Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland
Nytol One-A-Night 50 mg Tablets are indicated as a symptomatic aid to the relief of temporary sleep disturbance in adults.
One tablet to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the maximum dose of one tablet in 24 hours.
The product should only be given to the elderly if the benefits for the patient outweigh the potential risks (see section 4.4).
In patients with moderate to severe renal or hepatic impairment, a lower dose might be required (see section 4.4).
Nytol One-A-Night 50mg Tablets should not be used in children under 18 years.
Oral administration only.
Do not exceed the stated dose or frequency of dosing. The product should not be taken for more than 7 days without consulting a doctor.
Overdose is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes, such as QT prolongation and torsades de pointes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse.
Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.
2 years.
Store below 25°C.
Store in the original packaging in order to protect from light and moisture.
Nytol One-A-Night 50 mg Tablets are packaged into rigid UPVC/PVdCblister packs with a heat sealable aluminium foil. Strips of 4, 8, 10, 16 or 20 tablets. Not all pack sizes may be marketed.
No special requirements for disposal.
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