PHYSEPTONE

4). The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress).

Posology The dose is adjusted according to the degree of dependence with the aim of gradual reduction. Adults Initially 10 – 2 0mg per day, increasing by 10 - 20mg daily until there is no sign of withdrawal or intoxication. The usual dose is 40-60 mg per day.

Elderly In the case of the elderly or ill patients, repeated doses should be given with extreme caution. 3) Dosage in pregnancy: Drug withdrawal needs to be achieved 4-6 weeks before delivery if neonatal abstinence syndrome is to be certain to be avoided, but abrupt withdrawal can cause intrauterine death.

Detoxification to abstinence is least stressful to mother and foetus if undertaken during the mid trimester. Abstinence syndrome may not occur in the neonate for some days after birth. In the event that withdrawal is not possible prior to delivery, methadone administered to the mother may result in prolonged respiratory depression in the neonate and the administration of opioid antagonists may be required.

Method of administration For oral use only.

Endocrine Disorders Hyperprolactinaemia. Psychiatric disorders Confusion particularity at the start of the treatment can occur Changes of mood, including euphoria, and hallucinations are occasionally reported. 4). Nervous System Disorders Drowsiness and headache.

Methadone has the potential to increase intracranial pressure, particularly in circumstances where it is already raised. Eye Disorders Miosis, dry eyes Ear and labyrinth disorders Vertigo. Cardiac Disorders Bradycardia and palpitations can occur.

Cases of QT prolongation and torsades de pointes have been rarely reported. Vascular disorders Orthostatic hypotension, facial flushing. Respiratory, thoracic and mediastinal disorders Exacerbation of existing asthma, dry nose, respiratory depression particularly with larger doses.

Gastrointestlnal disorders Nausea and vomiting particularly at the start of treatment can occur. Constipation, dry mouth. Skin and subcutaneous tissue disorders Rashes. Long-term administration may produce excessive sweating Renal and urinarv disorders Less commonly micturition difficulties are observed.

Metabolism and nutrition disorders SOC Hypoglycaemia. Reproductive system and breast disorders Galactorrhoea, dysmenorrhoea, amenorrhoea General disorders Hypothermia, drug withdrawal syndrome. 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.

In the case of elderly or ill patients, repeated doses should only be given with extreme caution. Methadone is a drug of addiction and is controlled under the Misuse of Drugs Act 1971 (Schedule 2). Methadone has a long-half life and can therefore accumulate.

A single dose which will relieve symptoms may, if repeated on a daily basis, lead to accumulation and possibly death. Tolerance and dependence of the morphine type may occur. Methadone can produce drowsiness and reduce consciousness although tolerance to these effects can occur after repeated use.

3), convulsive disorders, depressed respiratory reserve, hypotension, shock, prostatic hyperplasia, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, myasthenia gravis or hypothyroidism. In cases of hepatic or renal impairment the use of methadone should be avoided or given in reduced doses.

Cases of QT interval prolongation and torsade de pointes have been reported during treatment with methadone, particularly at high doses (>100 mg/d). g. e. 5). In patients with recognised risk factors for QT prolongation, or in case of concomitant treatment with drugs that have a potential for QT-prolongation, ECG monitoring is recommended prior to methadone treatment, with a further ECG test at dose stabilisation.

ECG monitoring is recommended, in patients without recognised risk factors for QT prolongation, before dose titration above 100 mg/d and at seven days after titration. Caution should be exercised in patients who are concurrently taking CNS depressants.

Methadone, as with other opiates, has the potential to increase intracranial pressure especially where it is already raised. Drug dependence, tolerance and potential for abuse Prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.

, major depression). Overuse or misuse may result in overdose and/or death. 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.

1. 5) • Use during labour (prolonged duration of action increases the risk of neonatal depression) • Children (serious risk of toxicity) • Patients with ulcerative colitis, since methadone may precipitate toxic dilation or spasm of the colon.

• Patients dependent on non-opioid drugs • Patients with severe hepatic impairment as it may precipitate hepatic encephalopathy. • Patients with biliary and renal tract spasm