Pulse May 2019 issue - Page 56

Advanz Pharma Brand By prescribing Morphgesic ® SR tablets rather than generic Morphine modified release tablets * Tablet sizes not to scale PRESCRIBING INFORMATION Morphgesic SR 10mg, 30mg, 60mg & 100mg Tablets (morphine sulphate) Presentations: Controlled release tablets, each containing 10mg, 30mg, 60mg or 100mg morphine sulphate. Indications: For the prolonged relief of severe pain in adults. Dosage and administration: Oral administration. Adults: Twice daily at 12 hourly intervals. Starting dose of one or two 10mg tablets twice daily and increasing the dosage with increased severity of pain to achieve desired relief. Dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100mg). Tablets should be swallowed whole and not chewed. Dosage titration and clinical assessment may be appropriate. Dosage adjustment will be necessary in patients switching from parenteral therapy to compensate for any reduction in analgesic effect associated with oral administration. The dose should be gradually reduced prior to discontinuation. Do not use for post-operative pain during the first 24 hours. Use with caution post-operatively especially following abdominal surgery; gastric motility should have returned and be maintained. Elderly: Use with caution. Children: Not recommended. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Respiratory depression, paralytic ileus, acute abdomen, delayed gastric emptying, obstructive airways disease, or acute hepatic disease. Acute alcoholism, head injuries and conditions in which intracranial pressure is raised, attack of bronchial asthma, heart failure secondary to chronic lung disease, patients with excessive bronchial secretions, patients with ulcerative colitis, pregnancy and lactation. Not recommended for pre-operative use or for the first 24 hours post-operatively. Concurrent administration of monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of their use. Patients with severe hepatic impairment and moderate or severe renal impairment (glomerular filtration rate <20 ml/min). Precautions and warnings: Concomitant use of alcohol and Morphgesic SR tablets use should be avoided. Morphgesic SR tablets should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, or shock. It should be used with caution in patients with either obstructive bowel disorders or myasthenia gravis, convulsive disorders, hypotension with hypovolaemia, the elderly, opioid dependent patients, diseases of the biliary tract, pancreatitis and inflammatory bowel disorders, impaired respiratory function, delirium tremens, severe cor pulmonale and patients with a history of substance abuse. Morphine may lower the seizure threshold in patients with a history of epilepsy. May cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of adrenal insufficiency may include e.g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure. Should not be used where there is a possibility of paralytic ileus occurring. Treatment should be discontinued immediately if paralytic ileus is suspected. Extreme caution to be exercised in patients with phaeochromocytoma, since aggravated hypertension has been reported in association with diamorphine. Hyperalgesia that does not respond to a further dose increase of morphine may occur in particular in high doses. A morphine dose reduction or change in opioid may be required. Patients about to undergo additional pain-relieving procedures (e.g. cordotomy, surgery, plexus blockade) should not receive Morphgesic SR tablets for 24 hours prior to the intervention. If further treatment is indicated, then the dosage should be adjusted to the new post-operative requirement. The major risk of opioid excess is respiratory depression. The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use may lead to physical/ or psychological dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. It may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Morphine has an abuse potential and should be used with particular caution in patients with a history of alcohol or drug abuse. Abuse of Morphgesic SR tablets by parenteral administration can be expected to result in serious adverse events, which may be fatal. Urinary retention may occur in patients with urethral disease or prostatic hypertrophy. Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin. Patients, once titrated to an effective dose should not be changed from Morphgesic SR tablets to other slow, sustained or controlled release morphine or other potent narcotic analgesic preparations without re-titration and clinical assessment. Concomitant use of Morphgesic SR tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. 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. Patients and their caregivers to be aware of these symptoms. Due to a possible association between Acute Chest Syndrome (ACS) and morphine use in Sickle Cell Disease (SCD) patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted. Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored, and doses of morphine adjusted during and after treatment with rifampicin. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Driving: This medicine can impair cognitive function and can affect a patient's ability to drive safely. Interactions: Alcohol, monoamine oxidase inhibitors (MAOI’s), anaesthetics, hypnotics, sedatives, tricyclic antidepressants, phenothiazines, muscle relaxants, gabapentin, antihypertensives, mexilitine, metoclopramide, cimetidine, mixed agonist/antagonist opioid analgesics (e.g. buprenorphine, nalbuphine, pentazocine), dexamfetamin, hydroxyzine, anti-histamines, anti-parkinsonian agents, anti-emetics, rifampicin, diuretics, propranolol, ritonavir, sedative medicines such as benzodiazepines or related drugs. Pregnancy and lactation: Not recommended during pregnancy or lactation. Undesirable effects: Serious: Anaphylactic and anaphylactoid reaction, respiratory depression, bronchospasm, pulmonary oedema, coma, convulsions, circulatory failure, syncope, exacerbation of pancreatitis, biliary pain. Very common: Constipation and nausea. Common: Confusion, insomnia, headache, involuntary muscle contractions, somnolence, dizziness, abdominal pain, anorexia, vomiting, hyperhidrosis, rash, asthenic conditions, pruritus. (Please refer to the Summary of Product Characteristics for detailed information) Overdose: Signs & symptoms: Pin point pupils, skeletal muscle flaccidity, respiratory depression, bradycardia, hypotension. Circulatory failure and deepening coma in severe cases. Overdosage can result in death. Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage. Death may occur from respiratory failure. Pneumonia aspiration. Management: In the case of massive overdosage, administer naloxone 0.8mg intravenously. Repeat at 2-3-minute intervals as necessary, or by an infusion of 2mg in 500ml of normal saline or 5% dextrose. For less severe overdosage, administer naloxone 0.2mg intravenously followed by increments of 0.1mg every 2 minutes if required. Legal category: POM. CD (Sch. 2) Pack sizes and basic NHS prices: 60 x 10mg tablets £3.85; 60 x 30mg tablets £9.24; 60 x 60mg tablets £18.04; 60 x 100mg tablets £28.54 Marketing Authorisation numbers: Morphgesic SR 10, 30, 60 & 100mg Tablets: PL 20072/0231-0234 Marketing Authorisation Holder: Amdipharm UK Limited (a member of the Advanz Pharma group of companies), Capital House, 1 st Floor, 85 King William Street, London EC4N 7BL, UK Date of preparation: May 2013 Date of revision: January 2019 [ADV/MOR/PI/0002] Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Advanz Pharma Medical Information via telephone on +44 0 8700 70 30 33 or via e-mail at medicalinformation@advanzpharma.com References: 1. Advanz Pharma - Data on file March 2019 (Cost comparison of Advanz Pain Products vs. Drug Tariff ) ADV/MOR/PM/0005 Date of preparation - April 2019