ZORAC 0.05% GEL

Active substance: TAZAROTENE

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Zorac® Insert Ireland and UK - MOH

PACKAGE LEAFLET:
INFORMATION FOR THE USER

ZORAC® 0.05% Gel and ZORAC® 0.1% Gel
Tazarotene
Read all of this leaflet carefully before you start using this
medicine.
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What ZORAC Gel is and what it is used for
2. Before you use ZORAC Gel
3. How to use ZORAC Gel
4. Possible side effects
5. How to store ZORAC Gel
6. Further 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 are
affected. This is approximately equivalent to the area of skin on one
arm.

2. BEFORE YOU USE ZORAC GEL
Do not use ZORAC Gel









if you are hypersensitive (allergic) to tazarotene or any of the
other ingredients of ZORAC Gel,
if you are pregnant or breast-feeding or if you are considering
becoming pregnant,
in children under 18 years of age,
for the treatment of psoriasis with pus discharge (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).

Take special care with ZORAC Gel






Do not apply ZORAC Gel on more than 10% of the total surface
of the body (which is approximately equivalent to the area of the
skin on one arm).
Do only apply ZORAC Gel to affected areas of skin. Application
of ZORAC Gel to healthy, eczematous or inflamed skin may
cause irritation.
In case of psoriasis lesions on the hands, you should be extra
careful not to get any gel on the face or in the eyes. In case of
accidental contact with the eyes, rinse generously with lots of
water.
Avoid excessive exposure to UV rays (sun, solarium, PUVA
therapy or UVB. therapy) during the treatment.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Simultaneous use of other preparations on the skin should be
avoided if these have a pronounced drying effect. This applies to
certain medicines (e.g. disinfectants) and also cosmetics (e.g. soaps
and shampoos). Nevertheless, if such products are applied, it is
advisable to leave a one hour interval before and after application of
ZORAC Gel. Coal tar shampoos should also be avoided.
Pregnancy and breast-feeding
ZORAC Gel should not be taken during pregnancy, breast-feeding
(because this medicine passes into breast milk) and in women who
are considering becoming pregnant.
Animal studies have revealed damage to the unborn baby.
Women of child-bearing age should be informed of the potential
risk and adopt adequate contraceptive measures when treated with
ZORAC Gel.
If you discover you are pregnant during treatment, stop application of
this medicine and consult your doctor immediately.
Driving and using machines
Treatment with ZORAC Gel has no known effect on the ability to
drive or use machinery.

Artwork is created at 100%
Drop keylines and notes before printing
Part Number 71004MD91U
Drawing Number: 0176101
V-Code: XXXX

Important information about some of the ingredients of ZORAC
Gel
This medicine contains the ingredients butylhydroxyanisole and
butylhydroxytoluene. They can cause local skin reactions (e.g. skin
inflammation due to contact with the additional ingredients, i.e. the
so called ‘contact dermatitis’), irritate the eyes, skin and mucous
membranes.

3. HOW TO USE ZORAC GEL
Always take ZORAC Gel exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
ZORAC Gel is available in two different concentrations: 0.05% Gel
and 0.1% Gel. Your doctor will prescribe the concentration best
suited to your symptoms.
Dosage and duration of use
Apply ZORAC Gel once daily (evenings) in a thin film to the affected
areas.
Treatment usually lasts for up to 3 months. Clinical experience,
particularly concerning tolerance, has been documented over a period
of up to 12 months.
Method of application
Use the tip of the cap to break the seal.

Dry your skin well after bathing or showering, before applying

ZORAC Gel.
Only apply ZORAC Gel to the affected skin areas. The use of

ZORAC Gel on healthy, eczematous or inflamed skin should
be avoided, as this may cause irritations (itching, redness,
inflammation).
Not more than 10% of the body surface should be treated (this is

approximately equivalent to the surface of the skin of the arm).
Do not cover areas to be treated with dressings or bandages.

