Leaflet: information for the user

Daivobet 50 micrograms/0.5 mg/g gel

calcipotriol/betamethasone

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Daivobet is used as a topical treatment for scalp psoriasis in adults and to treat mild to moderate plaque psoriasis (psoriasis vulgaris) on other areas of the body in adults. The cause of psoriasis is the excessively rapid production of skin cells. This causes redness, scaling, and thickening of the skin.

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

Do not use Daivobet:

• if you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other components 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: 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)
• 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 use of Daivobet if:

• you are using other medicines that contain corticosteroids, as you may experience adverse 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 up' when steroids are suddenly stopped)
• you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
• a skin infection appears, as treatment may need to be interrupted
• you have a type of psoriasis called guttate psoriasis.
• if 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 hats, bandages or gauze as it increases steroid absorption
• Avoid using it on large areas of damaged skin, mucous membranes or skin folds (groins, armpits, under the breasts) as it increases steroid absorption
• 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 medicine is not recommended for use in children under 18 years.

Use of Daivobet with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor 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 operating machinery

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

Daivobet contains butylhydroxytoluene (E321)

Daivobet may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

How to use Daivobet: Topical use.

Container

Instructions for proper use

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Shake the container before use and remove the cap
• Apply the gel on a clean finger or directly on the psoriasis area
• Apply Daivobet with the tip of your fingers on the affected area and massage carefully until the affected area by psoriasis is covered with a thin layer of gel
• Do not put a bandage, cover or wrap the treated skin area
• Wash your hands thoroughly after using Daivobet. This way, accidental contact of the gel with other parts of your body (especially face, mouth and eyes) will be avoided
• Do not worry if accidentally some gel is applied on healthy skin near your psoriasis, but clean it if it has spread too much
• To achieve the best effect, it is recommended not to shower or bathe immediately after applying Daivobet gel
• After applying the gel, avoid contact with fabrics that can easily stain with grease (for example, silk).

If you have psoriasis on the scalp

-Before applying Daivobet on the scalp, brush your hair to remove the scales. Tilt your head to avoid Daivobet from spreading to your face. It may be helpful to separate your hair from the treated area before using Daivobet. Apply Daivobet with the tip of your fingers on the affected area and massage carefully.

You do not need to wash your hair before applying Daivobet.

To achieve the best effect, it is recommended not to wash your hair immediately after applying Daivobet. Leave Daivobet on the scalp for the night or during the day. When washing your hair, after application, the following instructions may be helpful:

If necessary, repeat steps 4 to 6 once or twice.

Treatment duration

• Use the gel once a day. It may be more comfortable to apply the gel at night
• The initial treatment period is usually 4 weeks for scalp areas and 8 weeks for other areas
• 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.

Applicator

Read the instructions for using the Daivobet gel applicator, including at the end of this leaflet, carefully before starting to use it.

You will find information on assembly, use, cleaning and storage of the Daivobet gel applicator in the Instructions for Use.

The Daivobet gel with applicator is referred to as "the applicator" throughout this leaflet.

Instructions for proper use of Daivobet

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Apply Daivobet with the applicator on the affected area and massage carefully until the affected area by psoriasis is covered with a thin layer of gel
• Do not put a bandage, cover or wrap the treated skin area
• Wash your hands thoroughly after using Daivobet if the gel comes into contact with your fingers. This way, accidental contact of the gel with other parts of your body (especially face, mouth and eyes) will be avoided
• Do not worry if accidentally some gel is applied on healthy skin near your psoriasis, but clean it if it has spread too much
• To achieve the best effect, it is recommended not to shower or bathe immediately after applying Daivobet gel
• After applying the gel, avoid contact with fabrics that can easily stain with grease (for example, silk).

You do not need to wash your hair before applying Daivobet.

To achieve the best effect, it is recommended not to wash your hair immediately after applying Daivobet. Leave Daivobet on the scalp for the night or during the day. When washing your hair, after application, the following instructions may be helpful:

If necessary, repeat steps 1 to 3 once or twice.

Treatment duration

• Use the gel once a day. It may be more comfortable to apply the gel at night
• The initial treatment period is usually 4 weeks for scalp areas and 8 weeks for other areas
• 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. This means that an applicator with 60 g should last at least 4 days
• Usually, an amount between 1 g and 4 g per day is sufficient for scalp treatment.

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.

One full stroke releases 0.05 g of Daivobet gel.

What should I expect when using Daivobet?

Most patients observe obvious results in 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 per day.

Excessive use of Daivobet may cause a problem with your blood calcium, which usually normalizes when the treatment is stopped.

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

Long-term and excessive use may also cause your adrenal glands to stop functioning properly (adrenal glands are located near the kidneys and produce hormones).

