Venlafaxin 1A Farma 300 mg Depottablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

venlafaxinhydroklorid

Tillgänglig från:

1A Farma A/S

ATC-kod:

N06AX16

INN (International namn):

venlafaxine hydrochloride

Dos:

300 mg

Läkemedelsform:

Depottablett

Sammansättning:

venlafaxinhydroklorid 339,4 mg Aktiv substans; laktosmonohydrat Hjälpämne; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 10 tabletter; Blister, 100 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 42 tabletter; Blister, 50 tabletter; Blister, 500 tabletter (sjukhusförpackning); Blister, 56 tabletter; Blister, 60 tabletter; Blister, 98 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-02-11

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFAXIN 1A FARMA 300 MG PROLONGED-RELEASE TABLET
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, please 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 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
contains the active substance venlafaxine, which 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 not fully understood how
antidepressants work, but they may help by increasing the levels of
serotonin and noradrenaline in the brain.
is used to treat 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
•
If you are allergic to venlafaxine or any of the other ingredients of
this medicine (listed in section 6).
•
If you are also taking or have taken within the last 14 days any
medicines known as irreversible
monoamine oxidase inhibitors (MAOIs), used to treat depression or
Parkinson’s disease. Taking an
irrevers

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Venlafaxin 1A Farma 300 mg prolonged-release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 300 mg venlafaxine (as
hydrochloride).
Excipient with known effect: lactose 8.8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
300 mg prolonged-release tablet, 12.8 mm round, biconvex, white tablet
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_
venlafaxine 300 mg prolonged-release tablet is recommended for
patients not responding to the initial
low doses of venlafaxine.
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 300 mg/day dose
and 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.
Lower strengths are available to facilitate dose titration when
initiating therapy and for individual dose
adjustment.
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.
_Eld