COLDREX

Adults, the elderly and adolescents 16 years and over: 2 tablets every 4 to 6 hours, if you need to, up to 4 times in any 24 hours. Do not take more than 8 tablets in any 24 hours. Children and adolescents aged 12 to 15 years: 1 tablet every 4 to 6 hours, if you need to, up to 4 times in any 24 hours.

Do not take more than 4 tablets in any 24 hours. These doses should not be repeated more frequently than every four hours. Do not take continuously for more than 7 days without medical advice. Do not use in children under the age of 12 years.

Method of Administration Oral.

Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

The frequency of these adverse events is not known (cannot be estimated from available data). Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bromchospasm * Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition High anion gap metabolic acidosis * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Phenylephrine The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Undesirable effect Psychiatric disorders Nervousness, irritability, restlessness and excitability Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, vomiting, diarrhoea Caffeine Body System Undesirable effect Central nervous system Nervousness Dizziness When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

g. 5). 5). Concomitant use of other flu, cold or decongestant medicines, or other paracetamol-containing medicines should be avoided. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5- oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Excessive intake of tea or coffee should be avoided while taking this product. If symptoms persist consult your doctor. Do not exceed the stated dose. Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Hypersensitivity to paracetamol, caffeine, phenylephrine hydrochloride, terpin hydrate, ascorbic acid or any of the other constituents. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease, angle closure glaucoma or phaeochromocytoma.

Patients taking tricyclic antidepressants, beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors.