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CALCIPOTRIOL 50 MICROGRAM/G / BETAMETHASONE 0.5MG/G OINTMENT

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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Transcript
Ref: 1579/290416/1/F

®

Dovobet Ointment
(calcipotriol / betamethasone dipropionate)
Patient Information Leaflet
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. 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.
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
Your medicine is called Dovobet Ointment but will be referred to as Dovobet
throughout the rest of this leaflet.

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.
Important information about some of the ingredients of Dovobet
ointment
Dovobet ointment contains butylhydroxytoluene (E321). This may
cause local skin reactions (e.g. contact dermatitis), or irritation to the
eyes and mucous membranes.
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.

1

What Dovobet is and what it is used for

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 ointment 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 the 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 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
.
Warning and precaution
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 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 the 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.
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.

Instruction for proper use
* Use only on your psoriasis and do not use on skin which does not have
psoriasis
* 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
* Do not bandage, tightly cover or wrap the treated skin area
* 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)
* Do not worry if some ointment accidentaly 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 ointment
* After applying the ointment avoid contact with textiles which are
easily stained by grease (e.g. silk).
Duration of treatment

* 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.
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 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 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
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.

Ref: 1579/290416/1/B

®

Dovobet Ointment
(calcipotriol / betamethasone dipropionate)
Patient Information Leaflet (continued)
Rare (may affect up to 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. 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 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 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
* Skin exfoliation
Uncommon (may affect up to 1 in 100 people)
* 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.
* Rash
* Burning sensation
* Infection of the skin
* Thinning of the skin
* Appearance of red or purple discolouration on the skin (purpura or
ecchymosis).
Rare (may affect up to 1 in 1,000 people)
* Bacterial or fungal infection of hair follicle (Furuncle)
* Allergic reactions
* Hypercalcaemia
* Stretch marks
* Sensitivity of the skin to light resulting in a rash
* Acne (pimples)
* Dry skin
* 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 blood vessels 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 store above 25 °C
Do not use Dovobet after the expiry date, which is stated on the tube or
carton label. The expiry date refers to the last day of that month
The tube should be discarded 1 year after first opening.
Write the date you first opened the tube in the space provided on the carton.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6

Contents of the pack and other information

What Dovobet contains:
Each gram of ointment contains 50 micrograms of calcipotriol
(as monohydrate) and 0.5mg of betamethasone (as dipropionate).
Also contains liquid paraffin, all-rac-a-tocopheral,
polyoxypropylene-11-stearyl ether, white soft paraffin and
butylhydroxytoluene (E321).
What Dovobet looks like and contents of the pack
Dovobet is an off-white to yellow coloured ointment
Each pack contains one 60g Tube of ointment or 2 x 60g Tubes
Manufacturer and Licence Holder
Manufactured by LEO Laboratories Ltd. Cashel Road, Dublin 12, Ireland and
is procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL: 15184/1579

Dovobet Ointment

Dovobet is a registered trademark of LEO Pharma A/S
Revision date: 29/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Calcipotriol 50 microgram/g / Betamethasone 0.5mg/g ointment

Ref: 1579/290416/1/F

(calcipotriol / betamethasone dipropionate)
Patient Information Leaflet
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. 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.
What is in this leaflet
1 What Calcipotriol / Betamethasone is and what it is used for?
2 What you need to know before you use Calcipotriol / Betamethasone
3 How to use Calcipotriol / Betamethasone
4 Possible side effects
5 How to store Calcipotriol / Betamethasone
6 Contents of the pack and other information
Your medicine is called Calcipotriol 50 microgram/g / Betamethasone
0.5mg/g ointment but will be referred to as Calcipotriol / Betamethasone
throughout the rest of this leaflet.

