Daivobet

PATIENT INFORMATION LEAFLET: USER INFORMATION

Daivobet, 50 micrograms/g + 0.5 mg/g
Calcipotriol+ Betamethasone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of further doubts, consult a doctor or pharmacist.
• 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Daivobet gel and what is it used for
• 2. Important information before using Daivobet gel
• 3. How to use Daivobet gel
• 4. Possible side effects
• 5. How to store Daivobet gel
• 6. Contents of the pack and other information

1. WHAT IS DAIVOBET GEL AND WHAT IS IT USED FOR

Daivobet gel is used for the local treatment of scalp psoriasis in adults and mild to moderate plaque psoriasis (psoriasis vulgaris) in adults, located on the skin of the body, other than the scalp. Psoriasis is caused by the rapid growth of skin cells, leading to redness, scaling, and thickening of the skin. Daivobet gel contains calcipotriol and betamethasone. Calcipotriol helps to restore the normal growth rate of skin cells, and betamethasone has an anti-inflammatory effect.

2. IMPORTANT INFORMATION BEFORE USING DAIVOBET GEL

When not to use Daivobet gel

• If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6).
• If you have disorders of calcium levels in the blood (consult your doctor).
• If you have other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or guttate psoriasis (consult your doctor).

Daivobet gel contains a strong steroid (betamethasone), so it should not be used in the treatment of skin diseases such as:

• skin viral infections (e.g., herpes or chickenpox)
• skin fungal infections (e.g., athlete's foot or dermatophyte infections)
• skin bacterial infections
• parasitic infections (e.g., scabies)
• tuberculosis
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile blood vessels, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne
• rosacea (severe facial redness or acne)
• ulcers or damaged skin

Warnings and precautions

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

• you are using other medicines containing corticosteroids, as side effects may occur
• you have been using this medicine for a long time and plan to stop using it (as there is a risk that psoriasis may worsen or rebound after sudden discontinuation of steroid treatment)
• you have diabetes, as steroid medicines may affect blood sugar levels
• you have a skin infection, as treatment may need to be interrupted
• you have guttate psoriasis
• you experience blurred vision or other vision disturbances

Precautions

• avoid using the medicine on more than 30% of the body surface and using more than 15g per day
• avoid using the medicine under bathing caps, bandages, or dressings, as this increases steroid absorption
• avoid using the medicine on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under breasts), as this increases steroid absorption
• avoid using the medicine on the face and genital areas, as they are particularly sensitive to steroids
• avoid excessive sunbathing, using sunbeds, or other forms of phototherapy

Children and adolescents

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

Daivobet gel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine. If your doctor agrees to breastfeeding, be careful not to apply Daivobet gel to the breast area.

Driving and using machines

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

Daivobet gel contains butylhydroxytoluene (E321)

Daivobet gel contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. HOW TO USE DAIVOBET GEL

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The way to use Daivobet gel is: apply to the skin. Instructions for proper use:

­Apply only to areas affected by psoriasis - do not apply to healthy skin

­Shake the bottle before use and remove the cap.

­Squeeze the gel onto a clean finger or directly onto the affected area.

­Apply Daivobet gel to the affected areas using your fingertips and gently rub it in until a thin layer is formed.

­Do not cover the treated area with bandages, tight dressings, or band-aids.

­After using Daivobet gel, wash your hands thoroughly to avoid accidentally transferring the gel to other parts of the body (especially the face, mouth, and eyes).

­Do not worry if a small amount of gel accidentally gets on healthy skin near the psoriasis area, but wipe off any excess.

­To achieve optimal effect, it is recommended not to take a shower or bath immediately after applying Daivobet gel.

­After applying the gel, avoid contact with fabrics that may stain easily due to the fat content (e.g., silk).

In case of use on the scalp:

­Before applying Daivobet gel to the skin, comb out your hair to remove any loose skin fragments. Tilt your head so that the medicine does not run onto your face. It may be helpful to part your hair before applying the medicine. Apply Daivobet gel to the affected areas using your fingertips, then gently massage it in.

No need to wash hair before applying Daivobet

Shake the bottle before use Apply a drop of Daivobet gel Apply the medicine directly to the affected skin area
using your fingertips
and rub it into the skin

­Depending on the size of the affected area, 1-4g (up to 1 teaspoon) is usually sufficient.

To achieve optimal effect, it is not recommended to wash your hair immediately after using Daivobet gel. Leave the medicine on the skin for the whole night or day.

When washing your hair after application, the following instructions may be helpful:

Apply a mild shampoo Leave the shampoo Wash your hair as usual.
to dry hair, especially on the scalp
for a few minutes
on the areas where the gel was applied

If necessary, steps 4-6 can be repeated once or twice.

Duration of treatment

­Apply the gel once a day. It may be more convenient to use the gel in the evening.

