Seropia XR 400 mg prolonged-release tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Quetiapine

から入手可能:

Clonmel Healthcare Ltd

ATCコード:

N05AH; N05AH04

INN（国際名）:

Quetiapine

投薬量:

400 milligram(s)

医薬品形態:

Prolonged-release tablet

投与経路:

Oral use

パッケージ内のユニット:

10, 20, 30, 60, 90, 100, 120, 180 and 200 tablets

処方タイプ:

Product subject to prescription which may not be renewed (A)

製:

Pharmathen S.A, Pharmathen International S.A, STADA Arzneimittel AG, STADA Arzneimittel GmbH, Clonmel Healthcare Ltd

治療群:

Antipsychotics; Diazepines, oxazepines, thiazepines and oxepines

治療領域:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

適応症:

It is indicated for: treatment of Schizophrenia; treatment of bipolar disorder; add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy

認証ステータス:

Marketed

承認日:

2015-04-02

情報リーフレット

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEROPIA XR 50 MG PROLONGED-RELEASE TABLETS
SEROPIA XR 150 MG PROLONGED-RELEASE TABLETS
SEROPIA XR 200 MG PROLONGED-RELEASE TABLETS
SEROPIA XR 300 MG PROLONGED-RELEASE TABLETS
SEROPIA XR 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 Seropia XR is and what it is used for
2.
What you need to know before you take Seropia XR
3.
How to take Seropia XR
4.
Possible side effects
5.
How to store Seropia XR
6.
Contents of the pack and other information
1.
WHAT SEROPIA XR IS AND WHAT IT IS USED FOR
Seropia XR contains a substance called quetiapine. This belongs to a
group of medicines called
antipsychotics. Seropia XR 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
judgement 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 Seropia XR 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

製品の特徴

Health Products Regulatory Authority
16 March 2022
CRN00CGW5
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seropia XR 400 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Seropia XR 400 mg contains 400 mg quetiapine (as quetiapine fumarate)
Excipient with known effect: 113 mg lactose per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
A white to off white, oval biconvex tablet, 20.7 mm in length, 10.2 mm
in width and 6.3 mm in thickness,engraved with “400”
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Seropia XR 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 quetiapine (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_
Seropia XR should be administered 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 tolerabili