VIEPAX 37.5

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

VENLAFAXINE AS HYDROCHLORIDE

Disponible depuis:

DEXCEL LTD, ISRAEL

Code ATC:

N06AX16

forme pharmaceutique:

TABLETS

Composition:

VENLAFAXINE AS HYDROCHLORIDE 37.5 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

DEXCEL LTD, ISRAEL

Groupe thérapeutique:

VENLAFAXINE

Domaine thérapeutique:

VENLAFAXINE

indications thérapeutiques:

For the treatment of depression.

Date de l'autorisation:

2014-03-31

Notice patient

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine can be sold with a physician’s prescription only
VIEPAX
® 37.5, 75, TABLETS
THE MEDICINE NAME AND ITS STRENGTH:
VIEPAX 37.5: each tablet contains 37.5 mg Venlafaxine as the
hydrochloride salt
VIEPAX 75: each tablet contains 75 mg Venlafaxine as the hydrochloride
salt
Inactive and allergic ingredients, contained in the medicine: see
section 6 "Additional
information" and "Important information about some of the ingredients
of the
medicine" in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have any
further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their medical condition seems similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
VIEPAX is intended for treatment of depression.
THERAPEUTIC GROUP: Venlafaxine is an antidepressant, which belongs to
a group of
medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs).
This group of
medicines is used to treat depression and other conditions such as
anxiety. . The
mechanism of action of antidepressants is not clear enough, however
the medicines
may affect by increasing the levels of serotonin and norepinephrine in
the brain.
Treating depression appropriately is important in order to improve
your condition.
Without treatment, your condition may not pass and may even worsen,
thus it will be
hard to treat in the future.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
• you are hypersensitive (allergic) to the active
ingredient (venlafaxine) or any of
the other ingredients the medicine contains (see section 6).
• you are taking or have taken monoamine oxidase
enzyme irreversible inhibitors
(MAOIs), used for
treatment of depression and Parkinson’s disease
in the last 14
days. Taking irreversibl

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
VIEPAX 37.5
VIEPAX 75
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Viepax 37.5
Each tablet contains 37.5mg venlafaxine (as venlafaxine
hydrochloride).
Excipient with known effect:
Each tablet contains approximately 79.2 mg lactose monohydrate.
Viepax 75
Each tablet contains 75mg venlafaxine (as venlafaxine hydrochloride).
Excipient with known effect:
Each tablet contains approximately 158.4
mg lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Mottled-beige, round tablets.
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)].
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of depression.
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 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).