NUMARK MAX STRENGTH SINUS RELIEF

The frequency of occurrence of undesirable effect is usually classified as follows: Very common (> 1/10) Common (> 1/100 to < 1/10) Uncommon (> 1/1,000 to < 1/100) Rare (> 1/10,000 to 1/1,000) Very rare (< 1/10,000) Not known (incidence cannot be assessed on the basis of the available data).

Adverse events of paracetamol 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.

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.

Paracetamol 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 disorders High anion gap metabolic acidosis (Frequency Unknown) * 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. Caffeine Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

Central Nervous system Nervousness and anxiety Irritability, Restlessness and Excitability Dizziness When the recommended paracetamol-caffeine 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.

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 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. 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 those with bladder outlet obstruction, such as prostatic hypertrophy. Very rare cases of serious skin reactions have been reported. 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 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.