Sifstad 0.7

Rx

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.

Dosage

Parkinson’s disease

• The daily dose is in equally divided doses 3 times a day.
• Initial treatment (daily dosage)
  1^st week: 1.5 tablets Sifstad 0.18.
  2^nd week: 3 tablets Sifstad 0.18 hoặc ¾ tablets Sifstad 0.7.
  3^rd 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.

Usage

• Sifstad 0.7 should be taken orally, swallowed with water, and can be taken either with or without food.

• Hypersensitivity to pramipexole or to any ingredient in the formulation.

Very common

• Dizziness, dyskinesia, somnolence, Nausea.

Common

• Abnormal dreams, confusion, hallucinations, insomnia;
• Headache;
• Visual impairment including diplopia, vision blurred and visual acuity reduced;
• Hypotension; constipation, vomiting;
• Fatigue.

• 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.
• Pramipexole can have a major influence on the ability to drive and use machines. Hallucinations or somnolence can occur. Patients being treated with pramipexole and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.