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DOVOBET GEL

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

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Add/Amend to make some minor amendments to Section 3.
By Aneela Mahmood at 4:07 pm, Oct 06, 2017

Previously assessed against the UK PIL dated December 2016
Package leaflet: Information for the user

Mock-up

Dovobet® Gel
(calcipotriol/betamethasone dipropionate)

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 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.
Your medicine is Dovobet® Gel, but will be referred to as Dovobet®
throughout this leaflet.

What is in 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® 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 dipropionate.
Calcipotriol helps to bring the rate of skin cell growth back to
normal and betamethasone dipropionate acts to reduce
inflammation.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
DOVOBET®
Do not use Dovobet®
• If you are allergic (hypersensitive) to calcipotriol, betamethasone
dipropionate 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.

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.

3. HOW TO USE DOVOBET®
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
How to put on Dovobet®: Cutaneous use.
Instructions for proper use
• Use only on your psoriasis and do not use on skin which does
not have psoriasis
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or directly onto the area
affected by psoriasis
• Apply Dovobet® to the affected area with your fingertips, 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®. 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).
If you have scalp psoriasis
• 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®. Apply Dovobet® to the affected area with your
fingertips, and rub it in gently
Washing your hair before application of Dovobet® is not
necessary.
Shake bottle before use.

Warnings and precautions
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.

Apply a drop of
Dovobet® to fingertip.

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
• Avoid excessive sunbathing, excessive use of solarium and
other forms of light treatment.

Apply directly to scalp areas
where you can feel the raised
plaque and rub the Dovobet® gel
on to the skin.
Depending on the affected area
1-4 g (up to 1 teaspoon) is
normally enough.

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

Children
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, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
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
This medicine should not have any effect on your ability to drive or
use machines.

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

Wash your hair as usual.

If necessary, repeat steps 4-6 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.
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.
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 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 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 a forgotten dose.
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®:
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 dipropionate (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.

Frequency unknown (frequency cannot be estimated from the
available data):
• White or grey hair can transiently change to a yellowish colour at
the application site when used on the scalp.
Less serious side effects caused by using betamethasone
dipropionate, 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)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis.
Reporting of side effects
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.

5. HOW TO STORE DOVOBET®





Keep out of the sight and reach of children.
Do not refrigerate.
Keep the bottle in the outer carton in order to protect from light.
Discard the bottle with any remaining gel 3 months after first
opening.
• Do not use Dovobet® after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or show any other signs
of deterioration, ask your pharmacist who will advise 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. These measures will help to protect the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Dovobet® contains
The active substances are: calcipotriol and betamethasone
dipropionate. One gram of gel contains 50 micrograms of
calcipotriol (as monohydrate) and 0.5 mg of betamethasone
dipropionate.
The other ingredients are: liquid paraffin, polyoxypropylene-11stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321),
all-rac-alpha-tocopherol.
What Dovobet® looks like and the contents of the pack
Dovobet® is an almost clear, colourless to slightly off-white gel
filled in high-density polyethylene bottles with low-density
polyethylene nozzle and a high-density polyethylene screw cap.
Pack sizes: 60 g and 2 x 60 g.
The Manufacturer is:
LEO Pharma A/S, Industriparken 55, DK - 2750 Ballerup,
Denmark.
(Or)
LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road –
Dublin 12, Ireland.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading
Estate, Slough, SL1 4NL, UK.

PL 39352/0393;
Dovobet® gel,

POM

Less serious side effects
The following less serious side effects have been reported for
Dovobet®

Dovobet® is a registered trademark of LEO Pharma A/S.

Common side effects (may affect up to 1 in 10 people)
• Itching.

To listen to or request a copy of
this leaflet in Braille, large print or
audio please call: 01753515054
(UK only)

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.

Leaflet date: 08/09/2017

+ 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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