Dovobet

Package leaflet: Information for the user

DOVOBET GEL 50 micrograms/0.5 mg/g gel

calcipotriol + betamethasone
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What DOVOBET is and what it is used for
2. What you need to know before using DOVOBET
3. How to use DOVOBET
4. Possible side effects
5. How to store DOVOBET
6. Contents of the pack and other information

1. What Dovobet is and what it is used for

Dovobet gel is used as a topical treatment for scalp psoriasis in adults and for plaque psoriasis (psoriasis vulgaris) of mild to moderate severity on the skin of other body areas in adults. Psoriasis is caused by skin cells that multiply too quickly. This leads to redness, scaling, and thickening of the skin.
Dovobet gel contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells, and betamethasone works by reducing inflammation.

2. What you need to know before using Dovobet

Do not use Dovobet:

• 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 (ask your doctor)
• If you have certain types of psoriasis, such as erythrodermic, exfoliative, or pustular psoriasis (ask your doctor).

Because Dovobet contains a potent steroid, DO NOT use it on skin affected by:

• Skin infections caused by viruses (such as cold sores or chickenpox)
• Skin infections caused by fungi (such as athlete’s foot or ringworm)
• Skin infections caused by bacteria
• Skin infections caused by parasites (such as scabies)
• Tuberculosis (TB)
• Perioral dermatitis (red skin eruptions around the mouth)
• Thin skin, fragile blood vessels, stretch marks
• Ichthyosis (dry, scaly skin resembling fish scales)
• Acne (pimples)
• Rosacea (flushing or redness of the facial skin)
• Open skin ulcers or wounds.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Dovobet if:

• You are using other medicines containing corticosteroids, as side effects may occur
• You have used this medicine for a long time and decide to stop treatment (when steroid treatment is stopped suddenly, there is a risk that psoriasis may worsen or flare up)
• You have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid
• Your skin lesions tend to become infected; it may be necessary to stop treatment
• You have a certain type of psoriasis called guttate psoriasis
• You experience blurred vision or other visual disturbances.

Special precautions

• Avoid applying the product to more than 30% of your body surface or using more than 15 g of the product per day.
• Avoid using a shower cap, bandages, or clothing that may increase steroid absorption.
• Avoid use over large areas of damaged skin, mucous membranes, or skin folds (e.g. groin, armpits, or under the breasts), as this increases corticosteroid absorption.
• Avoid applying the medicine to facial skin or genitals (sexual organs), which are sensitive to steroids.
• Avoid excessive sunbathing, excessive use of sunbeds, and other forms of light treatment.

Children
The use of Dovobet is not recommended in children under 18 years of age.
Other medicines and Dovobet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
If your doctor has determined that you may breastfeed, make sure not to apply Dovobet to the breast area.
Driving and using machines
This medicine is unlikely to affect your ability to drive or operate machinery.
Dovobet gel contains butylated hydroxytoluene (E321)
Dovobet gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (such as contact dermatitis), eye irritation, and irritation of mucous membranes.

3. How to use Dovobet

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
How to use Dovobet gel: for topical use.

Instructions for correct use

• Use Dovobet only on psoriasis-affected areas; do not use it on unaffected skin
• Shake the bottle well before use and remove the cap
• By squeezing the bottle, dispense the gel onto a clean finger or directly onto the psoriasis-affected area
• Apply Dovobet to the affected areas using your fingertips and gently rub in until the psoriasis-affected area is covered with a thin layer of gel
• Do not bandage, tightly wrap, or cover the treated skin areas
• Wash your hands thoroughly after applying Dovobet. This will help prevent accidental contact of the gel with other parts of the body (especially the face, mouth, and eyes)
• Do not be alarmed if a small amount of gel accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medication spreads too far from the psoriatic area
• To achieve optimal effect, it is recommended not to bathe or shower immediately after applying Dovobet gel
• After applying the gel, avoid contact with fabrics that may easily become greasy-stained (for example, silk)

If you have scalp psoriasis

• Before applying Dovobet to the scalp, brush your hair to remove any scales. Tilt your head so that Dovobet does not run onto your face. It may be helpful to divide the hair into sections before using Dovobet. Apply Dovobet to the affected areas with your fingertips and gently rub in.

