MORPHGESIC SR

4). Adults The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10 mg) twice daily is the recommended starting dosage for a patient presenting with severe pain.

With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.

It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration.

Dosage titration and clinical assessment may be appropriate. Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR Tablets, a higher dosage of morphine may be required.

Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration. Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.

Paediatric population Rhotard Morphine SR/ Morphgesic SR Tablets are not recommended for paediatric use. Method of administration Treatment goals and discontinuation Before initiating treatment with Rhotard Morphine SR/ Morphgesic SR Tablets, 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 Rhotard Morphine SR/ Morphgesic SR Tablets, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment Rhotard Morphine SR/ Morphgesic SR Tablets should not be used longer than necessary. Oral Rhotard Morphine SR / Morphgesic SR Tablets should be swallowed whole and not chewed.

In normal doses, the most common side effects of morphine are nausea, vomiting, constipation, difficulty in micturition and drowsiness. With chronic therapy, nausea and vomiting are unusual with Rhotard Morphine SR/ Morphgesic SR Tablets but should they occur the tablets can be readily combined with an anti-emetic if required.

Constipation may be treated with appropriate laxatives. A case of morphine induced thrombocytopenia has been reported. Morphine has a depressant effect on gonadal hormone secretion which can result in a reduction of testosterone leading to regression of secondary sexual characteristics in men on long-term therapy.

4) hyperaesthesia/al lodynia Hyperhidrosis Eye disorders Visual disturbance Miosis Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Bradycardia Tachycardia Vascular disorders Facial flushing Hypotension Circulatory failure Hypertension Respiratory, thoracic and mediastinal disorders Bronchospasm Pulmonary oedema Respiratory depression Cough decreased Central sleep apnoea syndrome Gastrointestinal disorders Constipation Nausea Abdominal pain Anorexia Vomiting Dyspepsia Ileus Taste perversion Narcotic bowel syndrome Dry mouth Pancreatitis Hepatobiliary disorders Increased hepatic enzymes Exacerbation of pancreatitis Biliary pain Spasm of sphincter of Oddi Skin and subcutaneous tissue disorders Hyperhidrosis Rash Urticaria Acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Urinary retention Ureteric spasm Dysuria Reproductive system and breast disorders Amenorrhea Decreased libido Erectile dysfunction General disorders and administration Asthenic conditions Peripheral oedema, drug withdrawal Drug tolerance Hypothermia site conditions Pruritus syndrome† Anxiety Dysphoric mood *Physical and psychological dependence may appear after administration of therapeutic doses for periods of 1 to 2 weeks.

Some cases of dependence have been observed after only 2 to 3 days. †Physiological withdrawal symptoms include: Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis.

Psychological symptoms include dysphoric mood, anxiety and irritability. In drug dependence, “drug craving” is often involved. Drug dependence Repeated use of Rhotard Morphine SR/ Morphgesic SR Tablets 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

Concomitant use of alcohol and Rhotard Morphine SR/ Morphgesic SR Tablets may increase the undesirable effects of Rhotard Morphine SR/ Morphgesic SR Tablets, concomitant use should be avoided. Rhotard Morphine SR/ 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. Caution in patients with convulsive disorders, hypotension with hypovolaemia, the elderly, opioid dependent patients, diseases of the biliary tract, pancreatitis and inflammatory bowel disorders.

Use with caution in patients with 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.

Sleep-related breathing disorders 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.

Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment. Most of these reactions occurred within the first 10 days of treatment.

Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.

Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Adrenal insufficiency Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.

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. Should paralytic ileus be suspected to occur during use, treatment should be discontinued immediately.

Extreme caution should be exercised when administering morphine to patients with phaeochromocytoma, since aggravated hypertension has been reported in association with diamorphine. g. cordotomy, surgery, plexus blockade) should not receive Rhotard Morphine SR/ Morphgesic SR Tablets for 24 hours prior to the intervention.

If further treatment with Rhotard Morphine SR/ Morphgesic SR Tablets is indicated then the dosage should be adjusted to the new post-operative requirement. Persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI) Do not use for acute post-operative pain owing to the increased risk of persistent post- operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI) The major risk of opioid excess is respiratory depression.

Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Rhotard Morphine SR/ Morphgesic SR Tablets. Repeated use of Rhotard Morphine SR/ Morphgesic SR Tablets 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 Rhotard Morphine SR/ Morphgesic SR Tablets may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (eg.

major depression, anxiety and personality disorders). A comprehensive patient history should be taken to document concomitant medications, including over the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. The clinical need for analgesic treatment should be reviewed regularly.

2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines).

For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with morphine sulfate.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, […]

1. Respiratory depression, paralytic ileus, acute abdomen, delayed gastric emptying, obstructive airways disease, or acute hepatic disease. It is also contra-indicated in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised.

Neither should it be given during an attack of bronchial asthma nor heart failure secondary to chronic lung disease. Patients with excessive bronchial secretions should not be given Rhotard Morphine SR/ Morphgesic SR Tablets as morphine diminishes the cough response.

Not recommended for pre-operative use or for acute post operative use. 6). Concurrent administration of monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of their use. Renal impairment Severe and prolonged respiratory depression may occur in patients with renal impairment given morphine; this is attributed to the accumulation of the active metabolite morphine-6- glucuronide.

Therefore Rhotard Morphine SR/ Morphgesic SR Tablets should not be administered to patients with moderate or severe renal impairment (glomerular filtration rate <20 ml/min). Hepatic impairment As with other opioid analgesic containing preparations Rhotard Morphine SR/ Morphgesic SR Tablets should not be administered to patients with severe hepatic impairment as it may precipitate coma.

Rhotard Morphine SR/ Morphgesic SR Tablets, as with other opioid containing preparations, is contraindicated in patients with ulcerative colitis, since such preparations may precipitate toxic dilation or spasm of the colon.