PANADOL ULTRA

Adults aged 18 years and over (including the elderly) Two tablets up to 4 times a day. This dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Children aged 16 to 18 years Two tablets up to 4 times a day. This dose should not be repeated more frequently than every 6 hours, and not more than 4 doses should be given in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Children aged 12 to15 years One tablet up to four times a day. This dose should not be repeated more frequently than every 6 hours, and not more than 4 doses should be given in any 24 hour period. Do not take for longer than 3 days without consulting a doctor.

Children (under12 years) Not recommended for children under 12 years of age. For oral administration only.

Treatment goals and discontinuation:

Before initiating treatment with Panadol Ultra Tablets, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed.

When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. 4). Do not take for more than 3 days continuously without medical review. The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.

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.

The following convention has been utilised for the classification of the frequency of adverse reactions: 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).

As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be very rare (<1/10,000). 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. Codeine Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class.

The frequency of these reactions is not known. Body System Undesirable effect Frequency Psychiatric disorders Drug dependency can occur after prolonged use of codeine at higher doses Not known Nervous system disorder Dizziness, worsening of headache with prolonged use, drowsiness Not known Gastrointestinal disorder Acute pancreatitis (see Warnings and precautions), vomiting, constipation, nausea, dyspepsia, dry mouth.

Not known Skin and subcutaneous tissue disorder Pruritus, sweating Not known Hepatobiliary disorders Sphincter of Oddi dysfunction Not known Drug dependence Repeated use of Panadol Ultra can lead to drug dependence, even at therapeutic doses.

4). 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.

4 Special Warnings and Special Precautions for Use Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis Care is advised in the administration of paracetamol to patients with: • Renal impairment • Hepatic 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. If symptoms persist or worsen, medical advice must be sought.

Serotonin Syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported in patients taking opioids, particularly with concomitant use of other serotonergic agents (including Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) and tricyclic antidepressants).

If concomitant treatment with opioids is clinically warranted, appropriate medical observation of the patient is advised (see Interactions). The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the stated dose.

As with other opioids, in case of insufficient pain control in response to an increased dose of codeine, the possibility of opioid-induced hyperalgesia should be considered. A dose reduction or treatment review may be indicated. Patients should be advised to consult their doctor if their headaches become persistent.

Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.

Patients should be advised not to take other paracetamol or codeine-containing products concurrently. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

Hypersensitivity to paracetamol, codeine, opioid analgesics or any of the other constituents. Codeine is contraindicated in all patients under 18 years who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Use of codeine containing products is contraindicated in mothers who are breast feeding.