Zorac 0.05% Gel
Out of date information, search anotherAPPROVED
ByAneela Mahmood at 11:09 am, Mar 18, 2008
Final Draft
Assessed against UK PIL dated September 2006
ZORAC 0.05% GEL / ZORAC 0.1% GEL
(tazarotene)
Your medicine is known by the above two names, but will be referred to as Zorac Gel throughout this leaflet.
PATIENT INFORMATION LEAFLET
Please read this information about Zorac Gel carefully before you start to take your medicine. It contains all the information you should need to know. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Keep this leaflet whilst you are taking this medicine, you may wish to refer to it again.
Your medicine is called Zorac Gel, it is a colourless to light yellow transparent gel, and contains either 0.05%, or 0.1% of the active ingredient tazarotene
Zorac Gel also contains benzyl alcohol, macrogol 400, hexylene glycol, carbomer, trometamol, poloxamer 407, polysorbate 40 (E434), ascorbic acid, butylated hydroxyanisole (E320), butylated hydroxytoluene (E321), dosodium edetate and purified water.
Zorac 0.1% Gel is available in tubes of 15g and 60g Zorac 0.05% Gel is available in tubes of 60g
POM
Zorac 0.05% Gel PL10383/1197
Zorac 0.1% Gel PL10383/1198
Zorac Gel is manufactured by Pierre Fabre Medicament Production, 45 Place Abel-Gance, 92654 Boulogne Cedex, France Procured from within the EU and repackaged by Product Licence Holder Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ
WHY YOU NEED TO TAKE THIS MEDICINE:
Zorac Gel is used in the treatment of mild to moderate plaque psoriasis for up to 10% of the body surface area.
You should not apply Zorac Gel to the face, hair covered scalp or to areas of intertrigo (inflammation occurring in moist skin folds).
BEFORE YOU TAKE YOUR MEDICINE:
Make sure it is safe for you to use Zorac Gel. Tell your doctor if any of the following apply:
• Are pregnant or planning to becoming pregnant?
If you are of childbearing potential, you must use adequate birth control while using Zorac as it may have an effect on an unborn child.
If you become pregnant while using Zorac Gel, you should stop treatment and contact your doctor immediately.
• Are you breast-feeding? You must not breast feed while using Zorac Gel.
• Are you allergic to any ingredients in this medicine?
• Are you already using other products that make your skin dry?
• Do you have a skin condition called eczema? Zorac Gel may cause severe irritation if applied to eczematous skin.
Zorac Gel contains butyl hydroxyanisole and butyl hydroxytoluene. May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Using your medicine
Your doctor may have told you to use Zorac in a different way to that recommended in this leaflet. If so, follow your doctor's instructions about when and how to use this gel. Read the directions on your prescription label carefully and ask you doctor or pharmacist to explain anything that you do not understand.
Before applying Zorac Gel:
If you use a cream or lotion to lubricate your skin, apply it to your skin and allow it to absorb completely before applying the gel, preferably one hour before application.
If you bathe or shower before using the gel, be sure your skin is dry before application.
Applying Zorac Gel:
To break the seal, use the top of the cap.
Apply a thin film of gel to your areas of psoriasis only, once a day before going to bed. Applying excessive amounts of Zorac Gel or more frequent applications will not provide faster or better results, and severe irritation or discomfort could occur. Zorac Gel should not be applied to more than 10% of the total body surface area (equivalent to the total skin area of one arm).
It is important to only apply the recommended amount of gel.
Avoid application of the gel to normal skin or in skin folds. Zorac Gel can be more irritating to normal skin. To prevent irritation, healthy skin around the psoriatic plaques can be covered by using zinc paste or emollients.
If you experience more drying or irritation, these symptoms can be reduced by applying an emollient to the areas of skin to be treated.
If you need to treat your hands, avoid contact with your eyes.
If Zorac Gel comes in contact with your eyes, wash your eyes with large amounts of cool water, and contact a doctor if the eye irritation persists.
AFTER USING YOUR MEDICINE:
After applying Zorac gel, some people notice a feeling of itching, burning or stinging. This feeling may occur less often as your skin gets used to the medication. Contact your doctor if the irritation becomes troublesome.
Do not apply any other creams or lotions until at least one hour after applying Zorac gel.
Do not cover treatment areas with dressings or bandages.
