PIRITON ALLERGY

Oral Administration only Do not exceed the stated dose or frequency of dosing Minimum dosing interval: 4 hours. Do not use continuously 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 (24mg) in any 24 hours.

Elderly:

The elderly are more likely to experience neurological anticholinergic effects. g. a maximum of 12mg in any 24 hours). Children aged 6 - 12 years: ½ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours. 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

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

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, Unknown anaphylactic reactions 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 Fatigue CommonGeneral disorders and administration site conditions 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 reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

). 3 Contraindications The tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs).

The tablets are therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen 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; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis and 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. 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. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Keep out of sight and reach of children.

The tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). The tablets are therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.