CYCLIMORPH

Posology Adults The usual dose is 10-20 mg morphine tartrate, given subcutaneously, intramuscularly or intravenously. Additional doses may not be given more frequently than 4 hourly. e. 3 ml of Cyclimorph 15 Injection) should be given in any 24-hour period.

Elderly Morphine doses should be reduced in elderly patients and titrated to provide optimal pain relief with minimal side effects since: - Increased duration of pain relief from a standard dose of morphine has been reported in elderly patients.

- A review of pharmacokinetic studies has suggested that morphine clearance decreases and half-life increases in older patients. - The elderly may be particularly sensitive to the adverse effects of morphine. Paediatric population This medicine should not be used in children under 12 years of age.

Method of administration Treatment goals and discontinuation Before initiating treatment with Cyclimorph, 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 Cyclimorph, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment Cyclimorph should not be used longer than necessary. By subcutaneous, intramuscular or intravenous injection.

4), hyperhidrosis Eye disorders Not known Miosis, blurred vision, oculogyric crisis Cardiac disorders Not known Tachycardia Vascular disorders Not known Orthostatic hypotension, hypertension Respiratory, thoracic and mediastinal disorders Not known Respiratory depression, bronchospasm, apnoea This medicine has demonstrated significant incidence of single cough or paroxysm of coughing immediately after its administration.

g. urticaria) drug rash, fixed drug eruption (rash), acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Not known Renal spasm, difficulty with micturition, urinary retention Reproductive system and breast disorders Not known 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.

General disorders and administration site conditions Uncommon Not known Drug withdrawal syndrome Injection site reactions including vein tracking, erythema, pain and thrombophlebitis, dysphoric mood, anxiety A case of psychomotor hyperactivity following intravenous administration of morphine during the induction of anaesthesia has been reported.

Case reports of paralysis have been received in patients using intravenous cyclizine. Some of the patients mentioned in these case reports had an underlying neuromuscular disorder. Rapid IV administration of cyclizine can lead to symptoms similar to overdose.

Case reports of Narcotic bowel syndrome and hyperaesthesia/ allodynia due to Morphine have also been reported. Drug dependence Repeated use of Cyclimorph 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.

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.

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, 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. This medicine should be used with caution in the debilitated since they may be more sensitive to the respiratory depressant effects.

This medicine should be used with caution (including consideration of dose administered) in the presence of the following: convulsive disorders delerium tremens severe cor pulmonale hypothyroidism adrenocortical insufficiency hypopituitarism prostatic hypertrophy shock diabetes mellitus myasthenia gravis hypotension and hypovolaemia pancreatitis obstructive bowel disorders inflammatory bowel disorders Extreme caution should be exercised when administering this medicine to patients with phaeochromocytoma, since aggravated hypertension has been reported in association with diamorphine.

Cyclizine may cause a fall in cardiac output associated with increase in heart rate, mean arterial pressure and pulmonary wedge pressure. This medicine should therefore be used with caution in patients with severe heart failure. Acute chest syndrome (ACS) in patients with sickle cell disease (SCD) 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.

Cyclizine should be avoided in patients with porphyria. Therefore use of this medicine should also be avoided in these patients. Case reports of paralysis have been received in patients using intravenous cyclizine. Some of the patients mentioned in these case reports had an underlying neuromuscular disorder.

Thus, intravenous cyclizine should be used with caution in all patients in general, and in patients with underlying neuromuscular disorders in particular. Because cyclizine has anticholinergic activity it may precipitate incipient glaucoma.

It should be used with caution and appropriate monitoring in patients with glaucoma and also in obstructive disease of the gastrointestinal tract. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Cyclizine Tartrate 50mg/ml and Morphine Tartrate 10mg/ml Injection 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 Cyclizine Tartrate 50mg/ml and Morphine Tartrate 10mg/ml Injection 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). Oral P2Y12 inhibitor antiplatelet therapy Within the first day of concomitant P2Y12 inhibitor and morphine treatment, reduced efficacy of P2Y12 inhibitor treatment has […]

1. This medicine, like other opioid-containing preparations, is contraindicated in patients with respiratory depression. Patients with excessive bronchial secretions should not be given this medicine as morphine diminishes the cough response.

This medicine should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. This medicine is contraindicated in patients with head injury or raised intra-cranial pressure. This medicine, as with other opioid-containing preparations, is contraindicated for children less than one year of age.

It is also contraindicated for pre-operative use or during the first 24 hours post- operatively. 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, this medicine 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 this medicine should not be administered to patients with severe hepatic impairment as it may precipitate coma.

This medicine is contra-indicated in the presence of acute alcohol intoxication. The antiemetic properties of cyclizine may increase the toxicity of alcohol. This medicine is contraindicated in individuals receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment.

This medicine, 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. This medicine is contraindicated in patients with paralytic ileus and delayed gastric emptying.

This medicine is contraindicated in biliary and renal tract spasm and in patients immediately after operative interventions in the biliary tract.