Zorac 0.05% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tazarotene

Available from:

Allergan Ltd

ATC code:

D05AX05

INN (International Name):

Tazarotene

Dosage:

500microgram/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200; GTIN: 5016007200157

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
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 illnessare 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%

Summary of Product characteristics

OBJECT 1
ZORAC 0.05% GEL
Summary of Product Characteristics Updated 28-Nov-2018 | Allergan Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
•
5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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