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DOVOBET GEL APPLICATOR

Active substance(s): BETAMETASONE / BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL / CALCIPOTRIOL MONOHYDRATE

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If you fly with your assembled Dovobet® gel Applicator, you may need to
pump the lever a few times to re-prime before applying.

Before Use again
L) Check expiry date
Always check the expiry date on the cartridge
label before use.
Do not use if the expiry is exceeded or 6
months after opening the cartridge.
The expiry date on the cartridge refers to the
last day of that month.

Applying the Dovobet ® gel to the affected area
E) Apply to the affected area
Place the applicator nozzle close to the
affected area and press the
lever one or more times to dispense the
Dovobet® gel.
Release the lever fully between each pump to
get
a full dispense. One full pump delivers 0.05 g
Dovobet® gel.

M) Remove cover
Remove the cover by lifting the tab at rear.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® gel Applicator

(calcipotriol /betamethasone dipropionate)
Read all of this leaflet carefully before you start using this medicine
 Avoid excessive sunbathing, excessive use of solarium and other forms
because it contains important information for you.
of light treatment.
Children

 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See Section
4.

Dovobet® is not recommended for the use in children below the age of 18
years.
Other medicines and Dovobet ®
Please tell your doctor, pharmacist or nurse if you are taking or have
recently taken any other medicines, including medicines obtained without
a prescription.

What is in this leaflet

Pregnancy and breast-feeding

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
Storage
F) Use spreading surfaces to massage
Dovobet ® gel across plaques
Use the spreading surfaces to gently massage the Dovobet® gel
into the affected skin.
Be careful not to press the lever when spreading.

Always ensure the cover is clicked in place to prevent dispensing the gel
during storage and transportation.
See further information about storage in section 5,
‘How to store Dovobet® ‘.
Disposal

G) To apply to scalp and hairline
Before applying Dovobet® to the scalp, comb
the hair to remove any loose scales.
Tilt your head to make sure Dovobet® does not
run onto your face. It may help to part your
hair before you use Dovobet®.
Locate the area to treat using your fingers and
part your hair.
Use the nozzle directly on the scalp to
dispense and massage in the Dovobet® gel.

See information about disposal in section 5, ‘How to store Dovobet® ‘.

Do not use Dovobet® if you are pregnant (or might be pregnant) or if you
are breast-feeding, unless you have agreed it with your doctor first. If your
doctor has agreed that you can breast-feed, take care and do not apply
Dovobet® to the breast area.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines

1. WHAT DOVOBET® IS AND WHAT IT IS USED FOR

This medicine should not have any effect on your ability to drive or use
machines.
Dovobet ® contains butylated hydroxytoluene (E321)
Dovobet® contains butylated hydroxytoluene (E321), which may cause
local skin reactions (e.g. contact dermatitis), or irritation to the eyes and
mucous membranes.

Dovobet® is used as topical treatment of scalp psoriasis in adults and on
the skin of other body areas to treat mild to moderate plaque psoriasis
(psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being
produced too quickly. This causes redness, scaling and thickness of your
skin.
Dovobet® contains calcipotriol and betamethasone. Calcipotriol helps to
bring the rate of skin cell growth back to normal and betamethasone acts
to reduce inflammation.

3. HOW TO USE DOVOBET®

DOVOBET® is a trademark of LEO Pharma A/S

Always use Dovobet® exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
How to put on Dovobet®: Cutaneous use.
Read the Instructions for Use for the Dovobet® gel Applicator included at
the end of this leaflet carefully before use.
In the Instructions for Use you will find information about assembling,
using, cleaning and storing of the Dovobet® gel Applicator.
The Dovobet® gel Applicator is called ‘the Applicator’ in the remainder of
this leaflet.
Instructions for proper use of Dovobet®
 Use only on your psoriasis and do not use on skin which does not have
psoriasis
 Apply Dovobet® to the affected area with the Applicator, and rub it in
gently until the area affected by psoriasis is covered by a thin layer of
gel
 Do not bandage, tightly cover or wrap the treated skin area
 Wash your hands well after using Dovobet® if you get gel on your
fingers. This will avoid accidentally spreading the gel to other parts of
your body (especially the face, mouth and eyes)
 Do not worry if some gel accidentally gets on normal skin near your
psoriasis, but wipe it off if it spreads too far
 In order to achieve optimal effect, it is recommended not to take a
shower or bath immediately after application of Dovobet® gel
 After applying the gel, avoid contact with textiles which are easily
stained by grease (e.g. silk)
Washing your hair before application of Dovobet ® is not necessary.
In order to achieve optimal effect, it is recommended that the hair is
not washed immediately after application of Dovobet ®. Let Dovobet®
remain on the scalp during the night or during the day.
When washing hair after application the following instructions might
be useful:

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET®
Do not use DOVOBET®:

Blind or partially sighted?
Is this leaflet hard to see or read?

H) After application
Check that the affected areas are sufficiently covered.
If needed, ask someone to help you apply the Dovobet® gel to areas you
cannot reach or see.
Wash hands after use, if you, or someone assisting you, get Dovobet®
gel on the fingers.
This will avoid accidentally spreading the gel to other parts of your body
(especially the face, mouth and eyes).

Phone Beachcourse,
Tel: 020 8896 9054
for help.

After use
I) Clean your Dovobet ® gel Applicator
after each use
Following use, wipe the applicator head
with a clean, dry tissue. Avoid pumping
while cleaning.
Note:
• Do not wash the Applicator with water,
detergents or any other substances.
• Do not use moist or wet materials to
wipe the Applicator.

 If you are allergic (hypersensitive) to calcipotriol, betamethasone or any
of the other ingredients of Dovobet® (listed in section 6)
 If you have problems with calcium levels in your body (ask your doctor)
 If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your doctor).
As Dovobet® contains a strong steroid, do NOT use it on skin affected by:
 skin infections caused by viruses (e.g. cold sores or chicken pox)
 skin infections caused by a fungus (e.g. athlete’s foot or ringworm)
 skin infections caused by bacteria
 skin infections caused by parasites (e.g. scabies)
 tuberculosis (TB)
 perioral dermatitis (red rash around the mouth)
 thin skin, easily damaged veins, stretch marks
 ichthyosis (dry skin with fish-like scales)
 acne (pimples)
 rosacea (severe flushing or redness of the skin on the face)
 ulcers or broken skin.
Warnings and precautions

J) Cover the Applicator
Replace the cover after each use to keep
the applicator head clean.
Always ensure the cover is clicked in place
to prevent dispensing Dovobet® gel during
storage and transportation.

K) Estimate the amount of remaining
Dovobet ® gel
To estimate the amount of remaining Dovobet®
gel, look in the bottom of the cartridge to see the
plunger position. The plunger moves upwards as
the gel is used.
4

Revision date: 17.01.2018
Leaflet Reference: DOVAPPLI

Talk to your doctor/nurse/pharmacist before using Dovobet® if:
 you are using other medicines that contain corticosteroids as you may
get side effects
 you have used this medicine for a long time and plan to stop (as there
is a risk your psoriasis will get worse or ‘flare up’ when steroids are
stopped suddenly)
 you have diabetes mellitus (diabetes) as your blood sugar/glucose level
may be affected by the steroid
 your skin becomes infected as you may need to stop your treatment
 you have a certain type of psoriasis called guttate psoriasis.
Special precautions
 Avoid use on more than 30% of your body or using more than 15 grams
per day
 Avoid using under a bathing cap, bandages or dressings as it increases
the absorption of the steroid
 Avoid use on large areas of damaged skin, on mucous membranes or
in skin folds (groin, armpits, under breasts) as it increases the
absorption of the steroid
 Avoid use on your face or genitals (sex organs) as they are very
sensitive to steroids

Apply a mild shampoo to
the dry hair, especially to
those areas where the gel
was applied.

