HALEON DAY NURSE

Posology The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Adults, including the elderly Two tablets up to three times daily as required for relief of symptoms. 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.

Paediatric Population Adolescents aged 16 to 18 years old One to two tablets up to three times daily as required for relief of symptoms. 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.

Adolescents aged 12 to 15 years old One tablet up to three times daily as required for relief of symptoms. 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.

3). Patients with renal impairment Pseudoephedrine is primarily excreted renally. 2). Patients with hepatic impairment Patients who have been diagnosed with hepatic impairment must seek medical advice before taking this medication. 4).

Method of administration For oral use. Patients should be advised not to use this product for more than 5 days and to seek medical advice if symptoms persist. Do not exceed the stated dose. The tablets should be taken with water.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (>1/10,000 and <1/1000) and very rare (<1/10,000) and not known (cannot be estimated from the available date).

Paracetamol:

System Organ Class Adverse Reaction Frequency Blood and lymphatic system disorders Blood dyscrasia, including thrombocytopenia and agranulocytosis Very rare Immune system disorders Hypersensitivity* Rare Metabolism and nutrition disorders High anion gap metabolic acidosis Not known* Anaphylaxis Cutaneous hypersensitivity reactions including, among others, Toxic Epidermal Necrolysis, Stevens Johnson syndrome, angioedema and skin rashes.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 4) Unknown Eye disorders Ischaemic optic neuropathy Not known Dry mouth, nausea, vomiting CommonGastrointestinal disorders Ischaemic colitis Not known Skin and subcutaneous disorders Allergic dermatitis*, rash Rare Severe skin reactions, including acute generalizes exanthematous pustulosis (AGEP) Not known Renal and urinary disorders Urinary retention** Dysuria Uncommon Minor tachycardia Uncommon Palpitations RareCardiac disorders Cardiac arrhythmias Rare Vascular disorders Increased blood pressure Rare *A variety of allergic skin reactions, with or without systemic features such as bronchospasm, 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 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

Contains paracetamol. Do not use 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 lead to liver transplant or death.

Use with caution in patients with hepatic impairment or mild to moderate renal impairment. Use with caution in patients with glutathione depletion due to metabolic deficiencies. Use with caution in patients with psychosis. Concomitant use of other cold and flu medicines should be avoided.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Use with caution in patients with diabetes mellitus, arrhythmias or phaeochromocytoma. Use with caution in patients taking antihypertensives or vasoconstrictive agents such as ergot alkaloids (see section

1. Not to be used by patients taking moclobemide or monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping the MAOI drug. 5). 5). 5). Paediatric Population Not to be used by children under 12 years of age.