LUNOX SLEEP AID

Route of administration:

Oral Dosage instructions: Two tablets 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.

Children:

Do not use in children under 16 years. This medicinal product should not be used continuously for longer 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 <1/1000). g. increased energy, restlessness, nervousness), depression, sleep disturbances * The elderly are more prone to confusion and paradoxical excitation.

Nervous system disorders:

Common: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness Unknown: convulsions, headache, paraesthesia, dyskinesias, hypoesthesia, restless leg syndrome Eye disorders: Unknown: blurred vision Cardiac disorders: Unknown: tachycardia, palpitations, arrhythmias Respiratory, thoracic and mediastinal disorders: Unknown; thickening of bronchial secretions Gastrointestinal disorders: Common: dry mouth Unknown: gastrointestinal disturbance including nausea, vomiting Musculoskeletal and connective tissue disorders: Unknown: muscle twitching Renal and urinary disorders: Unknown: urinary difficulty, urinary retention.

General disorders and administration site conditions:

Common: fatigue 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.

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Diphenhydramine should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, prostatic hypertrophy, urinary retention, narrow-angle glaucoma, 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 a serious underlying medical illness. This medicinal product should not be used continuously for longer 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. This medicinal product contains lactose. 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. Contraindicated for use in patients with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.