Zaluron XL 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Quetiapine fumarate

Available from:

Fontus Health 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: 5060421930077

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZALURON XL 50 MG, 150 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 Zaluron XL is and what it is used for
2. What you need to know before you take Zaluron XL
3. How to take Zaluron XL
4. Possible side effects
5. How to store Zaluron XL
6. Contents of the pack and other information
1.
WHAT ZALURON XL IS AND WHAT IT IS USED FOR
Zaluron XL contains a substance called quetiapine. This belongs to a
group of medicines
called anti-psychotics. Zaluron 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 Zaluron XL is being taken to treat major depressive episodes in
major depressive
disorder, it will be taken in addition to another medicine being used
to treat this illness.
Your doctor may continue to prescribe Zaluron XL even when you are
feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZALURON XL
DO NOT TAKE ZALURON XL

If you are allergic to

Summary of Product characteristics

OBJECT 1
ZALURON XL 400MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 30-Dec-2016 | Fontus Health
Ltd
1. Name of the medicinal product
Zaluron XL 400 mg prolonged-release tablets
2. Qualitative and quantitative composition
Zaluron XL 400 mg contains 400 mg quetiapine (as quetiapine fumarate)
Excipient with known effect: 113 mg lactose (anhydrous) per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged - release tablet
A white to off white, oval biconvex tablet, 20.7 mm in length, 10.2 mm
in width and 6.3 mm in thickness,
engraved with “400” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Zaluron XL 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 suboptimal 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
Zaluron XL should be administered 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 t