Wash your hands after applying Zorac gel to avoid contact with your eyes, unless you are treating your hands for psoriasis. If the gel accidentally gets on areas you do not need to treat, wash it off.
Contact your doctor if your psoriasis becomes worse.
Missed doses:
If you forget or miss a dose of Zorac gel, do not try to 'make it up'. Return to your normal application schedule as soon as you can. As with any medication, you may experience some unwanted side-effects.
The most frequently reported side-effects with Zorac gel are itching, burning, irritation and reddening of the skin. These may be more frequent or severe with the higher strength (0.1%) gel.
Flaking of the skin, rash, inflammation, skin pain, a worsening of psoriasis, stinging, inflamed and dry skin occurred less frequently.
If any of these unwanted effects become troublesome or if you notice any unwanted effects which are not listed in this leaflet, consult your doctor or pharmacist.
WARNINGS AND PRECAUTIONS:
• During treatment with Zorac Gel avoid excessive exposure to UV light (sunlight, use of a solarium, PUVA or UVB therapy)
• While using Zorac Gel, avoid the use of medicinal skin preparations or cosmetics which you have found to cause irritation or have a strong drying effect on your skin
• Avoid the use of tar shampoos while using Zorac Gel
• If Zorac Gel is swallowed by accident, contact your doctor
• This medicine should not be used in patients under 18 years of age.
STORAGE:
Do not use after the expiry date printed on the carton, label or tube.
Do not store above 30°C. Keep the tube tightly closed when not in use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop using the gel, please take it back to the pharmacist for safe disposal. Only keep them if your doctor tells you to. If the gel become discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
IMPORTANT:
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give to anyone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not contain complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has access to additional information.
Leaflet date: 12/03/08
For further information on Zorac 0.05% and 0.1% contact:
Allergan Ltd Marlow International The Parkway Marlow
Buckinghamshire SL7 1YL UK
Tel: +44 (0)1628 494026
FURTHER INFORMATION:
For further information on psoriasis contact:
The Psoriasis Association
7 Milton Street
Northampton
NN2 7JG
United Kingdom
Tel: 01604 711129
The Psoriatic Arthropathy Alliance
PO Box 111
St Albans
Hertfordshire
AL2 3JQ
United Kingdom
Tel: 01923 672837
Your medicine is known by the above two names, but will be referred to as Zorac Gel throughout this leaflet.
Mock up
|
[APPROVED | ||
|
Assessed against UK PIL dated September 2006 |
ByAneela Mahmood at 11:10 am, Mar 18, 2008 | |
ZORAC 0.05% GEL / ZORAC 0.1% GEL
(tazarotene)
PATIENT INFORMATION LEAFLET
Please read this information about Zorac Gel carefully before you start to take your medicine. It contains all the information you should need to know. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Keep this leaflet whilst you are taking this medicine, you may wish to refer to it again.
Your medicine is called Zorac Gel, it is a colourless to light yellow transparent gel, and contains either 0.05%, or 0.1 % of the active ingredient tazarotene
Zorac Gel also contains benzyl alcohol, macrogol 400, hexylene glycol, carbomer, trometamol, poloxamer 407, polysorbate 40 (E434), ascorbic acid, butylated hydroxyanisole (E320), butylated hydroxytoluene (E321), dosodium edetate and purified water.
Zorac 0.1 % Gel is available in tubes of 15g and 60g Zorac 0.05% Gel is available in tubes of 60g
Zorac 0.05% Gel PL10383/1197 |POM|
Zorac 0.1% Gel PL10383/1198
Zorac Gel is manufactured by Pierre Fabre Medicament Production, 45 Place Abel-Gance, 92654 Boulogne Cedex, France. Procured from within the EU and repackaged by Product Licence Holder Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ
WHY YOU NEED TO TAKE THIS MEDICINE:
Zorac Gel is used in the treatment of mild to moderate plaque psoriasis for up to 10% of the body surface area.
You should not apply Zorac Gel to the face, hair covered scalp or to areas of intertrigo (inflammation occurring in moist skin folds).
BEFORE YOU TAKE YOUR MEDICINE:
Make sure it is safe for you to use Zorac Gel. Tell your doctor if any of the following apply:
• Are pregnant or planning to becoming pregnant?
If you are of childbearing potential, you must use adequate birth control while using Zorac as it may have an effect on an unborn child.
If you become pregnant while using Zorac Gel, you should stop treatment and contact your doctor immediately.
