Tevaquel XL 400 mg Prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine

Available from:

Teva Pharma B.V.

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine

Dosage:

400 milligram(s)

Pharmaceutical form:

Prolonged-release 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:

2012-04-13

Patient Information leaflet

Quetiapine DE/H/6130; March 2022
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVAQUEL XL 50 MG, 200 MG, 300 MG, 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 Tevaquel XL is and what it is used for
2.
What you need to know before you take Tevaquel XL
3.
How to take Tevaquel XL
4.
Possible side effects
5.
How to store Tevaquel XL
6.
Contents of the pack and other information
1.
WHAT TEVAQUEL XL IS AND WHAT IT IS USED FOR
Tevaquel XL contains a substance called quetiapine. This belongs to a
group of medicines called anti-
psychotics. Tevaquel XL 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 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.
When Tevaquel 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 Tevaquel XL even when you feel
better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVAQUEL XL
DO NOT TAKE TEVAQUEL XL:
-
i

Summary of Product characteristics

Health Products Regulatory Authority
05 October 2022
CRN00D38K
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tevaquel XL 400 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg tablet contains 400 mg quetiapine (as quetiapine
fumarate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
400 mg
White, biconvex oblong film-coated tablets with embossing “Q400”
on one 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.

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_
Quetiapine 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 of the patient. For maintenance therapy in
schizophrenia no dosage adjustment is necessary.
_For th