Generally, 1–4 g (up to 1 teaspoon) is sufficient, depending on the affected areas.

If necessary, repeat steps 4–6 once or twice.
Duration of treatment

• Use the gel once daily. It may be more convenient to apply the gel in the evening.
• The usual initial treatment period is 4 weeks for the scalp and 8 weeks for areas other than the scalp.
• Your doctor may decide on a different treatment duration.
• Your doctor may consider repeating the treatment.
• Do not use more than 15 grams per day.

If you are using other medications containing calcipotriol, the total amount of medications containing calcipotriol
must not exceed 15 grams per day, and the treated area must not exceed 30% of the total body surface area.
What to expect with the use of Dovobet
Most patients notice clear improvement after 2 weeks, even though psoriasis may not have completely disappeared from the area.
If you use more Dovobet than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Dovobet may cause problems with calcium levels in the blood, which usually return to normal after stopping treatment.
Your doctor may consider it necessary to perform some blood tests to check whether excessive use of the gel has caused any problems with blood calcium levels.
Prolonged excessive use may also cause impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones).
If you forget to use Dovobet
Do not use a double dose to make up for the missed dose.
If you stop treatment with Dovobet
Treatment with Dovobet should be stopped as directed by your doctor. It may be necessary to discontinue use gradually, especially after prolonged use.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects

Contact your doctor or nurse immediately or as soon as possible if any of the following serious side effects occur. It may be necessary to stop treatment.

The following serious side effects have been reported with the use of Dovobet:

Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. Inform your doctor as soon as possible if your psoriasis worsens.

Some serious side effects are known to be caused by betamethasone (a potent steroid), one of the components of Dovobet. Inform your doctor as soon as possible if you experience a serious side effect. These side effects are more likely to occur after prolonged treatment, use in skin folds (e.g. groin, armpits or under the breasts), use under occlusive dressings, or application over large areas of skin.

Side effects include the following:

• The adrenal glands may stop functioning properly. Symptoms are: fatigue, depression and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty seeing at night, and sensitivity to light) or increased intraocular pressure (symptoms are: eye pain, red eyes, decreased vision or blurred vision).
• Infections (because your immune system, which fights infections, may become suppressed or weakened).
• Pustular psoriasis (red areas with yellow pustules, usually on the hands or feet). In this case, stop treatment with Dovobet and inform your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic, you may experience fluctuations in blood sugar levels).

Serious side effects known to be caused by calcipotriol

• Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and difficulty breathing may occur. If you experience an allergic reaction, stop using Dovobet and contact your doctor immediately or go to the nearest hospital emergency department.
• Treatment with this gel may increase calcium levels in your blood or urine (usually when excessive amounts are used). Symptoms of elevated calcium levels in the blood include: excessive urination, constipation, muscle weakness, confusion and coma. This can be serious and therefore you must contact your doctor as soon as possible. However, calcium levels return to normal when treatment is stopped.

Less serious side effects

The following less serious side effects have been reported with Dovobet:

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
• Skin burning sensation
• Skin pain or irritation
• Inflammation or swelling at the hair root (folliculitis)
• Skin rash with inflammation (dermatitis)
• Skin redness due to capillary dilation (erythema)
• Acne (pimples)
• Dry skin
• Skin rash
• Pustular skin rash
• Skin infection

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

• Allergic reactions
• Stretch marks
• Skin peeling
• Rebound effect: worsening of symptoms/psoriasis after stopping treatment.

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

• When used on the scalp, white or grey hair may temporarily turn yellowish at the site of application.
• Blurred vision.

Less serious side effects due to the use of betamethasone, especially with long-term use, include the following. If any of these side effects occur, you should inform your doctor or nurse as soon as possible:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rashes around the mouth (perioral dermatitis)
• Skin rashes, with inflammation or swelling (allergic contact dermatitis)
• Small golden-colored cysts (colloid milium)
• Skin discoloration (depigmentation)
• Inflammation or swelling at the hair root (folliculitis).

