Notiabolfen XL 400 mg prolonged-release Tablet

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Quetiapine fumarate

थमां उपलब्ध:

Accord Healthcare Limited

ए.टी.सी कोड:

N05AH; N05AH04

INN (इंटरनेशनल नाम):

Quetiapine fumarate

डोज़:

400 milligram(s)

फार्मास्यूटिकल फॉर्म:

Prolonged-release tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2011-11-25

सूचना पत्रक

PACKAGE LEAFLET: INFROMATION FOR THE
USER
NOTIABOLFEN XL 50 MG
PROLONGED-RELEASE TABLET
NOTIABOLFEN XL 200 MG
PROLONGED-RELEASE TABLET
NOTIABOLFEN XL 300 MG
PROLONGED-RELEASE TABLET
NOTIABOLFEN XL 400 MG
PROLONGED-RELEASE TABLET
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 or nurse.
-
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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What Notiabolfen XL Prolonged-release Tablet is
and what it is used for
2. What you need to know before you take
Notiabolfen XL Prolonged-release Tablets
3. How to take Notiabolfen XL Prolonged-release
Tablets
4. Possible side effects
5. How to store Notiabolfen XL Prolonged-release
Tablets
6. Contents of the pack and other information 1.
WHAT NOTIABOLFEN XL
PROLONGED-RELEASE TABLET IS AND
WHAT IT IS USED FOR
Notiabolfen XL Prolonged-release Tablet contains a
substance called quetiapine. This belongs to a
group of medicines called anti-psychotics.
Notiabolfen XL Prolonged-release Tablet can be
used to treat several illnesses, such as:
• 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.
• Mania: where you may feel very excited, elated,
agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive.
• 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.
When Notiabolfen XL Prolonged-relea

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Notiabolfen XL 400 mg prolonged-release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 400 mg Quetiapine (as
Quetiapine Fumarate)
Excipient(s) with known effect: 81.40 mg Lactose monohydrate and 7.1
mg sodium per tablet
For the full list of Excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White coloured, round shaped, biconvex, film coated tablets debossed
with ‘I4’ on one side and plain on other.
400mg tablet diameter is approximately 12.8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Notiabolfen 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 Notiabolfen XL (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
Notiabolfen XL 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 o