Metoclopramide Hydrochloride

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets for more than 12 weeks.

• ●if you are older, especially if you are a woman

• ●if you have diabetes

• ●It is not possible for your doctor to know if you will get TD if you take metoclopramide tablets.

• ●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 tablets?" for more information about side effects.

• ●to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablets help treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at the same time.

• ●It is not known if metoclopramide tablets are safe and work in children.

• ●have an adrenal gland tumor called a pheochromocytoma

• ●are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide tablets.

• ●take medicines that can cause uncontrolled movements, such as medicines for mental illness

• ●have seizures

• ●What should I tell my doctor before taking metoclopramide tablets?

• ●Parkinson's disease

• ●high blood pressure

• ●kidney problems. Your doctor may start with a lower dose.

• ●liver problems or heart failure. Metoclopramide tablets may cause your body to hold fluids.

• ●diabetes. Your dose of insulin may need to be changed.

• ●breast cancer

• ●you are pregnant or plan to become pregnant. It is not known if metoclopramide tablets will harm your unborn baby.

• ●you are breast-feeding. Metoclopramide tablets can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide tablets.

• ●Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Metoclopramide tablets 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 metoclopramide tablets until you talk with your doctor.

• ●a blood pressure medicine

• ●a medicine for depression, especially an Monoamine Oxidase Inhibitor (MAOI)

• ●insulin

• ●a medicine that can make you sleepy, such an anti-anxiety medicine, sleep medicines, and narcotics.

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

• ●Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you.

• ●You should not take metoclopramide tablets for more than 12 weeks.

• ●If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away.

• ●What should I avoid while taking metoclopramide tablets?

• ●Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide tablets affect you. Metoclopramide tablets may cause sleepiness.

• ●What are the possible side effects of metoclopramide tablets?

• ●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. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults under age 30.

• ●Depression, thoughts about suicide, and suicide. Some people who take metoclopramide tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide tablets have ended their own lives (suicide).

• ●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.

• ●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 receiving metoclopramide tablets.

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

• ●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

• ●Common side effects of metoclopramide tablets include:

• ●headache

• ●confusion

• ●trouble sleeping

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

• ●Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly.

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

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION