Wynzora 50 micrograms/g + 0.5 mg/g cream

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Calcipotriol; Betamethasone

Предлага се от:

Almirall, S.A.

АТС код:

D05AX52

INN (Международно Name):

Calcipotriol; Betamethasone

дозиране:

50 micrograms/g + 0.5 milligram(s)/gram

Лекарствена форма:

Cream

Терапевтична област:

calcipotriol, combinations

Статус Оторизация:

Marketed

Дата Оторизация:

2021-12-17

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
WYNZORA 50 MICROGRAMS/G + 0.5 MG/G CREAM
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 Wynzora is and what it is used for
2.
What you need to know before you use Wynzora
3.
How to use Wynzora
4.
Possible side effects
5.
How to store Wynzora
6.
Contents of the pack and other information
1.
WHAT WYNZORA IS AND WHAT IT IS USED FOR
Wynzora is used on the skin to treat mild to moderate psoriasis
vulgaris, including scalp psoriasis in
adults. Psoriasis is caused by your skin cells being produced too
quickly. This causes redness, scaling and
thickness of your skin.
Wynzora 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 WYNZORA
DO NOT USE WYNZORA:

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 Wynzora contains a strong steroid, do NOT use it 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)

tub

Данни за продукта

Health Products Regulatory Authority
16 August 2023
CRN00D9P3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wynzora 50 micrograms/g + 0.5 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Wynzora Cream contains 50 micrograms of calcipotriol and
betamethasone dipropionate equivalent to 0.5 mg
betamethasone.
Excipients with known effect:
Butylated hydroxyanisole (E 320) 1.0 mg/g cream
Macrogolglycerol hydroxystearate 3.4 mg/g cream
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Wynzora is indicated for topical treatment of mild to moderate
psoriasis vulgaris, including scalp psoriasis, in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Wynzora Cream should be applied to affected areas once daily.. Rub in
the cream thoroughly in a thin layer. The recommended
treatment period is up to 8 weeks. Treatment should be discontinued
when control is achieved. If it is necessary to continue or
restart treatment after this period, treatment should be continued
only 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 the scalp _
All the affected scalp areas may be treated with Wynzora Cream.
Special populations
_ _
_Renal and hepatic impairment_
The safety and efficacy of Wynzora Cream in patients with severe renal
insufficiency or severe hepatic disorders have not been
evaluated.
_Paediatric population_
The safety and efficacy of Wynzora Cream in children below 18 years
have not been established.
Currently available data in children aged 12 to 17 years are described
in sections 4.8, 5.1 and 5.2.
Method of administration
Health Products Regulatory Authority
16 August 2023
CRN00D9P3
Page 2 of 9
Wynzora Cream should not be applied directly