­The usual initial treatment period is 4 weeks on the scalp and 8 weeks on other skin areas.

­Your doctor may decide on a different treatment period.

­Your doctor may decide to repeat the treatment.

­Do not use more than 15g of the medicine per day.

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

What results to expect when using Daivobet gel

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

Using more Daivobet gel than recommended

If you use more than 15g per day, consult your doctor. Excessive use of Daivobet gel may also cause disturbances in calcium levels in the blood, which usually disappear after treatment is discontinued. Your doctor may order blood tests to check if the use of more than the recommended amount of gel has caused a disturbance in calcium levels in the blood. Prolonged use of Daivobet gel in large amounts may also cause adrenal gland disorders (adrenal glands are glands located near the kidneys that produce hormones).

Missing a dose of Daivobet gel

Do not use a double dose to make up for a missed dose.

Stopping treatment with Daivobet gel

Stop using Daivobet gel as directed by your doctor. It may be necessary to gradually stop using the medicine, especially if it has been used for a long time. If you have any further doubts about using the medicine, 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, tell your doctor or nurse immediately or as soon as possible. Treatment may need to be interrupted. There have been reports of the following severe side effects of Daivobet gel:

• Worsening of psoriasis. If your psoriasis worsens, tell your doctor as soon as possible.

It is known that some serious side effects are caused by betamethasone (a strong steroid) that is one of the ingredients of Daivobet gel. Tell your doctor as soon as possible if you experience any severe side effects. They are likely to occur after long-term use, use in skin folds (groin, armpits, under breasts), use under occlusive dressings, or use on large areas of skin. These side effects include:

• Adrenal gland disorders. Symptoms include fatigue, depression, and anxiety.
• Cataracts (blurred vision, difficulty seeing at night, and sensitivity to light) or increased eye pressure (eye pain, redness, and blurred vision).
• Infections (as the immune system that fights infection may be suppressed or weakened).
• Pustular psoriasis (red area with yellowish pustules, usually on the hands or feet). If you notice such symptoms, stop using Daivobet gel and tell your doctor as soon as possible.
• Effect on blood sugar control in diabetes (blood sugar levels may fluctuate).

Severe side effects caused by calcipotriol

• 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, stop using Daivobet gel and immediately tell your doctor or go to the emergency room.
• As a result of treatment with this gel, an increase in calcium levels in the blood or urine may occur (usually when too much gel is used). Signs of high calcium levels in the blood include excessive urination, constipation, muscle weakness, confusion, and coma. This condition can be severe and you should contact your doctor immediately.After treatment is discontinued, calcium levels return to normal.

Milder side effects

There have been reports of the following milder side effects of Daivobet gel. Common side effects (may affect up to 1 in 10 people)

• Itching

Uncommon side effects (may affect up to 1 in 100 people)

• Eye irritation
• Burning sensation of the skin
• Skin pain or irritation
• Inflammation or swelling of the hair follicle (folliculitis)
• Rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Acne
• Dry skin
• Rash
• Pustular psoriasis
• Skin infections

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

­Allergic reactions

­Stretch marks

­Skin peeling

­Rebound effect: worsening of psoriasis symptoms after treatment is stopped.

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

• White or gray hair may temporarily turn yellow at the application site in case of use on the scalp.
• Blurred vision

Milder side effects that you should tell your doctor or nurse about as soon as possible, usually caused by long-term use of betamethasone, include:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Change in hair growth rate
• Red rash around the mouth (perioral dermatitis)
• Skin rash with accompanying inflammation or swelling (allergic contact dermatitis)
• Golden bumps filled with a gel-like substance (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Other milder side effects caused by calcipotriol that have been reported include:

• Dry skin
• Skin sensitivity to light with a rash
• Rash
• Itching
• Skin irritation
• Burning or stinging sensation
• 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

• The Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.

5. HOW TO STORE DAIVOBET GEL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the bottle after the word EXP. The expiry date refers to the last day of that month.
• Do not store in the refrigerator. Store the bottle in the outer packaging to protect it from light.
• Discard all bottles containing any amount of gel after 6 months from the first opening.

Medicines should not be disposed of via wastewater or household waste. 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 gel contains

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

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

What Daivobet gel looks like and what the pack contains

Daivobet is a nearly transparent, colorless to slightly creamy gel. The packs are high-density polyethylene (HDPE) bottles with a low-density polyethylene (LDPE) nozzle and an HDPE cap, placed in cardboard boxes. Pack sizes:

1 bottle of 15g

1 bottle of 30g

1 bottle of 60g

2 bottles of 60g

3 bottles of 60g

1 bottle of 80g

2 bottles of 80g

Not all pack sizes may be available.

Marketing authorization holder

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

Manufacturer

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

LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland

To obtain more information about this medicine, contact the 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

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

Date of last revision of the leaflet: October 2019