TEVAQUEL 150 Milligram Film Coated Tablet

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

QUETIAPINE FUMARATE

Доступна с:

Teva Pharma B.V.

код АТС:

N05AH04

ИНН (Международная Имя):

QUETIAPINE FUMARATE

дозировка:

150 Milligram

Фармацевтическая форма:

Film Coated Tablet

Тип рецепта:

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

Терапевтические области:

Antipsychotics

Статус Авторизация:

Authorised

Дата Авторизация:

2009-02-20

тонкая брошюра

Quetiapine, UK/H/1228/001-5, 28.10.2016
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEVAQUEL 25 MG FILM-COATED TABLETS
TEVAQUEL 100 MG FILM-COATED TABLETS
TEVAQUEL 150 MG FILM-COATED TABLETS
TEVAQUEL 200 MG FILM-COATED TABLETS
TEVAQUEL 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 Tevaquel is and what it is used for
2.
What you need to know before you take Tevaquel
3.
How to take Tevaquel
4.
Possible side effects
5.
How to store Tevaquel
6.
Contents of the pack and other information
1.
WHAT TEVAQUEL IS AND WHAT IT IS USED FOR
Tevaquel contains a substance called quetiapine. This belongs to a
group of medicines called
antipsychotics.
Quetiapine 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 quetiapine even when you are
feeling better._ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVAQUEL
DO NOT TAKE TEVAQUEL:

if you are allergic to quetiapine or any of the other ingredients of
this medicine (listed in
section 6).

if you are tak

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tevaquel 150mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg quetiapine (as quetiapine
fumarate).
Excipient(s) with known effect
Each film-coated tablet contains 85 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow, round, biconvex, film-coated tablet, engraved “150”
on one side and plain on the other
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetiapine 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 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
For the treatment of schizophrenia, quetiapine should be administered
twice a day. The total daily dose for the first four
days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and
300 mg (Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective
dose of 300 to 450 mg/day. Depending on the
clinical response and tolerability of the individual patient, the dose
may be adjusted within the range 150 to 750
mg/day.
For the treatment of moderate to severe manic episodes in bipolar
disorder
For the treatment of manic episodes associated with bipolar disorder,
quetiapine should be administered twice a day.
The total daily dose for the first four days of therapy is 100 mg (Day
1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg
(Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should
be in increments