Zorac 0.05% gel

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Tazarotene

Mevcut itibaren:

Sigma Pharmaceuticals Plc

ATC kodu:

D05AX05

INN (International Adı):

Tazarotene

Doz:

500microgram/1gram

Farmasötik formu:

Cutaneous gel

Uygulama yolu:

Cutaneous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 13050200

Bilgilendirme broşürü

ZORAC
® 0.05% GEL
ZORAC
® 0.1% GEL
Tazarotene
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 ZORAC gel is and what it is used for
2.
What you need to know before you use ZORAC gel
3.
How to use ZORAC gel
4.
Possible side effects
5.
How to store ZORAC gel
6.
Contents of the pack and other information
1. WHAT ZORAC GEL IS AND WHAT IT IS USED FOR
ZORAC gel is a drug for the treatment of psoriasis. It is applied to
the skin.
ZORAC gel is used for the treatment of mild to moderate plaque
psoriasis (the most common form of psoriasis) if only small areas are
to be treated and only up to 10% of the body surface area is affected.
This is approximately equivalent to the area of skin on one arm.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZORAC GEL
DO NOT USE ZORAC GEL
-
if you are allergic to tazarotene or any of the other ingredients of
this medicine (listed in section 6),
-
if you are pregnant,
-
if you are planning a pregnancy,
-
if you are breast-feeding,
-
in children under 18 years of age,
-
for the treatment of suppurating, pustulating psoriasis (psoriasis
pustulosa) or psoriasis with increased scale formation (exfoliative
psoriasis),
-
on the face,
-
on the hair-covered scalp,
-
in moist, hair-covered areas such as armpits, groin etc,
-
under tightly secluded bandages (occlusive bandages) or in
combination with other drugs for psoriasis that are for external
use (including shampoos with coal tar).
WARNINGS AND PRECAUTIONS
-
Do not apply ZORAC gel on more than 10% of the total surface
of the body (wh

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ZORAC 0.05%, gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tazarotene ............................................ 0.05 g
Excipients with known effect:
Butylhydroxyanisole ............................. 0.05 g
Butylhydroxytoluene............................. 0.05 g
For 100 g of gel
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel.
Colourless to light yellow, translucent to homogeneous cloudy gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZORAC gel is indicated for the topical treatment of mild to moderate
plaque
psoriasis involving up to 10% body surface area.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ZORAC gel is available in two concentrations.
To initiate a treatment with ZORAC, it is advisable to start with
ZORAC
0.05% in order to evaluate the skin response and tolerance before
progressing
to ZORAC 0.1% if necessary.
Treatment with the lower concentration gel is associated with a
somewhat
lower incidence of local adverse events_ _(see sections 4.8
Undesirable effects
and 5. Pharmacological Properties).
Treatment with the higher concentration gel gives a faster and
numerically
higher response rate. The physician should choose the concentration to
be used
based
on
clinical
circumstances
and
the
principle
of
using
the
least
concentration of drug to achieve the desired effect.
Individual variations with respect to efficacy and tolerability are
possible. It is
thus advisable for patients to consult their physician on a weekly
basis when
initiating therapy.
_Paediatric population _
The safety and efficacy of ZORAC gel in children under the age of 18
years
has not been established.
Method of administration
A thin film of the gel should be applied once daily in the evening;
care should
be taken to apply it only to areas of affected skin, avoiding
application to
healthy skin or in skin folds. Treatment is limited to 10% body
surface area
(approximately equivalent to the total skin area of o