PARACETAMOL ASCORBICACID CAFFEINE TERPINHYDRATE PHENYLEPHRINEHYDROCHLORIDE

Adults aged 16 years and over: 1-2 tablets can be taken up to 4 times a day. Do not exceed 8 tablets in 24 hours. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. 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 adolescents under the age of 16 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 Effects 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 Metabolic and nutrition disorders High anion gap metabolic acidosis** Description of selected adverse reactions *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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 Effects 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 Effects 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. Skin and subcutaneous disorders Hypersensitivity reactions including cross-sensitivity with other sympathomimetics may occur 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.

g. 5). 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. 5).

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May cause allergic reactions. 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. 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:

Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you talk too much of this medicine, even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause 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.