet
3. How to use Daivobet
4. Possible side effects
5. Storing Daivobet
6. Contents of the pack and other information

1. What is Daivobet and what is it used for

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

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

2. What you need to know before you use Daivobet

Do not use Daivobet

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

Since Daivobet 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/nurse/pharmacist before and during the use of Daivobet 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 level 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
• 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 dressings as they increase the absorption of the steroid
• Avoid using it on large areas of damaged skin, mucous membranes, or skin folds (e.g., groin, armpits, under the breasts) as they increase the absorption of the steroid
• Avoid using it on the face or genitals (sex organs) as they are highly sensitive to steroids
• Avoid excessive sunbathing, excessive use of sunlamps, and other light treatments.

Children

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

Using Daivobet with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. If your doctor agrees that you can breastfeed, be careful and do not apply Daivobet to the breast area.

Driving and using machines

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

Daivobet ointment contains butylhydroxytoluene (E321)

Daivobet ointment may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene (E321).

3. How to use Daivobet

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

How to use Daivobet: Cutaneous use.

Instructions for proper use

• Use it only on your psoriasis and do not use it on skin without psoriasis
• Before the first use of the ointment, remove the cap and check that the seal of 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 psoriasis area until most of the ointment has disappeared from the skin
• Do not put a bandage or cover the treated skin area
• Wash your hands well after using Daivobet (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 if it has spread too much
• In order to achieve an optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet ointment
• After applying the ointment, avoid contact with fabrics that may stain easily with 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 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 should you expect when using Daivobet?

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

If you use more Daivobet than you should

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

Excessive use of Daivobet 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 blood tests 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 located near the kidneys and produce hormones).

Contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Daivobet

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

If you stop using Daivobet

The use of Daivobet 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 Daivobet

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 Daivobet and tell your doctor as soon as possible.

Some serious side effects are known to be caused by betamethasone (a potent steroid), one of the components of Daivobet. 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 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, 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 weakened or suppressed)
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using Daivobet 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 Daivobet, 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 Daivobet.

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
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to the 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
• 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)

• Bacterial or fungal infection of the hair follicle (furuncle)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Sensitivity of the skin to light leading to a rash
• Acne (pimples)
• Dry skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

Frequency not known (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 them, 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)
• Golden-colored papules (colloid milium)
• Discoloration of the skin (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 rash
• Eczema
• Itching
• Skin irritation
• Burning sensation and itching
• Redness of the skin due to the dilation of small blood vessels (erythema)
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Daivobet

• 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 label after EXP. The expiry date is the last day of the month shown
• Do not store the medicine at a temperature above 25°C
• The tube should be discarded one year after the first opening. Write the date when you first open the tube in 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 Daivobet

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
• all-rac-α-tocopherol
• polyoxypropylene stearyl ether
• white petrolatum
• butylhydroxytoluene (E321).

Appearance of Daivobet and contents of the pack

Daivobet ointment is a white to yellowish ointment that comes in aluminum/epoxyphenol tubes with a polyethylene screw cap.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

The manufacturer is:

LEO Laboratories Ltd.

Cashel Road, Dublin 12, Ireland.

This medicine is authorized in the Member States of the European Economic Area under 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

Date of last revision of this leaflet: August 2018

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/.