PANADOL NIGHTPAIN, PANADOL NIGHT

Oral administration only. Do not exceed the stated dose or frequency of dosing Adults (including the elderly) and children aged 16 years and over: Two tablets to be taken 20 minutes before bedtime.

Maximum daily dose:

Two tablets (1000 mg paracetamol, 50 mg diphenhydramine hydrochloride) in 24 hours. Other products containing paracetamol may be taken for daytime pain relief but at a reduced maximum dose of 6 tablets in 24 hours. The dose should not be repeated more frequently than every four hours.

Should not be used with other antihistamine-containing preparations, including those used on the skin (see Warnings and Precautions) The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

Not recommended for children under 16 years of age except on medical advice. Patients should not take the tablets for more than 7 consecutive nights without consulting their doctor.

Elderly:

Should not be taken by elderly patients with confusion. 4). Caution should be exercised in those with moderate to severe hepatic or renal impairment.

Adverse events from historical clinical trials data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency.

000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data). Paracetamol As the adverse reactions identified from post-marketing use are reported voluntarily from a population of uncertain size, the frequency is not known.

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

Diphenhydramine Adverse reactions which have been observed in clinical trials and which are considered to be common or very common are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown, but these reactions are likely to be uncommon or rare.

Body System Undesirable effect General disorders and administration site conditions Common: Fatigue Immune system disorders Not known: Hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema Psychiatric disorders Not known: confusion*, paradoxical excitation* (eg increased energy, restlessness, nervousness) *the elderly are more prone to confusion and paradoxical excitation Nervous system disorders Common: Sedation, drowsiness, disturbance in attention, unsteadiness, dizziness Not known: Convulsions, headache, paraesthesia, dyskinesias Eye disorders Not known: Blurred vision Cardiac disorders Not known: Tachycardia, palpitations Respiratory, thoracic mediastinal disorders and Not known: Thickening of bronchial secretions Gastrointestinal disorders Common: Dry mouth Not known: Gastrointestinal disturbance, including nausea, vomiting Musculoskeletal and connective tissue disorders Not known; Muscle twitching Renal and urinary disorders Not known: Urinary difficulty, urinary retention Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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 require liver transplant or lead to death.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Use with caution in patients with glutathione depletion due to metabolic deficiencies. Avoid use of other antihistamine-containing preparations, including topical antihistamine and cough and cold medicines.

Avoid concurrent use with alcohol, as diphenhydramine may increase the sedative effects of alcohol. Therefore, alcohol should be avoided (see Interactions). Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol containing products, other drugs with sedating properties, or alcohol concurrently. 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.

Medical advice should be sought before taking in patients with: • Hepatic or renal impairment. Underlying liver disease increases the risk of paracetamol-related liver damage • Glutathione depleted states as the use of paracetamol may increase the risk of metabolic acidosis • Concurrent use of drugs which cause sedation such as tranquillizers, hypnotics and anxiolytics as diphenhydramine may cause an increase in sedative effects (see interactions).

Use with caution in: • patients with epilepsy or seizure disorders, myasthenia gravis, narrow- angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), hepatic impairment and mild to moderate renal impairment.

Hypersensitivity to paracetamol, diphenhydramine hydrochloride or other constituents. . Porphyria.