RIVASTIGMINE 6 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RIVASTIGMINE

Available from:

Accord Healthcare Limited

ATC code:

N06DA03

INN (International Name):

RIVASTIGMINE

Dosage:

6 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anticholinesterases

Authorization status:

Authorised

Authorization date:

2018-04-20

Patient Information leaflet

* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
RIVASTIGMINE 1.5MG, 3MG, 4.5MG AND 6MG HARD CAPSULES UK_IRE
Black
Code Area
BBBA1195
C.Grant
23/08/17
20/09/17
S.Anson
170 x 440
9pts
Specifar S.A.
24/08/17
11/09/17
03
_Continued top of next column_
BBBA1195
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued over page_
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.
•
The full name of this medicine is Rivastigmine
1.5mg, 3mg, 4.5mg and 6mg Hard Capsules
but within this leaflet it will be referred to as
Rivastigmine Capsules.
WHAT IS IN THIS LEAFLET:
1
WHAT RIVASTIGMINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RIVASTIGMINE CAPSULES
3
HOW TO TAKE RIVASTIGMINE CAPSULES
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RIVASTIGMINE CAPSULES
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT RIVASTIGMINE CAPSULES ARE AND
WHAT THEY ARE USED FOR
The active substance of Rivastigmine Capsules 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,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivastigmine 6 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 (Capsule).
Off-white to slightly yellow powder in a hard capsule with red cap and
orange body, with red imprint “RIV 6mg” on
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 mg twice a day.
_Dose titration_
The starting dose is 1.5 mg twice a day. If this dose is well
tolerated after a minimum of two weeks of treatment, the
dose may be increased to 3 mg twice a day. Subsequent increases to 4.5
mg and then 6 mg twice a day should also be
based on good tolerability of the current dose and may be considered
after a minimum of two weeks of treatment at that
dose level.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of
appetite), weight decrease or worsening of
extrapyramidal symptoms (e.g. tremor) in patients with dementia
associated with Parkinson’s disease are observed
during treatment, these may respond to omitting one or more doses. If
adverse reactions persist, the daily dose should
be temporarily reduced to the pre