Finacea Topical

In the U.S.

• Azelex
• Finacea
• Finacea Plus

Available Dosage Forms:

• Gel/Jelly
• Foam
• Cream

Therapeutic Class: Antiacne Antibacterial

This section provides information on the proper use of a number of products that contain azelaic acid. It may not be specific to Finacea. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated.

This medicine is for use only on the skin. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off with water and check with your doctor right away.

To help clear up your acne or rosacea completely, it is very important that you keep using this medicine for the full treatment time. Do not miss any doses.

Avoid using alcoholic cleansers, tinctures and astringents, or abrasives and peeling agents with the foam or gel to prevent extra skin irritation.

Avoid eating spicy foods, thermally hot foods and drinks (eg, hot coffee, tea), and alcoholic beverages while you are using the gel.

The foam is flammable. Avoid fire, flame, and smoking when you apply the medicine and right after it is applied.

To use the cream, foam, or gel:

• Wash your hands with soap and water before and after using this medicine.
• Before applying, wash the affected area of your skin with water and a mild soap or a cleansing lotion that does not contain soap. Rinse well and pat dry.
• Shake the foam can well before using.
• Apply a small amount of the medicine to each affected area and gently rub it in.
• You may apply cosmetics after the foam or gel has dried.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For acne:
    • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) two times a day, in the morning and evening.
    • Children younger than 12 years—Use and dose must be determined by your doctor.
• For topical dosage forms (foam, gel):
  • For mild to moderate rosacea:
    • Adults—Apply a thin layer to the affected area(s) two times a day, in the morning and evening.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Throw away the gel pump 8 weeks after opening.

Do not store the foam can at temperatures above 49 degrees C (120 degrees F). Do not poke holes in the can or throw it into a fire, even if the can is empty. Throw away any unused medicine 8 weeks after using it for the first time.

Skin burning, stinging, tingling, or itching may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, some people have had unusual loss of skin color (hypopigmentation) after using this medication. This side effect may be easier to see in people with dark skin color. Tell your doctor right away if you notice this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

To help manage rosacea, avoid foods or liquids that may bring on redness, flushing, or blushing of the skin (such as spicy foods, alcohol, hot drinks).

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from heat and open flame. The contents of this can are flammable and under pressure. Do not puncture or burn the container. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.