Active ingredient
- tazarotene
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL41443/0002, PL41443/0003.
Zorac
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.
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
Warnings and precautions
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
Do not use ZORAC gel if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.
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.
Do not use Zorac gel if you are breast-feeding (because animal data indicates that excretion into milk is possible).
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 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)
Common side effects (may affect up to 1 in 10 people)
The frequency of the following side effects is not known (frequency can not be estimated from the available data)
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.
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 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
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, 30 g, 50 g, 60 g or 100 g gel. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Local Representative
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: [email protected]
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 July 2018
Version 4
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.
Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
+44 (0)1628 494444
+44 (0)1628 494026
+44 (0)1628 494026