Ebesque XL 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Quetiapine fumarate

Available from:

Ethypharm UK Ltd

ATC code:

N05AH04

INN (International Name):

Quetiapine fumarate

Dosage:

400mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5060078671651

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EBESQUE XL 50 MG PROLONGED-RELEASE TABLETS
EBESQUE XL 200 MG PROLONGED-RELEASE TABLETS
EBESQUE XL 300 MG PROLONGED-RELEASE TABLETS
EBESQUE XL 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 Ebesque XL is and what it is used for
2.
What you need to know before you take Ebesque XL
3.
How to take Ebesque XL
4.
Possible side effects
5.
How to store Ebesque XL
6.
Contents of the pack and other
information
1.
WHAT EBESQUE XL IS AND WHAT IT IS USED FOR
Ebesque XL contains a substance called quetiapine. This belongs to a
group of medicines
called antipsychotics. Ebesque XL can be used to treat several
illnesses, such as
•
Bipolar depression and major depressive episodes in major depressive
disorder: where
you feel sad or 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 Ebesque 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 Ebesque XL even when you feel
better.
2.
WHAT YOU NEED T

Summary of Product characteristics

OBJECT 1
EBESQUE XL 50MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 14-Oct-2016 | Ethypharm UK
Ltd
1. Name of the medicinal product
Ebesque XL 50 mg prolonged-release tablets
Ebesque XL 200 mg prolonged-release tablets
Ebesque XL 300 mg prolonged-release tablets
Ebesque XL 400 mg prolonged-release tablets
2. Qualitative and quantitative composition
One tablet contains 50 mg quetiapine (as quetiapine fumarate).
Excipients with known effect: 32.6 mg lactose per tablet.
One tablet contains 200 mg quetiapine (as quetiapine fumarate).
Excipients with known effect: 28.4 mg lactose per tablet.
One tablet contains 300 mg quetiapine (as quetiapine fumarate).
Excipients with known effect: 42.6 mg lactose per tablet.
One tablet contains 400 mg quetiapine (as quetiapine fumarate).
Excipients with known effect: 56.8 mg lactose per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
Light pink to pink coloured, capsule shaped, biconvex,
prolonged-release tablets, printed with '305' with
black ink.
Yellow coloured, capsule shaped, biconvex, prolonged-release tablets,
printed with '243' with black ink.
Pale yellow coloured, capsule shaped, biconvex, prolonged-release
tablets, printed with '244' with black
ink.
White to off-white capsule shaped, biconvex, prolonged-release
tablets, printed with '245' with black ink.
4. Clinical particulars
4.1 Therapeutic indications
Ebesque XL is indicated in adults for
• treatment of Schizophrenia, including:
o preventing relapse in stable schizophrenic patients who have been
maintained on Ebesque XL
• 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 in patients with bipolar disorder,
in patients whose manic or depressive
episode has responded to quetiapine treatment
• add-on treatment of major depressive episodes in patients with
Major Depressive D