Skip to Content

DALBECAL 50 MICROGRAM/G + 0.5MG/G OINTMENT

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL ANHYDROUS

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref:

231-30-20057-B LEA CALCIPOTRIOL / BETAMETHASONE 50mcg/g + 0.5mg/g OINT TUK
Version:

8

Trackwise Parent:

PL Number(s),
MA Holder & Packer:

PL 00289/1216. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA Limited, Zagreb.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-01395
231-10-01891
Univers

Base Font Size:

9 Pt

-

Child:

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

420 mm
160 mm
-

09 September 2013

-

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK
Template

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

DALBECAL
50 microgram/g + 0.5 mg/g
OINTMENT
calcipotriol/betamethasone
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 or 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.
WHAT IS IN THIS LEAFLET:

1. What Dalbecal Ointment is and what it is
used for
2. What you need to know before you use
Dalbecal Ointment
3. How to use Dalbecal Ointment
4. Possible side effects
5. How to store Dalbecal Ointment
6. Contents of the pack and other
information

1 WHAT DALBECAL OINTMENT

IS AND WHAT IT IS USED FOR

Dalbecal 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.
Dalbecal 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 DALBECAL
OINTMENT

Do not use Dalbecal Ointment:
• If you are allergic to calcipotriol,
betamethasone or any of the other
ingredients of this medicine (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 Dalbecal Ointment 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)
• infections caused by bacteria
• infections caused by parasites (e.g.
scabies)
• tuberculosis (TB) or syphilis
• 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
• itching of the anus (back passage) or
genitals (sex organs).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Dalbecal Ointment
• if you are using other medicines that
contain corticosteroids, as you may get
side effects
• if you use 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)
• if you have diabetes mellitus (diabetes),
as your blood sugar/glucose level may be
affected by the steroid
• if your skin becomes infected, as you
may need to stop your treatment
• if you have a certain type of psoriasis
called guttate psoriasis
• if you have serious liver or kidney
disease.




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 and adolescents
Dalbecal Ointment is not recommended for
the use in children below the age of 18 years.
Other medicines and Dalbecal Ointment
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine. If
your doctor has agreed that you can
breast-feed, take care and do not apply
Dalbecal Ointment to the breast area.
Driving and using machines
This medicine should not have any effect on
your ability to drive or use machines.
Dalbecal 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 DALBECAL
OINTMENT

Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
How to put on Dalbecal Ointment:
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
Dalbecal Ointment (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
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
Dalbecal 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 Dalbecal
Ointment?
Most patients see obvious results after 2
weeks, even if the psoriasis is not yet
cleared at that point.

If you have used more Dalbecal Ointment
than you should
Contact your doctor if you have used more
than 15 grams in one day. Excessive
Special precautions
prolonged use of Dalbecal Ointment may
• Avoid use on more than 30% of your body cause a problem with calcium in your blood,
or using more than 15 grams per day
which usually normalises when
• Avoid using under bandages or dressings discontinuing treatment.
as it increases the absorption of the
Your doctor may need to carry out blood
steroid
tests to check that using too much ointment
• Avoid use on large areas of damaged
has not caused a problem with calcium in
skin or skin folds (groin, armpits, under
your blood. Excessive prolonged use can

Ref:

231-30-20057-B LEA CALCIPOTRIOL / BETAMETHASONE 50mcg/g + 0.5mg/g OINT TUK
Version:

8

Trackwise Parent:

PL Number(s),
MA Holder & Packer:

PL 00289/1216. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA Limited, Zagreb.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-01395
231-10-01891
Univers

Base Font Size:

9 Pt

-

Child:

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

420 mm
160 mm
-

09 September 2013

-

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK
Template

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

also cause your adrenal glands to stop
working properly (these are found near the
kidneys and produce hormones).
If you forget to use Dalbecal Ointment
Do not take a double dose to make up for
forgotten individual doses.




Inflammation or swelling of the hair root
(folliculitis)
Changes in skin colour in the area you
have used the ointment.

Not known: frequency cannot be estimated
from the available data
• Rebound effect: A worsening of
symptoms/psoriasis after ended
treatment.

If you stop using Dalbecal Ointment
The use of Dalbecal Ointment should be
stopped as indicated by your doctor. It may
Less serious side effects reported for the
be necessary for you to stop this medicine
gradually, especially if you have used it for a components of Dalbecal Ointment
Calcipotriol
long time.
Less serious side effects known to be
If you have any further questions about the
caused by calcipotriol include the following
use of this medicine, ask your doctor or
• Dry skin
pharmacist.
• Sensitivity of the skin to light resulting in
a rash has also been reported
4 POSSIBLE SIDE EFFECTS
• Eczema.
If you notice the above or any other changes
Like all medicines, this medicine can cause in your health while taking this medicine,
side effects, although not everybody gets
tell your doctor.
them.
Betamethasone
Approximately 1 in 10 people may experience Less serious side effects caused by using
side effects but most of these are reactions betamethasone, include the following. You
at the site where the ointment has been
should tell your doctor as soon as possible
applied and are usually mild and temporary. if you notice them.
• Thinning of the skin
Serious side effects reported for Dalbecal
• Appearance of surface blood vessels or
Ointment:
stretch marks
Uncommon (may affect up to 1 in 100
• Changes in hair growth
people)
• Red rash around the mouth (perioral
• Worsening of your psoriasis. If your
dermatitis)
psoriasis gets worse, tell your doctor as

