VIEPAX XR 75

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

VENLAFAXINE AS HYDROCHLORIDE

Fáanlegur frá:

DEXCEL LTD, ISRAEL

ATC númer:

N06AX16

Lyfjaform:

CAPLETS

Samsetning:

VENLAFAXINE AS HYDROCHLORIDE 75 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

DEXCEL LTD, ISRAEL

Meðferðarhópur:

VENLAFAXINE

Lækningarsvæði:

VENLAFAXINE

Ábendingar:

For the treatment of depression.Maintenance of recurrent depression, generalized anxiety disorder (GAD) - short term and long-term, social anxiety disorder (SAD).

Leyfisdagur:

2014-02-28

Upplýsingar fylgiseðill

1
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS)
– 1986
This medicine can be sold with a physician’s prescription only
VIEPAX
® XR 75, PROLONGED RELEASE CAPLETS
VIEPAX
® XR 150 NEW FORMULATION, PROLONGED RELEASE TABLETS
VIEPAX
® XR 225, PROLONGED RELEASE TABLETS
ACTIVE INGREDIENT:
VIEPAX XR 75: each prolonged release caplet contains 75 mg Venlafaxine
(as hydrochloride)
VIEPAX XR 150 NEW FORMULATION: each prolonged release tablet contains
150 mg
Venlafaxine (as hydrochloride)
VIEPAX XR 225: each prolonged release tablet contains 225 mg
Venlafaxine (as
hydrochloride)
Inactive ingredients and allergens in the medicine - see section 6
"Additional information".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if you think that their medical condition is the same as yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
VIEPAX XR is intended for treatment of patients suffering from
depression as well as 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: Venlafaxine 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 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
norepinephrine in the
brain.
Treating depression and anxiety disorders is very important. Without
treatment, your condition
may not resolve and may even worsen, so that it will be more difficult
to treat in the future.
Antidepressants and anti-anxiety medicines increase the risk of
suicidal behavior and
thoughts in children, adoles

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VIEPAX XR 225
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Venlafaxine (as hydrochloride) 225 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Viepax XR 225 are white to off-white, mottled round shaped coated
tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviour
in children,
adolescents, and young adults in short-term studies. These studies did
not show an
increase in the risk of suicidal thoughts and behaviour 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 behaviours.
Advise
families and caregivers of the need for close observation and
communication with
the prescriber [see Warnings and Precautions (4.4)].
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 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, usual