Pramoxine Foam

Pramoxine Foam is used for:

Treating pain, soreness, burning, and itching of the anal area due to hemorrhoids.

Pramoxine Foam is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin. This helps relieve discomfort.

Do NOT use Pramoxine Foam if:

• you are allergic to any ingredient in Pramoxine Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pramoxine Foam:

Some medical conditions may interact with Pramoxine Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Pramoxine Foam. Because little, if any, of Pramoxine Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pramoxine Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pramoxine Foam:

Use Pramoxine Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pramoxine Foam is for use around the rectal area only.
• Wash your hands before and after using Pramoxine Foam.
• Shake well before each use.
• Wash the affected area with soap and water before applying Pramoxine Foam. Gently pat dry.
• Dispense foam onto a clean tissue and apply to the rectal area.
• Do not put Pramoxine Foam into the rectum using your fingers or any type of applicator. Do not insert any part of the aerosol container into the rectum.
• Do not apply Pramoxine Foam to large areas of the body.
• If you miss a dose of Pramoxine Foam, apply it as soon as possible. If you do not remember until the next day, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pramoxine Foam.

Important safety information:

• Pramoxine Foam is for use around the rectal area only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse them with cool tap water right away.
• If your symptoms do not improve within 7 days, or if they become worse, check with your doctor.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not store or use Pramoxine Foam near an open flame or use it while smoking. Do not burn or puncture the container even if it appears to be empty.
• Different brands of Pramoxine Foam may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pramoxine Foam while you are pregnant. It is not known if Pramoxine Foam is found in breast milk after topical use. If you are or will be breast-feeding while you are using Pramoxine Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pramoxine Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Pramoxine Foam. Seek medical attention right away if any of these SEVERE side effects occur:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Pramoxine Foam may be harmful if swallowed.

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 20 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is allowed. Avoid temperatures above 120 degrees F (49 degrees C). Do not refrigerate. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pramoxine Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Pramoxine Foam, please talk with your doctor, pharmacist, or other health care provider.
• Pramoxine Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pramoxine Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.