Rivastigmine 1.5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine hydrogen tartrate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine hydrogen tartrate

Dosage:

1.5mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000

Patient Information leaflet

Placement for Pharmacode no.
Placement for Pharmacode no.
Size : 160 x 350 mm Front/Back
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.
1. What Rivastigmine is and what it is used for
2. What you need to know before you take
Rivastigmine
3. How to take Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Contents of the pack and other information
WHAT RIVASTIGMINE IS AND WHAT IT
IS USED FOR
The active substance of Rivastigmine 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 is used for the symptomatic
treatment of in adult patients with mild to
moderately severe Alzheimer’s demetia, a
progression brain disorder that gradually affects
memory, intellectual ability and behaviour. The
capsules can also be used for the symptomatic
treatment of mild to moderately severe dementia
in adult patients with Parkinson’s disease.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE RIVASTIGMIN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rivastigmine 1.5 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1.5 mg rivastigmine as rivastigmine hydrogen
tartrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Size “2”, hard gelatin capsules with opaque yellow cap and opaque
yellow
body, containing off white to slightly yellow 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 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 previous
well-tolerated d