Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
RIVASTIGMINE HYDROGEN TARTRATE EQV RIVASTIGMINE
NOVARTIS (SINGAPORE) PTE LTD
N06DA03
1.5 mg
CAPSULE
RIVASTIGMINE HYDROGEN TARTRATE EQV RIVASTIGMINE 1.5 mg
ORAL
Prescription Only
Siegfried Barbera S.L.
ACTIVE
1998-09-24
EXELON Hard capsules. Brain-selective cholinesterase inhibitor. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Hard capsules ACTIVE SUBSTANCE Exelon hard capsules contain 1.5, 3.0, 4.5 or 6.0 mg rivastigmine (as the hydrogen tartrate salt). Certain dosage strengths may not be available in all countries. EXCIPIENTS 1.5 MG CAPSULES Gelatin; iron oxide, yellow (E 172); magnesium stearate; methylhydroxypropylcellulose; microcrystalline cellulose; printing ink, based on iron oxide, red (E 172); silica, colloidal anhydrous; titanium dioxide (E 171). 3.0 AND 6.0 MG CAPSULES Gelatin; iron oxide, red (E 172); iron oxide, yellow (E 172); magnesium stearate; methylhydroxypropylcellulose; microcrystalline cellulose; printing ink, based on iron oxide, red (E 172); silica, colloidal anhydrous; titanium dioxide (E 171). 4.5 MG CAPSULES Gelatin; iron oxide, red (E 172); iron oxide, yellow (E 172); magnesium stearate; methylhydroxypropylcellulose; microcrystalline cellulose; printing ink, based on titanium dioxide (E 171); silica, colloidal anhydrous; titanium dioxide (E 171). Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer’s Disease or Alzheimer’s Disease. Treatment of patients with mild to moderately severe dementia associated with Parkinson’s disease. Novartis Page 2 Country Specific Package Leaflet 27 May 2014 Exelon hard capsules DOSAGE AND ADMINISTRATION ADMINISTRATION Exelon hard capsules should be administered twice a day, with morning and evening meals. Izlasiet visu dokumentu
Exelon Capsule Dec 2022.SIN Page 1 of 18 EXELON Hard capsules. Brain-selective cholinesterase inhibitor. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Hard capsules ACTIVE SUBSTANCE Each Exelon hard gelatin capsule contains rivastigmine hydrogen tartrate corresponding to 1.5, 3.0, 4.5 or 6.0 mg rivastigmine base. Certain dosage strengths may not be available in all countries. EXCIPIENTS CAPSULES CAPSULE CONTENT: microcrystalline cellulose; magnesium stearate; hypromellose; silica, colloidal anhydrous. CAPSULES SHELL: gelatin; titanium dioxide (E 171); iron oxide, yellow (E 172); printing ink, based on iron oxide, red (E 172) and shellac. Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer’s Disease or Alzheimer’s Disease. Treatment of patients with mild to moderately severe dementia associated with Parkinson’s disease. DOSAGE REGIMEN AND ADMINISTRATION ADMINISTRATION Exelon Capsule Dec 2022.SIN Page 2 of 18 DOSAGE REGIMEN 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’ treatment at that dose level. If adverse effects (e.g., nausea, vomiting, abdominal pain, or loss of appetite) or weight decrease are observed during treatment, these may respond to omitting one or more doses. If adverse effects persist, the daily dose should be reduced to the previous well-tolerated dose. MAINTENANCE DOSE 1.5 mg to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well-tolerated dose. RECOMMENDED MAXIMUM DAILY DOSE 6 mg twice a day. RE-INITIATION OF THERAPY The incidence and severity of adverse events are ge Izlasiet visu dokumentu