APO-PRAMIPEXOLE

What it is

APO-PRAMIPEXOLE contains pramipexole dihydrochloride monohydrate as the active ingredient. APO-PRAMIPEXOLE tablets are round and white for each strength. The medicine is available in three strengths: 0.125 mg, 0.25 mg, and 1 mg tablets.

Approved indications

— Treatment of signs and symptoms of idiopathic Parkinson's disease. — It may be used as monotherapy or in combination with levodopa. — Symptomatic treatment of primary Restless Legs Syndrome.

Dosing overview

Dose adjustment is required in renal impairment. Dose adjustment in patients with hepatic failure is probably not necessary, as approximately 90% of absorbed drug is excreted through the kidneys.

Key safety warnings

**Somnolence and sudden onset of sleep.** APO-PRAMIPEXOLE has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease, with sudden onset of sleep during daily activities sometimes occurring without awareness or warning signs such as excessive drowsiness. Some of these events have been reported as late as one year after the initiation of treatment. Patients should neither drive a car nor operate other complex machinery until they have gained sufficient experience with APO-PRAMIPEXOLE to gauge whether or not it affects their mental and/or motor performance adversely. **Hallucinations and confusion.** Hallucinations and confusion are known side effects of treatment with dopamine agonists and levodopa in Parkinson's disease patients. Hallucinations were more frequent when APO-PRAMIPEXOLE was given in combination with levodopa in Parkinson's disease patients with advanced disease than monotherapy in patients with early disease. **Dyskinesias and dopaminergic complications.** In advanced Parkinson's disease in combination treatment with levodopa, dyskinesias can occur during the initial titration of APO-PRAMIPEXOLE, and if dyskinesias occur, the dose of levodopa should be decreased. It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with APO-PRAMIPEXOLE, and a reduction of the levodopa dose by 25% or more can be justified. **Augmentation in Restless Legs Syndrome.** Treatment of RLS with dopaminergic medications can result in augmentation, which refers to the earlier onset of symptoms in the evening or afternoon, increase in symptoms, and spread of symptoms to involve other extremities. **Compulsive behaviour.** Compulsive behaviour such as pathological gambling, hypersexuality, compulsive shopping, binge eating, medication use and punding has been reported in patients taking dopamine agonists for the treatment of Parkinson's disease, especially at high doses. **Drug withdrawal syndrome.** A drug withdrawal syndrome has been reported during or after discontinuation of dopamine agonists including APO-PRAMIPEXOLE, with withdrawal symptoms including apathy, anxiety, depression, fatigue, sweating and pain that may be severe.

Contraindications

APO-PRAMIPEXOLE is contraindicated in patients with hypersensitivity to pramipexole or any excipients.

Regulatory history

APO-PRAMIPEXOLE was first listed on the ARTG on 17 November 2015, with three tablet strengths (0.125 mg, 0.25 mg, and 1 mg) registered under licence category RE.