Atrolak XL 50mg prolonged-release Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

QUETIAPINE FUMARATE

Предлага се от:

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

АТС код:

N05AH04

INN (Международно Name):

QUETIAPINE FUMARATE 50 mg

Лекарствена форма:

PROLONGED-RELEASE TABLET

Композиция:

QUETIAPINE FUMARATE 50 mg

Вид предписание :

POM

Терапевтична област:

PSYCHOLEPTICS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2013-06-03

Листовка

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROLAK XL 50 MG
ATROLAK XL 200 MG
ATROLAK XL 300 MG
ATROLAK XL 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 or
nurse.
-
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 or
nurse. 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 T

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atrolak XL 50 mg prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg prolonged release tablet contains 50 mg quetiapine (as
quetiapine fumarate)
Excipient(s) with known effect: 140.925 mg Lactose monohydrate per
tablet
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet
Peach colored, round shaped, biconvex film coated tablets, debossed
with ‘Q50’ on one side and plain on the
other.
NOTE:
Diameter of the tablet 11.2 ± 0.2 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atrolak XL 50 mg 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 Atrolak XL
50 mg (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 50 mg 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 should be adjusted within the
effective dose range of 400 mg to 800 mg per day, depending on the
clinical response and tolerability