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DOVOBET OINMENT

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S366 LEAFLET Dovobet 20120731

Special precautions

PACKAGE LEAFLET: INFORMATION FOR USER



DOVOBET OINTMENT
(calcipotriol/betamethasone dipropionate)

Avoid use on more than 30 % of your body or using more than
15 grams per day



Avoid using under bandages or dressings as it increases the
absorption of the steroid

Your medicine is known as Dovobet Ointment but will be referred to
as Dovobet throughout the following leaflet.



Avoid use on large areas of damaged skin or skin folds (groin,
armpits, under breasts) as it increases the absorption of the
steroid

Read all of this leaflet carefully before you start using this
medicine



Avoid use on the face or genitals (sex organs) as they are very
sensitive to steroids



Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

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

Children



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

Dovobet is not recommended for the use in children below the age
of 18 years.



If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Taking other medicines

Pregnancy and breast-feeding
In this leaflet:
1. What Dovobet is and what it is used for
2. Before you use Dovobet
3. How to use 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.

4. Possible side effects

Ask your doctor or pharmacist for advice before taking any
medicine.

5. How to store Dovobet

Driving and using machines

6. Further information

This medicine should not have any effect on your ability to drive or
use machines.

1. WHAT DOVOBET IS AND WHAT IT IS USED FOR

Important information about some of the ingredients of
Dovobet

Dovobet is used on the skin to treat 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 butylhydroxytoluene (E321). This may cause local
skin reactions (e.g. contact dermatitis), or irritation to the eyes and
mucous membranes.

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

2. BEFORE YOU USE DOVOBET
Do not use Dovobet


If you are allergic (hypersensitive) to calcipotriol,
betamethasone or any of the other ingredients of 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.
Instruction for proper use


If you have problems with calcium levels in the body (ask your
doctor)

Use only on your psoriasis and do not use on skin which does
not have psoriasis



If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your doctor).

Remove the cap and check that the seal in the tube is not
broken before you first use the ointment



To break the seal, use the point in the back of the cap



Squeeze the ointment onto a clean finger



Rub gently into your skin to cover the affected area of psoriasis
until most of the ointment has disappeared into the skin

As Dovobet contains a strong steroid do NOT use on skin affected
by


infections caused by viruses (e.g. cold sores or chicken pox)



infections caused by a fungus (e.g. athlete’s foot or ringworm)



Do not bandage, tightly cover or wrap the treated skin area



infections caused by bacteria





infections caused by parasites (e.g. scabies)



tuberculosis (TB) or syphilis

Wash your hands well after using Dovobet (unless you are
using the ointment to treat your hands). This will avoid
accidentally spreading the ointment to other parts of your body
(especially the face, scalp, mouth and eyes)



perioral dermatitis (red rash around the mouth)





thin skin, easily damaged veins, stretch marks

Do not worry if some ointment accidentally gets on normal skin
near your psoriasis, but wipe it off if it spreads too far



ichthyosis (dry skin with fish-like scales)





acne (pimples)

In order to achieve optimal effect, it is recommended not to take
a shower or bath immediately after application of Dovobet



rosacea (severe flushing or redness of the skin on the face)



After applying the ointment avoid contact with textiles which are
easily stained by grease (e.g. silk).



ulcers or broken skin

Duration of treatment



itching of the anus (back passage) or genitals (sex organs).



Use the ointment once a day. It may be more convenient to use
the ointment in the evening



The normal initial treatment period is 4 weeks but 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.

Take special care with Dovobet
Before using this medicine, tell your doctor/nurse/pharmacist 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



you have serious liver or kidney disease.

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

Uncommon (affect less than 1 in 100 people)

Contact your doctor if you have used more than 15 grams in one
day. Excessive prolonged use of Dovobet may cause a problem
with calcium in your blood, which usually normalises when
discontinuing treatment.



Skin pain or irritation



Rash with inflammation of the skin (dermatitis)



Redness of the skin due to widening of the small blood vessels
(erythema)



Inflammation or swelling of the hair root (folliculitis)



Changes in skin colour in the area you have used the ointment.

Your doctor may need to carry out blood tests to check that using
too much ointment has not caused a problem with calcium in your
blood. Excessive prolonged use can also cause your adrenal
glands to stop working properly (these 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

Not known frequency


Rebound effect: A worsening of symptoms/psoriasis after
ended treatment.

Less serious side effects caused by using betamethasone, include
the following. You should tell your doctor as soon as possible if you
notice them.

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.



Thinning of the skin



Appearance of surface blood vessels or stretch marks

If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.



Changes in hair growth



Red rash around the mouth (perioral dermatitis)



Skin rash with inflammation or swelling (allergic contact
dermatitis)



Shiny brown gel-filled bumps (colloid milia)



Lightening of skin colour (depigmentation).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dovobet can cause side effects, although not
everybody gets them.
Approximately 1 in 10 people may experience side effects but most
of these are reactions at the site where the ointment has been
applied and are usually mild and temporary.

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


Dry skin

Serious side effects



Sensitivity of the skin to light resulting in a rash has also been
reported

Uncommon (affects less than 1 in 100 people)



Eczema.



If you notice the above or any other changes in your health while
taking this medicine, tell your doctor.

The following serious effects have been reported for Dovobet:
Worsening of your psoriasis. If your psoriasis gets worse, tell
your doctor as soon as possible.

Rare (affects less than 1 in 1,000 people)


Pustular psoriasis may occur (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.

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:

If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DOVOBET


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Dovobet should not be stored above 25 C. Discard 12 months
after first opening.

°



Your adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety



Do not use after the expiry date printed on the carton or tube
label.



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)



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



Infections (because your immune system which fights infections
may be suppressed or weakened)



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Impact on the metabolic control of diabetes mellitus (if you have
diabetes you may experience fluctuations in the blood glucose
levels).



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.

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
bandages or dressings or use on large areas of skin.
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 taking Dovobet, tell your doctor immediately or go
to the casualty department at your nearest hospital
Treatment with this ointment may cause the level of calcium in
your blood or urine to increase (usually when too much
ointment has been used). Signs of increased calcium in blood is
bone pain, constipation, poor appetite, nausea and vomiting.
This can be serious and you should contact your doctor as soon
as possible. However, when the treatment is stopped, the levels
return to normal.

6. FURTHER INFORMATION
What Dovobet contains


Dovobet contains calcipotriol 50 micrograms/g (as hydrate) and
betamethasone 500 micrograms/g (as dipropionate) as the
active ingredients.



Dovobet also contains the following inactive ingredients: white
soft paraffin, alpha-tocopherol, liquid paraffin and
polyoxypropylene-15-stearyl ether.

What Dovobet looks like and contents of the pack
Dovobet is an off white to yellow ointment.
Dovobet is available in tubes of 60g.

Less serious side effects
The following less serious side effects have been reported for
Dovobet. If any of them last a long time or cause you problems, you
should tell your doctor or nurse.
Common side effects (affect less than 1 in 100 people)

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.



Itching



Rash

Manufacturer



Burning sensation.

This product is manufactured by Leo Laboratories Limited, Cashel
Road, Dublin, Ireland.
POM

PL No: 19488/0366

Leaflet revision date: 31 July 2012
Dovobet is a registered trade mark of Leo Pharma A/S, Denmark.
S366 LEAFLET Dovobet 20120731

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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