Donepezil Mylan 5 mg Munsönderfallande tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

donepezilhydroklorid, vattenfri

Tillgänglig från:

Mylan AB

ATC-kod:

N06DA02

INN (International namn):

donepezil hydrochloride, anhydrous

Dos:

5 mg

Läkemedelsform:

Munsönderfallande tablett

Sammansättning:

donepezilhydroklorid, vattenfri 5 mg Aktiv substans; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Terapiområde:

Donepezil

Produktsammanfattning:

Förpacknings: Blister, 7 tabletter (Al); Blister, 98 tabletter (Al); Blister, 14 tabletter (Al); Blister, 84 tabletter (Al); Blister, 60 tabletter (Al); Blister, 28 tabletter (Al); Blister, 120 tabletter (Al); Blister, 10 tabletter (Al); Blister, 100 tabletter (Al); Blister, 56 tabletter (Al); Blister, 180 tabletter (Al); Blister, 30 tabletter (Al); Blister, 50 tabletter (Al)

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2010-05-21

Bipacksedel

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DONEPEZIL MYLAN 5 MG ORODISPERSIBLE TABLETS
DONEPEZIL MYLAN 10 MG ORODISPERSIBLE TABLETS
donepezil hydrochloride
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.
WHAT IS IN THIS LEAFLET
1.
What Donepezil Mylan is and what it is used for
2.
What you need to know before you take Donepezil Mylan
3.
How to take Donepezil Mylan
4.
Possible side effects
5.
How to store Donepezil Mylan
6.
Contents of the pack and other information
1.
WHAT DONEPEZIL MYLAN IS AND WHAT IT IS USED FOR
Donepezil Mylan contains the active substance donepezil hydrochloride.
Donepezil hydrochloride belongs to a group of medicines called
acetylcholinesterase
inhibitors. Donepezil hydrochloride increases the levels of a
substance (acetylcholine) in the
brain involved in memory function by slowing down the breakdown of
that substance.
It is used to treat the symptoms of dementia in people diagnosed as
having mild to moderately
severe Alzheimer’s disease. Symptoms of the illness include
increasing memory loss,
confusion and behavioural changes. As a result, sufferers of
Alzheimer’s disease find it more
difficult to carry out their normal daily activities.
It is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL MYLAN
DO NOT TAKE DONEPEZIL MYLAN:
-
if you are allergic to donepezil, to piperidine derivative medicines
(your doctor or
pharmacist can advise on this) or any of the other ingredients of this
medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to you

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Donepezil Mylan 5 mg orodispersible tablets
Donepezil Mylan 10 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains 5 mg donepezil hydrochloride (as
monohydrate), equivalent to 4.56
mg of donepezil free base.
Each 10 mg tablet contains 10 mg donepezil hydrochloride (as
monohydrate), equivalent to
9.12 mg of donepezil free base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Donepezil Mylan 5 mg are white coloured round flat bevelled edged
tablets, debossed with
“DL 5” on one side and “M” on the other side.
Donepezil Mylan 10 mg are yellow coloured round flat bevelled edged
tablets, debossed with
“DL 10” on one side and “M” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil Mylan 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 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 hydrochloride should only be started if a
caregiver is available who
will regularly monitor drug intake for the patient.
Maintenance treatment can be continued for as long as a therapeutic
benefit for the pati