DOVOBET 3 G Ointment

Зміст інструкції

1. DOVOBET GEL 50 micrograms/0.5 mg/g gel
   1. What is Dovobet and what is it 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. Package Contents and Other Information
2. Dovobet 50 micrograms/0.5 mg/g gel
   1. What is Dovobet and what is it 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. Package Contents and Other Information
3. Dovobet gel Applicator
4. DOVOBET ®
   1. WHAT YOU NEED TO KNOW BEFORE USING DOVOBET
   2. HOW TO USE DOVOBET
   3. POSSIBLE SIDE EFFECTS
   4. HOW TO STORE DOVOBET
   5. PACKAGE CONTENTS AND OTHER INFORMATION

DOVOBET GEL 50 micrograms/0.5 mg/g gel

calcipotriol + betamethasone

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even 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 you use 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 is Dovobet and what is it used for

Dovobet gel is used as a topical treatment for scalp psoriasis in adults and of the skin of
other areas of the body to treat plaque psoriasis (common psoriasis) of mild to moderate severity in
adults. Psoriasis is caused by skin cells that reproduce too quickly. This causes
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 and pustular (ask your doctor).

Since Dovobet contains a strong 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 rashes around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)
• rosacea (severe flushing or redness of the facial skin)
• ulcers or open wounds on the skin.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Dovobet if:

• you are using other medicines that contain corticosteroids, as side effects may occur
• you have used this medicine for a long time and decide to stop treatment (when treatment with steroids is stopped suddenly there is a risk that psoriasis will worsen or flare up)
• you have diabetes mellitus (diabetes), as steroid may affect blood sugar/glucose levels
• 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 the body or using more than 15 g of product per day.
• Avoid using a shower cap, bandage or clothing that may increase steroid absorption
• Avoid use on large areas of damaged skin, on mucous membranes or in skin folds (e.g. groin, armpits or under the breasts), as this increases the absorption of the corticosteroid
• Avoid applying the medicine to the skin of the face or genitals (sexual organs), which are sensitive to steroids
• Avoid excessive sun exposure, excessive use of the solarium and other forms of light treatment.

Children
The use of Dovobet is not recommended in children under the age of 18 years.

Other medicines and Dovobet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before using this medicine.
If your doctor has established that you can breastfeed, make sure not to apply Dovobet to the breast area.

Driving and using machines
This medicine should not affect your ability to drive or operate machinery.

Dovobet gel contains butylhydroxytoluene (E321)
Dovobet gel contains butylhydroxytoluene (E321), which may cause local skin reactions (such as contact
dermatitis), irritation of the eyes and mucous membranes.

3. How to use Dovobet

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
How to use Dovobet gel: for cutaneous use.
Instructions for correct use

• Use Dovobet only on psoriasis, do not use it on skin not affected by psoriasis
• 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 area affected by psoriasis.
• Apply Dovobet to the affected areas with your fingertips and gently rub until the area affected by psoriasis 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 avoid 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 medicine spreads too far from the psoriatic area.
• To achieve an optimal effect, it is recommended not to bathe or shower immediately after applying Dovobet gel
• After applying the gel, avoid contact with fabrics that could easily stain with grease (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 down your face. It may be helpful to divide the hair into sections before using Dovobet. Apply Dovobet to the areas affected by psoriasis with your fingertips and gently rub.

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 a day. It may be more convenient to apply the gel in the evening.
• The normal initial treatment period is 4 weeks for scalp areas and 8 weeks for areas other than the scalp.
• The doctor may decide on a different treatment period.
• The doctor may decide to repeat the treatment.
• Do not use more than 15 grams per day.

If you are using other medicines containing calcipotriol, the total amount of medicines containing calcipotriol
should not exceed 15 grams per day and the area should not exceed 30% of the total body surface area.

What to expect with the use of Dovobet
Most patients notice evident improvements after 2 weeks, even if the psoriasis has not 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 can cause problems with calcium levels in the blood, which usually normalize
after stopping treatment.
The doctor may deem it necessary to subject you to some blood tests to check if the use of excessive amounts of gel may have caused a problem with calcium levels in the blood.
Prolonged excessive use can also cause improper functioning 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 the treatment with Dovobet
The use of Dovobet must be stopped as indicated by your doctor. It may be necessary to stop
using the medicine gradually, especially after using it for a long time.
If you have any doubts 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 everybody gets them.
Serious side effects
Tell your doctor or nurse immediately or as soon as possible if any of the following side effects occur.
Treatment may need to be stopped.
The following serious side effects have been reported with the use of Dovobet
Uncommon (may affect up to 1 in 100 )

• worsening of psoriasis. Tell your doctor as soon as possible if your psoriasis gets worse.

Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the
components of Dovobet. Tell your doctor as soon as possible if you experience a serious side effect. These
side effects are more likely to occur after a long period of treatment, use in skin folds (e.g. groin, armpits or
under the breasts) or with the use of occlusive dressings or use on 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 pressure inside the eyes (symptoms are: 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 tell your doctor as soon as possible
• Interference with metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in blood sugar).

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 have an allergic reaction, stop using Dovobet, tell your doctor immediately or go to the nearest hospital emergency room
• Treatment with this gel may increase calcium levels in your blood or urine (usually when using excessive amounts). Symptoms of increased calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion and coma. This can be serious andtherefore you should 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 of the hair root (folliculitis)
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of capillaries (erythema)
• Acne (pimples)
• Dry skin
• Skin rash
• Pustular rash
• Skin infection.

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

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

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

• When used on the scalp, white or gray hair can temporarily turn yellowish in the application site
• Blurred vision.

Less serious side effects, due to the use of betamethasone, especially for a long period, include
those listed below. If any of these effects occur, you should tell your doctor or nurse
as soon as possible:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rashes, with inflammation or swelling (allergic contact dermatitis)
• Small gold-colored cysts (milia colloidale)
• Skin discoloration (depigmentation)
• Inflammation or swelling of 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
• Redness of the skin due to dilation of capillaries (erythema)
• Skin rash
• Skin rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 bottle after SCAD. The expiry date refers to the last day of that month.
• Do not refrigerate. Keep the bottle in the outer packaging to protect it from light.
• Discard the bottle with any remaining gel after 6 months from first opening.

Do not dispose of any medicine in 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 ingredients 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 ingredients are:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylated hydroxytoluene (E321)
• all-rac-α-tocopherol

Description of the appearance of Dovobet and package contents
Dovobet presents as a rather clear, colorless 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 80g, 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

Distributor in Italy
LEO Pharma S.p.A.
Via Elio Vittorini, 129
00144 Roma

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 with the
following denominations:
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.

Dovobet 50 micrograms/0.5 mg/g gel

calcipotriol/ betamethasone
Applicator

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even 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 you use 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 is Dovobet and what is it used for

Dovobet gel is used as a topical treatment for scalp psoriasis in adults and of the skin of
other areas of the body to treat plaque psoriasis (common psoriasis) of mild to moderate severity in
adults. Psoriasis is caused by skin cells that reproduce too quickly. This causes
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 other types of psoriasis ,such as erythrodermic, exfoliative and pustular (ask your doctor).

Since Dovobet contains a strong 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 rashes around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)
• rosacea (severe flushing or redness of the facial skin)
• ulcers or open wounds on the skin.

Warnings and precautions
Talk to your doctor, nurse or pharmacist before and during the use of Dovobet if:

• you are using other medicines that contain corticosteroids, as undesirable effects may occur
• you have used this medicine for a long time and decide to stop treatment (when treatment with steroids is stopped abruptly there is a risk that psoriasis will worsen or flare up)
• you have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid;
• 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 the body or using more than 15 g of product per day.
• Avoid using a shower cap, bandage or clothing that may increase the absorption of the steroid.
• Avoid use on large areas of damaged skin, on mucous membranes or in skin folds (e.g. groin, armpits or under the breasts), as this increases the absorption of the corticosteroid.
• Avoid applying the medicine to the skin of the face or genitals (sexual organs), which are sensitive to steroids.
• Avoid excessive sun exposure, excessive use of the solarium and other forms of light treatment.

Children
The use of Dovobet is not recommended in children under the age of 18 years.

Other medicines and Dovobet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before using this medicine.
If your doctor has established that you can breastfeed, make sure you do not apply Dovobet to the breast area.

Driving and using machines
This medicine should not affect your ability to drive or operate machinery.

Dovobet gel contains butylhydroxytoluene (E321)
Dovobet gel contains butylhydroxytoluene (E321) which may cause local skin reactions (such as contact
dermatitis), irritation of the eyes and mucous membranes.

3. How to use Dovobet

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
How to use Dovobet gel: for cutaneous 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 the assembly, use, cleaning and storage of the
Dovobet gel Applicator.
In the remaining part of this leaflet, the Dovobet gel Applicator is called “the Applicator”.
Instructions for the correct use of Dovobet

• Use Dovobet only on psoriasis, do not use it on skin not affected by psoriasis.
• Apply Dovobet to the affected areas with the Applicator and rub gently until the area affected by psoriasis 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 comes into contact with your fingers. This will avoid 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 medicine spreads too far from the psoriatic area.
• To achieve an optimal effect, it is recommended not to bathe or shower immediately after applying Dovobet gel.
• After applying the gel, avoid contact with fabrics that could easily stain with oil (for example, silk).

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

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

If you are using other medicines containing calcipotriol, the total amount of medicines containing calcipotriol
must not exceed 15 grams per day and the area must not exceed 30% of the total body surface area.
A full actuation delivers 0.05 g of Dovobet gel.

What to expect with the use of Dovobet
Most patients notice evident improvements after 2 weeks, even if the psoriasis has not 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 can cause problems with calcium levels in the blood which usually normalize
after stopping treatment.
The doctor may deem it necessary to subject you to some blood tests to check if the use of excessive amounts of gel may have caused a problem with calcium levels in the blood.
Prolonged excessive use can also cause improper functioning 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
The use of Dovobet must be stopped as indicated by your doctor. It may be necessary to stop
using the medicine gradually, especially after using it for a long time.
If you have any doubts 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 everybody gets them.
Serious side effects
Tell your doctor or nurse immediately or as soon as possible if any of the following side effects occur.
Treatment may need to be stopped.
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. Tell your doctor as soon as possible if your psoriasis gets worse.

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

• the adrenal glands may stop working properly. Symptoms are: fatigue, depression and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty seeing at night and sensitivity to light) or increased pressure inside the eyes (symptoms are: 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 tell your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic you may experience fluctuations in blood sugar).

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 hands or feet. Swelling of the mouth/throat and difficulty breathing may occur. If you have an allergic reaction, stop using Dovobet, tell your doctor immediately or go to the nearest hospital emergency room.
• Treatment with this gel may increase calcium levels in your blood or urine (usually when using excessive amounts). Symptoms of increased calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion and coma. This can be serious and therefore you should 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 of the hair root (folliculitis)
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of capillaries (erythema)
• Acne (pimples)
• Dry skin
• Skin rash
• Pustular 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 is stopped

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

• When used on the scalp, white or gray hair may temporarily turn yellowish in the application site
• Blurred vision.

Less serious side effects, due to the use of betamethasone, especially for a long period, include
those listed below. If any of these effects occur, you should tell 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 cysts (milia colloid)
• Skin discoloration (depigmentation)
• Inflammation or swelling of 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
• Redness of the skin due to dilation of capillaries (erythema)
• Skin rash
• Skin rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 cartridge after SCAD. The expiry date refers to the last day of the month.
• Do not refrigerate.
• The Applicator is for single use. Throw away the Applicator with any residual gel after 6 months from first opening.

Do not dispose of any medicine in the drains 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 ingredients 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 ingredients are:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylated hydroxytoluene (E321)
• all-rac-α-tocopherol

Description of Dovobet and package contents
Dovobet appears as a fairly clear, colorless or whitish gel, contained in a cartridge of
polypropylene (with a high-density polyethylene plunger and a screw cap). The cartridge and applicator head
(outer shell of polypropylene, lever of polyoxymethylene and thermoplastic elastomer dispenser) must be
assembled before first use. The polypropylene cap
is for storage.
The cartridge(s), the applicator head(s) and the cap(s) are inserted into a carton.
Packs: 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

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

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.

Instructions for Use

Dovobet gel Applicator

already used Dovobet gel previously.
Dovobet gel Applicator is formulated to apply Dovobet gel to the skin or scalp affected by
plaque psoriasis. By using Dovobet gel Applicator, you can apply Dovobet gel without the gel coming into
contact with your fingers.
Always follow your doctor's instructions regarding the treatment of your psoriasis.

