Tonpular XL 150mg Prolonged-Release Hard Capsules

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

VENLAFAXINE

Доступно од:

Wockhardt UK Limited

АТЦ код:

N06AX16

INN (Међународно име):

VENLAFAXINE

Фармацеутски облик:

PROLONGED-RELEASE CAPSULE

Састав:

VENLAFAXINE 150 mg

Тип рецептора:

POM

Терапеутска област:

PSYCHOANALEPTICS

Статус ауторизације:

Authorised

Датум одобрења:

2009-10-21

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
TONPULAR XL 75MG PROLONGED-RELEASE HARD CAPSULES
TONPULAR XL 150MG PROLONGED-RELEASE HARD CAPSULES
Venlafaxine Hydrochloride
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 hem, even if their signs of illness are
he 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 TONPULAR XL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TONPULAR XL
3. HOW TO TAKE TONPULAR XL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TONPULAR XL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT TONPULAR XL IS AND WHAT IT IS USED FOR
Tonpular XL contains the active substance venlafaxine
hydrochloride. Tonpular XL is an antidepressant that belongs to
a group of medicines called Serotonin and Noradrenaline
Reuptake Inhibitors (SNRIs). Everyone has substances in their
brain called serotonin and noradrenaline. It is thought that people
suffering from depression (and associated conditions) have less
of these substances compared to people who do not have
depression (and associated conditions). It is not fully understood
how antidepressants work, but they may help by increasing the
amount of serotonin and noradrenaline in the brain.
TONPULAR XL IS USED TO TREAT:
• DEPRESSION (INCLUDING ANXIETY SYMPTOMS)
If you are depressed, you may have feelings of extreme
sadness. These feelings can interfere with your everyday life
and last a long time (e g. weeks and months).
• PANIC DISORDER (PANIC ATTACKS)
Venlafaxine, which is contained in Tonpular XL, is also au horised
to treat other conditions which are not men ioned in his leaflet.
Ask your doctor or pharmacist if

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tonpular XL 150mg Prolonged-Release Hard Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release hard capsule contains 169.7mg of venlafaxine
hydrochloride, equivalent to
150mg of venlafaxine.
Excipients:
Sunset yellow FCF (E110) 0.2286mg
Tartrazine (E102) 0.0304mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Size '0' hard gelatin capsule with orange opaque cap and orange opaque
body filled with white to
off white pellets. The capsule is imprinted with
_W_
718
on cap in white colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of panic disorder, with or without agoraphobia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive episodes _
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily.
Patients not responding to the initial 75 mg/day dose may benefit from
dose increases up to a
maximum dose of 375 mg/day. Dosage increases can be made at intervals
of 2 weeks or more. If
clinically warranted due to symptom severity, dose increases can be
made at more frequent
intervals, but not less than 4 days.
Because of the risk of dose-related adverse effects, dose increments
should be made only after a
clinical evaluation (see section 4.4). The lowest effective dose
should be maintained.
Patients should be treated for a sufficient period of time, usually
several months or longer.
Treatment should be reassessed regularly on a case-by-case basis.
Longer-term treatment may also
be appropriate for prevention of recurrence of major depressive
episodes (MDE). In most of the
cases, the recommended dose in prevention of recurrence of MDE is the
same as the one used
during the current episode.
_ _
Antidepressive medicinal products should continue for at least six
months following remission.
_Panic disorder _
It is recomm