Soolantra 1% Cream- 45g

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.

IVERMECTIN CREAM - TOPICAL

(EYE-ver-MEK-tin)

COMMON BRAND NAME(S): Soolantra

USES: This medication is used to treat a certain skin condition called rosacea, a type of adult acne. Ivermectin may help to decrease symptoms caused by rosacea, such as redness, swelling, and pimples.

HOW TO USE: Read the manufacturer\'s Instructions for Use if available from your pharmacist before you start using ivermectin cream and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is for use only on the face. Clean the affected area with a mild soap or soap-free cleanser and pat dry. Apply this medication to the affected areas of the face as directed by your doctor, usually once a day. Use a pea-sized amount for each area of the face (such as the forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Wash your hands well after applying. Avoid getting this medication in your eyes, inside your nose, or on your lips. If this accidentally happens, rinse right away with plenty of cool water. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not use large amounts or apply this product more often than directed. Your condition will not clear faster, and the chance of side effects may be increased. It may take several weeks of continued use before you see the effects of this medication. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Skin irritation (such as redness or a burning feeling) may rarely occur. If this effect persists or worsens, 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. 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 ivermectin cream, 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. The form of this medication taken by mouth passes into breast milk in small amounts. It is unknown if this form of ivermectin 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.

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. Symptoms of overdose may include: rash, swelling, headache, dizziness, vomiting, diarrhea, numbness/tingling, seizures.

NOTES: Do not share this medication with others. Spending time in the sun can worsen rosacea. Wear a wide-brimmed hat and use sunscreen to avoid getting too much sun. Other triggers that may worsen rosacea include wind, hot beverages, spicy foods, alcohol, and either hot or cold weather.

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 light and moisture. Do not store in the bathroom. 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 June 2018. Copyright(c) 2018 First Databank, Inc.