CHLORPHENAMINE

For oral use Adults and children over 12 years: 4mg (one tablet) every 4 to 6 hours (maximum 24 mg daily).

Children:

Aged 6 –12 years: 2mg (equivalent to half a tablet) every 4 to 6 hours (Maximum 12mg daily) Not recommended for children under 6 years of age.

Elderly:

As for adults but such patients are prone to confusional psychosis and other neurological anticholinergic effects. g. a maximum of 3 tablets (12mg in total) in any 24 hours, taken 1 tablet 4 to 6 hourly.

Cardiac disorders: rarely palpitation, tachycardia, arrhythmias. Blood and lymphatic system disorders: rarely haemolytic anaemia and other blood dyscrasias.

Immune system disorders:

Unknown allergic reaction, angioedema, anaphylactic reactions Nervous system disorders*: Most commonly sedation, somnolence Commonly, dizziness, headache, impaired concentration ability, abnormal coordination and psychomotor impairment.

Occasionally insomnia, nervousness, tremors, convulsions. Eye disorders: commonly blurred vision. Ear and labyrinth disorders: rarely tinnitus. Respiratory, thoracic and mediastinal disorders: rarely increased viscosity of bronchial secretions Gastrointestinal disorders: Commonly gastro-intestinal disturbances such as nausea, vomiting, diarrhoea.

Occasionally abdominal pain, dyspepsia and anorexia; dry mouth. Renal and urinary disorders: occasionally urinary retention Skin and subcutaneous tissue disorders: rarely hypersensitivity reactions including exfoliative dermatitis, photosensitivity and skin reactions such as rash, urticaria.

Musculoskeletal and connective tissue disorders: rarely twitching and muscular weakness. Vascular disorders: rarely hypotension. General disorders and administration site conditions: commonly fatigue. Occasionally lassitude; rarely dizziness, tightness of chest and irritability.

Hepatobiliary disorders: rarely hepatitis, including jaundice. Psychiatric disorders: rarely depression, nightmares*, confusion*, excitation*, irritability*. *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. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

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. 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 and asthma, hepatic disease and thyrotoxicosis.

Sedation inappropriate in severe liver disease, avoid use of chlorphenamine. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

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 This medicine contains sunset yellow (E110), which can cause allergic- type reaction including asthma.

Allergy is more common in those people who are allergic to aspirin. This medicine also contains lactose. Patient with rare hereditary problems of glactose intolerance, the Lapp lactase deficiency of glucose-glactose malabsorption should not take this medicine.

Keep all medicines out of sight and reach of children

1. Use in patients hypersensitive to Chlorphenamine or any of the excipients in the tablet. 2. Coma or pre-coma states. 3. Known brain damage or epilepsy. The anticholinergic properties of Chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs).

Chlorphenamine is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days.