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methadone dispersible tablet - oral, Methadose (cont.)

SIDE EFFECTS: See also Warning section.Nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, stomach upset, and increased sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), difficulty urinating, vision changes.Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.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 methadone, tell your doctor or pharmacist if you are allergic to it; or to narcotic pain medications (such as propoxyphene); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain bowel diseases (paralytic ileus, infectious diarrhea).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), adrenal gland problem (such as Addison's disease), mental/mood disorders (such as toxic psychosis), intestinal diseases (such as colitis), disease of the pancreas (such as pancreatitis), gallbladder disease.Methadone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using methadone, tell your doctor or pharmacist if you have any of the following conditions: family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death), certain heart problems (slow/fast/irregular heartbeat, QT prolongation in the EKG, heart failure).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using methadone safely.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. Avoid alcoholic beverages.To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist that you are taking this medication.Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Pregnancy may also affect the amount of this drug in your body, so tell your doctor immediately if you become pregnant. You may require different dosing. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.This medication passes into breast milk and is unlikely to harm a nursing infant. Consult your doctor before breastfeeding. If breastfeeding is suddenly stopped, the nursing infant may experience withdrawal symptoms. Discuss with you doctor a plan for breastfeeding your baby.



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