Atrolak XL 150mg prolonged-release Tablet

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

QUETIAPINE FUMARATE

から入手可能:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATCコード:

N05AH04

INN（国際名）:

QUETIAPINE FUMARATE 150 mg

医薬品形態:

PROLONGED-RELEASE TABLET

構図:

QUETIAPINE FUMARATE 150 mg

処方タイプ:

POM

治療領域:

PSYCHOLEPTICS

認証ステータス:

Withdrawn

承認日:

2016-06-28

情報リーフレット

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROLAK XL 150 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 Atrolak XL is and what it is used for
2.
What you need to know before you take Atrolak XL
3.
How to take Atrolak XL
4.
Possible side effects
5.
How to store Atrolak XL
6.
Contents of the pack and other information
1.
WHAT ATROLAK XL IS AND WHAT IT IS USED FOR
Atrolak XL contains a substance called quetiapine. This belongs to a
group of medicines called anti-
psychotics. Atrolak XL can be used to treat several illnesses, such
as:
• 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.
• Mania: where you may feel very excited, elated, agitated,
enthusiastic or hyperactive or have
poor judgment including being aggressive or disruptive.
• 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.
When Atrolak XL is being taken to treat major depressive episodes in
major depressive disorder, it
will be taken in addition to another drug being used to treat this
illness.
Your doctor may continue to prescribe Atrolak XL even when you are
feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATROLAK XL
DO NOT TAKE ATROLAK XL_ _
-
If you are allergic (hypersensitive) to quetiapine

製品の特徴

PAGE 1 OF 23
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atrolak XL 150 mg prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 150 mg quetiapine (as
quetiapine fumarate)
Excipient(s) with known effect: 76 mg Lactose monohydrate per tablet
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet
White to off white, capsule shaped, biconvex, film coated tablets,
debossed with ‘AB2’ on
one side and plain on other side.
Tablet length is approximately 17.4 mm and width is approximately 6.7
mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atrolak XL 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
•
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 Atrolak XL (see
Section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Different dosing schedules exist for each indication. It must
therefore be ensured that patients
receive clear information on the appropriate dosage for their
condition.
ADULTS
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN BIPOLAR
DISORDER
Atrolak XL should be administrated at least one hour before a meal.
The daily dose at the
start of therapy is 300 mg on Day 1 and 600 mg on Day 2. The
recommended daily dose is
600 mg, however if clinically justified the dose may be increased to
800 mg daily. The dose
PAGE 2 OF 23
should be adjusted within the effective dose range of 400 mg to 800 mg
per day, depending
on t