VENLAFAXINE TEVA 37.5 Milligram Tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

VENLAFAXINE HYDROCHLORIDE

Доступно од:

Teva Pharma B.V.

АТЦ код:

N06AX16

INN (Међународно име):

VENLAFAXINE HYDROCHLORIDE

Дозирање:

37.5 Milligram

Фармацеутски облик:

Tablets

Тип рецептора:

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

Терапеутска област:

Other antidepressants

Статус ауторизације:

Authorised

Датум одобрења:

2008-10-10

Информативни летак

 
1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

25 MG TABLETS 
 37.5 MG TABLETS 
50 MG TABLETS 
75 MG TABLETS 
Venlafaxine 

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 of the 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  is and what it is used for 
2. 
What you need to know before you take  
3. 
How to take  
4. 
Possible side effects 
5. 
How to store  
6. 
Contents of the pack and other information 

1. 
WHAT  IS AND WHAT IT IS USED FOR 

 is an antidepressant that belongs to a group
of medicines called serotonin and 
norepinephrine reuptake inhibitors (SNRIs). This group
of medicines is used to treat depression and 
other conditions, such as anxiety disorders. It is thought
that people who are depressed and/or anxious 
have lower levels of serotonin and
noradrenaline in the brain. It is not fully understood how 
antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the 
brain.  

 is a treatment for adults with depression.
Treating depression properly is important to 
help you get better. If it is not treated, your condition may
not go away and may become more serious 
and more difficult to treat. 
�

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlafaxine Teva 37.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 37.5 mg of venlafaxine as 42.426 mg venlafaxine
hydrochloride.
_Excipients with known effect:_
Each tablet contains 92.18 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Mottled peach, round, flat bevelled tablet, on one side scored and
debossed “9” on one side of the score and “3” on the
other side of the score. Debossed with “7380” on the opposite side
of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Major depressive episodes
The recommended starting dose of immediate-release venlafaxine is 75
mg/day in two or three divided doses taken
with food. 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.
E