Notiabolfen XL 50 mg prolonged-release tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Quetiapine fumarate; Quetiapine fumarate

Beszerezhető a:

Accord Healthcare Limited

ATC-kód:

N05AH; N05AH04

INN (nemzetközi neve):

Quetiapine fumarate; Quetiapine fumarate

Adagolás:

50 milligram(s)

Gyógyszerészeti forma:

Prolonged-release tablet

Recept típusa:

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

Terápiás terület:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Engedélyezési státusz:

Marketed

Engedély dátuma:

2013-09-13

Betegtájékoztató

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

Termékjellemzők

Health Products Regulatory Authority
14 September 2018
CRN008L6D
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Notiabolfen XL 50 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg prolonged release tablet contains 50 mg quetiapine (as
quetiapine
fumarate)
Excipient(s) with known effect: 140.925 mg Lactose monohydrate per
tablet
For the full list of Excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release Tablets
Peach colored, round shaped, biconvex film coated tablets, debossed
with ‘Q50’ on
one side and plain on the other.
Note: Diameter of the tablet 11.2 ± 0.2 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Notiabolfen XL 50 mg 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 50 mg (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
Health Products Regulatory Authority
14 September 2018
CRN008L6D
Page 2 of 30
ADULTS
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN
BIPOLAR DISORDER
Notiabolfen XL 50 mg 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