ZIPEXOLE pramipexole dihydrochloride 0.5 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

pramipexole dihydrochloride monohydrate, Quantity: 0.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: silicon dioxide; povidone; pregelatinised maize starch; magnesium stearate; mannitol

Administration route:

Oral

Units in package:

10, 30, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pramipexole tablets are indicated for:,-the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.,-the symptomatic treatment of primary Restless Legs Syndrome.

Product summary:

Visual Identification: White, oval, uncoated tablets debossed with 'CL' and '4' debossed on one side with breakline in between and a breakline on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-09-23