REGLAN - metoclopramide hydrochloride tablet 
STAT RX USA LLC

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Medication Guide

REGLAN (REG-lan) Tablets
(metoclopramide tablets)

Read the Medication Guide that comes with REGLAN before you start taking it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN injection, REGLAN ODT, or metoclopramide oral syrup), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about REGLAN?

REGLAN can cause serious side effects, including:

Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping REGLAN. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking REGLAN.

Your chances for getting TD go up:

It is not possible for your doctor to know if you will get TD if you take REGLAN.

Call your doctor right away if you get movements you can not stop or control, such as:

See the section "What are the possible side effects of REGLAN?" for more information about side effects.

What is REGLAN?

REGLAN is a prescription medicine used:

It is not known if REGLAN is safe and works in children.

Who should not take REGLAN?

Do not take REGLAN if you:

What should I tell my doctor before taking REGLAN?

Tell your doctor about all your medical conditions, including if you have:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. REGLAN and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking REGLAN until you talk with your doctor.

Especially tell your doctor if you take:

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take REGLAN?

What should I avoid while taking REGLAN?

What are the possible side effects of REGLAN?

Reglan can cause serious side effects, including:

Call your doctor and get medical help right away if you:

Common side effects of Reglan include:

You may have more side effects the longer you take REGLAN and the more REGLAN you take. You may still have side effects after stopping REGLAN. You may have symptoms from stopping (withdrawal) REGLAN such as headaches, and feeling dizzy or nervous.

Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of REGLAN.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REGLAN?

Keep REGLAN and all medicines out of the reach of children.

General information about REGLAN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGLAN for a condition for which it was not prescribed. Do not give REGLAN to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about REGLAN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about REGLAN that is written for health professionals. For more information, go to www.alavenpharm.com or call 1-888-317-0001.

What are the ingredients in REGLAN?

Active ingredient: metoclopramide

Inactive ingredients:

 
REGLAN 10 mg tablets: magnesium stearate, mannitol, microcrystalline cellulose, stearic acid
 
REGLAN 5 mg tablets: corn starch, D&C yellow 10 aluminum lake, FD&C blue 1 aluminum lake, lactose, microcrystalline cellulose, silicon dioxide, stearic acid

Manufactured for:
ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30062

For Medical Inquiries, call toll-free 1-888-317-0001
www.alavenpharm.com

Rev. 07/2009
PCS 9360
6-151-10-16-1009

Revised July 2009

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 8/2010
STAT RX USA LLC