1

Uncommon (may affect up to 1 in 100 people)
 Worsening of your psoriasis. If your psoriasis gets worse, tell your
doctor as soon as possible.
Some serious side effects are known to be caused by betamethasone (a
strong steroid), one of the ingredients in Dovobet®. You should tell your
doctor as soon as possible if any of the serious side effects occur. These
side effects are more likely to happen after long-term use, use in skin
folds (e.g. groin, armpits or under breasts), use under occlusion or use on
large areas of skin.
The side effects include the following:
 Your adrenal glands may stop working properly. Signs are tiredness,
depression and anxiety
 Cataracts (signs are cloudy and foggy vision, difficulty seeing at night
and sensitivity to light) or an increase in pressure inside the eye (signs
are eye pain, red eye, decreased or cloudy vision)
 Infections (because your immune system, which fights infections, may
be suppressed or weakened)
 Pustular psoriasis (a red area with yellowish pustules usually on the
hands or feet). If you notice this, stop using Dovobet® and tell your
doctor as soon as possible
 Impact on the metabolic control of diabetes mellitus (if you have
diabetes you may experience fluctuations in the blood glucose levels).
Serious side effects known to be caused by calcipotriol
 Allergic reactions with deep swelling of the face or other parts of the
body such as the hands or feet. Swelling of the mouth/throat and
trouble breathing may occur. If you have an allergic reaction, stop using
Dovobet®, tell your doctor immediately or go to the casualty department
at your nearest hospital
 Treatment with this gel may cause the level of calcium in your blood or
urine to increase (usually when too much gel has been used). Signs of
increased calcium in blood are excessive secretion of urine,
constipation, muscle weakness, confusion and coma. This can be
serious, and you should contact your doctor immediately. However,
when the treatment is stopped, the levels return to normal.
Less serious side effects
The following less serious side effects have been reported for Dovobet®
Common side effects (may affect up to 1 in 10 people)
 Itching.
Uncommon (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)
 Rash with inflammation of the skin (dermatitis)
 Redness of the skin due to widening of the small blood vessels
(erythema)
 Acne (pimples)
 Dry skin
 Rash
 Pustular rash
 Infection of the skin.
Rare (may affect up to 1 in 1,000 people)
 Allergic reactions
 Stretch marks
 Skin exfoliation
 Rebound effect: A worsening of symptoms/psoriasis after ended
treatment.
Less serious side effects caused by using betamethasone, especially for
a long time, include the following. You should tell your doctor or nurse as
soon as possible if you notice any of them
 Thinning of the skin
 Appearance of surface veins or stretch marks
 Changes in hair growth
 Red rash around the mouth (perioral dermatitis)
 Skin rash with inflammation or swelling (allergic contact dermatitis)
 Golden coloured gel-filled bumps (colloid milia)
 Lightening of skin colour (depigmentation)
 Inflammation or swelling of the hair root (folliculitis).
Less serious side effects known to be caused by calcipotriol include the
following
 Dry skin
 Sensitivity of the skin to light resulting in a rash
 Eczema
 Itching
 Skin irritation
 Burning and stinging sensation
 Redness of the skin due to widening of the small blood vessels
(erythema)

Leave the shampoo on the
scalp for a couple of minutes
before washing.

Wash your hair as usual.

