Quetiapine 25mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Quetiapine fumarate

Beszerezhető a:

DE Pharmaceuticals

ATC-kód:

N05AH04

INN (nemzetközi neve):

Quetiapine fumarate

Adagolás:

25mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04020100

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROQUEL
®
25MG TABLETS
(quetiapine fumarate)
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.
The name of your medicine is Seroquel 25mg Tablets but will be
referred to as Seroquel throughout this leaflet. Please note that the
leaflet also contains information about other strengths Seroquel
100mg,
200mg and 300mg Tablets.
WHAT IS IN THIS LEAFLET
1.
What Seroquel is and what it is used for
2.
What you need to know before you take Seroquel
3.
How to take Seroquel
4.
Possible side effects
5.
How to store Seroquel
6.
Contents of the pack and other information
Seroquel contains a substance called quetiapine. This belongs to a
group of medicines called anti-psychotics. Seroquel 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 Seroquel even when you are
feeling better.
DO NOT TAKE SEROQUEL:
•
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 medicines:
-
Some medicines for HI

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Quetiapine 25 mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg quetiapine (as quetiapine
fumarate).
Excipient(s) with known effect
Each film-coated tablet contains 14 mg of lactose and 0.031 mg of
sunset yellow FCF
aluminium lake (E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Light-orange, round, biconvex, film-coated tablet, engraved “25”
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
dos