Uses

This combination medication is used to treat minor pain, itching, swelling, and discomfort caused by hemorrhoids and other problems of the anal area (such as anal fissures, itching) in adults. This medication contains pramoxine, an anesthetic that works by temporarily numbing the area. This product also contains hydrocortisone, a corticosteroid that reduces redness, itching, and swelling. This product also contains zinc that reduces itching and discomfort.

How To Use

This product is usually used in the morning and at bedtime, or after each bowel movement, or as directed by your doctor. Dosage is based on your medical condition and response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Avoid handling the suppository for too long because it will melt. Unwrap the suppository. You may moisten the tip with a few drops of water. Lie down on your left side with your right knee bent. Gently push the suppository, pointed end first, into the rectum with your finger, deep enough so it does not slide back out. Remain lying down for a few minutes. Avoid having a bowel movement for at least an hour so the medication will have time to work.

Wash hands immediately after use.

Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Burning, or itching may occur. If any of these effects last or worsen, 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:

• rectal bleeding
• change in skin appearance (such as color, thickness)
• skin redness/tenderness/pus or other signs of skin infection
• signs of serious infection (such as sore throat that doesn't go away, fever)

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

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 this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to hydrocortisone; 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, especially of:

• diabetes
• eye problems
• infections (especially rectal sores/infections)
• liver disease
• stomach/intestinal problems

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

During pregnancy, this medication should be used only when clearly needed. It should not be used for long periods of time or in large amounts. Discuss the risks and benefits with your doctor.

It is not known 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.

Some products that may interact with this drug are:

• other corticosteroids/immunosuppressants (such as prednisone)

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. 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

Lab and/or medical tests (such as cortisol levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. 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 for 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 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.