If necessary, repeat step 1-3 once or twice.
Duration of treatment
 Use the gel once a day. It may be more convenient to use the gel in the
evening
 The normal initial treatment period is 4 weeks for scalp areas and 8
weeks for non-scalp areas
 Your doctor may decide on a different treatment period
 Your doctor may decide on repeated treatment
 Do not use more than 15 grams in one day (corresponding to 300
pumps)
 For treatment of the scalp usually an amount between 1 g and 4 g per
day is sufficient (corresponding to 20 to 80 pumps)
If you use other calcipotriol containing medicines, the total amount of
calcipotriol medicines must not exceed 15 grams per day and the area
treated should not exceed 30% of the total body surface.
One full pump delivers 0.05 g Dovobet® gel.
What should I expect when I use Dovobet®?
Most patients see obvious results after 2 weeks, even if the psoriasis is
not yet cleared at that point.
If you have used more Dovobet ® than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Dovobet® may also cause a problem with calcium in
your blood, which usually normalises when discontinuing treatment.
Your doctor may need to carry out blood tests to check that using too
much gel has not caused a problem with calcium in your blood.
Excessive prolonged use can also cause your adrenal glands to stop
working properly (the adrenal glands are found near the kidneys and
produce hormones).
If you forget to use Dovobet®
Do not take a double dose to make up for forgotten individual doses.
If you stop using Dovobet ®
The use of Dovobet® should be stopped as indicated by your doctor. It
may be necessary for you to stop this medicine gradually, especially if
you have used it for a long time.
If you have any further questions about the use of this medicine, 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
Tell your doctor/nurse immediately or as soon as possible if any of the
following happens.
You may have to stop your treatment.
The following serious side effects have been reported for Dovobet®
2

Your Dovobet® gel Applicator

 Rash
 Rash with inflammation of the skin (dermatitis)
 Worsening of psoriasis.
Reporting of side effects

Cover

If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

Cartridge cap
(removable)

5. HOW TO STORE DOVOBET®

Cartridge
Small spreading
surface

 Keep out of the sight and reach of children
 Do not use Dovobet® after the expiry date, which is stated on the
cartridge after EXP. The expiry date refers to the last day of that month
 Do not refrigerate
 The Applicator is disposable. Discard the Applicator with any remaining
gel 6 months after first opening.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Larger
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

spreading
surface

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

Lever

Plunger (visible
from the bottom
of the cartridge)

Preparing your Dovobet® gel Applicator

The other ingredients are:
• paraffin, liquid
• polyoxypropylene stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.

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 that you assembled
the Applicator on the cartridge label.
Do not use the Applicator more than
6 months after this date.

What Dovobet® looks like and the contents of the pack
Is an almost clear, colourless to slightly off-white gel filled in a
polypropylene cartridge (with a high-density polyethylene plunger and
screw cap). The cartridge and the applicator head (polypropylene outer
casing, polyoxymethylene lever and thermoplastic elastomer nozzle) is
assembled prior to first use. The polypropylene cover is for storage.

B) Remove the cartridge cap
Holding the cartridge upright, twist the
cap anti-clockwise to remove.
Avoid tipping the cartridge as this may
result in spilling the gel.
Discard the cap after removing.

The cartridge(s), applicator head(s) and cover(s) are placed in a carton.
Pack sizes: 60 g (equivalent to 68 ml)
Who manufactured your medicine
LEO Laboratories Limited (LEO Pharma), 285 Cashel Road, Dublin 12
Ireland. Procured from within the EU and repackaged by the Product
Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 16378/0594

Applicator
nozzle

C) Attach applicator head tightly
Keep the cartridge upright and align the
applicator head. Screw the applicator head
clockwise until the applicator head feels tightly
sealed.
Clicking sounds will be heard until it is tightly
sealed.
Note:
Do not disassemble the Applicator. Attempts
to do so may break the Applicator.

POM

Instructions for Use of the Applicator are included at the end of this leaflet.
Revision date: 17.01.2018
Leaflet Reference: DOVAPPLI

Instructions for Use
Dovobet® gel Applicator
Before use, you should read all of the patient information and the
Instructions for Use carefully – even if you have used Dovobet® gel
before.
The Dovobet® gel Applicator is designed to apply Dovobet gel to your skin
and scalp affected by plaque psoriasis. Using the Dovobet® gel
Applicator, you can apply Dovobet® gel without getting any gel on your
fingers.
Always follow your doctor’s instructions on the treatment of your psoriasis.
Do not share the Dovobet® gel or the Applicator with others.
Keep this medicine out of the sight and reach of children.