• Are you breast-feeding? You must not breast feed while using Zorac Gel.
• Are you allergic to any ingredients in this medicine?
• Are you already using other products that make your skin dry?
• Do you have a skin condition called eczema? Zorac Gel may cause severe irritation if applied to eczematous skin.
Zorac Gel contains butyl hydroxyanisole and butyl hydroxytoluene. May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Using your medicine
Your doctor may have told you to use Zorac in a different way to that recommended in this leaflet. If so, follow your doctor's instructions about when and how to use this gel. Read the directions on your prescription label carefully and ask you doctor or pharmacist to explain anything that you do not understand.
Before applying Zorac Gel:
If you use a cream or lotion to lubricate your skin, apply it to your skin and allow it to absorb completely before applying the gel, preferably one hour before application.
If you bathe or shower before using the gel, be sure your skin is dry before application.
Applying Zorac Gel:
To break the seal, use the top of the cap.
Apply a thin film of gel to your areas of psoriasis only, once a day before going to bed. Applying excessive amounts of Zorac Gel or more frequent applications will not provide faster or better results, and severe irritation or discomfort could occur. Zorac Gel should not be applied to more than 10% of the total body surface area (equivalent to the total skin area of one arm).
Avoid application of the gel to normal skin or in skin folds. Zorac Gel can be more irritating to normal skin. To prevent irritation, healthy skin around the psoriatic plaques can be covered by using zinc paste or emollients.
If you experience more drying or irritation, these symptoms can be reduced by applying an emollient to the areas of skin to be treated.
If you need to treat your hands, avoid contact with your eyes.
If Zorac Gel comes in contact with your eyes, wash your eyes with large amounts of cool water, and contact a doctor if the eye irritation persists.
AFTER USING YOUR MEDICINE:
After applying Zorac gel, some people notice a feeling of itching, burning or stinging. This feeling may occur less often as your skin gets used to the medication. Contact your doctor if the irritation becomes troublesome.
Do not apply any other creams or lotions until at least one hour after applying Zorac gel.
Do not cover treatment areas with dressings or bandages.
Wash your hands after applying Zorac gel to avoid contact with your eyes, unless you are treating your hands for psoriasis. If the gel accidentally gets on areas you do not need to treat, wash it off.
Contact your doctor if your psoriasis becomes worse.
Missed doses:
If you forget or miss a dose of Zorac gel, do not try to 'make it up'. Return to your normal application schedule as soon as you can. As with any medication, you may experience some unwanted side-effects.
The most frequently reported side-effects with Zorac gel are itching, burning, irritation and reddening of the skin. These may be more frequent or severe with the higher strength (0.1%) gel.
Flaking of the skin, rash, inflammation, skin pain, a worsening of psoriasis, stinging, inflamed and dry skin occurred less frequently.
If any of these unwanted effects become troublesome or if you notice any unwanted effects which are not listed in this leaflet, consult your doctor or pharmacist.
WARNINGS AND PRECAUTIONS:
• During treatment with Zorac Gel avoid excessive exposure to UV light (sunlight, use of a solarium, PUVA or UVB therapy)
• While using Zorac Gel, avoid the use of medicinal skin preparations or cosmetics which you have found to cause irritation or have a strong drying effect on your skin
• Avoid the use of tar shampoos while using Zorac Gel
• If Zorac Gel is swallowed by accident, contact your doctor
• This medicine should not be used in patients under 18 years of age.
STORAGE:
Do not use after the expiry date printed on the carton, label or tube.
Do not store above 30°C. Keep the tube tightly closed when not in use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop using the gel, please take it back to the pharmacist for safe disposal. Only keep them if your doctor tells you to. If the gel become discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
IMPORTANT:
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give to anyone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not contain complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has access to additional information.
Leaflet date: 12/03/08
For further information on Zorac 0.05% and 0.1% contact:
Allergan Ltd Marlow International The Parkway Marlow
Buckinghamshire SL7 1YL UK
Tel: +44 (0)1628 494026
FURTHER INFORMATION:
For further information on psoriasis contact:
The Psoriasis Association
7 Milton Street
Northampton
NN2 7JG
United Kingdom
Tel: 01604 711129
The Psoriatic Arthropathy Alliance
PO Box 111
St Albans
Hertfordshire
AL2 3JQ
United Kingdom
Tel: 01923 672837
3