EFEXOR XR 75

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

VENLAFAXINE AS HYDROCHLORIDE

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

N06AX16

Legemiddelform:

CAPSULES EXTENDED RELEASE

Sammensetning:

VENLAFAXINE AS HYDROCHLORIDE 75 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Terapeutisk område:

VENLAFAXINE

Indikasjoner:

For the treatment of depression. Maintenance of recurrent depression. Generalized anxiety disorder (GAD) - short term and long-term. Social anxiety Disorder (SAD).

Autorisasjon dato:

2019-03-31

Informasjon til brukeren

Efexor XR 75; Efexor XR 150 Capsules PIL CC 140822
1
2021-0067337
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
EFEXOR
® XR 75
EACH CAPSULE CONTAINS: Venlafaxine (as hydrochloride) 75 mg
EFEXOR
® XR 150
EACH CAPSULE CONTAINS: Venlafaxine (as hydrochloride) 150 mg
EXTENDED RELEASE CAPSULES
Inactive ingredients and allergens in the preparation: See section 2
under ‘Important
information about some of this medicine’s ingredients’ and section
6 ‘Further
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
Antidepressants and anti-anxiety medicines increase the risk of
suicidal behavior
and thoughts in children, adolescents and young adults up to the age
of 25.
Upon initiation of treatment with the medicine, patients of all ages,
and their
relatives, must monitor behavioral changes such as: worsening of
depression,
suicidal thoughts, aggression and the like.
If such changes occur, refer to a doctor immediately (see section 2).
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Efexor XR is intended for treatment of patients with depression and
for maintenance
therapy of recurrent depression. It is also for treatment of patients
with the following
anxiety disorders: generalized anxiety and social anxiety.
THERAPEUTIC GROUP: Efexor XR is an antidepressant that belongs to a
group of
medicines called SNRIs (serotonin and norepinephrine reuptake
inhibitors).
This group of medicines is used to treat depression and other
conditions such as
various anxiety disorders. The mode of action of antidepressants is
not fully
understood, but the medicines can have an affect by increasing the
levels of
serotonin and no

Preparatomtale

Efexor XR 75 Efexor XR150 Capsules LPD WC 140822
1
2021-0067337
EFEXOR
® XR 75 EFEXOR
® XR 150
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efexor
®
XR 75
Efexor
®
XR 150
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Efexor XR 75 – Extended release capsules:
Each Extended -release capsule contains 84.85 mg of venlafaxine
hydrochloride, equivalent to 75 mg
of venlafaxine free base.
Efexor XR 150 – Extended release capsules:
Each Extended -release capsule contains 169.7 mg of venlafaxine
hydrochloride, equivalent to 150
mg of venlafaxine free base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard Extended -release capsule.
75mg:
Opaque peach capsules printed in red with ‘W’ and ’75’, hard
gelatin capsule, size 1.
150mg:
Opaque dark orange capsules printed in white with ‘W’ and
’150’, hard gelatin capsule, size 0.
•
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in
children, adolescents, and young adults in short-term studies. These
studies did
not show an increase in the risk of suicidal thoughts and behavior
with
antidepressant use in patients over age 25; there was a reduction in
risk with
antidepressant use in patients aged 65 and older [see Warnings and
Precautions
(4.4)].
In patients of all ages who are started on antidepressant therapy
monitor
closely for clinical worsening and emergence of suicidal thoughts and
behaviors. Advise families and caregivers of the need for close
observation and
communication with the prescriber [see Warnings and Precautions
(4.4)].
Efexor XR 75 Efexor XR150 Capsules LPD WC 140822
2
2021-0067337
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of depression.
Maintenance of recurrent depression.
Generalized anxiety disorder (GAD) - short term and long-term.
Social anxiety Disorder (SAD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxin