Daivobet

PATIENT INFORMATION LEAFLET: USER INFORMATION

Daivobet, (50 micrograms + 0.5 mg)/g, ointment

Calcipotriol+ Betamethasone

You should read the contents of this leaflet carefully before using the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• You should consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Daivobet and what is it used for
• 2. Important information before using Daivobet
• 3. How to use Daivobet
• 4. Possible side effects
• 5. How to store 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 psoriasis in adults. Psoriasis is caused by the skin cells being produced too quickly. This leads to redness, scaling, and thickening of the skin.
Daivobet ointment contains calcipotriol and betamethasone. Calcipotriol helps to slow down the rate of skin cell growth to normal, while betamethasone reduces inflammation.

2. IMPORTANT INFORMATION BEFORE USING DAIVOBET

When not to use Daivobet

Since Daivobet contains a strong steroid, DO NOT use this medicine for skin diseases such as:

• viral skin infections (e.g. herpes or chickenpox),
• fungal skin infections (e.g. athlete's foot or fungal infections caused by dermatophytes),
• bacterial skin infections,
• parasitic skin infections (e.g. scabies),
• tuberculosis
• perioral dermatitis (red rash around the mouth),
• thin skin, with easy bruising, stretch marks,
• ichthyosis (dry skin with scaling similar to fish scales),
• acne,
• rosacea (severe flushing or redness of the skin on the face),
• ulcers or broken skin.

Warnings and precautions

Before starting and during treatment with Daivobet, you should discuss with your doctor or pharmacist if:

• you are using other medicines containing corticosteroids, which may cause side effects,
• you have used this medicine for a long time and plan to stop treatment (as there is a risk of worsening or exacerbation of psoriasis in case of sudden discontinuation of steroids),
• you have diabetes, as steroids may affect blood sugar (glucose) levels,
• you have a skin infection that may require discontinuation of treatment,
• you have guttate psoriasis,
• you experience blurred vision or other vision disturbances

Special precautions

• Avoid using the medicine on more than 30% of the body surface and using more than 15 grams per day.
• Avoid using under bandages and dressings, as this increases the absorption of steroids.
• Avoid using on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases the absorption of steroids.
• Avoid using on the face and genital areas, as they are very sensitive to the effects of steroids.
• Avoid excessive sunbathing, excessive use of sunbeds, and other forms of light therapy.

Children and adolescents

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

Daivobet and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before using this medicine.
If your doctor has agreed that you can breastfeed, you should be careful and not use Daivobet on the breast area.
.

Driving and using machines

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

Daivobet contains butylhydroxytoluene (E 321)

Daivobet contains butylhydroxytoluene (E 321). This may cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.

3. HOW TO USE DAIVOBET

Daivobet ointment should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist again.
Method of administration: topical application.
Instructions for proper use

• Use only on skin affected by psoriasis; do not use on unaffected skin.
• Before first use, remove the cap from the tube and check if the seal is damaged.
• To break the seal, use the tip of the cap.
• Squeeze the ointment onto a clean finger.
• Rub the ointment gently into the skin to form a layer on the surface of the skin affected by psoriasis, until most of the ointment has disappeared from the skin.
• Do not cover the treated area with bandages, tight dressings, or bandages.
• After using Daivobet, wash your hands thoroughly (if you are not using the ointment to treat your hands). This will help prevent accidental transfer of the ointment to other parts of the body (especially the face, scalp, mouth, and eyes).
• Do not worry if a small amount of ointment accidentally gets on healthy skin near the psoriasis-affected area. Just rub it off if it spreads too far.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately after applying Daivobet ointment.
• After applying the ointment, you should avoid contact with fabrics that may stain easily due to the fat content (e.g. silk).

Duration of treatment

• The ointment should be used once a day. It may be more convenient to use the ointment in the evening.
• 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 of the medicine per day.

In case of using other medicines containing calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated skin area should not exceed 30% of the total body surface.

What to expect when using Daivobet

Most patients see noticeable treatment results after 2 weeks, even if the symptoms of psoriasis have not yet disappeared from the treated area.

Using more Daivobet than recommended

If you have used more than 15 grams in one day, you should contact your doctor.
Excessive use of Daivobet may cause disturbances in blood calcium levels, which usually return to normal after treatment is discontinued.
Your doctor may perform blood tests to check if using too much ointment has caused disturbances in your blood calcium levels.
Prolonged, excessive use may also cause adrenal insufficiency (the adrenal glands, located near the kidneys, produce hormones).

Missing a dose of Daivobet

You should not use a double dose to make up for a missed dose.

Stopping treatment with Daivobet

Daivobet should be discontinued as directed by your doctor. It may be necessary to gradually discontinue treatment, especially if it has been used for a long time.
If you have any further questions about using the medicine, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects
If you experience any of the following symptoms, you should inform your doctor or nurse immediately or as soon as possible. It may be necessary to discontinue treatment.
There have been reports of the following severe side effects of Daivobet:
Uncommon (may affect less than 1 in 100 people)

• Worsening of psoriasis. If you experience worsening of psoriasis, you should inform your doctor as soon as possible.

Rare (may affect less than 1 in 1,000 people)

• Pustular psoriasis (red area of skin with yellowish pustules, usually on the hands or feet). If you notice this, you should discontinue Daivobet and inform your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a strong steroid), one of the ingredients of Daivobet. If you experience any of the following severe side effects, you should inform your doctor as soon as possible.
These are likely to occur after prolonged use, use in skin folds (in the groin, under the arms, under the breasts), use under occlusive dressings, or use on large areas of skin.
The side effects include:
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Adrenal glands may stop working properly. Symptoms include fatigue, depression, and anxiety.
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Cataract (symptoms are blurred vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (symptoms are eye pain, redness of the eyes, decreased or blurred vision).
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Infections (related to suppression or weakening of the immune system's ability to fight infections).
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Pustular psoriasis (red area with yellowish pustules, usually on the hands or feet).
If you notice any of these symptoms, you should discontinue Daivobet and inform your doctor as soon as possible.
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Effect on metabolic control of diabetes (if you have diabetes, you may experience fluctuations in blood glucose levels).
Severe side effects caused by calcipotriol:
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Allergic reactions with deep swelling of the face or other parts of the body, such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If you experience an allergic reaction, you should discontinue Daivobet and immediatelyinform your doctor or go to the emergency department of the nearest hospital.
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Using this ointment may cause an increase in blood or urine calcium levels (usually when using too much ointment). Symptoms of high blood calcium levels include excessive urination, constipation, muscle weakness, confusion, and coma. These can be severe, so you should contact your doctor immediately.
After discontinuing treatment, these levels return to normal.
Milder side effects
Milder side effects of Daivobet have also been reported.
Common side effects (may affect less than 1 in 10 people)

• Itching
• Scaling of the skin

Uncommon (may affect less than 1 in 100 people)

• Pain or irritation of the skin
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair follicle (folliculitis)
• Changes in skin color at the site of application
• Rash
• Burning sensation
• Skin infections
• Thinning of the skin
• Appearance of red or purple skin discolorations (petechiae or purpura).

Rare (may affect less than 1 in 1,000 people)

• Bacterial or fungal infections of the hair follicle (furuncles)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Photosensitive skin reaction with rash
• Acne
• Dry skin
• Rebound effect: worsening of psoriasis symptoms after treatment is stopped.

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

• Blurred vision

Milder side effects caused by betamethasone, especially after prolonged use, are listed below. You should inform your doctor as soon as possible if you notice any of them.

• Thinning of the skin
• Appearance of superficial blood vessels and stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Rash with inflammation or swelling
• Yellowish, gel-filled bumps (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Other milder side effects caused by calcipotriol

• Dry skin
• Sensitivity of the skin to light, causing rash
• Urticaria
• Itching
• Skin irritation
• Burning or stinging sensation
• Redness of the skin due to dilation of small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 e-mail: [email protected] By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DAIVOBET

• Keep out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• The tube should be discarded 12 months after first opening. You should write the date of first opening of the tube in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Daivobet contains

The active substances are:
calcipotriol and betamethasone.
One gram of ointment contains 50 micrograms of calcipotriol (as calcipotriol monohydrate) and
0.5 mg of betamethasone (as dipropionate).
The other ingredients are

• liquid paraffin
• stearyl alcohol polyoxypropylene ether
• all-rac-α-tocopherol
• white vaseline
• butylhydroxytoluene (E 321)

What Daivobet looks like and contents of the pack

Daivobet ointment is a cream-colored to yellow ointment, in an aluminum tube with an inner epoxy coating, with a PE cap, in a cardboard box.
Pack sizes: 3 g, 15 g, 30 g, 60 g, 100 g, and 120 g.
Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer

LEO Laboratories Ltd.
Cashel Road 285
Dublin 12
Ireland
To obtain more detailed information, you should contact your local representative of the marketing authorization holder:
LEO Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel +48 22 244 18 40

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Daivobet: Bulgaria, Denmark, Estonia, Finland, France, Spain, Iceland, Lithuania, Latvia, Malta, Germany, Norway, Portugal, Czech Republic, Romania, Slovenia, Sweden, Hungary
Dovobet: Belgium, Cyprus, Greece, Netherlands, Ireland, Luxembourg, United Kingdom, Italy
Date of last revision of the leaflet:
August 2018

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.