PARACETAMOL PHENYLEPHRINE HCL & ASCORBIC ACID HALEON

Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system 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 casually related to paracetamol. Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Very rare cases of serious skin reactions have been reported.

Respiratory, thoracic and mediastinal disorders Bromchospasm* Hepatobiliary disorders Hepatic dysfunction * 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 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.

This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continue monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.

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