RIVASTIGMINE ORION
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
26-05-2024
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Virkt innihaldsefni:
RIVASTIGMINE
Fáanlegur frá:
Orion Corporation
Skammtar:
3 Milligram
Lyfjaform:
Capsules Hard
Leyfisdagur:
2009-06-25
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivastigmine Orion 3 mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate equivalent to 3.0 mg, rivastigmine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Off-white to slightly orange powder in a hard gelatin capsule with opaque orange cap and opaque yellow body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
- Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s
dementia or dementia associated with Parkinson’s disease. Diagnosis should be made according to current guidelines.
Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor medicinal
product intake by the patient.
Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed
whole.
Initial dose: 1.5 mg twice a day.
Dose titration: The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of
treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day
should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of
treatment at that dose level.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of
extrapyramidal symptoms (e.g. tremor) in patients wi
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