HISTERGAN

As an antihistamine:

Adults and Children over 12 years: Two 5ml spoonfuls 3 or 4 times per day.

Paediatric Population:

Children up to 1 year: Half a 5ml spoonful three times per day.

Children 1 to 5 years:

Half to One 5ml spoonful three times per day.

Children 6 to 12 years:

One 5ml spoonful three times per day.

Elderly:

As for adults.

As a sleep aid:

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

Paediatric Population:

Children: Not recommended for children under the age of 16.

Elderly:

As for adults Method of administration Oral

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 System Organ Class Very Common (≥1/10) Common ≥1/100, < 1/10 Uncommon ≥1/1,000, <1/100 Rare ≥1/10,000, <1/1000 Very Rare <1/10,000 Not known (cannot be estimated from available data) 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.

Histergan Syrup contains sucrose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 66g of sucrose in 5ml. This should be taken into account in patients with diabetes mellitus. Histergan Syrup contains parahydroxybenzoates (methyl E218, ethyl E214, propyl E216 & butyl): May cause allergic reactions (possibly delayed).

Histergan Syrup contains 260 mg propylene glycol in each 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

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.