Less serious side effects known to be caused by calcipotriol include the following:

• Dry skin
• Skin sensitivity to light, leading to skin rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Skin redness due to capillary dilation (erythema)
• Skin rash
• Skin rash with inflammation (dermatitis)
• Worsening of psoriasis

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dovobet

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the tube after EXP. The expiry date refers to the last day of that month.
• Do not refrigerate. Store the tube in the outer carton to protect it from light.
• Discard the tube with any remaining gel 6 months after first opening.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dovobet contains
The active substances 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 components are:

• liquid paraffin
• polyoxypolyoxyethylene stearate
• hydrogenated castor oil
• butylated hydroxytoluene (E321)
• all-rac-α-tocopherol

Description of the appearance of Dovobet and contents of the pack
Dovobet is presented as a fairly clear, colourless or whitish gel, contained in a high-density polyethylene bottle with a low-density polyethylene nozzle and a high-density polyethylene cap.
The bottle is contained in a cardboard box.
Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 bottles of 60 g, 2 bottles of 80 g, 3 bottles of 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LEO Pharma A/S
55 Industriparken
2750 Ballerup
Denmark

Licensee in Italy
LEO Pharma S.p.A.
Via Elio Vittorini, 129
00144 Rome
Italy

Manufacturer
LEO Pharma A/S
55 Industriparken
2750 Ballerup
Denmark
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road – Dublin 12
Ireland

This medicinal product is authorised 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.

Patient Information Leaflet

Dovobet 50 micrograms/0.5 mg/g gel

calcipotriol / betamethasone
Applicator
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What DOVOBET is and what it is used for
2. What you need to know before using DOVOBET
3. How to use DOVOBET
4. Possible side effects
5. How to store DOVOBET
6. Contents of the pack and other information

1. What Dovobet is and what it is used for

Dovobet gel is used as a topical treatment for scalp psoriasis in adults and for plaque psoriasis (psoriasis vulgaris) of mild to moderate severity on the skin of other body areas in adults. Psoriasis is caused by skin cells that reproduce too quickly. This leads to redness, scaling, and thickening of the skin.
Dovobet gel contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells, and betamethasone works by reducing inflammation.

2. What you need to know before using Dovobet

Do not use Dovobet:

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

Since Dovobet contains a potent steroid, DO NOT use it on skin affected by:

• Skin infections caused by viruses (such as cold sores or chickenpox).
• Skin infections caused by fungi (such as athlete’s foot or ringworm).
• Skin infections caused by bacteria.
• Skin infections caused by parasites (such as scabies).
• Tuberculosis (TB).
• Perioral dermatitis (red skin rashes around the mouth).
• Thin skin, fragile blood vessels, or stretch marks.
• Ichthyosis (dry, scaly skin resembling fish scales).
• Acne (pimples).
• Rosacea (flushing or redness of the facial skin).
• Open skin ulcers or wounds.

Warnings and precautions
Talk to your doctor, nurse, or pharmacist before and during treatment with Dovobet if:

• You are using other medicines containing corticosteroids, as side effects may occur.
• You have used this medicine for a long time and decide to stop treatment (if steroid treatment is stopped suddenly, your psoriasis may worsen or flare up).
• You have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid.
• Your skin lesions tend to become infected; it may be necessary to stop treatment.
• You have a certain type of psoriasis called guttate psoriasis.
• You experience blurred vision or other visual disturbances.

Special precautions

• Avoid applying the product to more than 30% of your body surface or using more than 15 g of the product per day.
• Avoid using a shower cap, bandages, or clothing that may increase steroid absorption.
• Avoid use over large areas of damaged skin, mucous membranes, or skin folds (e.g., groin, armpits, or under the breasts), as this increases corticosteroid absorption.
• Avoid applying the medicine to the skin of the face or genitals (sexual organs), which are sensitive to steroids.
• Avoid excessive sunbathing, overuse of sunbeds, and other forms of light therapy.

