Metoclopramide Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• METOCLOPRAMIDE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• INDICATIONS & USAGE
• METOCLOPRAMIDE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• METOCLOPRAMIDE HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

METOCLOPRAMIDE HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS

INDICATIONS & USAGE

METOCLOPRAMIDE HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

METOCLOPRAMIDE HYDROCHLORIDE ADVERSE REACTIONS

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

• ●     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

• ●     in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide tablets relieve daytime heartburn and heartburn after meals. It also helps ulcers in the esophagus to heal.

• ●     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.

• ●     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 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

• ●     depression

• ●     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 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.

• ●     another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets, or metoclopramide oral solution

• ●     a blood pressure medicine

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

• ●     insulin

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

• ●     Metoclopramide comes as a tablet you take by mouth.

• ●     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.

• ●     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, work with machines, or do dangerous tasks until you know how metoclopramide tablets affects you. Metoclopramide tablets may cause sleepiness.

• ●      Abnormal muscle movements. SeeWhat is the most important information I need to know about 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.

• ●     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

• ●     feeling restless, sleepy, tired, dizzy, or exhausted

• ●     headache

• ●     confusion

• ●     trouble sleeping

• ●     Keep metoclopramide tablets at room temperature between 68to 77(20to 25

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION