Uses of Azelaic Acid Gel:

• It is used to treat rosacea.

What do I need to tell my doctor BEFORE I take Azelaic Acid Gel?

• If you are allergic to azelaic acid gel; any part of azelaic acid gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take azelaic acid gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Azelaic Acid Gel?

• Tell all of your health care providers that you take azelaic acid gel. This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• If you use azelaic acid gel too often, your skin problem may become worse.
• Use of other skin products while using azelaic acid gel may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• If you have asthma, use azelaic acid gel with care. Worsening of asthma has happened in people using azelaic acid gel. Call your doctor right away if your asthma gets worse while you use azelaic acid gel.
• Avoid alcohol, hot foods and drinks, and spicy foods while using azelaic acid gel.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Azelaic Acid Gel) best taken?

Use azelaic acid gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take azelaic acid gel by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If azelaic acid gel gets in the eyes, rinse with a lot of water. If eye irritation lasts for a while, talk with the doctor.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Use only mild soaps or cleansing lotions free of soap for facial cleaning.
• Put a thin layer on the affected skin and rub in gently.
• Use as you have been told, even if your signs get better.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Makeup may be used after the skin has dried.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in color of skin.
• Shortness of breath.

What are some other side effects of Azelaic Acid Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• It is common to have skin irritation with azelaic acid gel. Skin irritation may include burning, itching, or stinging. Most of the time, skin irritation happened during the first few weeks after starting azelaic acid gel. Call your doctor if you have skin irritation that is very bad, bothers you, or does not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Azelaic Acid Gel?

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• If using the pump product, throw away any part not used 8 weeks after opening.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about azelaic acid gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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