PALLADONE

4). Transferring patients between oral and parenteral hydromorphone Switching patients from parenteral hydromorphone to oral hydromorphone should be guided by the sensitivity of the individual patient. 2). Adults and children aged 12 years and above Palladone capsules should be used at 4 hourly intervals.

The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. 3 mg of hydromorphone has an efficacy approximately equivalent to 10 mg of morphine given orally. A patient presenting with severe pain should normally be started on a dosage of one Palladone capsule 4 hourly.

Increasing severity of pain may require increased dosage of hydromorphone to achieve the desired relief. Elderly and patients with renal impairment The elderly and patients with renal impairment should be dose titrated with Palladone capsules in order to achieve adequate analgesia.

It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia. Patients with hepatic impairment Contraindicated. Paediatric population Not recommended. Method of administration For oral use.

The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

Treatment goals and discontinuation:

Before initiating treatment with Palladone capsules, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, 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 hydromorphone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4).

Duration of treatment:

Hydromorphone should not be used longer than necessary.

Hydromorphone may cause constipation, nausea and vomiting. Constipation may be treated with appropriate laxatives. When nausea and vomiting are troublesome Palladone capsules can be readily combined with antiemetics. 4) Central sleep apnoea syndrome Eye disorders Visual impairment Miosis Cardiac disorders Tachycardia Vascular disorders Hypotension Flushing Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Constipation Nausea Abdominal pain Dry mouth Vomiting Diarrhoea Dysgeusia Paralytic ileus Hepatobiliary disorders Hepatic enzymes increased Skin and subcutaneous tissue disorders Pruritus Hyperhidrosis Rash Urticaria Renal and urinary disorders Urinary retention Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Asthenia Drug withdrawal syndrome Fatigue Malaise Peripheral oedema Drug tolerance Drug withdrawal syndrome neonatal Description of selected adverse reactions Drug dependence Repeated use of Palladone capsules 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

, Addison’s disease) • Severely impaired renal function • Severely impaired hepatic function • Alcoholism • Delirium tremens • Convulsive disorders • Constipation • Shock or reduced respiratory reserve. Respiratory depression The major risk of opioid excess is respiratory depression.

Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner in some patients. 8). In patients who present with CSA, consider decreasing the total opioid dosage.

Risk from concomitant use of sedative medicines such as benzodiazepines (and other CNS depressants): Concomitant use of Palladone capsules and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Palladone capsules concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.

8). In patients who present with CSA, consider decreasing the total opioid dosage Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as hydromorphone.

Repeated use of Palladone can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Palladone may result in overdose and/or death.

1). • Severe respiratory depression with hypoxia and/or hypercapnia • Severe chronic obstructive lung disease • Severe bronchial asthma • Paralytic ileus • Acute abdomen • Coma • Hepatic impairment • Concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use.