SEVREDOL

4). Route of administration Oral. Treatment goals and discontinuation Before initiating treatment with Sevredol 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 Sevredol tablets, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment Sevredol tablets should not be used longer than necessary. Discontinuation of therapy An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore, the dose should be gradually reduced prior to discontinuation.

Adults and children over 12 years. The dosage of Sevredol tablets is dependent on the severity of pain and the patient’s previous history of analgesic requirements. One tablet to be taken every four hours or as directed by a physician.

Increasing severity of pain or tolerance to morphine will require increased dosage of Sevredol tablets using 10 mg, 20 mg or 50 mg alone or in combination to achieve the desired relief. Patients receiving Sevredol 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.

Usually such increased requirement is of the order of 100%. In such patients, individual dose adjustments are required. Elderly A reduction in adult dosage may be advisable. Paediatric population 3-5 years 5mg 4-hourly 6-12 years 5-10mg 4-hourly

In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with Sevredol tablets but should they occur the tablets can be readily combined with an anti-emetic if required.

Constipation may be treated with appropriate laxatives.

The following frequencies are the basis for assessing undesirable effects:

Very common (≥1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). 4) Eye disorders Visual impairment Miosis Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Bradycardia Tachycardia Vascular disorders Facial flushing Hypotension Hypertension Respiratory thoracic and mediastinal disorders Bronchospasm Pulmonary oedema Respiratory depression Cough decreased Central sleep apnoea syndrome Very Common Common Uncommon Not known Gastrointestinal disorders Constipation Nausea Abdominal pain Anorexia Dry mouth Vomiting Dyspepsia Ileus Taste perversion Pancreatitis Hepatobiliary disorders Increased hepatic enzymes Biliary pain Exacerbation of pancreatitis Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Rash Urticaria Acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Urinary retention Ureteric spasm Reproductive system and breast disorders Amenorrhoea Decreased libido Erectile dysfunction General disorders and administration site conditions Asthenia Fatigue Malaise Pruritus Peripheral oedema Drug withdrawal syndrome Drug tolerance Drug withdrawal (abstinence) syndrome neonatal Drug dependence and withdrawal (abstinence) syndrome Repeated use of Sevredol 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.

5) • Opioid Use Disorder • Acute alcoholism • Delirium tremens • Head injury, intracranial lesions or increased intracranial pressure, reduced level of consciousness of uncertain origin. • Hypotension with hypovolaemia • Hypothyroidism, • Adrenocortical insufficiency • Convulsive disorders • Biliary tract disorders • Pancreatitis • Prostatic hypertrophy • Inflammatory bowel disorders • Severely impaired renal function • Severely impaired hepatic function • Constipation As with all narcotics a reduction in dosage may be advisable in the elderly.

Sevredol tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Sevredol tablets should be discontinued immediately. Respiratory Depression The major risk of opioid excess is respiratory depression.

Sleep-related breathing disorders Opioids can 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 fashion. 8). 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.

Morphine may lower the seizure threshold in patients with a history of epilepsy. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Sevredol tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

1. • Severe chronic obstructive pulmonary disease • Severe bronchial asthma • Severe respiratory depression with hypoxia and/or hypercapnia • Paralytic ileus • Acute abdomen • Head injury • Delayed gastric emptying • Known morphine sensitivity • Acute hepatic disease • Concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use.

Not recommended during pregnancy. Not recommended for children below 3 years of age.