Do not sharethe Dovobet gel or the Applicator with other people.
Keep this medicine out of the sight and reach of children.
Your Dovobet gel Applicator

Preparation of Dovobet gel Applicator

A) Check the expiration date on the
cartridge
Check the expiration date on the label
of the cartridge.
Do not use if expired.
The expiration date on the cartridge refers to
the last day of that month.
Write the date 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 could
cause the gel to leak.
Dispose of the cap after removing it.

C)Insertfirmlythe
applicator head
Hold the cartridge in an upright position and
align the applicator head.
Screw the applicator head clockwise
until the applicator head is
securely sealed.
You will hear clicking sounds until the head is securely sealed.

Caution:
Do not disassemble the Applicator.
In attempting to do so, the Applicator may
break.

D) Priming before first
use
To prime:
Make sure the applicator head and the
cartridge are securely assembled.
Gently push on the centerof the
plunger while pressing the lever until you
see product at the tip of the dispenser.
If you fly your assembled Dovobet gel Applicator, you may need to press the
lever several times to re-prime before use.

Apply the Dovobet gel to the affected areas

E) Apply to the affected area
Place the dispenser near the affected area and press the lever one or more times to
dispense the Dovobet gel.
Release the lever completely between each push
to obtain a complete delivery.
One complete push delivers 0.05 g of Dovobet
gel.

F)Usetheappropriate
surface of the dispenser to massage Dovobet
gel onto the plaques.
Use the appropriate surface to gently massage
the Dovobet gel onto the affected skin.
Be careful not to press the lever while
dispensing the product.

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

H) After application
Check that the affected areas are sufficiently covered.
If necessary, ask someone to apply Dovobet gel to areas that you are unable to reach or
see.

Wash your handsafter 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 your body (especially the face, mouth and eyes):

After use

I) Clean the applicator after each use
Following use, dry the applicator head with a clean, dry cloth.
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 materialsto dry the applicator.

J) Cover the applicator
To keep the applicator head clean
replace the cap after each
use.
Make sure the cap is inserted
correctly to prevent Dovobet gel from leaking during storage and
transport.

K) Assess the remaining amount of Dovobet
gel
To assess 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 upwards.

Before using it again

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

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

Storage
Always make sure that the cap is positioned correctly to prevent the gel from leaking
during storage and transport. See further information on storage in section 5
‘How to store Dovobet’.

Disposal of the product
See the information on disposal in section 5 ‘How to store Dovobet’.

DOVOBET ®

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

Read this leaflet carefully before you use this medicine as 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 pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even 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 you use 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 (common psoriasis) 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 NEED TO KNOW BEFORE USING DOVOBET

Do not use DOVOBET:

• if you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the excipients of 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 (ask your doctor).

Since Dovobet contains a strong 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 rashes around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)
• rosacea (severe flushing or redness of the facial skin)
• ulcers or open wounds on the skin

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

• you are using other medicines that contain corticosteroids, as side effects may occur
• you have used this medicine for a long time and decide to stop treatment (when treatment with steroids 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
• skin lesions tend to become infected, you may need to stop treatment
• you have a certain type of psoriasis called guttate psoriasis

Special precautions

• avoid applying the product to more than 30% of the body or using more than 15 g of product per day
• avoid using bandages or clothing that may increase the absorption of the steroid
• avoid use on large areas of damaged skin or on mucous membranes or in skin folds (e.g. groin, armpits, under the breasts) as this may increase the absorption of the steroid.
• avoid applying the medicine to the skin of the face or to the genitals (sexual organs), which are very sensitive to steroids
• avoid excessive sunbathing, excessive use of the solarium and other forms of light treatment.

Children
The use of Dovobet is not recommended in children under the age of 18 years.

Other medicines and Dovobet
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.

Pregnancy and breastfeeding
Do not use Dovobet if you are pregnant (or may be pregnant) or if you are breastfeeding, without having
first spoken to your doctor. If the doctor has established that you can breastfeed, make sure you do not apply Dovobet
ointment to the breast area.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine should not affect your ability to drive vehicles or use machines.

Important information about some excipients of DOVOBET
Dovobet ointment contains butylhydroxytoluene (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 told you. If you have any doubts, ask your doctor or
pharmacist .
How to use Dovobet: for cutaneous use.

Instructions for correct use

• Use Dovobet only on psoriasis; do not use on skin not affected by psoriasis.
• Remove the cap and check that the tube seal is not broken before you use the ointment for the first time.
• To break the seal, use the back of the cap.
• By squeezing the tube, dispense the ointment onto a clean finger.
• Gently rub until the area affected by psoriasis is covered and most of the ointment has been absorbed by the skin.
• Do not bandage, tightly wrap or cover the treated skin areas.
• Wash your hands thoroughly after using Dovobet (unless you have used the ointment to treat your hands). This will avoid 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 the ointment accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medicine spreads too far from the psoriatic area.
• To achieve an optimal effect, it is recommended not to bathe or shower immediately after applying Dovobet ointment.
• After applying the ointment, avoid contact with fabrics that could easily be stained with grease (for example: silk).

Duration of treatment

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

If you are using other medicines containing calcipotriol, the total amount of medicines 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 significant improvements after 2 weeks, even if psoriasis has not 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 can cause problems with calcium levels in the blood, which usually normalize after stopping treatment.
The doctor may consider it necessary to subject you to some blood tests to check if the use of excessive amounts of ointment may have caused a problem with calcium levels in the blood.
Excessive and prolonged use can also cause improper functioning 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 application.

If you stop using DOVOBET
The use of Dovobet must be discontinued as directed by your doctor. It may be necessary to discontinue the drug gradually, especially after using it for a long time.
If you have any doubts about the use of Dovobet, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dovobet can cause side effects, although not everybody gets them.
Serious side effects:
Inform your doctor/nurse immediately or as soon as possible if you experience any of the events
listed below. It may be necessary to stop treatment.
The following serious side effects 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 gets worse.

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

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

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 frequent after prolonged use, use in skin folds (e.g.
groin, armpits or under the breasts), use with occlusive dressings or use on a large skin area
Side effects include:

• The adrenal glands may stop functioning properly. Symptoms are fatigue, depression and anxiety.
• Cataract (symptoms are blurred or misty vision, difficulty seeing at night and sensitivity to light) or increased pressure inside the eyes (symptoms are eye pain, red eyes, decreased 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 that usually appears on the hands or feet). If you notice this, stop using 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).

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 have an allergic reaction, stop using Dovobet, inform your doctor immediately or go to theemergency room of the nearest hospital.
• Treatment with this ointment may increase the levels of calcium in your blood or urine (usually when using excessive amounts of ointment). Symptoms of increased calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion and coma. This can be serious and therefore you should contact your doctor immediately.However, levels will return to normal when treatment is stopped.

Less serious side effects
The following less serious side effects 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
• Rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of capillaries (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin color in the area where the ointment has been applied
• Rash
• Burning sensation on the skin
• Skin infection
• Thinning of the skin
• Appearance of red or purple discoloration on the skin (purpura or ecchymosis)

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

• Infection of hair follicles caused by fungi or bacteria (boils)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Skin sensitization to the sun and resulting rash
• Acne (pimples)
• Dry skin
• Rebound effect: a worsening of psoriasis symptoms after treatment is stopped

Less serious side effects, due to the use of betamethasone, especially for a prolonged time,
include those listed below; 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 rash around the mouth (perioral dermatitis)
• Rash, with inflammation or swelling (allergic contact dermatitis)
• Small gold-colored cysts (milia colloid)
• 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, with resulting rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to dilation of capillaries (erythema)
• Rash
• Rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through
By reporting side effects 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 after “EXP”. The expiry date refers to the last day of the month.
• Do not store at a temperature above 25°C.
• The tube must not be used 1 year after first opening. Write the date of first opening of the tube in the designated space on the packaging.

Medicines should not be disposed of 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 ointment contains
The active ingredients are:
calcipotriol and betamethasone
1 gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone
(as dipropionate)
The excipientsare:

• liquid paraffin
• all-rac-  -tocopherol
• polyoxypropylene-11-stearyl ether
• soft white paraffin
• butylated hydroxytoluene (E321)

Description of DOVOBET and package contents
Dovobet ointment is an ointment of ivory to yellow color, supplied in aluminum/epoxyphenol tubes with a screw
cap made of polyethylene.
Pack sizes: 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, 55 Industriparken – 2750 Ballerup (DK)
The manufacturer is:
LEO Laboratories Ltd., Cashel Road, Dublin 12 – Ireland
For further information on this medicinal product, contact the local representative of the marketing authorisation
holder:

LEO Pharma S.p.A., Via Amsterdam 125 -00144 Rome
This medicinal product is authorised in other member states of the European Economic Area under the following
names:
Daivobet: Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Latvia,
Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden

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