1

What is Calcipotriol / Betamethasone is and what it
is used for

Calcipotriol / Betamethasone ointment 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.
Calcipotriol / Betamethasone ointment 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 Calcipotriol /
Betamethasone

Do not use Calcipotriol / Betamethasone :
* If you are allergic (hypersensitive) to calcipotriol, betamethasone or
any of the other ingredients of Calcipotriol / Betamethasone (listed in
section 6)
* If you have problems with calcium levels in the body (ask your doctor)
* If you have certain types of psoriasis: these are erythrodermic, exfoliative
and pustular (ask your doctor).
As Calcipotriol / Betamethasone contains a strong steroid do NOT use 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
Warning and precaution
Talk to your doctor/nurse/pharmacist before using Calcipotriol /
Betamethasone 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 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 the 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.
Children
Calcipotriol / betamethasone is not recommended for the use in children
below the age of 18 years.
Other medicines and Calcipotriol / betamethasone
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 Calcipotriol / Betamethasone 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 Calcipotriol / betamethasone 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.
Important information about some of the ingredients of Calcipotriol /
Betamethasone
Calcipotriol / Betamethasone ointment contains butylhydroxytoluene (E321).
This may cause local skin reactions (e.g. contact dermatitis), or irritation to
the eyes and mucous membranes.
3

How to use Calcipotriol / Betamethasone

Always use Calcipotriol / Betamethasone exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
How to put on Calcipotriol / Betamethasone : Cutaneous use.
Instruction for proper use
* Use only on your psoriasis and do not use on skin which does not have
psoriasis
* 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
* Do not bandage, tightly cover or wrap the treated skin area
* Wash your hands well after using Calcipotriol / betamethasone (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)
* Do not worry if some ointment accidentaly 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 Calcipotrio /
Betamethasone ointment
* After applying the ointment avoid contact with textiles which are
easily stained by grease (e.g. silk).
Duration of treatment
* 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.
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 Calcipotriol / Betamethasone?
Most patients see obvious results after 2 weeks, even if the psoriasis
is not yet cleared at that point.
If you have used more Calcipotriol / Betamethasone than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Calcipotriol / Betamethasone may 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 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 Calcipotriol / Betamethasone
Do not take a double dose to make up for forgotten individual doses.
If you stop using Calcipotriol / Betamethasone
The use of Calcipotriol / Betamethasone 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, Calcipotriol / Betamethasone 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.

Calcipotriol 50 microgram/g / Betamethasone 0.5mg/g ointment

Ref: 1579/290416/1/B

(calcipotriol / betamethasone dipropionate)
Patient Information Leaflet (continued)
Rare (may affect up to 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 Calcipotriol / Betamethasone.
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
calcipotriol / betamethasone,
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 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
Calcipotriol / Betamethasone.
Common side effects (may affect up to 1 in 10 people)
* Itching
* Skin exfoliation
Uncommon (may affect up to 1 in 100 people)
* 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.
* Rash
* Burning sensation
* Infection of the skin
* Thinning of the skin
* Appearance of red or purple discolouration on the skin (purpura or
ecchymosis).
Rare (may affect up to 1 in 1,000 people)
* Bacterial or fungal infection of hair follicle (Furuncle)
* Allergic reactions
* Hypercalcaemia
* Stretch marks
* Sensitivity of the skin to light resulting in a rash
* Acne (pimples)
* Dry skin
* 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 blood vessels 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 Calcipotriol / Betamethasone

Keep out of the sight and reach of children
Do not store above 25 °C
Do not use Calcipotriol / Betamethasone after the expiry date, which is
stated on the tube or carton label. The expiry date refers to the last day of
that month.The tube should be discarded 1 year after first opening.
Write the date you first opened the tube in the space provided on the carton.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
6

Contents of the pack and other information

What Calcipotriol / Betamethasone contains:
Each gram of ointment contains 50 micrograms of calcipotriol
(as monohydrate) and 0.5mg of betamethasone (as dipropionate).
Also contains liquid paraffin, all-rac-a-tocopherol,
polyoxypropylene-11-stearyl ether, white soft paraffin and
butylhydroxytoluene (E321).
What Calcipotriol / Betamethasone looks like and contents of the pack
Calcipotriol / betamethasone is an off-white to yellow coloured ointment
Each pack contains one 60g Tube of ointment or 2 x 60g Tubes
Manufacturer and Licence Holder
Manufactured by LEO Laboratories Ltd. Cashel Road, Dublin 12, Ireland and
is procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL: 15184/1579

Calcipotriol 50 microgram/g /
Betamethasone 0.5mg/g ointment

Revision date: 01/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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