Brancico XL 200mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Quetiapine fumarate

Tilgængelig fra:

Zentiva Pharma UK Ltd

ATC-kode:

N05AH04

INN (International Name):

Quetiapine fumarate

Dosering:

200mg

Lægemiddelform:

Modified-release tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04020100; GTIN: 5000283658283

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRANCICO XL 200 MG, 300 MG OR 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 Brancico XL is and what it is used for
2. What you need to know before you take
Brancico XL
3. How to take Brancico XL
4. Possible side effects
5. How to store Brancico XL
6. Contents of the pack and other information
1. WHAT BRANCICO XL IS AND WHAT IT IS USED FOR
Brancico XL contains a substance called quetiapine.
This belongs to a group of medicines called
antipsychotics. Brancico 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 Brancico 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 Brancico XL
even when you feel better.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BRANCICO XL
DO NOT TAKE BRANCICO XL
•
If you are allergic to quetiap

Produktets egenskaber

OBJECT 1
BRANCICO XL 200 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 27-Sep-2016 | Zentiva
1. Name of the medicinal product
Brancico XL 200 mg prolonged-release tablets
2. Qualitative and quantitative composition
Brancico XL 200 mg contains 200 mg quetiapine (as quetiapine fumarate)
Excipient with known effect: 56 mg lactose (anhydrous) per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
200 mg: a white to off white, oblong biconvex tablet, 15.2 mm in
length, 7.7 mm in width and 4.8 mm in
thickness, engraved with “200“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
Brancico 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 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_
Brancico 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