Daivobet

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

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

1. What Daivobet is and what it is 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 DAIVOBET IS AND WHAT IT IS USED FOR

Daivobet ointment is applied to the skin for the treatment of psoriasis vulgaris in adults. Psoriasis
is caused by excessive skin cell production. This leads to redness, scaling, and thickening of the skin.
Daivobet ointment contains calcipotriol and betamethasone. Calcipotriol helps normalize the rate of skin cell growth, while betamethasone reduces inflammation.

2. IMPORTANT INFORMATION BEFORE USING DAIVOBET

When not to use Daivobet

• if the patient is allergic (hypersensitive) to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has disorders of calcium levels in the body (this should be discussed with a doctor),
• if the patient has been diagnosed with certain types of psoriasis, e.g. erythrodermic psoriasis or pustular psoriasis (this should be discussed with a doctor).

Because Daivobet contains a potent corticosteroid, DO NOT use this medicine in the following
skin conditions:

• viral skin infections (e.g. herpes simplex or chickenpox),
• fungal skin infections (e.g. athlete’s foot or dermatophyte infections),
• bacterial skin infections,
• parasitic skin infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin with easy bruising, fragile blood vessels, or stretch marks,
• ichthyosis (dry, scaly skin resembling fish scales),
• acne,
• rosacea (severe flushing or facial redness),
• skin ulcers or breaks in the skin integrity.

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

• the patient is using other medicines containing corticosteroids that may cause adverse effects,
• the patient has been using this medicine for a long time and plans to discontinue treatment (as there is a risk of worsening or rebound of psoriasis following sudden discontinuation of steroids),
• the patient has diabetes, as steroids may affect blood glucose levels,
• the patient has a skin infection that may require discontinuation of treatment,
• the patient has guttate psoriasis,
• the patient experiences blurred vision or other visual disturbances.

Special precautions

• Avoid using the medicine on more than 30% of the body surface area and using more than 15 g per day.
• Avoid use under bandages or dressings, as this increases absorption of steroids.
• Avoid use on large areas of damaged skin, mucous membranes, or in 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 highly sensitive to steroid effects.
• Avoid excessive sun exposure, 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to use.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
If the doctor approves breastfeeding, caution should be exercised and Daivobet 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 ointment contains butylhydroxytoluene (E 321)
Daivobet ointment contains butylhydroxytoluene (E 321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE DAIVOBET

Daivobet ointment should always be used as directed by the physician. If in doubt,
contact the physician or pharmacist again.
Method of administration of Daivobet ointment: application to the skin.
Instructions for proper use

• Apply only to skin affected by psoriasis; do not apply to unaffected skin.
• Before first use of the ointment, remove the cap from the tube and check whether the seal inside the tube is damaged.
• To break the seal, use the tip of the cap's reverse side.
• Squeeze the ointment onto a clean finger.
• Gently rub the ointment into the skin until a thin layer covers the psoriatic skin area, continuing until most of the ointment has disappeared from the skin surface.
• Do not cover the treated area with bandages, occlusive dressings, or wraps.
• After using Daivobet, wash hands thoroughly (unless the patient is treating the hands with the ointment). This helps prevent accidental transfer of the ointment to other parts of the body (especially the face, hairy scalp, mouth, and eyes).
• There is no need for concern if a small amount of ointment accidentally spreads to healthy skin adjacent to the psoriatic area. Simply wipe it off if it spreads too far.
• For optimal effectiveness, avoid taking a shower or bath immediately after applying Daivobet ointment.
• After applying the ointment, avoid contact with fabrics that are easily stained by oily substances (e.g. silk).

Duration of treatment

• The ointment should be used once daily. Application in the evening may be more convenient.
• The initial treatment period is usually 4 weeks, but the physician may decide on a different duration.
• The physician may decide to repeat the treatment course.
• Do not use more than 15 grams of the medication per day.

