NUMARK SLEEP AID

Oral administration only. One tablet to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the stated dose or frequency of dosing. Do not use in children under 16 years. This medication should not be used continuously for more than 2 weeks without consulting a doctor.

Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in > 1/100 to < 1/10) or very common (occurring in > 1/10) are listed below by MedDRA System Organ Class.

The frequency of other adverse reactions identified during post- marketing use is unknown, but these reactions are likely to be uncommon (occurring in > 1/1,000 to <1/100) or rare (occurring in < 1/1,000). g. increased energy, restlessness, nervousness) Unknown Nervous system disorders sedation, drowsiness, disturbance in attention, unsteadiness, dizziness, convulsions, headache, paraesthesia, dyskinesias, hypoesthesia, restless leg syndrome Common Unknown Eye disorders blurred vision Unknown Cardiac disorders tachycardia, palpitations Unknown Respiratory, thoracic and mediastinal disorders thickening of bronchial secretions Unknown Gastrointestinal disorders dry mouth gastrointestinal disturbance including Common Unknown Musculoskeletal and connective tissue disorders muscle twitching Unknown Renal and urinary disorders urinary difficulty, urinary retention Unknown * The elderly are more prone to confusion and paradoxical excitation.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Nytol One-A-Night should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment.

Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of serious underlying medical illness. This medication should not be used continuously for more than 2 weeks without consulting a doctor.

May increase the effects of alcohol, therefore alcohol should be avoided. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines. Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.

Use with caution in the elderly, who are more likely to experience adverse effects. Avoid use in elderly patients with confusion. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Keep out of the sight and reach of children.

1 Nytol One-A-Night is contraindicated in those with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.