Indications
Treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.
Symptomatic treatment of moderate to severe idiopathic restless legs syndrome.
Contraindications
Hypersensitivity to pramipexole or to any ingredient in the formulation.
Compositon/Ingredients
Pramipexole 0.18mg
Dosage and administration
Parkinson’s disease: The daily dose is in equally divided doses 3 times a day.
Initial treatment (daily dosage)
- 1st week: 1.5 tablets Sifstad 0.18.
- 2nd week: 3 tablets Sifstad 0.18 hoặc ¾ tablets Sifstad 0.7.
- 3rd week: 6 tablets Sifstad 0.18 hoặc 1.5 tablets Sifstad 0.7.
- Then the daily dose should be increased by 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7 at weekly intervals up to a maximum dose of 18 tablets Sifstad 0.18 or 4.5 tablets Sifstad 0.7 per day.
Maintenance treatment (daily dosage)
- 5 tablets Sifstad 0.18 to a maximum of 18 tablets Sifstad 0.18 or 4.5 tablets Sifstad 0.7.
- Efficacy was observed starting at a daily dose of 6 tablets Sifstad 0.18 or 1.5 tablets Sifstad 0.7.
Treatment discontinuation: Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome. Pramipexole should be tapered off until the daily dose has been reduced to 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7. Thereafter the dose should be reduced by 1.5 tablets Sifstad 0.18.
Patients with renal impairment:
- Clcr = 20 – 50 ml/min, start at ½ tablet Sifstad 0.18 twice a day, a maximum daily dose is 9 tablets Sifstad 0.18 or 2 ¼ tablets Sifstad 0.7.
- Clcr < 20 ml/min, start at ½ tablet Sifstad 0.18, a maximum daily dose is 6 tablets Sifstad 0.18 or 1.5 tablets Sifstad 0.7.
Restless legs syndrome
Start with ½ tablet Sifstad 0.18 taken once daily 2 – 3 hours before bedtime, the dose may be increased every 4 – 7 days to a maximum of 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7 per day.
Patient’s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Treatment discontinuation: Can be discontinued without tapering off.
Precaution
Not recommended for use in pregnant and breast-feeding women.
In case of severe cardiovascular disease, care should be taken.
The following should be taken into account: Hallucinations; ophthalmologic monitoring is recommended at regular intervals; the dose of levodopa should be decreased if dyskinesia occurs; caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole; symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Patients being treated with pramipexole and presenting with somnolence and/or sudden sleep must refrain from driving or operating machines.
Co-administration of antipsychotic medicinal products with pramipexole should be avoided.
Storage
Store at temperature below 30°C, protect from light.
