NYTOL LIQUID CARAMEL FLAVOUR

As a sleep aid:

Adults: 10 to 25ml at bedtime, or after retiring when sleep is not readily achieved.

Paediatric Population:

Adolescents and children: Not recommended for adolescents and children under the age of 16.

Elderly:

As for adults Do not use continuously for more than 2 weeks without consulting a doctor. Method of administration Oral Do not exceed the stated dose or frequency of dosing

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 postmarketing 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.

Renal and urinary disorders urinary difficulty, urinary retention Respiratory, thoracic and mediastinal disorders thickening of bronchial secretions 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.

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).

Patients with moderate to severe hepatic impairment and moderate to severe renal impairment should consult their doctor before using this medicine. Tolerance may develop with continuous use. The patient should not take the product for more than two weeks without consulting a doctor, and seek medical advice if sleeplessness persists, as insomnia may be a symptom of a serious underlying medical illness.

Cases of abuse and dependence were reported with diphenhydramine in adolescents or young adults for recreational use and/or in patients with psychiatric disorders and/or history of abuse disorders. The onset of signs or symptoms raising abuse should be monitored.

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.

This product should not be used to sedate a child due to the possibility of respiratory depression, lethargy, sleep apnoea and cardiorespiratory arrest. Use with caution in the elderly, who are more likely to experience side-effects.

Avoid use in elderly patients with confusion. 8).

This medicinal product contains sucrose:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 66g of sucrose in 5ml. This should be taken into account in patients with diabetes mellitus This medicinal product contains parahydroxybenzoates (methyl E218, ethyl E214, propyl E216 & butyl): May cause allergic reactions (possibly delayed).

1. 5). Sedation of children under the age of 16 should only be under medical direction, consequently use as a sedative in this age group is contraindicated.