Finacea - Consumer Medicine Information
|Class:||Topical acne agents, Topical anti-rosacea agents|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||azelaic acid gel, benzoic acid, disodium edetate, lecithin, polyacrylic acid, polysorbate 80, propylene glycol, medium-chain triglycerides, sodium hydroxide|
azelaic acid gel
About this Medication
What the medication is used for
FINACEA is used to treat rosacea (when the skin on the face is unusually red). FINACEA is for topical use only. This means that it is put on the skin.
What it does
The exact way that FINACEA works in rosacea is unknown. However, several studies showed that it reduced the redness and swelling of rosacea.
When it should not be used
Do not use FINACEA if you are allergic or hypersensitive to azelaic acid, propylene glycol or to any of the other ingredients in FINACEA. See the section titled "What the important non medicinal ingredients are" in this leaflet.
What the medicinal ingredient is
azelaic acid gel, 15%
What the important nonmedicinal ingredients are
benzoic acid, disodium edetate, lecithin, polyacrylic acid, polysorbate 80, propylene glycol, medium-chain triglycerides, sodium hydroxide
What dosage forms it comes in
FINACEA is available in 15% gel in tubes of 5 g, 30 g and 50 g.
Warnings and Precautions
BEFORE you use FINACEA, talk to your doctor or pharmacist if:
- you are pregnant or breast-feeding, ask your doctor for advice before using FINACEA.
- you are allergic or hypersensitive to azelaic acid, propylene glycol or to any of the other ingredients in FINACEA.
Children and adolescents
The safety and effectiveness of FINACEA in children and adolescents has not yet been established.
Interactions with this Medication
There have been no formal studies evaluating the interaction of FINACEA with other drugs.
Proper Use of this Medication
Usual adult dose
Before applying FINACEA, the skin should be thoroughly cleaned with water or with a mild skin-cleansing agent. Pat dry with a soft towel before applying FINACEA.
Apply FINACEA sparingly to the affected skin areas twice a day, in the morning and evening, and rub it gently into the skin. About one finger-tip length (i.e. 2.5 cm or 1 inch) of gel squeezed from the tube is sufficient for your entire face. Avoid contact with the eyes, since it might irritate them.
In case of accidental contact of FINACEA with the eyes, inside of the nose, or mouth, wash your eyes, nose or mouth immediately with large quantities of water. If your eyes continue to hurt, tell your doctor.
If your skin becomes irritated, you should either:
- reduce the amount of FINACEA you apply each time; or
- apply it only once a day; or
- stop treatment for a few days.
Always wash your hands after using FINACEA.
Do not cover the treated area with dressings. Avoid alcoholic cleansers, tinctures and astringents, as well as abrasives and peeling agents.
Medication-free cosmetics or cosmetics which do not cause acne may be applied after FINACEA has dried.
Make sure very young children do not touch the treated area of your skin because of the mild irritant effect of FINACEA.
The length of time for which FINACEA must be used varies from person to person and also depends upon the severity of rosacea when you start treatment.
You should see a distinct improvement after about four to eight weeks. FINACEA should be used only as prescribed by your doctor.
If you have rosacea, you should avoid spicy foods, hot foods and drinks, and alcoholic drinks, since these may make rosacea worse. You should also use only mild skin-cleansing products to wash your face.
FINACEA will not affect your ability to drive and use machines.
FINACEA is for use on the skin only. If you apply too much and your skin becomes irritated, talk with your doctor. You may be instructed to start using less FINACEA less frequently, or to stop using FINACEA altogether until the irritation goes away.
Do not use increased amounts of FINACEA to make up for a dose that you missed. Continue with your usual dosing schedule.
Side Effects and what to do about them
Like all medicines, FINACEA can have side effects. Skin irritation may occur, usually at the start of treatment. Common undesirable side effects include burning/stinging or itching sensations, reddening, skin dryness and scaling. Allergic skin reaction and infection of the hair follicle are uncommon side effects. In the majority of cases, the irritation symptoms are mild and go away over the course of treatment.
In very rare cases, allergic skin reactions may occur.
No serious side effects related to the use of FINACEA have been reported.
If you see any unusual changes in your skin colour, you should see your doctor.
If you notice side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking FINACEA, contact your doctor or pharmacist.
How to Store it
Store FINACEA at room temperature (15 - 30°C). Keep FINACEA out of the reach and sight of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
For more information, please contact your health professional or pharmacist first, or Bayer Medical Information at 1-800-265-7382 or firstname.lastname@example.org.