HAYLEVE, CHLORPHENAMINE MALEATE

Do not exceed the stated dose or frequency of dosing. Minimum doing interval : 4 hours Do not use continuouly for more than two weeks without consulting a doctor. Adults and children over 12 years: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) 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: 1/2 tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12 mg) in any 24 hours.

Children aged less than 6 years:

Not recommended for children under the age of 6 years. Populations Patients with renal or hepatic impairment should seek doctor’s advice prior to taking this medicine. (See Section

Adverse reactions identified during post- marketing use with chlorphenamine are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of some reactions is unknown but likely to be rare or very rare: System Organ Class Adverse Reaction Frequency Sedation, somnolence Very commonNervous system disorders* Disturbance in attention, abnormal coordination, dizziness headache Common Eye disorders Blurred Vision Common Nausea, dry mouth CommonGastrointestinal disorders Vomiting, abdominal pain, diarrhoea, dyspepsia Unknown Immune system disorders Allergic reaction, angioedema, anaphylactic reactions Unknown Metabolism and nutritional disorders Anorexia Unknown Blood and lymphatic system disorders Haemolytic anaemia, blood dyscrasias Unknown Musculoskeletal and connective tissue disorders Muscle twitching, muscle weakness Unknown Psychiatric disorders Confusion*, excitation*, irritability*, nightmares*, depression Unknown Renal and urinary disorders Urinary retention Unknown Skin and subcutaneous disorders Exfoliative dermatitis, rash, urticaria, photosensitivity Unknown Respiratory, thoracic and mediastinal disorders Thickening of bronchial secretions Unknown Vascular disorders Hypotension Unknown Hepatobiliary disorders Hepatitis, including jaundice Unknown Ear and labyrinth disorders Tinnitus Unknown Cardiac disorders Palpitations, tachycardia, arrythmias Unknown General disorders and administration site conditions Fatigue Common Chest tightness Unknown *Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg.

Increased energy, restlessness, nervousness). Reporting of suspected adverse reactions Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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). 1. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitor (MAOIs). The tablets are therefore contra-indicted in patients who have been treated with MAOIs within the last 14 days. 4 Special warnings and precautions for use Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma ; prostatic hypertrophy; hepatic impairment, renal impairment, bronchitis, bronchiectasis or asthma severe hypertension or cardiovascular disease.

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. 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.

Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines. This medicine contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Keep out of sight and reach of children.

1. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitor (MAOIs). The tablets are therefore contra-indicted in patients who have been treated with MAOIs within the last 14 days.