Almuriva 4.6mg/24hours transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine

Available from:

Sandoz Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine

Dosage:

4.6mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5055382301424

Summary of Product characteristics

OBJECT 1
ALMURIVA 4.6 MG/24H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 04-Oct-2017 | Sandoz
Limited
1. Name of the medicinal product
Almuriva 4.6 mg/24h transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Each transdermal patch of 5 cm
2
contains 9 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers. The outside of
the backing layer is beige and labelled with “RIV”, 4.6 mg/24 h.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderately severe Alzheimer's
dementia.
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. Diagnosis should be made according to current
guidelines. Similar to any
treatment initiated in patients with dementia, therapy with
rivastigmine should only be started if a
caregiver is available to regularly administer and monitor the
treatment.
Posology
TRANSDERMAL PATCHES
RIVASTIGMINE _IN VIVO_ RELEASE RATES PER 24 H
Almuriva 4.6 mg/24 h
4.6 mg
Almuriva 9.5 mg/24 h
9.5 mg
Almuriva 13.3 mg/24 h*
13.3 mg
*The 13.3 mg/24 h dose strength cannot be achieved with this product.
For conditions where this strength
should be used, please refer to other rivastigmine products for which
transdermal patches of the 13.3
mg/24 h strength are available.
Initial dose
Treatment is started with 4.6 mg/24 h.
Maintenance dose
After a minimum of four weeks of treatment and if well tolerated
according to the treating physician, the
dose of 4.6 mg/ 24 h should be increased to 9.5 mg/24 h, the daily
recommended effective dose, which
should be continued for as long as the patient continues to
demonstrate therapeutic benefit.
Dose escalation
9.5 mg/24 h is the recommended daily effective dose which should be
continued for as