SPL MEDGUIDE

Metoclopramide Orally Disintegrating Tablets

(MET-oh-KLOE-pra-mide)

Read this Medication Guide before you start taking Metoclopramide Orally Disintegrating Tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN tablets, REGLAN ODT, REGLAN injection or metoclopramide oral solution), 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 Metoclopramide Orally Disintegrating Tablets? Metoclopramide Orally Disintegrating Tablets can cause serious side effects, including:

Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping Metoclopramide Orally Disintegrating Tablets. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking Metoclopramide Orally Disintegrating Tablets.

Your chances for getting tardive dyskinesia go up:

• the longer you take Metoclopramide Orally Disintegrating Tablets and the more Metoclopramide Orally Disintegrating Tablets you take. You should not take Metoclopramide Orally Disintegrating Tablets for more than 12 weeks.
• if you are older, especially if you are an older woman.
• if you have diabetes.

It is not possible for your doctor to know if you will get tardive dyskinesia if you take Metoclopramide Orally Disintegrating Tablets. Call your doctor right away if you have movements you cannot stop or control, such as:

• lip smacking, chewing, or puckering of your lips
• frowning or scowling
• sticking out your tongue
• blinking and moving your eyes
• shaking of your arms and legs

See the section "What are the possible side effects of Metoclopramide Orally Disintegrating Tablets?" for more information about side effects.

What is Metoclopramide Orally Disintegrating Tablets?

Metoclopramide Orally Disintegrating Tablets is a prescription medicine used in adults:

• for 4 to 12 weeks to relieve heartburn symptoms of gastroesophageal reflux disease (GERD) when certain other treatments do not work.
• to relieve the symptoms of slow stomach emptying in people with diabetes.

Metoclopramide Orally Disintegrating Tablets is not recommended for use in children.

Do not take Metoclopramide Orally Disintegrating Tablets if you:

• have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Metoclopramide Orally Disintegrating Tablets or a medicine that works like Metoclopramide Orally Disintegrating Tablets.
• have stomach or intestine problems that could get worse with Metoclopramide Orally Disintegrating Tablets, such as bleeding, blockage or a tear in your stomach or bowel wall.
• have a type of tumor that can cause high blood pressure such as pheochromocytoma.
• have epilepsy (seizures). Metoclopramide Orally Disintegrating Tablets can increase your chance for seizures and make them worse.
• are allergic to metoclopramide or any of the ingredients in Metoclopramide Orally Disintegrating Tablets. Metoclopramide Orally Disintegrating Tablets can cause serious allergic reactions. Stop taking Metoclopramide Orally Disintegrating Tablets right away and get emergency help if you have any of these symptoms:

• swelling of your tongue, throat, lips, eyes or face.
• trouble swallowing or breathing.
• skin rash, hives, sores in your mouth, or skin blisters.

See the end of this Medication Guide for a list of ingredients in Metoclopramide Orally Disintegrating Tablets.

Before you take Metoclopramide Orally Disintegrating Tablets, tell your doctor about all of your medical conditions, including if you:

• have kidney or liver disease.
• had problems controlling your muscle movements after taking any medicine.
• have depression or mental illness.
• have high blood pressure.
• have heart failure or heart rhythm problems.
• have diabetes. Your dose of insulin may need to be changed.
• have Parkinson's disease.
• have breast cancer.
• drink alcohol.
• have seizures.
• are pregnant or plan to become pregnant. Metoclopramide Orally Disintegrating Tablets may harm your unborn baby if taken during the end of pregnancy.  Talk to your healthcare provider if you become pregnant while taking Metoclopramide Orally Disintegrating Tablets.
• are breastfeeding or plan to breastfeed. Metoclopramide Orally Disintegrating Tablets can pass into your breastmilk and may harm your baby. You and your doctor should decide if you will take Metoclopramide Orally Disintegrating Tablets or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements. Metoclopramide Orally Disintegrating Tablets and some medicines can affect each other and may not work as well, or cause possible side effects. Do not start any new medicine while taking Metoclopramide Orally Disintegrating Tablets until you talk with your doctor.

Especially tell your doctor if you take:

• another medicine that contains metoclopramide, such as REGLAN injection, tablets, REGLAN ODT, or metoclopramide oral syrup
• a blood pressure medicine
• a medicine for depression, especially a monoamine oxidase inhibitor (MAOI)
• an anti-psychotic medicine, used to treat mental illness such as schizophrenia
• insulin
• medicines that can make you sleepy, such as anti-anxiety medicines, sleep medicines, and narcotics. 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 your medicines to show your doctor and pharmacist when you get new medicine.

How should I take Metoclopramide Orally Disintegrating Tablets?

