PREPARATION H REFORMULATED JUN 2013 Rectal

Introduction

This medication is used to temporarily relieve swelling, burning, pain, and itching caused by hemorrhoids. It contains phenylephrine, which belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the area. This effect decreases swelling and discomfort. Some products may also contain substances (e.g., cocoa butter, hard fat, mineral oil, shark liver oil) that form a protective barrier to prevent too much irritating contact with stool.

Side Effects of PREPARATION H REFORMULATED JUN 2013 Rectal

This medication does not usually have bothersome side effects when used as directed. Mild pain/stinging may occur if the rectal tissue is raw or bleeding. 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.

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