Children
The use of Dovobet is not recommended in children under 18 years of age.
Other medicines and Dovobet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
If your doctor has determined that you may breastfeed, make sure not to apply Dovobet to the breast area.
Driving and using machines
This medicine is unlikely to affect your ability to drive or operate machinery.
Dovobet gel contains butylated hydroxytoluene (E321)
Dovobet gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (such as contact dermatitis), eye irritation, and irritation of mucous membranes.

3. How to use Dovobet

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to use Dovobet gel: for topical use.
Read carefully the instructions for use of the Dovobet Gel Applicator included at the end of this leaflet before use.
In the instructions for use, you will find information regarding assembly, use, cleaning, and storage of the

Dovobet Gel Applicator

In the remainder of this leaflet, Dovobet gel applicator is referred to as "the Applicator".
Instructions for the correct use of Dovobet

• Use Dovobet only on psoriasis-affected areas; do not use it on unaffected skin.
• Apply Dovobet to the affected areas using the Applicator, gently massaging until the psoriatic area is covered with a thin layer of gel.
• Do not bandage, tightly wrap, or cover the treated skin areas.
• Wash your hands thoroughly after applying Dovobet if the gel has come into contact with your fingers. This will prevent accidental transfer of the gel to other parts of the body (especially the face, mouth, and eyes).
• Do not be alarmed if a small amount of gel accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medication spreads too far from the psoriatic area.
• To achieve optimal results, it is recommended not to bathe or shower immediately after applying Dovobet gel.
• After applying the gel, avoid contact with fabrics that may easily become greasy or stained (for example, silk).

If necessary, repeat steps 1–3 one or two times.
Duration of treatment

• Use the gel once daily. It may be more convenient to apply the gel in the evening.
• The usual initial treatment period is 4 weeks for the scalp and 8 weeks for areas other than the scalp.
• Your doctor may decide on a different treatment duration.
• Your doctor may consider repeating the treatment.
• Do not use more than 15 grams per day. This means that a 60 g applicator should last at least 4 days.
• For treatment of the scalp, a daily amount between 1 and 4 g is generally sufficient.

If other medicinal products containing calcipotriol are used, the total amount of calcipotriol-containing
medications must not exceed 15 grams per day, and the treated area must not exceed 30% of the total body surface area.
One full actuation delivers 0.05 g of Dovobet gel.
What to expect with the use of Dovobet
Most patients notice clear improvement after 2 weeks, even if psoriasis has not completely cleared from the area.
If you use more Dovobet than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Dovobet may cause disturbances in blood calcium levels, which usually return to normal after discontinuation of treatment.
Your doctor may consider it necessary to perform blood tests to check whether excessive use of the gel has caused problems with blood calcium levels.
Prolonged excessive use may also lead to impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones).
If you forget to use Dovobet
Do not use a double dose to make up for a missed dose.
If you stop using Dovobet
Treatment with Dovobet should be discontinued as directed by your doctor. It may be necessary to stop using the medication gradually, especially after long-term use.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Tell your doctor or nurse immediately or as soon as possible if any of the following side effects occur.
You may need to stop treatment.
The following serious side effects have been reported with the use of Dovobet.
Uncommon side effects (may affect up to 1 in 100 people)

• Worsening of psoriasis. Inform your doctor as soon as possible if your psoriasis worsens.

Some serious side effects are known to be caused by betamethasone (a potent steroid), one of the components of Dovobet. Inform your doctor as soon as possible if you experience a serious side effect. These side effects are more likely to occur after long-term treatment, use in skin folds (e.g. groin, armpits or under the breasts), or with the use of occlusive dressings or application over large areas of skin.
Side effects include the following:

• The adrenal glands may stop functioning properly. Symptoms are: tiredness, depression, and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty seeing at night, and light sensitivity) or increased internal eye pressure (symptoms are: eye pain, red eyes, decreased vision or blurred vision).
• Infections (because your immune system, which fights infections, may be suppressed or weakened).
• Pustular psoriasis (red areas with yellow pustules, usually on the hands or feet). In this case, stop treatment with Dovobet and inform your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic, you may experience fluctuations in blood sugar levels).

