ELDEPRYL

Posology 10 mg daily either alone or as an adjunct to levodopa or levodopa/peripheral decarboxylase inhibitor. When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an average of 10 -30%. Reduction of the levodopa dose should be gradual in steps of 10% every 3 to 4 days.

No dosage adjustment is required for patients with renal or hepatic impairment. Method of administration Selegiline may be administered either as a single dose in the morning or in two divided doses of 5 mg, taken at breakfast and lunch.

The following undesirable effects have been reported with selegiline during clinical trials and/or post-marketing use. They are listed below as MedDRA preferred term by system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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 established from the available data). System Organ Class Frequency Undesirable effects Infections and infestations Uncommon Pharyngitis Blood and lymphatic system disorders Uncommon Leucocytopenia, thrombocytopenia Metabolism and nutrition disorders Uncommon Loss of appetite Common Sleeping disorders, confusion, hallucinations, depression Uncommon Abnormal dreams, agitation, anxiety, psychoses, mood change Psychiatric disorders Not known Impulse control disorders and compulsions* Nervous system Common Abnormal movements (such as dyskinesias, akinesia, bradykinesia), dizziness, headache, impaired balance, tremor disorders Uncommon mild transient sleep disorder Eye disorders Uncommon Blurred vision Ear and labyrinth disorders Common Vertigo Common Bradycardia Cardiac disorders Uncommon Arrhythmias, palpitations, angina pectoris, supraventricular tachycardia Common hypotension, hypertension Uncommon Orthostatic hypotensionVascular disorders Rare Postural hypotension Common Nasal congestion, sore throat Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Very common Stomatitis Common Nausea, constipation, diarrhoea, mouth ulceration Gastrointestinal disorders Uncommon Dry mouth Hepato-biliary disorders Uncommon Transient rise of serum alanine aminotransferase (ALAT) Common Sweating increased Uncommon Hair loss, skin eruptions Skin and subcutaneous tissue Rare Skin reactions Common Arthralgia, back pain, muscle cramps Muskuloskeletal and lymphatic system disorders Uncommon Myopathy Uncommon Micturition disorders Renal and urinary disorders Not known Urinary retention Common FatigueGeneral disorders and administration site conditions Uncommon Chest pain, irritability, ankle oedema Injury, poisoning and procedural Complications Common Fall Investigations Common Mild hepatic enzymes increased * Parkinson's disease patients treated with dopamine agonists and other dopaminergic treatments have been reported as exhibiting impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, binge eating and compulsive eating, compulsive spending or buying/shopping, and different kinds of compulsive/repetitive activities (punding).

The precise dose at which selegiline becomes a non-selective inhibitor of all MAO has not been determined, but with doses higher than 10 mg/day there is a theoretical risk of hypertension after ingestion of tyramine-rich food. Concomitant treatment with medicines which inhibit MAO-A, (or non-selective MAO inhibitors) can cause hypotensive reactions.

Hypotension, sometimes sudden in onset, has been reported with conventional selegiline. 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Special care should be taken when administering selegiline to patients who have labile hypertension, cardiac arrhythmias, severe angina pectoris, psychosis or a history of peptic ulceration as aggravation of these conditions may occur during treatment Although serious hepatic toxicity has not been observed, caution is recommended in patients with a history of hepatic dysfunction.

Transient or continuing abnormalities with a tendency for elevated plasma concentrations of liver enzymes have been described during long-term therapy with conventional tablets of selegiline. Selegiline should be used with caution in severe liver or kidney dysfunction.

Caution should be exercised in patients receiving MAO inhibitors during general anaesthesia in surgery. MAO inhibitors, including selegiline, may potentiate the effects of CNS depressants used for general anaesthesia. 5). Some studies concluded in an increased risk of mortality in patients receiving selegiline and levodopa compared to those receiving levodopa only.

1. g. sumatriptan, naratriptan, zolmitriptan and rizatriptan). Selegiline is also contra-indicated for concomitant use with pethidine and other opioids. g. g citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline. 5 interactions).

g. linezolid. 5). Selegiline should not be used in patients with active duodenal or gastric ulcer. Selegiline should not be used in patients with other extrapyramidal disorders not related to dopamine deficiency. Selegiline in combination with levodopa is contra-indicated in severe cardiovascular disease, arterial hypertension, hyperthyroidism, phaeochromocytoma, narrow-angle glaucoma, prostatic adenoma with appearance of residual urine, tachycardia, arrhythmias, severe angina pectoris, psychoses, advanced dementia and thyrotoxicosis.