• Take Metoclopramide Orally Disintegrating Tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you to.
• Take Metoclopramide Orally Disintegrating Tablets on an empty stomach at least 30 minutes before eating and at bedtime. Do not repeat your dose if you accidentally take it with food.
• Metoclopramide Orally Disintegrating Tablets comes as a tablet that melts in your mouth.
• Leave the tablet in the sealed blister Metoclopramide Orally Disintegrating Tablets pack until you are ready to take it.
• Use dry hands to open a blister and take out a tablet. If the tablet breaks or crumbles throw it away and take a new tablet out of the blister pack.
• Put the tablet on your tongue right away. Let it melt and then swallow. This should take about 1 minute. You do not need water to take Metoclopramide Orally Disintegrating Tablets.
• You should not take Metoclopramide Orally Disintegrating Tablets for more than 12 weeks.
• If you take too much Metoclopramide Orally Disintegrating Tablets, call your poison control center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking Metoclopramide Orally Disintegrating Tablets?

• Do not drink alcohol while taking Metoclopramide Orally Disintegrating Tablets. Alcohol may make some side effects of Metoclopramide Orally Disintegrating Tablets worse, such as feeling sleepy.
• Do not drive, work with machines, or do dangerous tasks until you know how Metoclopramide Orally Disintegrating Tablets affects you. Metoclopramide Orally Disintegrating Tablets may cause sleepiness or dizziness.

What are the possible side effects of Metoclopramide Orally Disintegrating Tablets?

Metoclopramide Orally Disintegrating Tablets can cause serious side effects, including:

• Tardive dyskinesia (abnormal muscle movements). See "What is the most important information I should know about Metoclopramide Orally Disintegrating Tablets?"
• Other changes in muscle control and movement, such as:

• Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia) . These muscle spasms can cause abnormal movements and body positions, and speech problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may cause trouble breathing. These spasms happen more often in adults younger than 30 years of age.
• Parkinsonism . Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you have Parkinson's Disease, your symptoms may become worse while you are taking Metoclopramide Orally Disintegrating Tablets.
• Being unable to sit still or feeling you need to move your hands, feet, or body (akathisia) . Symptoms can include feeling jittery, anxious, irritated or unable to sleep (insomnia), feeling the need to walk around (pacing) and tapping feet.

• Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious condition that can happen with Metoclopramide Orally Disintegrating Tablets. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
• Depression, thoughts about suicide, and suicide . Some people who take Metoclopramide Orally Disintegrating Tablets may become depressed. You may have thoughts about hurting or killing yourself. Some people who have taken metoclopramide products have ended their own lives (suicide).
• High blood pressure . Metoclopramide Orally Disintegrating Tablets can cause your blood pressure to increase.
• Too much body water . People who have certain liver problems or heart failure and take Metoclopramide Orally Disintegrating Tablets may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet.
• Increased prolactin . Tell your doctor if your menstrual periods stop, your breasts get larger and make milk, or you cannot have sex (impotence). These symptoms go away when you stop taking Metoclopramide Orally Disintegrating Tablets.

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

• feel depressed or have thoughts about hurting or killing yourself
• have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
• have muscle movements you cannot stop or control
• have muscle movements that are new or unusual

The most common side effects of Metoclopramide Orally Disintegrating Tablets are:

• restlessness
• drowsiness
• tiredness
• lack of energy

You may have more side effects the longer you take Metoclopramide Orally Disintegrating Tablets and the more Metoclopramide Orally Disintegrating Tablets you take. You may still have side effects after stopping Metoclopramide Orally Disintegrating Tablets. You may have symptoms from stopping Metoclopramide Orally Disintegrating Tablets such as headaches and feeling dizzy or nervous.

Tell your doctor about any side effects that bothers you or that does not go away. These are not all the possible side effects of Metoclopramide Orally Disintegrating Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA-1088.

How do I store Metoclopramide Orally Disintegrating Tablets?

• Store Metoclopramide Orally Disintegrating Tablets at room temperature between 68° to 77°F (20° to 25°C).
• Keep Metoclopramide Orally Disintegrating Tablets away from moisture.
• Throw away any Metoclopramide Orally Disintegrating Tablets that is not used.

Keep Metoclopramide Orally Disintegrating Tablets and all medicines out of reach of children.

General information about the safe and effective use of Metoclopramide Orally Disintegrating Tablets.

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

If you would like more information about Metoclopramide Orally Disintegrating Tablets, talk with your doctor. You can ask your doctor or pharmacist for information about Metoclopramide Orally Disintegrating Tablets that is written for health professionals. For more information, call 1-866-403-7592.

What are the ingredients in Metoclopramide Orally Disintegrating Tablets?

Active ingredient: Metoclopramide Hydrochloride, USP

Inactive ingredients: phosphoric acid, mannitol and starch, microcrystalline cellulose, colloidal silicon dioxide, amino methacrylate copolymer, butylated hydroxyanisole, butylated hydroxytoluene, crospovidone, aspartame, N-C mint flavor, magnesium  stearate

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873 USA

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

PI5800000203

SAP code: 260278

Rev. 10/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.           Revised:  October 2019