Quetiapin Orion 100 mg Filmdragerad tablett

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

kvetiapinfumarat

Διαθέσιμο από:

Orion Corporation

Φαρμακολογική κατηγορία (ATC):

N05AH04

INN (Διεθνής Όνομα):

quetiapine fumarate

Δοσολογία:

100 mg

Φαρμακοτεχνική μορφή:

Filmdragerad tablett

Σύνθεση:

laktosmonohydrat Hjälpämne; kvetiapinfumarat 115,12 mg Aktiv substans

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

Förpacknings: Blister, 10 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2019-01-28

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUETIAPIN ORION 25 MG FILM-COATED TABLETS
QUETIAPIN ORION 100 MG FILM-COATED TABLETS
QUETIAPIN ORION 200 MG FILM-COATED TABLETS
QUETIAPIN ORION 300 MG FILM-COATED TABLETS
quetiapine
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 Quetiapin Orion
is and what it is used for
2.
What you need to know before you take Quetiapin Orion
3.
How to take Quetiapin Orion
4.
Possible side effects
5.
How to store Quetiapin Orion
6.
Contents of the pack and other information
1.
WHAT QUETIAPIN ORION IS AND WHAT IT IS USED FOR
Quetiapin Orion contains a substance called quetiapine
. This belongs to a group of medicines
called antipsychotics.
Quetiapin Orion can be used to treat several illnesses, such as:
-
Bipolar depression: where you feel sad. You may find that you feel
depressed, feel guilty, lack
energy, lose your appetite or can’t sleep.
-
Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or have poor
judgment including being aggressive or disruptive.
-
Schizophrenia: where you may hear or feel things that are not there,
believe things that are not
true or feel unusually suspicious, anxious, confused, guilty, tense or
depressed.
Your doctor may continue to prescribe Quetiapin Orion even when you
are feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
QUETIAPIN ORION
DO NOT TAKE
QUETIAPIN ORION
-
if you are allergic
to quetiapine or any of the other ingredients of this medicine (listed
in section
6)
-
if you are taking any

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Quetiapin Orion 25 mg film-coated tablets
Quetiapin Orion 100 mg film-coated tablets
Quetiapin Orion 200 mg film-coated tablets
Quetiapin Orion 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg tablet: Each film-coated tablet contains quetiapine fumarate
equivalent to 25 mg quetiapine.
100 mg tablet: Each film-coated tablet contains quetiapine fumarate
equivalent to 100 mg quetiapine.
200 mg tablet: Each film-coated tablet contains quetiapine fumarate
equivalent to 200 mg quetiapine.
300 mg tablet: Each film-coated tablet contains quetiapine fumarate
equivalent to 300 mg quetiapine.
Excipient with known effect:
25 mg tablet: Each tablet contains 4.9 mg lactose (as monohydrate).
100 mg tablet: Each tablet contains 19.7 mg lactose (as monohydrate).
200 mg tablet: Each tablet contains 39.3 mg lactose (as monohydrate).
300 mg tablet: Each tablet contains 59 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: Peach, round film-coated tablets with diameter 6 mm, debossed
‘F71’ on one side and plain on
the other side.
100 mg: Yellow, round film-coated tablets with diameter 9 mm, debossed
‘F73’ on one side and plain
on the other side.
200 mg: White, round film-coated tablets with diameter 11 mm, debossed
‘F75’ on one side and plain
on the other side.
300 mg: White, capsule-shaped film-coated tablets with length 19 mm,
debossed ‘F76’ on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapin Orion is indicated for:
•
treatment of schizophrenia
•
treatment of bipolar disorder
o
for the treatment of moderate to severe manic episodes in bipolar
disorder
o
for the treatment of major depressive episodes in bipolar disorder
o
for the prevention of recurrence of manic or depressed episodes in
patients with bipolar
disorder who previously responded to quetiapine treatment.
4.2
POSOLOGY AND METHOD O