Uses of Pramoxine Rectal Foam:

• It is used to treat signs of hemorrhoids or rectal irritation.

What do I need to tell my doctor BEFORE I take Pramoxine Rectal Foam?

• If you are allergic to pramoxine rectal foam; any part of pramoxine rectal foam; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have rectal bleeding.

This is not a list of all drugs or health problems that interact with pramoxine rectal foam.

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 pramoxine rectal foam 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 Pramoxine Rectal Foam?

• Tell all of your health care providers that you take pramoxine rectal foam. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told by the doctor.
• This medicine may cause harm if swallowed. If pramoxine rectal foam is swallowed, call a doctor or poison control center right away.
• Do not use near an open flame or while smoking. It may burst.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using pramoxine rectal foam while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Pramoxine Rectal Foam) best taken?

Use pramoxine rectal foam as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take pramoxine rectal foam by mouth. Use on your skin only. Keep out of your mouth, nose, ears, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Do not put pramoxine rectal foam into the rectum by using your fingers or any type of applicator. Follow what the doctor has told you to do.
• Shake well before use.
• Do not put the applicator into the rectum.

What do I do if I miss a dose?

• If you use pramoxine rectal foam on a regular basis, 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.
• Many times pramoxine rectal foam is used on an as needed basis. Do not use more often than told by the doctor.

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.
• Irritation where pramoxine rectal foam is used.
• Swelling, warmth, or redness of the skin.
• Bleeding from rectum or rectal pain.

What are some other side effects of Pramoxine Rectal Foam?

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 you have any side effects that bother you or do 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 Pramoxine Rectal Foam?

• Store at room temperature. Do not refrigerate or freeze.
• Store upright with the cap on.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• 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 pramoxine rectal foam, 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.