CHLORPHENAMINE

Posology Do not exceed the stated dose or frequency of dosing. Adults and Children 12 years and over: 10ml (4mg) every 4 to 6 hourly. Maximum daily dose: 60ml (24mg) in any 24 hours.

Elderly:

The elderly are more likely to experience neurological anticholinergic effects. g. a maximum of 12 mg in any 24 hours). Children aged 6 - 12 years: 5ml (2mg) every 4 to 6 hourly. Maximum daily dose: 30ml (12mg) in any 24 hours. 5ml (1mg) every 4 to 6 hourly.

Maximum daily dose: 15ml (6mg) in any 24 hours. 5ml (1mg) twice daily. The minimum interval between the doses should be 4 hours. Maximum daily dose: 5ml (2mg) in any 24 hours. Not recommended for children below 1 year. Method of administration Oral administration only.

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% to <10% of subjects) or very common (occurring in ≥10% of subjects) are listed below by MedDRA System Organ Class.

The frequency of other adverse events identified during post-marketing use is unknown.

Blood and lymphatic system disorders:

Unknown: haemolytic anaemia, blood dyscrasias Immune system disorders: Unknown: allergic reaction, angioedema, anaphylactic reactions Metabolism and nutritional disorders: Unknown: anorexia Psychiatric disorders: Unknown: confusion*, excitation*, irritability*, nightmares*, depression Nervous system disorders*: Very common: sedation, somnolence Common: disturbance in attention, abnormal coordination, dizziness, headache Eye disorders: Common: blurred vision Ear and labyrinth disorders: Unknown: tinnitus Cardiac disorders: Unknown: palpitations, tachycardia, arrythmias Vascular disorders: Unknown: hypotension Respiratory, thoracic and mediastinal disorders: Unknown: thickening of bronchial secretions Gastrointestinal disorders: Common: nausea, dry mouth Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia Hepatobiliary disorders: Unknown: hepatitis including jaundice Skin and subcutaneous tissue disorders: Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity Musculoskeletal and connective tissue disorders: Unknown: muscular twitching, muscle weakness Renal and urinary disorders: Unknown: urinary retention General disorders and administration site conditions: Common: fatigue Unknown: chest tightness *Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (eg increased energy, restlessness, nervousness) Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment; renal impairment.

Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness). Avoid use in elderly patients with confusion. The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.

The effects of alcohol may be increased and therefore concurrent use should be avoided. Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines. Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Patients with rare hereditary problems of fructose intolerance should not take this medicine, as it contains maltitol liquid. Maltitol may also have a mild laxative effect. 25g of maltitol liquid. 3 kcal/g maltitol. This medicine contains sodium methyl and propyl parahydroxybenzoates (E219 & E217) which may cause allergic reactions (possibly delayed).

96 mg/ml. This medicine contains less than 1 mmol sodium (23mg) per 5ml dose, that is to say “essentially sodium free”. Keep out of the sight and reach of children.

1. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine Oral Solution is therefore contra- indicated in patients who have been treated with MAOIs within the last fourteen days.