Finacea: Uses, Side Effects and Dosage

What FINACEA 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.

How FINACEA works:

FINACEA is believed to reduce the production of substances known to contribute to inflammation. This helps reduce the inflammation caused by rosacea.

The ingredients in FINACEA are:

Medicinal ingredient: azelaic acid gel, 15% w/w.

Non-medicinal ingredients: benzoic acid, disodium edetate, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, sodium hydroxide.

FINACEA comes in the following dosage form(s):

gel (15% w/w) in tubes of 5 g and 50 g.

Do not use FINACEA if:

• You are allergic to azelaic acid, propylene glycol or to any other ingredient of this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FINACEA about any health conditions or problems you may have, including if you:

• You are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed.

Other warnings you should know about:

• FINACEA is for topical (skin) use only. It is not for ophthalmic (eyes), oral, rectal or intravaginal use.

• FINACEA will not affect your ability to drive and/or use machines.

• If you see any unusual changes in your skin colour, tell your healthcare professional.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take FINACEA:

FINACEA should be used only as directed by your healthcare professional.

Usual 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 healthcare professional.
• If your skin becomes irritated, you should either: reduce the amount of FINACEA you apply each time; or apply it 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.

Overdose:

FINACEA is for use on the skin only. If you apply too much and your skin becomes irritated, talk with your healthcare professional. You may be instructed to start using less FINACEA less frequently, or to stop using FINACEA altogether until the irritation goes away.

If you think you, or a person you are caring for, have taken too much FINACEA contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

Possible side effects from using FINACEA:

These are not all the possible side effects you may have when taking FINACEA. If you experience any side effects not listed here, tell your healthcare professional. Side effects may include:

• Skin irritation at the start of the treatment. Symptoms include burning, stinging, tingling, itching, reddening, dryness and scaling of the skin. The symptoms are mild and go away over the course of treatment.
• Infection of the hair follicle.

Serious side affects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15 – 30°C).

Keep out of the reach and sight of children.

If you want more information about FINACEA:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website http://www.leo-pharma.ca; or by calling 1-800-263-4218.

Date of Authorization: 2026-03-04

FINACEA® is a registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc. Canada

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