Rivastigmine Aurobindo 4.5mg Capsules, Hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVASTIGMINE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N06DA03

INN (International Name):

RIVASTIGMINE 4.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

RIVASTIGMINE 4.5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2012-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVASTIGMINE AUROBINDO 1.5 MG CAPSULES, HARD
RIVASTIGMINE AUROBINDO 3 MG CAPSULES, HARD
RIVASTIGMINE AUROBINDO 4.5 MG CAPSULES, HARD
RIVASTIGMINE AUROBINDO 6 MG CAPSULES, HARD
rivastigmine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Rivastigmine Aurobindo is and what it is used for
2.
What you need to know before you take Rivastigmine Aurobindo
3.
How to take Rivastigmine Aurobindo
4.
Possible side effects
5.
How to store Rivastigmine Aurobindo
6.
Contents of the pack and other information
1.
WHAT RIVASTIGMINE AUROBINDO IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine Aurobindo is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. In patients with
Alzheimer’s dementia or dementia due to Parkinson’s disease,
certain nerve cells die in the brain,
resulting in low levels of the neurotransmitter acetylcholine (a
substance that allows nerve cells to
communicate with each other). Rivastigmine works by blocking the
enzymes that break down
acetylcholine:
acetylcholinesterase
and
butyrylcholinesterase.
By
blocking
these
enzymes,
Rivastigmine Aurobindo allows levels of acetylcholine to be increased
in the brain, helping to
reduce the symptoms of Alzheimer’s disease and dementia associated
with Parkinson’s disease.
Rivastigmine Aurobindo is used for the treatment of adult patients
with mild to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affects memory,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Aurobindo 1.5 mg Capsules, Hard
Rivastigmine Aurobindo 3 mg Capsules, Hard
Rivastigmine Aurobindo 4.5 mg Capsules, Hard
Rivastigmine Aurobindo 6 mg Capsules, Hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 2.400 mg rivastigmine tartrate equivalent
to rivastigmine 1.5 mg.
Each hard capsule contains 4.800 mg rivastigmine tartrate equivalent
to rivastigmine 3 mg.
Each hard capsule contains 7.200 mg rivastigmine tartrate equivalent
to rivastigmine 4.5 mg.
Each hard capsule contains 9.600 mg rivastigmine tartrate equivalent
to rivastigmine 6 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
_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.
_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.
_4.5 MG: _
Red cap and red body colored size ‘2’ capsules imprinted in black
ink with ‘H’ on cap and ‘69’ on
body, containing white to off-white granular powder.
_6 MG: _
Red cap and orange body colored size ‘2’ capsules imprinted in
black ink with ‘H’ on cap and ‘70’ on
body, containing white to off-white granular powder.
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 wil