DAIVOBET 50 micrograms/0.5 mg/g GEL

Introduction

Package Leaflet: Information for the User

Daivobet 50 micrograms/0.5 mg/g gel

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 and other information

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

Contents of the pack and further information

1. What is Daivobet and what is it used for

Daivobet is used as a topical treatment for scalp psoriasis in adults and to treat plaque psoriasis (psoriasis vulgaris) of mild to moderate severity on other areas of the body 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 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)
• bacterial skin infections
• parasitic skin infections (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 facial skin)
• 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 experience 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.
• 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 occlusive dressings, bandages, or gauzes 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 sun exposure, excessive use of artificial sunlight, and other forms of light therapy.

Children

Daivobet 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 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).

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.

How to use Daivobet: Cutaneous use.

Bottle

Instructions for proper use

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Shake the bottle before use and remove the cap
• Apply the gel to a clean finger or directly to the affected area
• Apply Daivobet with your fingertips to the affected area and massage carefully until the affected area is covered with a thin layer of gel
• Do not cover or bandage the treated skin area
• Wash your hands well after using Daivobet. This will prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes)
• Do not worry if you accidentally apply a little gel to the healthy skin near your psoriasis, but clean it if it has spread too much
• In order 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 tissues that may be easily stained with grease (e.g., silk).

If you have psoriasis on the scalp

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

It is not necessary to wash your hair before applying Daivobet.

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

If necessary, repeat steps4 to6 one or two times.

Treatment duration

• Use the gel once a day. It may be more convenient to apply the gel at night
• The initial treatment period is normally 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 in a 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.

Applicator

Read the instructions for using the Daivobet gel applicator, included at the end of this leaflet, carefully before you start using it.

In the Instructions for Use, you will find information on the assembly, use, cleaning, and maintenance of the Daivobet gel applicator.

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 to the affected area and massage carefully until the affected area is covered with a thin layer of gel
• Do not cover or bandage the treated skin area
• Wash your hands well after using Daivobet if the gel comes into contact with your fingers. This will prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes)
• Do not worry if you accidentally apply a little gel to the healthy skin near your psoriasis, but clean it if it has spread too much
• In order 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 tissues that may be easily stained with grease (e.g., silk).

It is not necessary to wash your hair before applying Daivobet.

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

If necessary, repeat steps 1 to 3 one or two times.

Treatment duration

• Use the gel once a day. It may be more convenient to apply the gel at night
• The initial treatment period is normally 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 in a day. This means that a 60g applicator should last at least 4 days
• Normally, an amount between 1g and 4g per day is sufficient for the treatment of the scalp.

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.

A full press of the applicator delivers 0.05g of Daivobet gel.

What can 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 a day.

Excessive use of Daivobet 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 gel 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 (the adrenal glands 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 the forgotten dose.

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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Inform your doctor/nurse immediately or as soon as possible if you suffer from any of the adverse effects mentioned below. You may need to interrupt your treatment.

The following severe adverse effects have been reported for Daivobet

Uncommon (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 adverse effects are caused by betamethasone (a potent steroid), one of the components of Daivobet. If you suffer from any severe adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur after long-term use, when used in skin folds (e.g., groin, armpits, or under the breasts), when the area is covered, or when used on large areas of skin.

The adverse effects include the following:

• Your adrenal glands may stop functioning properly. The symptoms are fatigue, 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 depressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop applying Daivobet and inform your doctor as soon as possible.
• Effect on the metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels).

Severe Adverse Effects Caused by Calcipotriol

• Allergic reactions with intense swelling of the face or other parts of the body, such as 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 emergency room of the nearest hospital.
• Treatment with this gel may cause an increase in calcium levels in your blood or urine (usually when too much gel is used). The 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 discontinued, levels return to normal.

Less Severe Adverse Effects

The following less severe adverse effects have been reported for Daivobet

Common Adverse Effects (may affect up to 1 in 10 people)

• Itching.

Uncommon (may affect up to 1 in 100 people)

• Eye irritation.
• Skin burning sensation.
• Skin pain or irritation.
• Inflammation or swelling of the hair root (folliculitis).
• Skin rash with skin inflammation (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.
• Stretch marks.
• Skin peeling.
• Rebound effect: Worsening of symptoms/psoriasis after treatment ends.

Frequency Not Known (frequency cannot be estimated from available data)

• When used on the scalp, white or gray hair may temporarily change to a yellowish color at the application site.
• Blurred vision.

The less severe adverse effects caused by the use of betamethasone, especially during prolonged periods, include the following. If you notice any of them, you should inform your doctor or nurse as soon as possible

• Skin thinning.
• 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).
• Skin discoloration (depigmentation).
• Inflammation or swelling of the hair root (folliculitis).

The less severe adverse effects caused by calcipotriol include

• Dry skin.
• Skin sensitivity to light leading to a skin rash.
• Eczema.
• Itching.
• Skin irritation.
• Burning and itching sensation.
• Redness of the skin due to dilation of small blood vessels (erythema).
• Skin rash.
• Skin rash with skin inflammation (dermatitis).
• Worsening of psoriasis.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Daivobet

• Keep this medicine out of sight and reach of children.

Bottle

• Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerate. Store the bottle in the outer packaging to protect it from light.
• Discard the bottle with the remaining gel 6 months after the first opening.

Applicator

• Do not use this medicine after the expiration date stated on the cartridge after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerate.
• The applicator is disposable. Discard the applicator with the remaining gel 6 months after the first opening.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Daivobet

The active ingredients 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 ingredients are:

• liquid paraffin.
• polyoxypropylene stearyl ether.
• hydrogenated castor oil.
• butylhydroxytoluene (E321).
• all-rac-α-tocopherol.

Appearance of Daivobet and Package Contents

Bottle

Daivobet is a nearly transparent, colorless or slightly whitish gel presented in high-density polyethylene bottles with a low-density polyethylene nozzle and a high-density polyethylene screw cap.

The bottles come in cardboard boxes.

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

Applicator

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

The cartridge(s), applicator head(s), and cap(s) are included in a cardboard box.

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

Not all package 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 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 medicine is authorized in the Member States of the European Economic Area under 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.

Date of the last revision of this leaflet: October 2019.

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/.

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Instructions for Use

of the Daivobet gel applicator

Read the entire leaflet and the Instructions for Use carefully before starting to use this medicine – 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 treatment instructions for your psoriasis indicated by your doctor.

Do not shareDaivobet gel or the applicator with other people.

Keep this medicine out of sight and reach of children.

Your Daivobet gel

If you take a flight with the Daivobet gel applicator assembled, you may need to press the lever several times to re-prime it before use.

• After application.

Check that the affected areas are sufficiently covered by the 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 avoid accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).

Storage

Make sure the cap is always properly placed (you will hear a click) to avoid the gel spilling during storage and transport.

In section 5, 'Storage of Daivobet', you will find additional information related to the storage of the product.

Disposal

In section 5, 'Storage of Daivobet', you will find information on the disposal of the product.