Calcipotriol/Betamethasone 50 microgram/g + 0.5 mg/g gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone; Calcipotriol

Available from:

Aristo Pharma GmbH

ATC code:

D05AX52

INN (International Name):

Betamethasone; Calcipotriol

Dosage:

50 microgram/g +0.5 milligram(s)/gram

Pharmaceutical form:

Gel

Therapeutic area:

calcipotriol, combinations

Authorization status:

Marketed

Authorization date:

2021-06-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL/BETAMETHASONE 50 MICROGRAM/G + 0.5 MG/G GEL
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, 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.
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
1.
WHAT CALCIPOTRIOL/BETAMETHASONE IS AND WHAT IT IS USED FOR
Calcipotriol/Betamethasone contains the active substances calcipotriol
and betamethasone. Calcipotriol
helps to bring the rate of skin cell growth back to normal and
betamethasone acts to reduce
inflammation.
Calcipotriol/Betamethasone is used as a 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CALCIPOTRIOL/BETAMETHASONE
DO NOT USE CALCIPOTRIOL/BETAMETHASONE
•
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 your body (ask your
doctor)
•
if you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask
your doctor).
As Calcipotriol/Betamethasone cont

Summary of Product characteristics

Health Products Regulatory Authority
21 June 2021
CRN009RS3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcipotriol/Betamethasone 50 microgram/g + 0.5 mg/g gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 50 micrograms calcipotriol (as monohydrate)
and 0.5 mg betamethasone (as dipropionate).
Excipients with known effect
Butylhydroxytoluene (E321) up to 270 micrograms/g gel
Castor oil, hydrogenated 16.7 mg/g gel
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
An almost clear, colourless to slightly off-white gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of scalp psoriasis in adults.
Topical treatment of mild to moderate "non-scalp" plaque psoriasis
vulgaris in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Calcipotriol/Betamethasone should be applied to affected areas once
daily. The recommended treatment period is 4 weeks for
scalp areas and 8 weeks for "non-scalp" areas. If it is necessary to
continue or restart treatment after this period, 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).
_If used on thes calp_
All the affected scalp areas may be treated with
Calcipotriol/Betamethasone gel. Usually an amount between 1 g and 4 g
per
day is sufficient for treatment of the scalp (4 g corresponds to one
teaspoon).
Special populations
_Renal and hepatic impairment_
The safety and efficacy of Calcipotriol/Betamethasone gel in patients
with severe renal insufficiency or severe hepatic disorders
have not been evaluated.
_Paediatric population_
The safety and efficacy of Calcipotriol/Betamethasone in children and
adolescents below 18 years have not been established.
Currently available data in adolescents aged 12 to 17 years are
described