Daivobet

Daivobet, 50 micrograms/g + 0.5 mg/g, gel
Calcipotriol + Betamethasone
Read the entire package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the package leaflet:

1. What Daivobet gel is and what it is 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 package and other information

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

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

2. IMPORTANT INFORMATION BEFORE USING DAIVOBET GEL

When not to use Daivobet gel

• If the patient is allergic (hypersensitive) to calcipotriol, betamethasone, or any of the other ingredients of this gel (listed in section 6).
• If the patient has disorders of calcium levels in the blood (consult a doctor).
• If the patient has other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or acrodermatitis continua (consult a doctor).

Daivobet gel contains a potent steroid medicine (betamethasone); therefore, this medicine should not be used in conditions such as:

• Viral skin infections (e.g. herpes simplex or chickenpox)
• Fungal skin infections (e.g. athlete's foot or dermatophyte infections)
• Bacterial skin infections
• Parasitic infections (e.g. scabies)
• Tuberculosis
• Perioral dermatitis (red rash around the mouth)
• Thin skin, fragile blood vessels, skin striae (stretch marks)
• Ichthyosis (dry, scaly skin resembling fish scales)
• Acne
• Rosacea (severe redness or flushing of the facial skin)
• Skin ulcers or damaged skin

Warnings and precautions
Before starting and during treatment with Daivobet gel, consult your doctor or pharmacist if:

• The patient is using other medicines containing corticosteroids, as adverse effects may occur.
• The patient has used this medicine for a long time and plans to discontinue treatment (because there is a risk that psoriasis may worsen or flare up due to abrupt discontinuation of steroid-containing medicine).
• The patient has diabetes, as steroid-containing medicines may affect blood sugar/glucose levels.
• A skin infection develops, as treatment may need to be interrupted.
• The patient has guttate psoriasis.
• The patient experiences blurred vision or other visual disturbances.

Precautions

• Avoid using the gel on more than 30% of the body surface and using more than 15 g per day.
• Avoid applying the gel under occlusive dressings such as bathing caps, bandages, or wraps, as this increases steroid absorption.
• Avoid applying the gel over large areas of damaged skin, mucous membranes, or skin folds (e.g. groin, armpits, under the breasts), as this increases steroid absorption.
• Avoid use on the face and genital organs (genitalia), as these areas are particularly sensitive to steroids.
• Avoid excessive sun exposure, use of 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
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
If the doctor approves breastfeeding, caution should be exercised and Daivobet gel should not be applied to the breast area.
Driving and operating machinery
This medicine is unlikely to affect the ability to drive or operate machinery.
Daivobet gel contains butylhydroxytoluene (E321)
Daivobet gel contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE DAIVOBET GEL

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Method of administration of Daivobet gel: topical application to the skin.

Instructions for correct use:

• Apply only to areas affected by psoriasis – do not use on skin that is not affected by psoriasis.
• Shake the bottle well before use and remove the cap.
• Squeeze the gel onto a clean finger or directly onto the psoriatic lesion.
• Apply Daivobet gel to the affected areas using the fingertips, gently rubbing it in until a thin layer of gel is formed.
• Do not cover the treated area with bandages, occlusive dressings, or wraps.
• After using Daivobet gel, wash your hands thoroughly. This helps prevent accidental transfer of the gel to other parts of the body (especially the face, mouth, and eyes).
• Do not be concerned if a small amount of gel accidentally spreads to healthy skin near the psoriatic lesion, but excessive amounts should be wiped off.
• To achieve optimal effect, it is recommended not to take a shower or bathe immediately after applying Daivobet gel.
• After applying the gel, avoid contact with textiles that are easily stained by oily substances (e.g. silk).

When using Daivobet gel for psoriasis affecting the scalp:

• Before applying Daivobet gel, comb the hair to remove any flaked skin. Tilt the head to prevent Daivobet gel from running onto the face. It may be helpful to part the hair before application. Apply Daivobet gel directly to the affected areas using the fingertips and gently massage in. It is not necessary to wash the hair before applying Daivobet gel.

Shake the bottle before use. Apply a drop of Daivobet gel onto the fingertip and apply directly to the affected skin areas, then rub the Daivobet gel into the skin.
Depending on the size of the affected area,
1–4 g (up to 1 teaspoon)
is usually sufficient.
To achieve optimal effectiveness, washing the hair immediately after using Daivobet gel is not recommended. The product should be left on the skin overnight or during the day.
When washing the hair after application, the following instructions may be helpful:

Apply a gentle shampoo to dry hair, especially to areas where the gel was applied. Leave the shampoo on the scalp for several minutes before washing. Wash hair as usual.
If necessary, steps 4–6 may be repeated once or twice.

Duration of treatment:

• The gel should be used once daily. It may be more convenient to apply the gel in the evening.
• The initial treatment period is usually 4 weeks for the scalp and 8 weeks for other skin areas.
• Your doctor may decide on a different treatment duration.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams of the medicine per day.
• When using other medicines containing calcipotriol, the total daily amount of calcipotriol-containing medicines must not exceed 15 grams, and the treated skin area should not exceed 30% of the total body surface area.

What results to expect when using Daivobet gel: Most patients will see clear improvement within 2 weeks, even if psoriatic symptoms have not yet completely resolved at the treated site.

Use of more than the recommended dose of Daivobet gel: If more than 15 g per day is used, contact your doctor.
Excessive use of Daivobet gel at high doses may cause disturbances in blood calcium levels, which usually resolve after stopping treatment.
Your doctor may order blood tests to check whether the use of a higher-than-recommended dose has caused disturbances in blood calcium levels.
Prolonged use of Daivobet gel at high doses may also lead to adrenal gland dysfunction (adrenal glands are glands located next to the kidneys that produce hormones).

Missed dose of Daivobet gel: Do not use a double dose to make up for a missed dose.

Stopping Daivobet gel treatment: Daivobet gel treatment should be discontinued according to your doctor's instructions. Gradual discontinuation may be necessary, especially if the treatment has been used for a prolonged period.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following symptoms occur, 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 serious adverse reactions with Daivobet gel:
Uncommon (may affect up to 1 in 100 people)

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

It is known that some serious adverse reactions are caused by betamethasone (a potent steroid), one of the components of Daivobet gel. You should inform your doctor as soon as possible if any serious adverse symptoms occur. These are likely to occur after prolonged use, use in skin folds (groin, underarms, under breasts), use under occlusive dressings, or application over large areas of skin.
Adverse reactions include:

• Adrenal gland dysfunction. Symptoms include fatigue, depression, and anxiety.
• Cataract (blurred vision, difficulty seeing at night, and light sensitivity) or increased intraocular pressure (eye pain, redness of the eye, blurred or impaired vision).
• Infections (because the immune system fighting infection may be suppressed or weakened).
• Pustular psoriasis (red areas with yellowish pustules, usually on hands or feet). If such symptoms are observed, stop using Daivobet gel and inform your doctor immediately.
• Effect on metabolic control in diabetes (in patients with diabetes, fluctuations in blood glucose levels may occur).

Serious adverse reactions caused by calcipotriol

• Allergic reactions with deep swelling of the face or other body parts such as hands or feet. Swelling of the lips or throat and difficulty breathing may occur. If an allergic reaction occurs, stop using Daivobet gel immediately and seek medical advice or go to the nearest hospital emergency department without delay.
• Treatment with this gel may lead to increased calcium levels in blood or urine (usually after excessive use of the gel). Signs of elevated calcium levels in blood include excessive urination, constipation, muscle weakness, confusion, and coma. This condition may be serious and you should contact your doctor immediately. Calcium levels return to normal after discontinuation of treatment.

Less serious adverse reactions
There have been reports of the following less serious adverse reactions with Daivobet gel.
Common adverse reactions (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 inflammation (dermatitis)
• Skin redness due to dilation of small blood vessels (erythema)
• Acne
• Dry skin
• Rash
• Pustular psoriasis
• Skin infections

Rare (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 available data)

• White or grey hair may temporarily turn yellowish at the site of application when the medicine is used on hairy scalp.
• Blurred vision

Less serious adverse reactions that should be reported to your doctor or nurse as soon as they are noticed, usually caused by prolonged use of betamethasone, include:

• Skin thinning
• 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, gel-filled bumps (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of hair follicles (folliculitis)

Other less serious adverse reactions associated with calcipotriol that have been reported include:

• Dry skin
• Skin sensitivity to light, manifesting as rash
• Rash
• Itching
• Skin irritation
• Burning or pricking sensation
• Skin redness due to dilation of small blood vessels (erythema)
• Rash
• Rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181 C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

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 following the word EXP. The expiry date refers to the last day of the specified month.
• Do not store in a refrigerator. Store the bottle in its outer packaging to protect from light.
• Discard all bottles containing any amount of gel after 6 months from the first opening.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• all-rac-α-tocopherol
• butylhydroxytoluene (E 321)

What Daivobet gel looks like and contents of the pack
Daivobet is a nearly transparent gel, colourless to slightly cream-coloured.
The medicine is supplied in bottles made of high-density polyethylene (HDPE) with a nozzle made of low-density polyethylene (LDPE) and a cap made of HDPE, packed in cardboard boxes.
Pack sizes:
1 bottle of 15 g
1 bottle of 30 g
1 bottle of 60 g
2 bottles of 60 g
3 bottles of 60 g
1 bottle of 80 g
2 bottles of 80 g
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Leo Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel +48 22 244 18 40

This medicinal product is authorised for sale in 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, the Netherlands, Ireland, Luxembourg, United Kingdom, Italy.