WARNING: Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this drug is stopped. Sometimes, signs may lessen or go away over time after this drug is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take this drug or with higher doses. Muscle problems may also occur after short-term use with low doses.
Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing. Avoid taking this drug for more than 12 weeks. Talk with the doctor.
It is used to treat heartburn. It is used to treat or prevent upset stomach and throwing up. It is used to treat gastroesophageal reflux disease (GERD; acid reflux). It is used to treat a slow moving GI (gastrointestinal) tract in some people. It may be given to you for other reasons. Talk with the doctor. Children: This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child. For full prescribing information, view the drug label information.
BEFORE USING THIS MEDICINE: WHAT DO I NEED TO TELL MY DOCTOR BEFORE I TAKE THIS DRUG?
TELL YOUR DOCTOR:
HOW TO USE THIS MEDICINE: HOW IS THIS DRUG BEST TAKEN?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects. Take at least 30 minutes before eating and at bedtime unless your doctor has told you otherwise.
HOW DO I STORE AND/OR THROW OUT THIS DRUG?
Store at room temperature. Protect from light. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
WHAT DO I DO IF I MISS A DOSE?
If you take this drug on a regular basis, take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
POSSIBLE SIDE EFFECTS: WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION:
Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight. Shakiness, trouble moving around, or stiffness. Restlessness. Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. Shortness of breath, a big weight gain, or swelling in the arms or legs. Enlarged breasts. Nipple discharge. Not able to get or keep an erection. Period (menstrual) changes. A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen.
Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot. A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs.
Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache. Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at www.fda.gov/medwatch.
Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. Have blood work checked as you have been told by the doctor. Talk with the doctor. It may take several weeks to see the full effects. If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Avoid alcohol or other drugs and natural products that slow your actions. If you stop taking this drug all of a sudden, you may have signs of withdrawal. Tell your doctor if you have any bad effects. This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs. If you are 65 or older, use this drug with care. You could have more side effects. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider.
Copyright 2018 CDI, LLC. All rights reserved. All rights reserved. Issue Date: November 14, 2018 This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.