Brimonidine 0.33% Gel Pump-30g

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BRIMONIDINE GEL - TOPICAL

(bri-MON-i-deen)

COMMON BRAND NAME(S): Mirvaso

USES: This medication is used to treat a certain skin disorder called rosacea. It works by narrowing blood vessels to reduce redness. Brimonidine belongs to a class of drugs known as alpha agonists.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is for use on the skin only. Avoid getting this medication into your eyes or mouth, on your lips, on any areas of broken/irritated skin including after laser treatment, or in and around the vaginal area. Wash your hands before and after applying this medication. Clean and dry the affected area before applying the medication. Apply a pea-sized amount of the medication to the affected area(s) (such as the forehead, chin, nose, and each cheek) and gently spread a thin layer of the medication over that area as directed by your doctor, usually once daily. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. To reduce your risk of side effects, your doctor may direct you to apply a smaller amount of medication at first and gradually increase your dose. Follow your doctor\'s instructions carefully. Tell your doctor if your condition does not improve or if it worsens. Keep this medicine in a safe place to prevent accidental use or misuse. Children who have accidentally swallowed this medication have had serious side effects, including trouble breathing, weakness, slow heartbeat, confusion, sweating. If a child swallows this drug, get medical help right away.

SIDE EFFECTS: Flushing and redness/burning of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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. Tell your doctor right away if you have any serious side effects, including: slow heartbeat, dizziness, fainting, pale/whitening skin. 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.

PRECAUTIONS: Before using brimonidine, tell your doctor or pharmacist if you are allergic to it; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients (such as phenoxyethanol), 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, especially of: blood vessel diseases (thromboangiitis obliterans), blood circulation disorders (cerebral or coronary insufficiency), heart disease, depression, Raynaud\'s disease, low blood pressure upon standing (orthostatic hypotension), a certain immune system disorder (Sjogren\'s syndrome), a certain skin/connective tissue disease (scleroderma). Avoid certain triggers that may worsen rosacea such as wind, hot beverages, spicy foods, alcohol, and extreme cold. Discuss with your doctor. Sun exposure can worsen rosacea. Limit exposure to the sun by wearing a wide-brimmed hat and using a sunscreen that is SPF 15 or greater. 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. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Avoid the use of skin care products that can cause further irritation (such as cleaners that contain alcohol, tinctures, astringents, abrasives, and peeling agents). Consult your doctor or pharmacist for details.

OVERDOSE: 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. This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

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. 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 October 2022. Copyright(c) 2023 First Databank, Inc.