OLBAS MAX STRENGTH ALL-IN-ONE COLD AND FLU

The active ingredients are usually well tolerated in normal use. PARACETAMOL 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.

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.

Very rare cases of serious skin reactions have been reported. 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, angioedema and Stevens Johnson syndrome, toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Gastrointestinal disorders Acute pancreatitis Metabolism and nutrition disorders 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.

** Frequency “Not known” (cannot be estimated from the available data). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. GUAIFENESIN The frequency of these events is unknown but considered likely to be rare.

Body System Undesirable effect Immune system disorders Allergic reactions, angioedema, anaphylactic reactions Respiratory, thoracic and mediastinal disorders Dyspnoea* Gastrointestinal disorders Nausea, vomiting, abdominal discomfort, Skin and subcutaneous disorders Rash, urticaria PHENYLEPHRINE HYDROCHLORIDE 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 cross- sensitivity with other sympathomimetics may occur. Renal and urinary disorders Dysuria.

Urinary retention. This is most likely to occur in men with an enlarged prostate. 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.

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

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