DAY NURSE SINUS AND PAIN RELIEF

For oral use.

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

Two tablets every four to six hours, to be taken orally. The dose should not be repeated more frequently than every four hours nor should more than three doses be given in any 24 hour period. Minimum dosing interval: 4 hours. Do not exceed the stated dose.

Should not be used with other paracetamol-containing or decongestant products. Users should be advised to seek medical advice if symptoms persist for more than 7 days. Not to be used in children under 16 years of age.

The following convention has been utilized for the classification of undesirable effects; very common (>/=1/10), common (>=1/100, <1/10), common (<=1/1000, <1/100), rare (>=1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

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.

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.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. **There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Pseudoephedrine The frequency of reactions identified during post-marketing use is not known. 4). Cardiac Disorders Tachycardia, palpitations Vascular Disorders Increased blood pressure* Gastrointestinal Disorders Vomiting, dry mouth, nausea Skin and subcutaneous tissue disorders Rash, allergic dermatitis**, Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP) Renal and Urinary Disorders Dysuria, urinary retention*** Eye disorders Ischaemic optic neuropathy * Increases in systolic blood pressure have been observed.

At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant. ** A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine *** Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

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.

Care is advised in the administration of this product in patients with liver impairment or mild to moderate kidney impairment. Caution should also be exercised in patients with arrhythmias or prostatic enlargement. Caution is needed in patients with a history of drug abuse.

There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. 3). Symptoms reported included sudden onset of severe headache, nausea, vomiting, and visual disturbances.

Most cases improved or resolved within a few days following discontinuation and appropriate treatment. Pseudoephedrine should be discontinued immediately and medical advice sought if the following signs/symptoms of PRES/RCVS develop: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.

This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.

Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Day Nurse Sinus and Pain Relief should be discontinued and appropriate measures taken if needed.

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. If symptoms persist, medical advice must be sought. Keep out of the reach and sight of children.

Risks of abuse Pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. 2).

This product is contraindicated in patients: • With a previous history of hypersenstivity to paracetamol, pseudoephedrine or excipients • With cardiovascular disease including severe hypertension or uncontrolled hypertension or severe coronary artery disease who are receiving other sympoathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychosimulants) • With severe acute or chronic kidney disease/renal failure, hyperthyroidism, prostatic enlargement, diabetes, glaucoma or phaeochromocytoma • Who are receiving Monoamine Oxidase Inhibitors (MAOIs), or for two weeks after stopping an MAOI drug • Who are taking beta-blockers or other anti-hypertensives