When using other medications containing calcipotriol, the total daily amount of calcipotriol-containing products must not exceed 15 grams, and the treated skin area should not exceed 30% of the total body surface area.
What to expect when using Daivobet
Most patients will see clear improvement within 2 weeks, even if psoriasis symptoms have not completely resolved at the treated site.
Use of more than the recommended dose of Daivobet
A patient who has used more than 15 grams in one day should contact their physician.
Excessive use of Daivobet may cause disturbances in blood calcium levels, which usually return to normal after discontinuation of treatment.
The physician may perform blood tests to check whether excessive use of the ointment has caused abnormal calcium levels in the patient's blood.
Prolonged, excessive use may also lead to adrenal insufficiency (the adrenal glands, located near the kidneys, produce hormones).
Missed dose of Daivobet
Do not use a double dose to make up for a missed dose.
Stopping Daivobet treatment
Daivobet treatment should be discontinued according to the physician's instructions. Gradual discontinuation may be necessary, especially if the medication has been used for a prolonged period.
If there are any further doubts regarding the use of the medication, consult the physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, 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 quickly as possible. It may be necessary to discontinue treatment.

There have been reports of the following serious adverse reactions with Daivobet:

Uncommon (may affect less than 1 in 100 people)

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

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

• Pustular psoriasis may occur (red areas of skin with yellowish pustules, usually on the palms or soles). If this is observed, stop using Daivobet and 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. If any of the following serious adverse reactions occur, inform your doctor as soon as possible. These are likely to occur after prolonged use, use in skin folds (such as the groin, underarms, under the breasts), use under occlusive dressings, or application over large areas of skin.

Adverse reactions include:

­ The adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.

­ Cataract (symptoms include blurred and hazy vision, difficulty seeing at night, and sensitivity to light) or increased pressure inside the eye (symptoms include eye pain, redness of the eye, and reduced or blurred vision).

­ Infections (due to suppression or weakening of the immune system's ability to fight infections).

­ Pustular psoriasis (red areas with yellowish pustules, usually on the hands or feet). If such symptoms are observed, stop using Daivobet and inform your doctor as soon as possible.

­ Effect on diabetes control (if the patient has 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 mouth or throat and difficulty breathing may also occur. If an allergic reaction occurs, stop using Daivobet and inform your doctor immediately or go to the nearest hospital emergency department.

­ Use of this ointment may lead to increased calcium levels in the blood or urine (usually due to excessive use of the ointment). Signs of elevated calcium levels include excessive urination, constipation, muscle weakness, confusion, and coma. These may be serious, therefore contact your doctor immediately. After stopping treatment, calcium levels return to normal.

Less serious adverse reactions
Less serious adverse reactions with Daivobet have also been reported.

Common adverse reactions (may affect up to 1 in 10 people)

• Itching
• Skin peeling

Uncommon (may affect up to 1 in 100 people)

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

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

• Bacterial or fungal infections of hair follicles (boils)
• Allergic reactions
• Hypercalcemia
• Striae (stretch marks)
• Photosensitivity reaction causing rash
• Acne (pimples)
• Dry skin
• Rebound effect: worsening of psoriasis symptoms after stopping treatment

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

• Blurred vision

Less serious adverse reactions associated with the use of betamethasone, especially with prolonged use, are listed below. Inform your doctor as soon as possible if any of these occur:

• Skin thinning
• Appearance of superficial blood vessels and stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Rash with inflammation or swelling (allergic contact dermatitis)
• Yellowish gel-filled elevations (colloid milium)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of hair follicles (folliculitis)

Other less serious adverse reactions caused by calcipotriol:

• Dry skin
• Skin sensitivity to light causing rash
• Eruption
• 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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]
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE DAIVOBET

• Keep out of the 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 the specified month.
• Do not store above 25°C.
• The tube should be discarded 12 months after first opening. The date of first opening of the tube should be written in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. CONTENTS OF THE PACKAGE 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 polyoxyethylene ether
• all-rac-α-tocopherol
• white vaseline
• butylhydroxytoluene (E 321)

What Daivobet looks like and contents of the pack
Daivobet ointment is a cream to yellowish ointment in an aluminium tube internally coated with epoxy lacquer, with a polyethylene cap, packed 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 Authorisation Holder
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer
LEO Laboratories Ltd.
285 Cashel Road
Dublin 12
Ireland

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

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

August 2018

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