D) Prime before first use
To prime:
Make sure that the applicator
head and cartridge are tightly
assembled.
Gently push up on the centre of
the plunger while squeezing the
lever until you see gel at the
nozzle tip.
3

If you fly with your assembled Dovobet® gel Applicator, you may need to
pump the lever a few times to re-prime before applying.

Before Use again
L) Check expiry date
Always check the expiry date on the cartridge
label before use.
Do not use if the expiry is exceeded or 6
months after opening the cartridge.
The expiry date on the cartridge refers to the
last day of that month.

Applying the Dovobet ® gel to the affected area
E) Apply to the affected area
Place the applicator nozzle close to the
affected area and press the
lever one or more times to dispense the
Dovobet® gel.
Release the lever fully between each pump to
get
a full dispense. One full pump delivers 0.05 g
Dovobet® gel.

M) Remove cover
Remove the cover by lifting the tab at rear.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® gel Applicator

(calcipotriol /betamethasone dipropionate)
Read all of this leaflet carefully before you start using this medicine
 Avoid excessive sunbathing, excessive use of solarium and other forms
because it contains important information for you.
of light treatment.
Children

 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See Section
4.

Dovobet® is not recommended for the use in children below the age of 18
years.
Other medicines and Dovobet ®
Please tell your doctor, pharmacist or nurse if you are taking or have
recently taken any other medicines, including medicines obtained without
a prescription.

What is in this leaflet

Pregnancy and breast-feeding

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
Storage
F) Use spreading surfaces to massage
Dovobet ® gel across plaques
Use the spreading surfaces to gently massage the Dovobet® gel
into the affected skin.
Be careful not to press the lever when spreading.

Always ensure the cover is clicked in place to prevent dispensing the gel
during storage and transportation.
See further information about storage in section 5,
‘How to store Dovobet® ‘.
Disposal

G) To apply to scalp and hairline
Before applying Dovobet® to the scalp, comb
the hair to remove any loose scales.
Tilt your head to make sure Dovobet® does not
run onto your face. It may help to part your
hair before you use Dovobet®.
Locate the area to treat using your fingers and
part your hair.
Use the nozzle directly on the scalp to
dispense and massage in the Dovobet® gel.

See information about disposal in section 5, ‘How to store Dovobet® ‘.

Do not use Dovobet® if you are pregnant (or might be pregnant) or if you
are breast-feeding, unless you have agreed it with your doctor first. If your
doctor has agreed that you can breast-feed, take care and do not apply
Dovobet® to the breast area.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines

1. WHAT DOVOBET® IS AND WHAT IT IS USED FOR

This medicine should not have any effect on your ability to drive or use
machines.
Dovobet ® contains butylated hydroxytoluene (E321)
Dovobet® contains butylated hydroxytoluene (E321), which may cause
local skin reactions (e.g. contact dermatitis), or irritation to the eyes and
mucous membranes.

Dovobet® is used as topical treatment of scalp psoriasis in adults and on
the skin of other body areas to treat mild to moderate plaque psoriasis
(psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being
produced too quickly. This causes redness, scaling and thickness of your
skin.
Dovobet® contains calcipotriol and betamethasone. Calcipotriol helps to
bring the rate of skin cell growth back to normal and betamethasone acts
to reduce inflammation.

3. HOW TO USE DOVOBET®

DOVOBET® is a trademark of LEO Pharma A/S

Always use Dovobet® exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
How to put on Dovobet®: Cutaneous use.
Read the Instructions for Use for the Dovobet® gel Applicator included at
the end of this leaflet carefully before use.
In the Instructions for Use you will find information about assembling,
using, cleaning and storing of the Dovobet® gel Applicator.
The Dovobet® gel Applicator is called ‘the Applicator’ in the remainder of
this leaflet.
Instructions for proper use of Dovobet®
 Use only on your psoriasis and do not use on skin which does not have
psoriasis
 Apply Dovobet® to the affected area with the Applicator, and rub it in
gently until the area affected by psoriasis is covered by a thin layer of
gel
 Do not bandage, tightly cover or wrap the treated skin area
 Wash your hands well after using Dovobet® if you get gel on your
fingers. This will avoid accidentally spreading the gel to other parts of
your body (especially the face, mouth and eyes)
 Do not worry if some gel accidentally gets on normal skin near your
psoriasis, but wipe it off if it spreads too far
 In order to achieve optimal effect, it is recommended not to take a
shower or bath immediately after application of Dovobet® gel
 After applying the gel, avoid contact with textiles which are easily
stained by grease (e.g. silk)
Washing your hair before application of Dovobet ® is not necessary.
In order to achieve optimal effect, it is recommended that the hair is
not washed immediately after application of Dovobet ®. Let Dovobet®
remain on the scalp during the night or during the day.
When washing hair after application the following instructions might
be useful:

