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). 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.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If possible, clean the affected area with mild soap and water, rinse well, and pat dry. Shake the foam canister well before using. After filling the applicator, hold it by the barrel and gently insert the applicator tip just 1/2 to 1 inch (1.5 to 2.5 centimeters) inside the anus. Push the plunger to release the foam, then gently withdraw the applicator. Take the applicator apart and clean it thoroughly with warm water. Do not insert any part of the foam canister into the anus, and do not insert the applicator more than 1/2 to 1 inch (1.5 to 2.5 centimeters) inside the anus. Do not use your finger or a tissue to apply this product inside the anus.

To apply the product to the outside of the anus, spray a small amount of foam onto a tissue and gently pat onto the affected area. Do not cover the area with plastic or waterproof bandages unless directed to do so by your doctor. Covering the treated area may increase the absorption of the medication through the skin. This may improve how well the drug works, but it may also increase the risk of side effects.

Wash hands immediately after use. Avoid getting the product in your eyes, nose, ears or mouth. If the medication gets in these areas, rinse the area immediately with clean water.

Use this product as directed by your doctor, usually 3 to 4 times daily, or after each bowel movement. The dosage is based on your medical condition and response to treatment. 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.

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.

Inform your doctor if your condition does not improve or if it worsens after 2 to 3 weeks.

Side Effects

Redness, burning, or itching at the application site may occur. If any of these effects last or get worse, contact 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 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.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

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.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. 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 unless it is almost time for the next dose. In that case, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the foam canister upright at room temperature. Do not refrigerate. Do not store at temperatures above 120 degrees F (49 degrees C). The contents of this container are under pressure. Do not burn or puncture the aerosol container. 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.