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[GSK logo] Piriton™ Tablets For fast relief of allergic symptoms including runny nose, watery eyes and itchy skin. Description Each Piriton tablet contains Chlorpheniramine Maleate 4mg. Indications Piriton is a potent antihistamine for the speedy relief of cold symptoms such as runny nose and sneezing. It is also highly effective against itchy skin, insect bites, food allergies and watery eyes. Dosage and Administration Oral administration only. Do not exceed the stated dose or frequency of dosing. Adults: 1 tablet three or four times a day. Children (aged 6 to 12 years): ½ tablet three or four times a day. Not recommended for children under the age of 6 years. Medical advice should be sought for patients with kidney or liver problems. Contraindications Piriton is contra-indicated in patients with a history of hypersensitivity to antihistamines or to any of the constituents. It is also contra-indicated in patients that have had monoamine oxidase inhibitor therapy within the previous fourteen days. Warnings and Precautions 1. In common with other drugs having anticholinergic effects, chlorpheniramine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma. 2. Chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patient’s ability to drive and operate machine. 3. Caution is required when there is concurrent usage of alcohol. 4. 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 chlorpheniramine concurrently with these medicines. 5. Children and elderly patients are more likely to experience neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).. 6. Chlorpheniramine should not be used with other antihistamine containing products, including antihistamine containing cough and cold preparations. 7. Keep this and all medications out of the reach of children. 8. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Drug Interactions Chlorpheniramine may have an additive effect when used concurrently with hypnotics and anxiolytics causing potentiation of drowsiness. A similar additive effect will result from concurrent usage of alcohol with chlorpheniramine. As monoamine oxidase inhibitor therapy intensifies the anticholinergic effects of chlorpheniramine, concurrent therapy is contra-indicated. Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity. Pregnancy and Lactation Piriton should only be used during pregnancy when clearly needed and when the potential benefit to the mother outweighs the potential risks to the foetus. Use during the third trimester may result in reactions in the newborn or premature neonates. Use by nursing mothers is not recommended because of the risks of adverse effects in the infant. Antihistamines may inhibit lactation. Ability to perform tasks that require judgement, motor or cognitive skills The anticholinergic properties of chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery (see Warnings and Precautions). Adverse reactions Sedation, somnolence, inability to concentrate, fatigue, headaches, dizziness, muscle twitching, muscular weakness and incoordination. Tinnitus, depression, irritability and nightmares infrequently occur. Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness). Gastro-intestinal disturbances such as dryness of the mouth, nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, anorexia, hepatitis including jaundice. Palpitation, tachycardia, arrhythmias, hypotension, tightness of the chest. Blurred vision, urinary retention, thickening of bronchial secretions. Haemolytic anaemia and other blood dyscrasias. Allergic reactions including exfoliative dermatitis, photosensitivity, skin reactions, angioedema, anaphylactic reactions and urticaria. The effects of alcohol may be increased. Storage Piriton tablets should be stored below 30°C. Version: GDSv1.0 (SI) Date: 13 February 2009 Piriton is a trademark of the GlaxoSmithKline group of companies. [GSK logo]