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET®
Do not use DOVOBET®:

Blind or partially sighted?
Is this leaflet hard to see or read?

H) After application
Check that the affected areas are sufficiently covered.
If needed, ask someone to help you apply the Dovobet® gel to areas you
cannot reach or see.
Wash hands after use, if you, or someone assisting you, get Dovobet®
gel on the fingers.
This will avoid accidentally spreading the gel to other parts of your body
(especially the face, mouth and eyes).

Phone Beachcourse,
Tel: 020 8896 9054
for help.

After use
I) Clean your Dovobet ® gel Applicator
after each use
Following use, wipe the applicator head
with a clean, dry tissue. Avoid pumping
while cleaning.
Note:
• Do not wash the Applicator with water,
detergents or any other substances.
• Do not use moist or wet materials to
wipe the Applicator.

 If you are allergic (hypersensitive) to calcipotriol, betamethasone or any
of the other ingredients of Dovobet® (listed in section 6)
 If you have problems with calcium levels in your body (ask your doctor)
 If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your doctor).
As Dovobet® contains a strong steroid, do NOT use it on skin affected by:
 skin infections caused by viruses (e.g. cold sores or chicken pox)
 skin infections caused by a fungus (e.g. athlete’s foot or ringworm)
 skin infections caused by bacteria
 skin infections caused by parasites (e.g. scabies)
 tuberculosis (TB)
 perioral dermatitis (red rash around the mouth)
 thin skin, easily damaged veins, stretch marks
 ichthyosis (dry skin with fish-like scales)
 acne (pimples)
 rosacea (severe flushing or redness of the skin on the face)
 ulcers or broken skin.
Warnings and precautions

J) Cover the Applicator
Replace the cover after each use to keep
the applicator head clean.
Always ensure the cover is clicked in place
to prevent dispensing Dovobet® gel during
storage and transportation.

K) Estimate the amount of remaining
Dovobet ® gel
To estimate the amount of remaining Dovobet®
gel, look in the bottom of the cartridge to see the
plunger position. The plunger moves upwards as
the gel is used.
4

Revision date: 17.01.2018
Leaflet Reference: DOVAPPLI

Talk to your doctor/nurse/pharmacist before using Dovobet® if:
 you are using other medicines that contain corticosteroids as you may
get side effects
 you have used this medicine for a long time and plan to stop (as there
is a risk your psoriasis will get worse or ‘flare up’ when steroids are
stopped suddenly)
 you have diabetes mellitus (diabetes) as your blood sugar/glucose level
may be affected by the steroid
 your skin becomes infected as you may need to stop your treatment
 you have a certain type of psoriasis called guttate psoriasis.
Special precautions
 Avoid use on more than 30% of your body or using more than 15 grams
per day
 Avoid using under a bathing cap, bandages or dressings as it increases
the absorption of the steroid
 Avoid use on large areas of damaged skin, on mucous membranes or
in skin folds (groin, armpits, under breasts) as it increases the
absorption of the steroid
 Avoid use on your face or genitals (sex organs) as they are very
sensitive to steroids

Apply a mild shampoo to
the dry hair, especially to
those areas where the gel
was applied.

