Prometax

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

rivastigmine

Available from:

Novartis Europharm Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Alzheimer Disease; Parkinson Disease; Dementia

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: 46

Authorization status:

Authorised

Authorization date:

1998-12-03

Patient Information leaflet

90
B. PACKAGE LEAFLET
91
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROMETAX 1.5 MG HARD CAPSULES
PROMETAX 3.0 MG HARD CAPSULES
PROMETAX 4.5 MG HARD CAPSULES
PROMETAX 6.0 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prometax is and what it is used for
2.
What you need to know before you take Prometax
3.
How to take Prometax
4.
Possible side effects
5.
How to store Prometax
6.
Contents of the pack and other information
1.
WHAT PROMETAX IS AND WHAT IT IS USED FOR
The active substance of Prometax 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, Prometax
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.
Prometax 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
behaviour. The capsules and oral solution can also be used for the
treatment of dementia in adult
patients

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Prometax 1.5 mg hard capsules
Prometax 3.0 mg hard capsules
Prometax 4.5 mg hard capsules
Prometax 6.0 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prometax 1.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Prometax 3.0 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3.0 mg rivastigmine.
Prometax 4.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Prometax 6.0 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
6.0 mg rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Prometax 1.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with yellow cap and
yellow body, with red imprint
“ENA 713 1,5 mg” on body.
Prometax 3.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with orange cap and
orange body, with red imprint
“ENA 713 3 mg” on body.
Prometax 4.5 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and red
body, with white imprint
“ENA 713 4,5 mg” on body.
Prometax 6.0 mg hard capsules
Off-white to slightly yellow powder in a capsule with red cap and
orange body, with red imprint
“ENA 713 6 mg” on body.
3
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 re