Serious side effects known to be caused by calcipotriol

• Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and difficulty breathing may also occur. If you have an allergic reaction, stop using Dovobet, inform your doctor immediately or go to the nearest hospital emergency department.
• Treatment with this gel may increase calcium levels in your blood or urine (usually when excessive amounts are used). Symptoms of increased calcium levels in the blood include: excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and therefore you must contact your doctor as soon as possible. However, levels return to normal when treatment is stopped.

Less serious side effects
The following less serious side effects have been reported with Dovobet.
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 at the hair root (folliculitis)
• Skin rash with inflammation (dermatitis)
• Skin redness due to capillary dilation (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular skin rash
• Skin infection

Rare side effects (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 the available data)

• When used on the scalp, white or grey hair may temporarily turn yellowish at the application site
• Blurred vision

Less serious side effects due to the use of betamethasone, especially with long-term use, include the following. If any of these effects occur, you should inform your doctor or nurse as soon as possible:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rashes around the mouth (perioral dermatitis)
• Skin rashes with inflammation or swelling (allergic contact dermatitis)
• Small golden-colored cysts (colloid milium)
• Skin discoloration (depigmentation)
• Inflammation or swelling at the hair root (folliculitis).

Less serious side effects known to be caused by calcipotriol include the following:

• Dry skin
• Skin sensitivity to light, resulting in a rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Skin redness due to capillary dilation (erythema)
• Rash
• Skin rash with inflammation (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dovobet

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cartridge after EXP. The expiry date refers to the last day of the month.
• Do not refrigerate.
• The Applicator is for single use only. Dispose of the Applicator together with any residual gel 6 months after first opening.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dovobet contains
The active substances 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 components are:

• liquid paraffin
• polyoxyl 15 hydroxystearate
• hydrogenated castor oil
• butylated hydroxytoluene (E321)
• all-rac-α-tocopherol

Description of the appearance of Dovobet and package contents
Dovobet is a fairly clear, colourless or whitish gel contained in a cartridge made of
polypropylene (with a plunger made of high-density polyethylene and a screw cap). The cartridge and the
applicator head (outer casing made of polypropylene, lever made of polyoxymethylene, and dispenser made of thermoplastic elastomer) must be assembled before first use. The polypropylene cap is used for storage.
The cartridge(s), applicator head(s) and cap(s) are contained in a carton.
Pack sizes: 60 g (equivalent to 68 ml) and 2 x 60 g (equivalent to 2 x 68 ml).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LEO Pharma A/S
55 Industriparken
2750 Ballerup
Denmark

Marketing Authorisation Holder in Italy
LEO Pharma S.p.A.
Via Elio Vittorini, 129
00144 Roma
Italy

Manufacturer
LEO Pharma A/S
55 Industriparken
2750 Ballerup
Denmark
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road – Dublin 12
Ireland

Instructions for use of the applicator are included at the end of this leaflet.

This medicinal product is authorised in the European Economic Area countries 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.

Instructions for Use

Dovobet Gel Applicator

Read the patient information leaflet and these instructions carefully before using this medicine – even if you have used Dovobet gel previously.
Dovobet Gel Applicator is designed to apply Dovobet gel to skin or scalp affected by plaque psoriasis. Using the Dovobet Gel Applicator allows you to apply Dovobet gel without the gel coming into contact with your fingers.
Always follow your doctor’s instructions regarding treatment of your psoriasis.
Do not share the Dovobet gel or the Applicator with other people.
Keep this medicine out of the sight and reach of children.

Your Dovobet Gel Applicator

Preparing the Dovobet Gel Applicator

A) Check the expiry date on the cartridge
Check the expiry date on the cartridge label.
Do not use if expired.
The expiry date on the cartridge refers to the last day of that month.
Write the date when you assemble the Applicator on the cartridge label.
Do not use the Applicator for more than 6 months after this date.

B) Remove the cartridge cap
Holding the cartridge in an upright position, turn the cap counterclockwise to remove it.
Avoid tilting the cartridge, as this may cause the gel to leak out.
Discard the cap after removal.

C) Securely screw on the applicator head
Hold the cartridge upright and align the applicator head.
Screw the applicator head on clockwise until it is firmly sealed.
You will hear clicking sounds until the head is securely sealed.
Caution:
Do not disassemble the Applicator.
Attempting to do so may break the Applicator.