1

Uncommon (may affect up to 1 in 100 people)
 Worsening of your psoriasis. If your psoriasis gets worse, tell your
doctor as soon as possible.
Some serious side effects are known to be caused by betamethasone (a
strong steroid), one of the ingredients in Dovobet®. You should tell your
doctor as soon as possible if any of the serious side effects occur. These
side effects are more likely to happen after long-term use, use in skin
folds (e.g. groin, armpits or under breasts), use under occlusion or use on
large areas of skin.
The side effects include the following:
 Your adrenal glands may stop working properly. Signs are tiredness,
depression and anxiety
 Cataracts (signs are cloudy and foggy vision, difficulty seeing at night
and sensitivity to light) or an increase in pressure inside the eye (signs
are eye pain, red eye, decreased or cloudy vision)
 Infections (because your immune system, which fights infections, may
be suppressed or weakened)
 Pustular psoriasis (a red area with yellowish pustules usually on the
hands or feet). If you notice this, stop using Dovobet® and tell your
doctor as soon as possible
 Impact on the metabolic control of diabetes mellitus (if you have
diabetes you may experience fluctuations in the blood glucose levels).
Serious side effects known to be caused by calcipotriol
 Allergic reactions with deep swelling of the face or other parts of the
body such as the hands or feet. Swelling of the mouth/throat and
trouble breathing may occur. If you have an allergic reaction, stop using
Dovobet®, tell your doctor immediately or go to the casualty department
at your nearest hospital
 Treatment with this gel may cause the level of calcium in your blood or
urine to increase (usually when too much gel has been used). Signs of
increased calcium in blood are excessive secretion of urine,
constipation, muscle weakness, confusion and coma. This can be
serious, and you should contact your doctor immediately. However,
when the treatment is stopped, the levels return to normal.
Less serious side effects
The following less serious side effects have been reported for Dovobet®
Common side effects (may affect up to 1 in 10 people)
 Itching.
Uncommon (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)
 Rash with inflammation of the skin (dermatitis)
 Redness of the skin due to widening of the small blood vessels
(erythema)
 Acne (pimples)
 Dry skin
 Rash
 Pustular rash
 Infection of the skin.
Rare (may affect up to 1 in 1,000 people)
 Allergic reactions
 Stretch marks
 Skin exfoliation
 Rebound effect: A worsening of symptoms/psoriasis after ended
treatment.
Less serious side effects caused by using betamethasone, especially for
a long time, include the following. You should tell your doctor or nurse as
soon as possible if you notice any of them
 Thinning of the skin
 Appearance of surface veins or stretch marks
 Changes in hair growth
 Red rash around the mouth (perioral dermatitis)
 Skin rash with inflammation or swelling (allergic contact dermatitis)
 Golden coloured gel-filled bumps (colloid milia)
 Lightening of skin colour (depigmentation)
 Inflammation or swelling of the hair root (folliculitis).
Less serious side effects known to be caused by calcipotriol include the
following
 Dry skin
 Sensitivity of the skin to light resulting in a rash
 Eczema
 Itching
 Skin irritation
 Burning and stinging sensation
 Redness of the skin due to widening of the small blood vessels
(erythema)

Leave the shampoo on the
scalp for a couple of minutes
before washing.

Wash your hair as usual.

