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chloral hydrate suppositories - rectal, Aquachloral (cont.)

SIDE EFFECTS: Unwanted sleepiness and trouble waking up in the morning may occur. Less common side effects may include persistent tiredness, headache, and nightmares. 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, disorientation, thinking that others wish to harm you), staggering walk, lightheadedness.Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.Long-term use may cause a decrease in the amount of urine. Tell your doctor immediately if you notice this effect.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.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: See also How to Use section.Before using chloral hydrate, tell your doctor or pharmacist if you are allergic to it; 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: severe kidney or liver problems.Before using this medication, tell your doctor or pharmacist your medical history, especially of: illegal drug use, alcoholism, mental/mood conditions (e.g., depression, thoughts of suicide), a certain blood/liver disease (porphyria), sleep apnea.Chloral hydrate 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 chloral hydrate, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).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 chloral hydrate safely.This drug causes drowsiness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Do not use alcoholic beverages while taking this medication. Doing so increases serious side effects (sudden pounding heartbeat, flushing, unpleasant feeling of being high). Very severe (sometimes fatal) side effects from use with alcohol may also include inability to wake up and slowed breathingCaution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially mental/mood changes.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. This can cause undesirable side effects in a nursing infant. Consult your doctor before breast-feeding.



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