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MEDICATION GUIDE

Metoclopramide (MET-oh-KLOE-pra-mide) tablets, oral use

Read this Medication Guide before you start taking metoclopramide tablets 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.

• These movements happen mostly in the face or tongue, and sometimes in other body parts. You cannot control these movements.
• These symptoms may not go away even after stopping metoclopramide tablets.

Your chances of getting tardive dyskinesia increase:

• the longer you take metoclopramide tablets and the more metoclopramide tablets you take.

            o Use the lowest dose possible for the shortest time needed.

            o People taking metoclopramide tablets to relieve heartburn symptoms with gastroesophageal reflux should not take metoclopramide tablets for more than 12 weeks.

            o People taking metoclopramide tablets to relieve symptoms of slow stomach emptying due to diabetes, should not take metoclopramide tablets for more than 12 weeks. If you require treatment for longer than 12 weeks, your healthcare provider should frequently monitor you for signs and symptoms of tardive dyskinesia.

• 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

will get tardive dyskinesia if you take metoclopramide tablets.

Stop taking metoclopramide tablets and 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

Your healthcare provider may decide not to continue treatment with metoclopramide tablets if you develop signs or symptoms of tardive dyskinesia.

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

Metoclopramide tablets are 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 tablets are not recommended for use in children or for longer than 12 weeks if you are being treated to relieve heart burn symptoms with gastroesophageal reflux.

• have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking metoclopramide tablets or a medicine that works like metoclopramide tablets.
• have stomach or intestine problems that could get worse with metoclopramide tablets, 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 tablets can increase your chance for seizures and make them worse.
• are allergic to metoclopramide. Metoclopramide tablets can cause serious allergic reactions. Stop taking metoclopramide tablets right away and get emergency help if you have any of these symptoms:

            o swelling of your tongue, throat, lips, eyes or face.

            o trouble swallowing or breathing.

            o skin rash, hives, sores in your mouth, or skin blisters.

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

• had problems controlling your muscle movements after taking any medicine.
• have Parkinson’s disease.
• have or had depression or mental illness.
• have kidney or liver disease.
• have heart failure or heart rhythm problems.
• have high blood pressure.
• drink alcohol.
• have diabetes. Your dose of insulin may need to be changed.
• are pregnant or plan to become pregnant. Metoclopramide 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 tablets.
• are breastfeeding or plan to breastfeed. Metoclopramide tablets can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take metoclopramide tablets or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Metoclopramide tablets may affect the way other medicines work, and other medicines may affect how metoclopramide tablets 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, metoclopramide orally disintegrating tablets (ODT), metoclopramide oral solution, or Gimoti nasal spray
• an anti-psychotic medicine, used to treat mental illness such as schizophrenia
• a medicine for Parkinson’s disease
• a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)
• 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.

• Take metoclopramide tablets exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.
• Metoclopramide tablets come as a tablet you take by mouth.
• Take metoclopramide tablets at least 30 minutes before each meal and at bedtime.
• You should not take medicines containing metoclopramide (including metoclopramide tablets) for more than 12 weeks.

            o If you are being treated with metoclopramide tablets to relieve the symptoms of slow stomach emptying due to diabetes and require treatment for longer than 12 weeks, your healthcare provider should frequently monitor you for signs and symptoms of tardive dyskinesia.

• If you take too much metoclopramide tablets, call your poison control center at 1-800-222-1222 or go to the nearest emergency room right away.
• Keep all follow-up visits with your healthcare provider as scheduled, so that your healthcare provider can see how you are responding to treatment with metoclopramide tablets.

What should I avoid while taking metoclopramide tablets?

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

What are the possible side effects of metoclopramide tablets?

• Tardive dyskinesia (abnormal muscle movements). See "What is the most important information I need to know about  metoclopramide tablets?"
• Other changes in muscle control and movement, such as:

             o

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 who took higher doses of metoclopramide tablets.

             o

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 tablets.

             o

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 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 tablets 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 tablets have ended their own lives (suicide).
• High blood pressure.Metoclopramide tablets can cause your blood pressure to increase.
• Too much body water. People who have certain liver problems or heart failure and take metoclopramide 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 tablets.

Stop taking metoclopramide tablets, call your healthcare provider and get medical help right away if you:

• have muscle movements you cannot stop or control
• have muscle movements that are new or unusual
• 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

The most common side effects of metoclopramide tablets include:

•    restlessness
•    drowsiness
•    tiredness
•    lack of energy

You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take.
You may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping metoclopramide tablets 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 tablets. 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 tablets?

• Store metoclopramide tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep metoclopramide tablets in the bottle it comes in and away from light. Keep the bottle closed tightly.

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

General information about the safe and effective use of  metoclopramide tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which it was not prescribed. Do not give metoclopramide tablets 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 tablets that is written for health professionals.

What are the ingredients in  metoclopramide tablets?
Active ingredient: metoclopramide
Inactive ingredients:

• Metoclopramide Tablets USP, 5 mg:microcrystalline cellulose, lactose monohydrate and magnesium stearate.
• Metoclopramide Tablets USP, 10 mg:microcrystalline cellulose, lactose monohydrate and magnesium stearate.

Manufactured by:
A&Z Pharmaceutical Inc.
180 Oser Ave. Suite 300
Hauppauge, NY 11788

Manufactured for:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

For more information, call ScieGen Pharmaceuticals, Inc., at 1-855-724-3436.

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