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

If you forgot to use Daivobet

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

If you stop using Daivobet

Daivobet use should be stopped as indicated by your doctor. It may be necessary to stop using this medication gradually, 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 your treatment.

The following severe side effects have been reported for Daivobet

Rare (may affect up to 1 in 100 people)

• Worsening of your psoriasis. If your psoriasis worsens, 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 on skin folds (such as elbows, axillae, 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 or hazy vision, decreased night vision, and light sensitivity) 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 Daivobet 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. It may cause swelling of the mouth/throat and respiratory problems. 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 gel may cause an increase in calcium levels in your blood or urine (usually when too much gel 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.

Rare (may affect up to 1 in 100 people)

• Irritation of the eyes
• Sensation of burning skin
• Pain or irritation of the skin
• Inflammation or swelling of the hair follicle (folliculitis)
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Skin rash
• Pustular rash
• Skin infection.

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions
• Striae
• Skin exfoliation
• Rebound effect: A worsening of symptoms/psoriasis after treatment is stopped.

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

-When used on the scalp, white or gray hair may temporarily change to a yellowish color in the application area

-Blurred vision.

Mild side effects caused by the use of betamethasone, especially during prolonged use, include the following. If you notice 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
• Red rash around the mouth (perioral dermatitis)
• Red rash with inflammation or swelling of the skin (allergic contact dermatitis)
• 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
• Irritation of the skin
• Sensation of burning and itching
• Redness of the skin due to dilation of small blood vessels (erythema)
• Skin rash
• Skin rash with inflammation of the skin (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 Spanish System for Pharmacovigilance of Medicines for Human Use: 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

Container

• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated
• Do not refrigerate. Store the container in the outer packaging to protect it from light
• Dispose of the container with remaining gel within 6 months of the first opening.

Applicator

• Do not use this medication after the expiration date that appears on the cartridge after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerate
• The applicator is disposable. Dispose of the applicator with remaining gel within 6 months of the first opening.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.in the environment.

Composition of Daivobet

The active principles are:

Calcipotriol and betamethasone.

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

The other components are:

• liquid paraffin
• polyoxipropylene ester
• hydrogenated ricin oil
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.

Appearance of Daivobet and packaging contents

Container

Daivobet is a nearly transparent, colorless, or slightly white gel that is presented in high-density polyethylene containers with a low-density polyethylene nozzle and a high-density polyethylene cap.

The containers are packaged in cardboard boxes.

Packaging sizes: 15 g, 30 g, 60g, 80 g, 2 x 60 g, 2 x 80 g, and 3 x 60 g.

Applicator

Daivobet is a nearly transparent, colorless, or slightly white gel that is presented in a polypropylene cartridge (with a cap and a high-density polyethylene piston and plunger) that is assembled before first use. The cartridge and the applicator head (polypropylene outer cover, polyoxymethylene lever, and thermoplastic elastomer nozzle) are assembled before first use. The polypropylene cap is for conservation after use.

The cartridge, the applicator head, and the cap are included in a cardboard box.

Packaging sizes: 60 g (equivalent to 68 ml) and 2 x 60 g (equivalent to 2 x 68 ml).

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

The marketing authorization holder is:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

The manufacturers are:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

or

LEO Laboratories Ltd. (LEO Pharma)

285 Cashel Road

Dublin 12

Ireland

The Instructions for Use of the applicator are included at the end of this leaflet.

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

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

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

Last review date of this leaflet: October 2019.

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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Instructions for Use

of the Daivobet gel applicator

Read this leaflet carefully before you start using this medicinal product – even if you have used Daivobet gel before.

The Daivobet gel applicator is designed to apply Daivobet gel to your skin and scalp affected by psoriasis plaques. Using the Daivobet gel applicator, you can apply Daivobet gel without the gel coming into contact with your fingers.

Always follow the psoriasis treatment instructions given by your doctor.

Do not shareDaivobet gel or the applicator with others.

Keep this medicinal productout of the sight and reach of children.

Your Daivobet gel

If you travel by air with the Daivobet gel applicator attached, you may need to press the lever several times to re-prime it before use.

H) After application

Check that the affected areas are sufficiently covered with gel.

If necessary, ask someone to help you apply Daivobet gel to areas you cannot reach or see.

Wash your handsafter use, if Daivobet gel comes into contact with your fingers or those of the person who applied the gel.

This will prevent accidental contact with other parts of your body (especially your face, mouth, and eyes).

Storage

Ensure the cap is always correctly placed (you will hear a click) to prevent Daivobet gel from spilling during storage and transportation.

For additional information on storing the product, see section 5 ‘Storage of Daivobet’.

Disposal

For additional information on disposing of the product, see section 5 ‘Storage of Daivobet’.