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ZORAC 0.1% GEL

Active substance(s): TAZAROTENE

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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 illness
are the same as yours.
- If you get any of the 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 or breast-feeding or if you are considering
becoming pregnant,
• 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 (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 facial skin 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. This is especially
relevant when taking certain other medicines also known to cause
sensitivity to light (see below (Other medicines and ZORAC gel)).
Children
Do not give this medicine to children under the age of 18 years as safety
and efficacy of ZORAC gel has not been established in this age group.
Other medicines and ZORAC gel
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
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.
Use of ZORAC gel with certain medicines (e.g., thiazides, tetracyclines,
fluoroquinolones, phenothiazines, sulfonamides) is known to cause
sensitivity to light. See section 2 above (Warnings and precautions).
Pregnancy, breast-feeding and fertility
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.
ZORAC gel contains butylhydroxyanisole and butylhydroxytoluene.
They can cause local skin reactions (e.g. skin inflammation due to
contact with the additional ingredients, the so called contact dermatitis),
irritate the eyes, skin and mucous membranes.
3. How to use ZORAC gel
Always take this medicine exactly as your doctor has told you. 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.
Use in 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
Do not use a double dose 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, this medicine can cause side effects, although not
everybody gets them.
Very common side effects (may affect more than 1 in 10 people)
- itchy skin,
- burning sensation on the skin,
- redness and irritation.
Common side effects (may affect up to 1 in 10 people)
- 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 the following side effects is not known (frequency can
not be estimated from the available data)
- blister,
- alteration of the pigmentation of the skin (including hyperpigmentation
or hypopigmentation).
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme;
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.

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 41443/0002 or 0.05%
reference number PL 41443/0003.
This is a service provided by the
Royal National Institute of Blind
People.

5. How to store ZORAC gel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
crimped end of the tube and on the carton. The expiry date refers to
the last day of that month.
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 this medicine at temperatures above 30°C.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other 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
10 g, 15 g, 30g 50 g, 60g or 100 g 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 revised in May 2015.

71722MD047F

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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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