D) Priming before first use
To prime:
Ensure that the applicator head and cartridge are securely assembled.
Gently press the center of the plunger while squeezing the lever until product appears at the tip of the dispenser.
If you travel by air with your assembled Dovobet Gel Applicator, you may need to re-prime by pressing the lever several times before use.

Applying Dovobet Gel to affected areas

E) Apply to the affected area
Position the dispenser close to the affected area and press the lever one or more times to dispense Dovobet gel.
Fully release the lever between each press to ensure complete dispensing.
One full press dispenses 0.05 g of Dovobet gel.

F) Use the designated surface of the dispenser to massage Dovobet gel into plaques
Use the designated surface to gently massage Dovobet gel into the affected skin.
Be careful not to press the lever while spreading the product.

G) To apply to scalp and hairline
Before applying Dovobet to the scalp, comb the hair to remove loose scales.
Tilt the head so that Dovobet does not run onto the face. It may help to part the hair before using Dovobet.
Locate the area to be treated using your fingers and part the hair.
Use the dispenser directly on the scalp to dispense and massage in the Dovobet gel.

H) After application
Check that the affected areas are adequately covered.
If needed, ask someone to help you apply Dovobet gel to areas you cannot reach or see.
Wash your hands after use if your fingers, or the fingers of someone helping you, come into contact with Dovobet gel.
This may prevent accidental contact of the gel with other parts of the body (especially face, mouth, and eyes):

After use

I) Clean the applicator after each use
After use, wipe the applicator head with a clean, dry tissue.
Avoid operating the device during cleaning.
Caution:

• Do not wash the Applicator with water, detergent, or any other substance.
• Do not use wet or damp materials to dry the applicator.

J) Cover the applicator
To keep the applicator head clean, replace the cap after each use.
Ensure the cap is properly fitted to prevent leakage of Dovobet gel during storage and transport.

K) Check remaining amount of Dovobet gel
To check the remaining amount of Dovobet gel, look at the bottom of the cartridge to see the position of the plunger. As the gel is used, the plunger moves upward.

Before using again

L) Check the expiry date
Always check the expiry date on the cartridge label before use.
Do not use if the expiry date has passed or after 6 months from opening the cartridge.
The expiry date on the cartridge refers to the last day of that month.

M) Removing the cap
Remove the cap by lifting the tab at the back.

Storage
Always ensure the cap is properly in place to prevent leakage during storage and transport. See further storage information in section 5 ‘How to store Dovobet’.
Disposal of the product
See disposal information in section 5 ‘How to store Dovobet’.

Package leaflet: Information for the user

DOVOBET®

50 micrograms/ + 0.5 mg/g
ointment
calcipotriol/betamethasone

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
1. What DOVOBET is and what it is used for
2. What you need to know before using DOVOBET
3. How to use DOVOBET
4. Possible side effects
5. How to store DOVOBET
6. Contents of the pack and other information

1. WHAT DOVOBET IS AND WHAT IT IS USED FOR
Dovobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is a condition in which skin cells are produced too quickly. This causes redness, scaling, and thickening of the skin.
Dovobet ointment contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells, and betamethasone works by reducing inflammation.

2. WHAT YOU SHOULD KNOW BEFORE USING DOVOBET

Do not use DOVOBET:

• if you are allergic (hypersensitive) to calcipotriol, betamethasone, or to any of the excipients in Dovobet (listed in section 6);
• if you have problems with calcium levels in your body (ask your doctor);
• if you have other types of psoriasis: such as erythrodermic, exfoliative, or pustular psoriasis (ask your doctor).

