Donepezil 5mg orodispersible tablets sugar free

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Donepezil hydrochloride

Saadav alates:

Actavis UK Ltd

ATC kood:

N06DA02

INN (Rahvusvaheline Nimetus):

Donepezil hydrochloride

Annus:

5mg

Ravimvorm:

Orodispersible tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04110000; GTIN: 5012617022592

Infovoldik

Donepezil Orodispersible 5mg & 10mg tablet leaflet - UK
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TECHNICAL APPROVAL
black
Code area
AAAI3052
1
17.09.15
jh
Genepharm
180 x 240
7 pt
17.09.15
24.09.15
* 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.
DONEPEZIL HYDROCHLORIDE 5MG AND 10MG
ORODISPERSIBLE TABLETS
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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.
• The full name of this medicine is Donepezil hydrochloride
5mg and 10mg Orodispersible Tablets but within the
leaflet it will be referred to as Donepezil tablets.
WHAT IS IN THIS LEAFLET:
1 WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED
FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL
TABLETS
3 HOW TO TAKE DONEPEZIL TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DONEPEZIL TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED
FOR
Donepezil tablets belong to a group of medicines called
acetylcholinesterase inhibitors. It is used to treat the symptoms of
dementia in people diagnosed as having mild to moderately severe
Alzheimer’s disease. Donepezil tablets are for use in adult patients
only.
2 WHAT YOU NEED

Toote omadused

OBJECT 1
DONEPEZIL HYDROCHLORIDE 5MG ORODISPERSIBLE
TABLETS
Summary of Product Characteristics Updated 18-Jan-2016 | Accord-UK Ltd
1. Name of the medicinal product
Donepezil hydrochloride 5mg Orodispersible Tablets
2. Qualitative and quantitative composition
Each Donepezil hydrochloride 5mg orodispersible tablet contains 5 mg
donepezil hydrochloride.
Excipients with known effect:
Each Donepezil hydrochloride 5 mg orodispersible tablet contains 124.7
mg lactose (as lactose
monohydrate) and 5 mg aspartame (E951).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet.
Donepezil hydrochloride 5 mg orodispersible tablets are white to
off-white round, flat tablets with
bevelled edges, embossed with '5' on one side.
4. Clinical particulars
4.1 Therapeutic indications
Donepezil hydrochloride 5mg Orodispersible Tablets is indicated for
the symptomatic treatment of mild
to moderately severe Alzheimer's dementia.
4.2 Posology and method of administration
Posology
_Adults/Elderly _
Treatment is initiated at 5 mg/day (once-a-day dosing).
The 5 mg/day dose should be maintained for at least one month in order
to allow the earliest clinical
responses to treatment to be assessed and to allow steady-state
concentrations of donepezil hydrochloride
to be achieved. Following a one-month clinical assessment of treatment
at 5 mg/day, the dose of
Donepezil hydrochloride 5mg Orodispersible Tablets can be increased to
10 mg/day (once-a-day dosing).
The maximum recommended daily dose is 10 mg. Doses greater than 10
mg/day have not been studied in
clinical trials.
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of
Alzheimer's dementia. Diagnosis should be made according to accepted
guidelines (e.g. DSM IV, ICD
10). Therapy with donepezil should only be started if a caregiver is
available who will regularly monitor
medicinal product intake for the patient. Maintenance treatment can be
continued for as long as a
therapeutic benefit for the patient