Gimoti

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.

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 use. The risk is also increased in older adults (especially women) and in people with diabetes. Metoclopramide comes in different forms (such as tablets, solution, injection). Do not use metoclopramide products for longer than 12 weeks. Talk to your doctor about the risks and benefits of this medication.

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.

See also Warning section.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using metoclopramide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication in the nose as directed by your doctor, usually 1 spray in one nostril up to 4 times daily (30 minutes before meals and at bedtime). It is usually used for 2 to 8 weeks until your gut is working well. Follow the instructions to properly prime the spray if you are using the spray for the first time or if you have not used it for 2 weeks or more. When priming the spray, make sure to spray away from your face so that the medication does not get into your eyes.

To use the spray, remove the protective cap and safety clip. Tilt your head slightly forward and carefully insert the tip of the spray nozzle into a nostril. Make sure to point the tip away from the center of your nose. Close the other nostril with the other index finger and then press down on the bottle to spray the medicine into your nostril. Breathe in gently through the open nostril and breathe out slowly through your mouth. Clean the nozzle with a clean tissue and replace the cap and safety clip.

If you are unsure if you received the full dose of the medication, do not repeat the dose. Use the next dose at the regularly scheduled time.

Because of the risk of tardive dyskinesia, do not use this drug more often, in larger doses, or for longer than directed by your doctor.

If directed, use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as dizziness, nervousness, headaches). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used metoclopramide for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition lasts or gets worse.

See also Warning section.

Drowsiness, dizziness, tiredness, trouble sleeping, headache, changes in taste, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, depression, thoughts of suicide), 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), swelling of the hands/feet, decreased sexual ability, abnormal breast-milk production, enlarged/tender breasts, 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 are: antipsychotic drugs (such as aripiprazole, haloperidol), atovaquone, dopamine agonists (such as cabergoline, pergolide, ropinirole), fosfomycin, MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), pramlintide, phenothiazines (such as promethazine, prochlorperazine), rivastigmine.

Other medications can affect the removal of metoclopramide from your body, which may affect how metoclopramide works. Examples include bupropion, fluoxetine, paroxetine, quinidine, among others.

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 using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

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.

Do not share this medication with others.

Before using 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 using this medication, tell your doctor or pharmacist your medical history, especially of: history of movement/muscle disorders (such as tardive dyskinesia, dystonia) caused by a medication, 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), a certain adrenal gland tumor (pheochromocytoma), seizures, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of 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. See also Uses section.

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. Since the dose of the nasal spray cannot be adjusted, this form of metoclopramide is not recommended as initial treatment in older adults.

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. Consult your doctor before breastfeeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Store at room temperature. Once the bottle is opened, this medication expires after 4 weeks. 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.