Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Use this medication only on the skin as directed by your doctor. Do not use on irritated skin or skin that has not healed from other treatments or surgery. Do not apply right after taking a shower or less than 2 hours before bedtime.
The strength prescribed and treatment time depends on the application site. For use on the face or scalp, apply to the affected area(s) once a day for three days in a row. For use on your body, arms, hands, or legs, apply to the affected area(s) once a day for 2 days in a row. After spreading evenly on the treatment area, let the medication dry for 15 minutes. Wash your hands right away with soap and water. Avoid getting the drug on other areas, including near the eyes, lips, or mouth. If you accidentally get ingenol in your eyes, flush them well with large amounts of water and get medical care right away. Avoid washing and touching the treated area, or doing activities that cause excessive sweating, for 6 hours after application. After this time, you may wash the area with a mild soap.
Use a new tube of gel for each use. Throw away any open tube after use even if there is medication still left in it.
The treated area commonly becomes red or irritated during treatment. Skin reactions will usually improve after 2 to 4 weeks. Do not cover the area with bandages or other dressings.
Do not use more ingenol than you need to cover the treatment area or use it more often than directed. Your condition will not clear faster, and the risk of skin reactions will increase.
Tell your doctor if your condition does not improve or if it worsens.
Skin redness, itching, irritation, flaking/peeling, crusting, pain, or swelling commonly occur at the site of application. Eye/eyelid, nose, or throat irritation or headache may also occur. If any of these effects persist or worsen, 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.
Tell your doctor right away if you have any serious side effects, including: blisters, pus, or ulcers at the application site.
Get medical help right away if you have any very serious side effects, including: painful rash (especially on one side of the face or body), vision changes (including increased sensitivity to light, vision loss).
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 ingenol, 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 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.
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.
This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room 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.
Do not share this medication with others.
Discard any unused medication when the treatment is finished. Do not use it for any other skin conditions unless directed to do so by your doctor.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Store in a refrigerator between 36-46 degrees F (2-8 degrees C) away from moisture. Brief storage between 32-59 degrees F (0-15 degrees C) is permitted. Do not freeze. 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 2015. Copyright(c) 2015 First Databank, Inc.
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