Kagitz 300 mg Depottablett

国家: 瑞典

语言: 瑞典文

来源: Läkemedelsverket (Medical Products Agency)

有效成分:

kvetiapinfumarat

可用日期:

Aristo Pharma GmbH

ATC代码:

N05AH04

INN（国际名称）:

quetiapine fumarate

剂量:

300 mg

药物剂型:

Depottablett

组成:

kvetiapinfumarat 345,405 mg Aktiv substans; laktosmonohydrat Hjälpämne

处方类型:

Receptbelagt

產品總結:

Förpacknings: Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Burk, 60 tabletter

授权状态:

Avregistrerad

授权日期:

2017-03-06

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KAGITZ 50 MG PROLONGED-RELEASE TABLETS
KAGITZ 300 MG PROLONGED-RELEASE TABLETS
KAGITZ 400 MG PROLONGED-RELEASE 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 Kagitz is and what it is used for
2.
What you need to know before you take Kagitz
3.
How to take Kagitz
4.
Possible side effects
5.
How to store Kagitz
6.
Contents of the pack and other information
1.
WHAT KAGITZ IS AND WHAT IT IS USED FOR
Kagitz contains a substance called quetiapine. This belongs to a group
of medicines called anti-
psychotics. Kagitz can be used to treat several illnesses, such as:

Bipolar depression and major depressive episodes in major depressive
disorder: 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.
When Kagitz prolonged-release tablet is being taken to treat major
depressive episodes in major
depressive disorder, it will be taken in addition to another medicine
being used to treat this illness.
Your doctor may continue to prescribe Kagitz even when you are feeling
better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAGITZ
DO NOT TAKE KAGITZ:

i

产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kagitz 50 mg prolonged-release tablets
Kagitz 300 mg prolonged-release tablets
Kagitz 400 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kagitz 50 mg contains 50 mg quetiapine (as quetiapine fumarate)
Excipient: 119mg lactose monohydrate per tablet
Kagitz 300 mg contains 300 mg quetiapine (as quetiapine fumarate)
Excipient: 96 mg lactose monohydrate per tablet
Kagitz 400 mg contains 400 mg quetiapine (as quetiapine fumarate)
Excipient: 128 lactose monohydrate per tablet
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Kagitz 50 mg tablets are peach, bi-convex, capsule shaped, coated
tablets, of dimension about
16.5 mm x 6.6 mm, debossed “AI001” on one side and plain on other
side.
Kagitz 300 mg tablets are pale yellow, bi-convex, capsule shaped,
coated tablets, of dimension about 19.1
mm x 8.1 mm, debossed “AI004” on one side and plain on other side.
Kagitz 400 mg tablets are white to off white, bi-convex, capsule
shaped, coated tablets, of dimension about
20.5 mm x 9.3 mm, debossed “AI005” on one side and plain on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kagitz prolonged-release tablet is indicated for:

Treatment of schizophrenia

Treatment of bipolar disorder
-
For the treatment of moderate to severe manic episodes in bipolar
disorder
-
For the treatment of major depressive episodes in bipolar disorder
-
For the prevention of recurrence of manic or depressed episodes in
patients with bipolar disorder
who previously responded to quetiapine treatment.

Add-on treatment of major depressive episodes in patients with Major
Depressive Disorder (MDD)
who have had sub-optimal response to antidepressant monotherapy (see
Section 5.1). Prior to initiating
treatment, clinicians should consider the safety profile of Kagitz
(see Section 4.4).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication.