Rivastigmine 4.5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine hydrogen tartrate

Available from:

Mylan

ATC code:

N06DA03

INN (International Name):

Rivastigmine hydrogen tartrate

Dosage:

4.5mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5016695004426 5016695004433

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVASTIGMINE 1.5 MG CAPSULES
RIVASTIGMINE 3 MG CAPSULES
RIVASTIGMINE 4.5 MG CAPSULES
RIVASTIGMINE 6 MG 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 of the 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 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
1.
WHAT RIVASTIGMINE IS AND WHAT IT IS USED FOR
The active substance of this medicine 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.
This medicine 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.
This medicine can also be used for the treatment of mild to moderately
severe dementia in adult

Summary of Product characteristics

OBJECT 1
RIVASTIGMINE MYLAN 4.5 MG HARD CAPSULES
Summary of Product Characteristics Updated 22-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Rivastigmine Mylan 4.5 mg hard capsules
2. Qualitative and quantitative composition
Each capsule contains rivastigmine hydrogen tartrate equivalent to
rivastigmine 4.5 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Hard gelatine capsule comprised of a reddish-brown body marked “RG
45” in red ink, and a reddish-
brown cap marked with “G” in red ink. Containing a white 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
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 t