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DOVOBET 50MICROGRAMS/G & 0.5 MG/G GEL

Active substance(s): BETAMETHASONE / CALCIPOTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dovobet® 50micrograms/g & 0.5mg/g gel.
(calcipotriol/betamethasone)
This product will be referred to as Dovobet throughout the
remainder of this leaflet.

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.

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.

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.

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

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).

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. Calcipotriol
helps to bring the rate of skin cell growth back to normal and
betamethasone 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 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).

3.

HOW TO USE DOVOBET®

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.

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.

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

Shake bottle before use.

Apply a drop of
Dovobet to fingertip.

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 or
have recently taken 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 breastfeeding, 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.

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

Wash your hair as usual.

If necessary, repeat step 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 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
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 longterm 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)
 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 use Dovobet after the expiry date which is stated on
the bottle after EXP. The expiry date refers to the last day of
that month
 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.
 Medicines should not be disposed of 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.
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 11
stearyl ether, hydrogenated castor oil, butylated hydroxytoluene
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 a low-density
polyethylene nozzle and a high-density polyethylene screw cap.
The bottles are placed in cartons.
Dovobet is available in a 30g bottle.
Manufacturer:
Leo Laboratories Ltd. 285 Cashel Road, Dublin 12, Ireland.
OR
Leo Pharma A/S, Industrial Park 55, Ballerup, DK-2750
Denmark.
Procured within the EU & repackaged by the PL holder:
G-Pharma Ltd, Salford M50 2PU
Dovobet® 50micrograms/g & 0.5mg/g gel
POM

PL: 16369/1547
Revision Date: 23/12/2015
For further information about psoriasis, you can contact:
The Psoriasis Association.
mail@psoriasis-association.org.uk

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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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