WELLDORM ELIXIR Oral solution Ref.[9779] Active ingredients: Chloral hydrate

Elderly patients are more likely to experience the undesirable effects of hypnotics such as ataxia and confusion which may lead to falls and injury. For use in the frail elderly it is recommended that a lower dose be administered. (See 4.2 Posology and method of administration)

Best avoided in the presence of gastritis and in patients who have previously exhibited an idiosyncrasy or hypersensitivity to chloral hydrate.

Alcohol potentiates the sedative effect. Chloral hydrate followed by intravenous frusemide may result in sweating, hot flushes and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state. Delirium may occur, especially in the elderly, particularly when used in conjunction with psychotropics or anticholinergics. In patients taking anticoagulants, when chloral hydrate is added to or withdrawn from the drug regimen, or its dosage changed, careful monitoring of the prothrombin time is required.

Chloral Hydrate may interfere with laboratory tests of thyroid function.

Chloral Hydrate Oral Solution should not be used in pregnancy and lactation.

Patients receiving Chloral Hydrate Oral Solution should be warned that their ability to drive or use machinery may be impaired by drowsiness.

Gastric irritation, abdominal distension and flatulence may occur. Excitement, tolerance, allergic skin reactions, headache and ketonuria have occasionally been reported. There is a danger of abuse or chronic intoxication and the possibility that habituation may develop. In such patients gastritis and parenchymatous renal injury may develop. After long term use, sudden withdrawal may result in delirium.

Elderly patients are more susceptible to the undesirable effects of hypnotic medications such as Chloral Hydrate Oral Solution and are therefore more susceptible to ataxia, confusion, falls and injuries.

None known.