Rivastigmine Hexal

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

rivastigmine

Available from:

Hexal AG 

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Dementia; Alzheimer Disease; Parkinson Disease

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.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2009-12-11

Patient Information leaflet

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVASTIGMINE HEXAL 1.5 MG HARD CAPSULES
RIVASTIGMINE HEXAL 3 MG HARD CAPSULES
RIVASTIGMINE HEXAL 4.5 MG HARD CAPSULES
RIVASTIGMINE HEXAL 6 MG HARD CAPSULES
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 HEXAL is and what it is used for
2.
What you need to know before you take Rivastigmine HEXAL
3.
How to take Rivastigmine HEXAL
4.
Possible side effects
5.
How to store Rivastigmine HEXAL
6.
Contents of the pack and other information
1.
WHAT RIVASTIGMINE HEXAL IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine HEXAL 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 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 HEXAL is used for the treatment of adult patients with
mild to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affects memory, intellectual ability
and behav

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine HEXAL 1.5 mg hard capsules
Rivastigmine HEXAL 3 mg hard capsules
Rivastigmine HEXAL 4.5 mg hard capsules
Rivastigmine HEXAL 6 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6 mg 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. The capsules
should be swallowed whole.
Initial dose
1.5