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Morphine has a risk for abuse and addictionwhich can lead to overdose and death. Morphine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of morphine that works, and take it for the shortest possible time. See also How to Use section for more information about addiction. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death.
Film coated, biconvex tablet marked with the NAPP logo on one side and the strength of the tablet on the other. For the prolonged relief of severe and intractable pain, and for the relief of post-operative pain.
The dosage is dependent upon the severity of the pain, the patient's age and history of analgesic requirements. Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with morphine in order to minimise the risk of addiction and drug withdrawal syndrome see section 4. A patient presenting with severe pain, uncontrolled by weaker opioids e.
Increasing severity of pain will require an increased dosage of the tablets.
The correct dosage for any individual patient is that which is sufficient to control pain with no, or tolerable, side effects for a full 12 hours. It is recommended that the mg strength is reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations. Patients receiving MST CONTINUS tablets in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration.
In such patients, individual dose adjustments are required. For children with severe cancer pain, a starting dose in the range of 0. Doses should then be titrated as for adults. MST CONTINUS tablets are not recommended in the first 24 hours post-operatively or until normal bowel function has returned; thereafter it is suggested that the following dosage schedule be observed at the physician's discretion:.
Supplemental parenteral morphine may be given if required but with careful attention to the total dosages of morphine, and bearing in mind the prolonged effects of morphine in this prolonged release formulation. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potentially fatal dose of morphine see section 4.
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An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore, the dose should be gradually reduced prior to discontinuation.
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. Opioids may also cause worsening of pre-existing sleep apnoea see section 4. In patients who present with CSA, consider decreasing the total opioid dosage.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:.
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 MST CONTINUS tablets concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible see also general dose recommendation in section 4.
The patients should be followed closely for s and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms see section 4. Due to a possible association between ACS and morphine use in SCD patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.
Patients about to undergo additional pain relieving procedures e. MST CONTINUS tablets should be used with caution post-operatively, and following abdominal surgery as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function.
It is not possible to ensure bio-equivalence between different brands of prolonged release morphine products. Therefore, it should be emphasised that patients, once titrated to an effective dose, should not be changed from MST CONTINUS preparations to other slow, sustained or prolonged release morphine or other potent narcotic analgesic preparations without retitration and clinical assessment.
For all patients, prolonged use of this product may lead to drug dependence addictioneven at therapeutic doses.
The risks are increased in individuals with current or past history of substance misuse disorder including alcohol misuse or mental health disorder e. Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.
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. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
Patients may also supplement their treatment with additional pain relievers. These could be s that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.
It is important that patients only use medicines that are prescribed and do not give this medicine to anyone else. 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. 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.
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Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate. If women take this drug during pregnancy there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.
Symptoms of adrenal insufficiency may include e. Some changes that can be seen with long-term use of opioid analgesics include an increase in serum prolactin, and decreases in plasma cortisol and testosterone in association with inappropriately low or normal ACTH, LH or FSH levels. Some premenopausal women may have low oestrogen levels. Clinical symptoms include decreased libido, impotence or amenorrhea which may be manifested from these hormonal changes.
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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. Within the first day of concomitant P2Y12 inhibitor and morphine treatment, reduced efficacy of P2Y12 inhibitor treatment has been observed see section 4.
The prolonged release tablets must be swallowed whole, and not broken, chewed, dissolved or crushed. Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited see section 4. Drugs which depress the CNS include, but are not limited to: other opioids, anxiolytics, sedatives and hypnotics including benzodiazepinesantiepileptics including gabapentinoids, e.
Morphine sulfate should not be co-administered with monoamine oxidase inhibitors or within two weeks of such therapy. Medicinal products that block the action of acetylcholine, for example antihistamines, anti-parkinsons and anti-emetics, may interact with morphine sulfate to potentiate anticholinergic adverse events. A delayed and decreased exposure to oral P2Y12 inhibitor antiplatelet therapy has been observed in patients with acute coronary syndrome treated with morphine. This interaction may be related to reduced gastrointestinal motility and apply to other opioids. The clinical relevance is unknown, but data indicate the potential for reduced P2Y12 inhibitor efficacy in patients co-administered morphine and a P2Y12 inhibitor see section 4.
In patients with acute coronary syndrome, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered. Although there are no pharmacokinetic data available for concomitant use of ritonavir with morphine sulfate, ritonavir induces the hepatic enzymes responsible for the glucuronidation of morphine sulfate, and may possibly decrease plasma concentrations of morphine sulfate.
Regular use in pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in pregnant women, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.
Administration to nursing women is not recommended as morphine is secreted in breast milk and may cause respiratory depression in the infant. Morphine may modify the patient's reactions to a varying extent depending on the dosage and susceptibility.
If affected, patients should not drive or operate machinery. This medicine can impair cognitive function and can affect a patient's ability to drive safely.
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told:. In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. Constipation may be treated with appropriate laxatives. Visual impairment.
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Ear and labyrinth disorders. Cardiac disorders. Facial flushing. Hepatobiliary disorders. Increased hepatic enzymes. Renal and urinary disorders. Urinary retention. Reproductive system and breast disorders. An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued or opioid antagonists administered, or can sometimes be experienced between doses. For management, see section 4.
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. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.