Skin rash with inflammation or swelling
soon as possible.
(allergic contact dermatitis)
Rare (may affect up to 1 in 1,000 people)
• Shiny brown gel-filled bumps (colloid
• Pustular psoriasis may occur (a red area
milia)
with yellowish pustules usually on the
• Lightening of skin colour
hands or feet). If you notice this, stop
(depigmentation).
using Dalbecal Ointment and tell your
Reporting of side effects
doctor as soon as possible.
If you get any side effects, talk to your
Serious side effects reported for the
doctor, pharmacist or nurse. This includes
components of Dalbecal Ointment:
any possible side effects not listed in this
Calcipotriol
leaflet. You can also report side effects
Serious side effects known to be caused by directly via the Yellow Card Scheme at:
calcipotriol
www.mhra.gov.uk/yellowcard
• Allergic reactions with deep swelling of
By reporting side effects you can help
the face or other parts of the body such
provide more information on the safety of
as the hands or feet. Swelling of the
this medicine.
mouth/throat and trouble breathing may
occur. If you have an allergic reaction,
5 HOW TO STORE DALBECAL
stop taking Dalbecal Ointment, tell your
OINTMENT
doctor immediately or go to the casualty
Keep this medicine out of the sight and
department at your nearest hospital.
• Treatment with this ointment may cause reach of children.
the level of calcium in your blood or
Do not use Dalbecal Ointment after the
urine to increase (usually when too much
expiry date, which is stated on the label after
ointment has been used). Signs of
EXP. The expiry date refers to the last day of
increased calcium in blood is bone pain,
that month.
constipation, poor appetite, nausea and
Do not store the medicine above 25°C.
vomiting. This can be serious and you
should contact your doctor as soon as
The tube should be discarded 1 year after
possible. However, when the treatment is
first opening. Write the date you first
stopped, the levels return to normal.
opened the tube in the space provided on
the carton.
Betamethasone
Some serious side effects are known to be
Do not throw away any medicines via
caused by betamethasone (a strong steroid),
wastewater or household waste. Ask your
one of the ingredients in Dalbecal Ointment.
pharmacist how to throw away medicines
You should tell your doctor as soon as
you no longer use. These measures will help
possible if any of the serious side effects
protect the environment.
occur:
• Your adrenal glands may stop working
6 CONTENTS OF THE PACK AND
properly. Signs are tiredness, depression
OTHER INFORMATION
and anxiety.
• Cataracts (signs are cloudy and foggy
What Dalbecal Ointment contains
vision, difficulty seeing at night and
The active substances are:
sensitivity to light) or an increase in
calcipotriol and betamethasone.
pressure inside the eye (signs are eye
pain, red eye, decreased or cloudy vision) One gram of ointment contains 50
• Infections (because your immune system micrograms of calcipotriol (anhydrous) and
0.5 mg of betamethasone (as 0.643 mg
which fights infections may be
betamethasone dipropionate).
suppressed or weakened)
• Impact on the metabolic control of
The other ingredients are:
diabetes mellitus (if you have diabetes
• liquid paraffin
you may experience fluctuations in the
• polyoxypropylene-15-stearyl ether
blood glucose levels).
• white soft paraffin
These side effects are more likely to happen • butylhydroxytoluene (E321).

after long-term use, use in skin folds (e.g.
What Dalbecal Ointment looks like and
groin, armpits or under breasts), use under contents of the pack
bandages or dressings or use on large areas
Dalbecal Ointment is an off-white to yellow
of skin.
coloured ointment filled in aluminium tubes
Less serious side effects reported for
with polyethylene closures.
Dalbecal Ointment
Pack sizes: 30, 60 and 120 g.
The following less serious side effects have Not all pack sizes may be marketed.
been reported for Dalbecal Ointment. If any
Marketing Authorisation Holder and
of them last a long time or cause you
Manufacturer
problems, you should tell your doctor or
nurse.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne,
Common side effects (may affect up to 1 in
BN22 9AG, UK
10 people)
• Itching
Manufacturer
• Rash
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
• Burning sensation.
Prilaz baruna Filipovica 25,
Zagreb, 10000, Croatia
Uncommon (may affect up to 1 in 100
people)
This leaflet was last revised in 09/2013.
• Skin pain or irritation
PL 00289/1216
• Rash with inflammation of the skin
(dermatitis)
• Redness of the skin due to widening of
20057-B
the small blood vessels (erythema)
160 x 420

Expand view ⇕

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.

Hide