PANADOL COLD & SINUS

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

Two tablets up to three times daily as required for relief of symptoms. No more than eight tablets should be taken in 24 hours. Elderly patients Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing.

Paediatric population Children aged 12 to 15 years old:

One tablet up to three times daily as required for relief of symptoms. Not to be used in children under 12 years of age. 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.

Do not exceed the stated dose. Method of administration For oral use. The tablets should be taken with water. 9). Minimum dosing interval: 4 hours. If pain or fever persist for more than 3 days or get worse, or if any other symptoms occur, treatment should be discontinued and a physician consulted.

Special Populations Pseudoephedrine is primarily excreted renally. Pseudoephedrine should not be used by those with severe renal impairment (see Contraindications) and should be used with caution in those with moderate renal impairment (see

Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

The following adverse reactions have been reported with products containing paracetamol and/or pseudoephedrine. 4) Eye disorders Not Known Ischaemic optic neuropathy Common Dry mouth, nausea, vomitingGastrointestinal disorders Not known Ischaemic colitis Rare Rash, dermatitis allergic* Very Rare Very rare cases of serious skin reactions have been reported.

Skin and subcutaneous tissue disorders Not known Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP) Renal and urinary disorders Uncommon Urinary retention**, dysuria Uncommon Minor tachycardiaCardiovascular disorders Rare Cardiac arrhythmias, hypertension Hepatic disorders Very Rare Hepatic dysfunction Respiratory disorders Very Rare Bronchospasm is more likely in patients sensitive to aspirin or NSAIDs.

Metabolism and nutrition disorders Not known High anion gap metabolic acidosis*** *A variety of allergic skin reactions, with or without systemic features such as bronchospasm, angioedema have been reported following use of pseudoephedrine.

Hypersensitivity reactions, including skin rashes, Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, angioedema and anaphylaxis have been reported very rarely with paracetamol. **Urinary retention is most likely to occur in those with bladder outlet obstruction such as prostatic hypertrophy.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.

2 Pharmacokinetics). Paracetamol and pseudoephedrine Renal impairment Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours.

The kidney impairment restrictions relate to the use of both paracetamol and pseudoephedrine. 4). Paracetamol Hepatic impairment Patients who have been diagnosed with hepatic impairment or Gilbert’s Syndrome must seek medical advice before taking this medication.

4). 1. Not to be used by patients taking moclobemide or monoamine oxidase inhibitors (MAOI’s) or for two weeks after stopping the MAOI drug. The antibiotics furazolidone and linezolid should not be taken with Panadol Cold & Sinus (see section

1. Not to be used by patients taking moclobemide or monoamine oxidase inhibitors (MAOI’s) or for two weeks after stopping the MAOI drug. The antibiotics furazolidone and linezolid should not be taken with Panadol Cold & Sinus (see section