MEDICATION GUIDE

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

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

Metoclopramide 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. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking metoclopramide.

Your chances for getting tardive dyskinesia increase:

• the longer you take metoclopramide and the more metoclopramide you take. You should not take metoclopramide 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 healthcare provider to know if you will get tardive dyskinesia if you take metoclopramide. Call your healthcare provider right away if you get movements you cannot stop or control, such as:
• lip smacking, chewing, or puckering up your mouth
• 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?" for more information about side effects.

What is metoclopramide?

Metoclopramide is a prescription medicine used in adults:

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

Metoclopramide is not recommended for use in children.

Do not take metoclopramide if you:

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

Before taking METOCLOPRAMIDE, tell your healthcare provider about all of your medical conditions, including if you:

• have diabetes. Your dose of insulin may need to be changed.
• had problems controlling your muscle movements after taking any medicine.
• have Parkinson’s disease.
• have a type of tumor that can cause high blood pressure (pheochromocytoma).
• have kidney or liver disease.
• have or had depression or mental illness.
• have high blood pressure.
• have heart failure or heart rhythm problems.
• have breast cancer.
• drink alcohol.
• have seizures
• are pregnant or plan to become pregnant. Metoclopramide may harm your unborn baby if taken during the end of pregnancy. Talk to your healthcare provider if you become pregnant while taking metoclopramide.
• are breastfeeding or plan to breastfeed. Metoclopramide can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take metoclopramide or breastfeed.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Metoclopramide may affect the way other medicines work, and other medicines may affect how metoclopramide works.
• Tell your healthcare provider before you start or stop other medicines.
• Especially tell your healthcare provider if you take:
• another medicine that contains metoclopramide, such as metoclopramide injection or metoclopramide oral solution
• a medicine for Parkinson’s disease
• 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 healthcare provider or pharmacist.

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

How should I take metoclopramide?

• Take metoclopramide exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.
• Metoclopramide comes as a tablet you take by mouth.
• You should not take metoclopramide for more than 12 weeks.
• Take metoclopramide at least 30 minutes before each meal and at bedtime.
• If you take too much metoclopramide, 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?

• Do not drink alcohol while taking metoclopramide. Alcohol may make some side effects of metoclopramide worse, such as feeling sleepy.
• Do not drive, operate machinery, or do other dangerous activities until you know how metoclopramide affects you. Metoclopramide may cause sleepiness or dizziness.

What are the possible side effects of metoclopramide?

• Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need to know about metoclopramide?”
• 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 less than 30 years of age.
  • Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson's Disease, your symptoms may become worse while you are taking metoclopramide.
  • 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 your feet.
• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide. 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 become depressed, even if they have no history of depression. You may have thoughts about hurting or killing yourself. Some people who have taken metoclopramide have ended their own lives (suicide).
• High blood pressure. Metoclopramide can cause your blood pressure to increase.
• Too much body water. People who have certain liver problems or heart failure and take metoclopramide 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.
• Call your healthcare provider 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 include:
• restlessness
• drowsiness
• tiredness
• lack of energy

You may have more side effects the longer you take metoclopramide and the more metoclopramide you take.

You may still have side effects after stopping metoclopramide. You may have symptoms from stopping metoclopramide such as headaches, and feeling dizzy or nervous.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of metoclopramide. 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 metoclopramide?

• Store metoclopramide at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of metoclopramide.

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

You can ask your pharmacist or healthcare provider for information about metoclopramide that is written for health professionals.