PHENYLEPHRINE/PRAMOXINE HEMORRHOIDAL CREAM - RECTAL

PHONETIC PRONUNCIATION: (FEN-il-EF-rin/pram-OX-een)

COMMON BRAND NAME(S): Preparation H

GENERIC NAME(S): phenylephrine HCl/pramoxine HCl/glycerin/white petrolatum

Uses

USES: This medication is used to temporarily relieve swelling, burning, pain, and itching caused by hemorrhoids. This product contains phenylephrine and pramoxine. Phenylephrine is a sympathomimetic amine that works by temporarily narrowing the blood vessels in the area. This effect decreases swelling and discomfort. Pramoxine belongs to a class of drugs known as local anesthetics. It works on nerves in the skin to block or reduce the feeling of pain and itching. Some products may also contain substances (e.g., cocoa butter, hard fat, mineral oil, shark liver oil) that soothe or form a protective barrier to prevent too much irritating contact with stool.

How to use PHENYLEPHRINE/PRAMOXINE HEMORRHOIDAL CREAM - RECTAL

HOW TO USE: Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist. Before use, clean the area with mild soap and water, rinse well, and pat dry. Apply the product to the skin of the affected area up to 4 times daily, usually in the morning and bedtime, or after each bowel movement, or as directed by your doctor. To apply this product inside the lower part of the anus, use the applicator tip/cap/nozzle. Follow all instructions in the product package, or use as directed by your doctor. Do not apply the product high up inside the rectum. Dosage is based on your medical condition and response to treatment. Do not use more often or for a longer time than recommended. If symptoms do not improve within 7 days, if bleeding/worsening pain occurs, or if you think you may have a serious medical problem, consult your doctor promptly.

Side Effects

SIDE EFFECTS: This medication does not usually have bothersome side effects when used as directed. Mild pain/stinging may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that 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. Stop using this medication and tell your doctor right away if any of these rare but very serious side effects occur: fast/irregular heartbeat, pounding headache, nervousness, shakiness (tremor), trouble sleeping. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to phenylephrine; or to pramoxine; or to any of its ingredients; 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. If you have any of the following health problems, consult your doctor or pharmacist before using this product: diabetes, heart problems (e.g., chest pain, heart attack), high blood pressure, overactive thyroid (hyperthyroidism), difficult urination due to blockage (e.g., enlarged prostate). Do not use this product in children 12 years or younger without talking with the doctor. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this product, tell your doctor or pharmacist if you use any of the following prescription and nonprescription/herbal products: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), drugs to treat high blood pressure (e.g., guanethidine, beta blockers such as metoprolol). Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

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. Canada residents can call a provincial poison control center.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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