Since Dovobet contains a potent corticosteroid, DO NOT use it on skin affected by:

• viral skin infections (e.g., cold sores or chickenpox)
• fungal skin infections (such as athlete’s foot or ringworm)
• bacterial skin infections
• parasitic skin infections (such as scabies)
• tuberculosis (TB)
• perioral dermatitis (red skin rashes around the mouth)
• thin skin, fragile blood vessels, stretch marks
• ichthyosis (dry, scaly skin resembling fish scales)
• acne (pimples)
• rosacea (flushing or redness of the facial skin)
• open skin ulcers or wounds

Warnings and precautions
Before using the medicine, tell your doctor, nurse, or pharmacist if:

• you are using other medicines containing corticosteroids, as adverse effects may occur
• you have used this medicine for a long time and decide to stop treatment (when corticosteroid treatment is stopped abruptly, there is a risk that psoriasis may worsen or flare up)
• you have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid
• your skin lesions tend to become infected; it may be necessary to stop treatment
• you have a certain type of psoriasis called guttate psoriasis

Special precautions

• avoid applying the product to more than 30% of your body surface or using more than 15 g of product per day
• avoid using occlusive dressings or clothing that may increase steroid absorption
• avoid use over large areas of damaged skin, on mucous membranes, or in skin folds (e.g., groin, armpits, under the breasts), as this may increase steroid absorption
• avoid applying the medicine to facial skin or genital areas (sexual organs), which are highly sensitive to steroids
• avoid excessive sunbathing, excessive use of sunbeds, and other forms of light therapy.

Children
The use of Dovobet is not recommended in children under 18 years of age.
Other medicines and Dovobet
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those obtained without a prescription.
Pregnancy and breastfeeding
Do not use Dovobet if you are pregnant (or think you might be pregnant) or if you are breastfeeding, unless you have discussed it first with your doctor. If your doctor has determined that you may breastfeed, make sure not to apply Dovobet ointment to the breast area.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machinery.
Important information about some excipients in DOVOBET
Dovobet ointment contains butylated hydroxytoluene (E321). It may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE DOVOBET

Always take Dovobet exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
How to use Dovobet: for topical use.
Instructions for correct use

• Use Dovobet only on psoriasis-affected areas; do not use on unaffected skin.
• Remove the cap and check that the tube seal is intact before first use.
• To break the seal, use the back of the cap.
• Squeeze the tube to dispense the ointment onto a clean finger.
• Gently rub the ointment into the affected area until the psoriatic lesion is covered and most of the ointment has been absorbed by the skin.
• Do not bandage, tightly cover, or occlude the treated skin areas.
• Wash your hands thoroughly after using Dovobet (unless you have applied the ointment to treat your hands). This will prevent accidental contact of the ointment with other parts of the body (especially the face, scalp, mouth, and eyes).
• Do not be alarmed if a small amount of ointment accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medication spreads too far from the psoriatic area.
• For optimal effect, it is recommended not to bathe or shower immediately after applying Dovobet ointment.
• After applying the ointment, avoid contact with fabrics that may be easily soiled by greasy substances (e.g., silk).

Duration of treatment

• Use the ointment once daily. It may be more convenient to apply the ointment in the evening.
• The initial treatment period is normally 4 weeks, but your doctor may decide on a different duration.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams per day.

If you are using other medications containing calcipotriol, the total amount of calcipotriol-containing medications must not exceed 15 grams per day, and the treated area must not exceed 30% of the total body surface area.
What to expect with the use of DOVOBET
Most patients notice clear improvement after 2 weeks, even though psoriasis may not have completely disappeared from the area.
If you use more DOVOBET than you should
Contact your doctor if you have used more than 15 g in one day.
Excessive use of Dovobet may cause problems with calcium levels in the blood, which usually return to normal after stopping treatment.
Your doctor may consider it necessary to perform blood tests to check whether excessive use of the ointment has caused problems with blood calcium levels.
Prolonged and excessive use may also cause impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones).
If you forget to use DOVOBET
Do not use a double dose to make up for the missed application.
If you stop using DOVOBET
Use of Dovobet should be stopped as directed by your doctor. It may be necessary to discontinue the medication gradually, especially after prolonged use.
If you have any doubts about using Dovobet, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Dovobet can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions:
Inform your doctor or nurse immediately or as soon as possible if you experience any of the following events.
You may need to stop treatment.
The following serious adverse reactions have been reported with Dovobet:
Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. Inform your doctor as soon as possible if your psoriasis worsens.

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

• Pustular psoriasis may occur (reddened areas with yellowish pustules, usually on the hands or feet). In this case, stop using Dovobet and inform your doctor as soon as possible.