Please wash your hands after applying the gel, unless your

hands themselves are being treated. Do not get the gel in your
eyes.
In cases of very dry skin or skin irritations, it is recommended

to apply an inert fatty ointment base to the affected skin areas
at least one hour before using ZORAC Gel, in order to improve
tolerance and/or to apply zinc ointment to the healthy skin
surrounding the psoriasis plaques.
Note that you should not use skin care products or cosmetics

within one hour before or after applying ZORAC Gel.
Nevertheless, if such products are used, make sure these
preparations have been fully absorbed by the skin before
application of ZORAC Gel.
In case of skin irritation, treatment with ZORAC Gel should

be discontinued. Seek advice from the dermatologist or
doctor who is treating you.
Children
The safety and efficacy of ZORAC Gel has not been verified for
treatment of patients under 18 years of age.
Elderly Patients
There are no special warnings for elderly patients.
If you use more ZORAC Gel than you should
Overdoses to the skin can cause redness, scaling and discomfort.
If ZORAC Gel is swallowed accidentally, symptoms such as those
associated with excessive vitamin A intake may develop. These
include severe headache, vomiting, tiredness, irritability and itchy
skin. It can be expected, however, that these symptoms will subside.
If these symptoms persist please contact your doctor.
ZORAC Gel is intended for once daily external application only. More
frequent application will not provide faster or better results.
If you forget to use ZORAC Gel
If you forget a dose of ZORAC Gel do not try to make up for a
forgotten dose. Return to your normal application schedule once a
day (in the evening).
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, ZORAC Gel can cause side effects, although not
everybody gets them.
For the assessment of side effects, the following descriptions of
frequency have been used:
Very common

in more than 1 in 10 patients treated

Common

in less than 1 in 10, but more than 1 in 100
patients treated

Uncommon

in less than 1 in 100, but more than 1 in 1000
patients treated

Rare

in less than 1 in 1000, but more than 1 in 10
000 patients treated

Very rare

in less than 1 in 10 000 patients treated,
including isolated reports

Zorac® Insert Ireland and UK - MOH

The side effects observed during treatment with ZORAC Gel are:

Skin and subcutaneous tissue disorders
Very common
itchy skin, burning sensation on the skin, redness and irritation
Common
scaling, non-specific skin rash, skin inflammation (contact dermatitis)
caused by a reaction to certain substances, painful skin and
exacerbation of the psoriasis, stinging, inflamed and dry skin
The frequency of these undesirable effects appears to depend on
the dose and the duration of the treatment. The more concentrated
gel (0.1%) may cause skin irritation more frequently than the less
concentrated gel (0.05%), especially during the first 4 weeks of
treatment.
After applying ZORAC Gel, some people notice a feeling of itching,
burning or stinging of the affected skin areas. This sensation may
lessen as your skin gets used to the medication. Contact your doctor
if the irritation becomes troublesome. Furthermore skin discoloration
may occur.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

TO LISTEN TO OR REQUEST A COPY
OF THIS LEAFLET IN BRAILLE, LARGE
PRINT OR AUDIO PLEASE CALL, FREE
OF CHARGE: 0800 198 5000 (UK ONLY).
PLEASE BE READY TO GIVE
THE FOLLOWING INFORMATION:
TAZAROTENE 0.1% REFERENCE
NUMBER PL 05179/0002 OR 0.05%
REFERENCE NUMBER PL 05179/0003.
THIS IS A SERVICE PROVIDED BY THE
ROYAL NATIONAL INSTITUTE OF BLIND
PEOPLE.

5. HOW TO STORE ZORAC GEL
Keep out of the reach and sight of children.
Do not use ZORAC Gel after the expiry date which is stated on the
crimped end of the tube and on the carton.
Keep the tube tightly closed between applications.
Do not use any remaining gel after 6 months from when the pack
was first opened.
Do not store ZORAC Gel at temperatures above 30 °C.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What ZORAC Gel contains



The active substance is tazarotene. This belongs to the retinoid
group of substances, derived from vitamin A.
The other ingredients are: benzyl alcohol; macrogol 400;
hexylene glycol; carbomer 974P; trometamol; poloxamer 407;
polysorbate 40; ascorbic acid; butylhydroxyanisole (E320);
butylhydroxytoluene (E321); disodium edetate; purified water.

What ZORAC Gel looks like and contents of the pack
ZORAC Gel is a colourless to light yellowish, translucent to slightly
cloudy, homogeneous gel. It is available in aluminium tubes,
internally lacquered, epoxyphenolic, with white polypropylene cap
containing 30g or 60g gel. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
Local Representative
Allergan Limited
Marlow International
The Parkway
Marlow
Bucks SL7 1YL
United Kingdom
IF YOU WOULD LIKE FURTHER INFORMATION, OR REQUIRE
THIS LEAFLET IN A LARGER FORMAT PLEASE CONTACT
MEDICAL INFORMATION AT ALLERGAN LTD, UK.
TEL: 01628 494026 OR EMAIL: UK_MEDINFO@ALLERGAN.COM
ZORAC Gel is an original investigational product from Allergan, Inc
ZORAC is a trademark of Allergan, Inc. Irvine, C.A., USA
This leaflet was last approved in mm/yyyy.

71004MD91U

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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