Rivastigmine 6mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine hydrogen tartrate

Available from:

Sandoz Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine hydrogen tartrate

Dosage:

6mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5050650080070 5050650080087

Summary of Product characteristics

OBJECT 1
RIVASTIGMINE SANDOZ 1.5 MG HARD CAPSULES
Summary of Product Characteristics Updated 26-Aug-2016 | Sandoz
Limited
1. Name of the medicinal product
Rivastigmine Sandoz 1.5 mg hard capsules
Rivastigmine Sandoz 3 mg hard capsules
Rivastigmine Sandoz 4.5 mg hard capsules
Rivastigmine Sandoz 6 mg hard capsules
2. Qualitative and quantitative composition
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1,5mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4,5mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6mg rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule
Off-white to slightly yellow powder in a capsule with yellow cap and
yellow body, with red imprint
“RIV 1.5 mg“ on the body.
Off-white to slightly yellow powder in a capsule with orange cap and
orange body, with red imprint
“RIV 3 mg“ on the body.
Off-white to slightly yellow powder in a capsule with red cap and red
body, with white imprint “RIV 4.5
mg“ on the body.
Off-white to slightly yellow powder in a capsule with red cap and
orange body, with red imprint “RIV 6
mg“ on the 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 intake of the medicinal product
by the patient.
Posology
Rivastigmine should be administered twice a day, with morning and
evening meals