HISTERGAN

As an antihistamine:

Adults and Children over 12 years: 1 or 2 tablets three or four times per day. In severe or chronic conditions this may be increased at the discretion of a doctor, but not to exceed 300mg in any 24 hour period.

Paediatric Population:

Not recommended for children under the age of 12.

Elderly:

As for adults, use cautiously, reduce dose if required.

As a sleep aid:

Adults: 1 or 2 tablets at bedtime, or after retiring when sleep is not readily achieved Paediatric Population: Not recommended for children under the age of 16 Elderly: As for adults, use cautiously, reduce dose if required.

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), 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. 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. Use with caution in the elderly, who are more likely to experience side-effects. Avoid use in elderly patients with confusion.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Contraindicated for use in patients with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.

When used as a sleep aid:

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.