Quetiapine 300 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine fumarate

Available from:

Actavis Group PTC ehf

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine fumarate

Dosage:

300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Authorization status:

Marketed

Authorization date:

2009-05-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Quetiapine 25 mg film-coated tablets
Quetiapine 100 mg film-coated tablets
Quetiapine 150 mg film-coated tablets
Quetiapine 200 mg film-coated tablets
Quetiapine 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 Quetiapine is and what it is used for
2.
What you need to know before you take Quetiapine
3.
How to take Quetiapine
4.
Possible side effects
5.
How to store Quetiapine
6.
Contents of the pack and other information
1.
WHAT QUETIAPINE IS AND WHAT IT IS USED FOR
Quetiapine contains a substance called quetiapine. This belongs to a
group of medicines called anti-
psychotics.
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 QUETIAPINE
DO NOT TAKE QUETIAPINEQUETIAPINE
-
if you are allergic to quetiapine or any of the other ingredients of
this medicine (listed in section
6).
-
if you are taking any of the following medic

Summary of Product characteristics

Health Products Regulatory Authority
14 May 2019
CRN008Y30
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine 300 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet 300 mg contains 300 mg Quetiapine (as fumarate).
Excipient with known effect:
Lactose monohydrate corresponding to 63.5 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Quetiapine 300 mg film-coated tablet is oval with dimensions of 19 mm
x 7.6 mm, biconvex, white and engraved with “Q” on
one side and “300” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Quetiapine 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.
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 (D