Some serious adverse reactions are known to be caused by betamethasone (a potent corticosteroid), one of the components of Dovobet. Inform your doctor as soon as possible if you experience a serious adverse reaction. These adverse reactions occur more frequently after prolonged use, use in skin folds (e.g. groin, armpits, or under the breasts), use under occlusive dressings, or application over a large skin surface.
Adverse reactions include:

• Adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
• Cataract (symptoms include blurred or hazy vision, difficulty seeing at night, and light sensitivity) or increased intraocular pressure (symptoms include eye pain, red eyes, reduced vision, or blurred vision).
• Infections (because the immune system, which fights infections, may be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules, usually appearing on the hands or feet). If you notice this, stop using Dovobet and inform your doctor as soon as possible.
• Interference with blood glucose control in diabetes mellitus (if you are diabetic, you may experience fluctuations in blood sugar levels).

Serious adverse reactions known to be caused by calcipotriol:

• Allergic reactions with severe swelling of the face or other body parts such as hands or feet. Swelling of the mouth/throat and difficulty breathing may occur. If you have an allergic reaction, stop using Dovobet and contact your doctor immediately or go to the emergency department of the nearest hospital.
• Treatment with this ointment may increase calcium levels in your blood or urine (usually when excessive amounts of ointment are used). Symptoms of elevated blood calcium levels include: excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and therefore you must contact your doctor immediately. However, calcium levels will return to normal once treatment is stopped.

Less serious adverse reactions
The following less serious adverse reactions have been reported with Dovobet.
Common (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 rashes with skin inflammation (dermatitis)
• Skin redness due to capillary dilation (erythema)
• Inflammation or swelling at the hair root (folliculitis)
• Changes in skin color at the site of ointment application
• Skin rash
• Burning sensation on the skin
• Skin infection
• Thinning of the skin
• Appearance of red or purple discolored spots on the skin (purpura or bruising)

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

• Fungal or bacterial infection of hair follicles (boils)
• Allergic reactions
• Hypercalcemia
• Skin striae (stretch marks)
• Increased skin sensitivity to sunlight, resulting in rash
• Acne (pimples)
• Dry skin
• Rebound effect: worsening of psoriasis symptoms after treatment ends

Less serious adverse reactions due to betamethasone use, especially with prolonged use, include the following; if any of these effects occur, you should inform your doctor or nurse as soon as possible:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rashes around the mouth (perioral dermatitis)
• Skin rashes with inflammation or swelling (allergic contact dermatitis)
• Small golden-colored cysts (colloid milium)
• Skin discoloration (depigmentation)
• Inflammation or swelling at the hair root (folliculitis)

Less serious adverse reactions known to be caused by calcipotriol include:

• Dry skin
• Skin sensitivity to light, leading to rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Skin redness due to capillary dilation (erythema)
• Skin rash
• Skin rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the relevant reporting system. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOVOBET

• Keep out of the reach and sight of children.
• Do not use Dovobet after the expiry date stated on the label, following “EXP”. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• The tube must not be used more than 1 year after first opening. Write the date of first opening in the space provided on the carton.

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What DOVOBET ointment contains
The active substances are:
calcipotriol and betamethasone
1 gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone
(as dipropionate).

The excipients are:

• liquid paraffin
• all-rac- \alpha -tocopherol
• polyoxypolyethylene-11-stearyl ether
• soft white paraffin
• butylated hydroxytoluene (E321)

Description of the appearance of DOVOBET and contents of the package
Dovobet ointment is an ointment ranging in colour from ivory to yellow, supplied in aluminium/epoxy-phenolic tubes with a polyethylene screw cap.
Pack sizes: 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, 55 Industriparken – 2750 Ballerup (DK)

Manufacturer:
LEO Laboratories Ltd., Cashel Road, Dublin 12 – Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
LEO Pharma S.p.A., Via Amsterdam 125 - 00144 Roma

This medicinal product is authorized in other European Economic Area countries under the following names:
Daivobet: Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Sweden
Dovobet: Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, Netherlands, United Kingdom