Product Summary

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PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. METOCLOPRAMIDE - ORAL (MET-oh-KLOE-pra-mide) COMMON BRAND NAME(S): Reglan

WARNING: This medication may cause a serious movement disorder called tardive dyskinesia. In some cases, this condition may be permanent. The risk of tardive dyskinesia is increased with the longer use of the medication and the more medication that you take. The risk is also increased in older adults (especially women) and in people with diabetes. Do not use metoclopramide for longer than 12 weeks. Talk to your doctor about the risks and benefits of this medication. In rare cases, some patients may need to use this medication longer than 12 weeks. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs). There is no treatment for tardive dyskinesia, but in some cases the symptoms may lessen or stop once metoclopramide is stopped.

USES: This medication is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing. Metoclopramide is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines. This drug is not recommended for use in children younger than 1 year due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to prevent nausea/vomiting from chemotherapy or radiation treatments for cancer.

HOW TO USE: See also Warning section. Read the Medication Guide provided by your pharmacist before you start taking metoclopramide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or exactly as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are using the disintegrating tablet, do not remove the tablet from the blister pack until right before your dose. Dry your hands before using this medication. Do not use the tablet if it is broken or crumbled. Immediately after removing the tablet, place it on the tongue. Allow it to dissolve completely, then swallow it with saliva. You do not need to take this product with water. Dosage is based on your weight, medical condition, and response to treatment. If heartburn only occurs at certain times (such as after the evening meal), your doctor may direct you to take a single dose before those times instead of taking it throughout the day. This will reduce your risk of side effects. Because of the risk of tardive dyskinesia, do not take this more often, in larger doses, or for longer than directed by your doctor. According to the manufacturer, treatment should not exceed 12 weeks. To treat diabetic gastroparesis, this medication is usually taken for 2 to 8 weeks until your gut is working well. This condition may recur from time to time. Your doctor may direct you to start taking this medication as soon as your symptoms reappear and stop when you feel better. Ask your doctor for directions for starting and stopping this medication. Take this medication regularly as directed to get the most benefit from it. To help you remember, take it at the same times before a meal each day. If this medication has been used regularly for a long time or in high doses, withdrawal symptoms (such as dizziness, nervousness, headaches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, tiredness, trouble sleeping, agitation, headache, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, confusion, depression, thoughts of suicide), decreased sexual ability, inability to keep still/need to pace, muscle spasms/uncontrolled muscle movements (such as twisting neck, arching back), Parkinson-like symptoms (such as shaking, slowed/difficult movement, mask-like facial expression), abnormal breast-milk production, enlarged/tender breasts, swelling of the hands/feet, changes in menstruation in women. This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness, severe confusion, sweating, fast/irregular heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking metoclopramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before taking this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blockage/hole in the intestines/stomach, breast cancer, high blood pressure, kidney problems, heart failure, mental/mood problems (such as depression, thoughts of suicide), Parkinson's disease, liver problems (such as cirrhosis, porphyria), pheochromocytoma, seizures, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Liquid products may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit alcohol. Ask your doctor or pharmacist about using this product safely. Disintegrating tablets may contain aspartame or phenylalanine. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame or phenylalanine in your diet, ask your doctor or pharmacist about using this medication safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have high or low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Children may be more sensitive to the side effects of this drug, especially muscle spasms/uncontrolled muscle movements. Older adults may be more sensitive to the effects of this drug, especially drowsiness, tardive dyskinesia, and Parkinson's type muscle problems. Drowsiness can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: antipsychotic drugs (such as aripiprazole, haloperidol), dopamine agonists (such as cabergoline, pergolide, ropinirole), fosfomycin, pramlintide, phenothiazines (such as promethazine, prochlorperazine), rivastigmine. Metoclopramide causes food and medication to move through your stomach more quickly, which may affect the absorption of some drugs. Talk to your doctor or pharmacist to see if any of the drugs that you are taking may be affected. Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as endoscopy for ulcer) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

Metoclopramide 5mg/ml Single Dose Vial 2ml x 25