ALRIVA 1.5 (Rivastigmine Capsules 1.5 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

RIVASTIGMINE HYDROGEN TARTRATE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

RIVASTIGMINE HYDROGEN TARTRATE

Unit dalam pakej:

4X7capsule Capsules

Dikeluarkan oleh:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Risalah maklumat

ALVIRA
_Consumer Medication Information Leaflet (RiMUP)_
Rivastigmine Hydrogen Tartarate (1.5mg & 3mg)
1
WHAT IS IN THIS LEAFLET
1.
What ALVIRA is used for
2.
How ALVIRA works
3.
Before you use ALVIRA
4.
How to use ALVIRA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of product
name
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS ALVIRA USED FOR
ALVIRA is used for the treatment of
patients with mild to moderately
severe dementia of Alzheimer’s
Type, also termed probable
Alzheimer’s disease. Treatment of
patients with mild to moderately
severe dementia associated with
Parkinson’s disease.
HOW ALVIRA WORKS
Rivastigmine which is the active
ingredient of ALVIRA inhibits the
degradation of a chemical called
acetylcholine that is present in the
nerve pathways. Rivastigmine
inhibits the enzyme which breaks
down acetylcholine, prolonging its
action in the nerve pathways. This
improves acetylcholine function and
cognitive deficits in dementia
associated with Alzheimer’s disease
and Parkinson’s disease.
BEFORE YOU USE ALVIRA
-When you must not use it
Do not use if you are hypersensitive
to the active substance, other
carbamate derivatives or to any of
the excipients used in the
formulation.
-Before you start to use it
The incidence and severity of
adverse reactions generally increase
with higher doses. Tell your doctor if
you have or are prone to gastric
problems as ALVIRA may increase
gastric acid secretions. Your doctor
must also be aware if you have any
problems relating to the heart before
prescribing you ALVIRA.
Tell your doctor if you have a history
of asthma or a lung condition called
obstructive pulmonary disease.
Tell your doctor if you are pregnant,
planning to get pregnant or if you are
breastfeeding. Despite limited studies
on pregnant and breastfeeding
women, it is not recommended to
take ALVIRA during these stages
unless really necessary as determined
by your doctor.
-Taking other medications
Inform your doctor

Ciri produk

SECTION D MARKETING AUTHORISATION APPLICATION RIVASTIGMINE CAPSULES 3 MG PAGE 1
D 3 PROPOSED PACKAGING INSERT
The proposed packaging insert of Rivastigmine Capsule 3 mg is enclosed
overleaf.
SUMMARY OF PRODUCT CHARACTERISTICS
Rx Only
ALRIVA
Rivastigmine Capsules 1.5 mg, 3 mg
NAME OF DRUG PRODUCT :
Rivastigmine Capsules 1.5 mg
Rivastigmine Capsules 3 mg
(TRADE) NAME OF DRUG PRODUCT :
ALRIVA 1.5
ALRIVA 3
STRENGTH: 1.5 mg, 3 mg.
PHARMACEUTICAL DOSAGE FORM: Capsule.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivastigmine Capsules 1.5 mg:
Each capsule contains Rivastigmine tartrate equivalent to Rivastigmine
1.5 mg.
Rivastigmine Capsules 3 mg:
Each capsule contains Rivastigmine tartrate equivalent to Rivastigmine
3 mg.
PHARMACEUTICAL FORM
_Rivastigmine Capsules 1.5 mg:_ Yellow cap and yellow body colored
size '2'
capsules imprinted in black ink with 'H' on cap and '67 on body,
containing white to
off-white granular powder.
_Rivastigmine Capsules 3 mg:_ Orange cap and orange body colored size
'2'
capsules imprinted in black ink with 'H' on cap and '68 on body,
containing white to
off-white granular powder.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of patients with mild to moderately severe dementia of
alzeimer’s type,
also termed probable Alzheimer’s disease. Treatment of patients with
mild to
moderately severe dementia associated with Parkinson’s disease.
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.
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
tol