Rivastigmine 6mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Rivastigmine hydrogen tartrate

Dostępny od:

Actavis UK Ltd

Kod ATC:

N06DA03

INN (International Nazwa):

Rivastigmine hydrogen tartrate

Dawkowanie:

6mg

Forma farmaceutyczna:

Capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04110000; GTIN: 5690528373103 5690528373110

Ulotka dla pacjenta

Rivastigmine All Strengths Capsules PIL Central Procedure Group - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions: 170 x 440
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 07.12.15
supplier:
technically app. date: 10.12.15
min pt size: 9 pts
TECHNICAL APPROVAL
AAAI5561
2
07.12.15
R.Paul
10.12.15
R.Paul
Iceland
* Please note that only Actavis Global Artwork Studios are 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.
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 Rivastigmine Actavis is and what it is used for
2. What you need to know before you take Rivastigmine
Actavis
3. How to take Rivastigmine Actavis
4. Possible side effects
5. How to store Rivastigmine Actavis
6. Contents of the pack and other information
1. WHAT RIVASTIGMINE ACTAVIS IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine Actavis 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 butyry

Charakterystyka produktu

OBJECT 1
RIVASTIGMINE ACTAVIS 1.5MG HARD CAPSULES
Summary of Product Characteristics Updated 18-Jan-2016 | Accord-UK Ltd
1. Name of the medicinal product
Rivastigmine Actavis 1.5 mg hard capsules
Rivastigmine Actavis 3 mg hard capsules
Rivastigmine Actavis 4.5 mg hard capsules
Rivastigmine Actavis 6 mg hard capsules
2. Qualitative and quantitative composition
Rivastigmine Actavis 1.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
1.5 mg rivastigmine.
Rivastigmine Actavis 3 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
3 mg rivastigmine.
Rivastigmine Actavis 4.5 mg hard capsules
Each capsule contains rivastigmine hydrogen tartrate corresponding to
4.5 mg rivastigmine.
Rivastigmine Actavis 6 mg hard capsules
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).
Rivastigmine Actavis 1.5 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with yellow cap
and yellow body, with red imprint
“RIV 1.5mg“ on body.
Rivastigmine Actavis 3 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with orange cap
and orange body, with red imprint
“RIV 3mg“ on body.
Rivastigmine Actavis 4.5 mg hard capsules
Off-white to slightly yellow powder in a hard capsule with red cap and
red body, with white imprint
“RIV 4.5mg“ on body.
Rivastigmine Actavis 6 mg hard capsules
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 o