Calcipotriol/Betamethasone Sandoz Ointment 50mcg per g/ 500mcg per g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIPOTRIOL MONOHYDRATE, BETAMETHASONE DIPROPIONATE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

D05AX52

INN (International Name):

CALCIPOTRIOL MONOHYDRATE 50 µg/g BETAMETHASONE DIPROPIONATE 0.5 mg/g

Pharmaceutical form:

OINTMENT

Composition:

CALCIPOTRIOL MONOHYDRATE 50 µg/g BETAMETHASONE DIPROPIONATE 0.5 mg/g

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-02-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL/BETAMETHASONE SANDOZ OINTMENT 50MCG PER G/ 500MCG PER G
calcipotriol/betamethasone
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.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Calcipotriol/Betamethasone Sandoz Ointment
is and what it is used for
2.
What you need to know before you take Calcipotriol/Betamethasone
Sandoz Ointment
3.
How to use Calcipotriol/Betamethasone Sandoz Ointment
4.
Possible side effects
5.
How to store Calcipotriol/Betamethasone Sandoz Ointment
6.
Contents of the pack and other information
1.
WHAT CALCIPOTRIOL/BETAMETHASONE SANDOZ OINTMENT IS AND WHAT IS USED
FOR
Calcipotriol/Betamethasone Sandoz 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 Sandoz 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 SANDOZ
OINTMENT
DO NOT USE
Calcipotriol/Betamethasone Sandoz 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcipotriol/Betamethasone Sandoz Ointment 50mcg per g/ 500mcg per g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ointment.
Off white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Calcipotriol/Betamethasone Sandoz ointment should be applied to the
affected area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of
Calcipotriol/Betamethasone Sandoz Ointment
up to 52 weeks. If it is necessary to continue or
restart treatment after 4 weeks, treatment should be continued after
medical review and under
regular medical supervision.
When using calcipotriol containing medicinal products, the maximum
daily dose should not exceed
15 g. The body surface area treated with calcipotriol containing
medicinal products should not
exceed 30 % (see section 4.4).
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Special populations
_Renal and hepatic impairment _
The safety and efficacy of Calcipotriol/Betamethasone Sandoz ointment
in patients with severe
renal insufficiency or severe hepatic disorders have not been
evaluated.
_Paediatric population _
The safety and efficacy of Calcipotriol/Betamethasone Sandoz Ointment
in children below 18 years
have not been established. Currently available data in children aged
12 to 17 years are described in
section 4.8 and 5.1 but no recommendation on a posology can be made.
_ _
_Method of administration _
_ _
Calcipotriol/Betamethasone Sandoz Ointment
should be applied to the affected area. In order to
achieve optimal effect, it is not recommended to take a shower or bath
immediately after
application of Calcipotriol/Betamethasone Sandoz Ointment.
4.3
CONTRAINDICA