HALEON COLD AND FLU RELIEF ALL IN ONE

For oral use. Swallow whole with water, do not chew.

Adults, the elderly and children aged 16 years and over:

Two capsules every four hours as required. Do not take more than 8 capsules (4 doses) in any 24 hour period. Do not exceed the stated dose. Minimum dosing interval: 4 hours. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

8 mg phenylephrine HCl) in any 24 hour period. Not to be given to children under 16 years except on medical advice. Do not take continuously for more than 5 days without medical advice.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class.

Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post- marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Immune system disorders Very rare cases of serious skin reactions have been reported.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients). (Frequency not known). Respiratory, thoracic and mediastinal disorders Bronchospasm in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Hepatic dysfunction Gastrointestinal disorders Acute pancreatitis 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 Adverse reactions identified during post-marketing use are listed below.

The frequency of these reactions is unknown but likely to be rare. g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics. Renal and urinary disorders Dysuria, urinary retention.

Contains paracetamol. Do not take with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

Concomitant use of decongestants and other cough and cold medicines should be avoided. g. Raynaud’s Phenomenon) • Glutathione depletion due to metabolic deficiencies • Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

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. g. ergotamine and methysergide) • digoxin and cardiac glycosides Do not take with a cough suppressant.

5). Special label warnings If you are taking medication or are under medical care, consult your doctor before using this medicine. Do not exceed the stated dose. If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Contains paracetamol. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Special leaflet warnings Contains paracetamol. 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.

Known hypersensitivity to any of the ingredients. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. 5).