If necessary, repeat step 1-3 once or twice.
Duration of treatment
 Use the gel once a day. It may be more convenient to use the gel in the
evening
 The normal initial treatment period is 4 weeks for scalp areas and 8
weeks for non-scalp areas
 Your doctor may decide on a different treatment period
 Your doctor may decide on repeated treatment
 Do not use more than 15 grams in one day (corresponding to 300
pumps)
 For treatment of the scalp usually an amount between 1 g and 4 g per
day is sufficient (corresponding to 20 to 80 pumps)
If you use other calcipotriol containing medicines, the total amount of
calcipotriol medicines must not exceed 15 grams per day and the area
treated should not exceed 30% of the total body surface.
One full pump delivers 0.05 g Dovobet® gel.
What should I expect when I use Dovobet®?
Most patients see obvious results after 2 weeks, even if the psoriasis is
not yet cleared at that point.
If you have used more Dovobet ® than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Dovobet® may also cause a problem with calcium in
your blood, which usually normalises when discontinuing treatment.
Your doctor may need to carry out blood tests to check that using too
much gel has not caused a problem with calcium in your blood.
Excessive prolonged use can also cause your adrenal glands to stop
working properly (the adrenal glands are found near the kidneys and
produce hormones).
If you forget to use Dovobet®
Do not take a double dose to make up for forgotten individual doses.
If you stop using Dovobet ®
The use of Dovobet® should be stopped as indicated by your doctor. It
may be necessary for you to stop this medicine gradually, especially if
you have used it for a long time.
If you have any further questions about the use of this medicine, 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
Tell your doctor/nurse immediately or as soon as possible if any of the
following happens.
You may have to stop your treatment.
The following serious side effects have been reported for Dovobet®
2

Your Dovobet® gel Applicator

 Rash
 Rash with inflammation of the skin (dermatitis)
 Worsening of psoriasis.
Reporting of side effects

Cover

If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

Cartridge cap
(removable)

5. HOW TO STORE DOVOBET®

Cartridge
Small spreading
surface

 Keep out of the sight and reach of children
 Do not use Dovobet® after the expiry date, which is stated on the
cartridge after EXP. The expiry date refers to the last day of that month
 Do not refrigerate
 The Applicator is disposable. Discard the Applicator with any remaining
gel 6 months after first opening.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Larger
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

spreading
surface

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

Lever

Plunger (visible
from the bottom
of the cartridge)

Preparing your Dovobet® gel Applicator

The other ingredients are:
• paraffin, liquid
• polyoxypropylene stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.

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 that you assembled
the Applicator on the cartridge label.
Do not use the Applicator more than
6 months after this date.

What Dovobet® looks like and the contents of the pack
Is an almost clear, colourless to slightly off-white gel filled in a
polypropylene cartridge (with a high-density polyethylene plunger and
screw cap). The cartridge and the applicator head (polypropylene outer
casing, polyoxymethylene lever and thermoplastic elastomer nozzle) is
assembled prior to first use. The polypropylene cover is for storage.

B) Remove the cartridge cap
Holding the cartridge upright, twist the
cap anti-clockwise to remove.
Avoid tipping the cartridge as this may
result in spilling the gel.
Discard the cap after removing.

The cartridge(s), applicator head(s) and cover(s) are placed in a carton.
Pack sizes: 60 g (equivalent to 68 ml)
Who manufactured your medicine
LEO Laboratories Limited (LEO Pharma), 285 Cashel Road, Dublin 12
Ireland. Procured from within the EU and repackaged by the Product
Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 16378/0594

Applicator
nozzle

C) Attach applicator head tightly
Keep the cartridge upright and align the
applicator head. Screw the applicator head
clockwise until the applicator head feels tightly
sealed.
Clicking sounds will be heard until it is tightly
sealed.
Note:
Do not disassemble the Applicator. Attempts
to do so may break the Applicator.

POM

Instructions for Use of the Applicator are included at the end of this leaflet.
Revision date: 17.01.2018
Leaflet Reference: DOVAPPLI

Instructions for Use
Dovobet® gel Applicator
Before use, you should read all of the patient information and the
Instructions for Use carefully – even if you have used Dovobet® gel
before.
The Dovobet® gel Applicator is designed to apply Dovobet gel to your skin
and scalp affected by plaque psoriasis. Using the Dovobet® gel
Applicator, you can apply Dovobet® gel without getting any gel on your
fingers.
Always follow your doctor’s instructions on the treatment of your psoriasis.
Do not share the Dovobet® gel or the Applicator with others.
Keep this medicine out of the sight and reach of children.

D) Prime before first use
To prime:
Make sure that the applicator
head and cartridge are tightly
assembled.
Gently push up on the centre of
the plunger while squeezing the
lever until you see gel at the
nozzle tip.
3

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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