Venlafaxine 75mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Venlafaxine hydrochloride

Disponible desde:

Bristol Laboratories Ltd

Código ATC:

N06AX16

Designación común internacional (DCI):

Venlafaxine hydrochloride

Dosis:

75mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030400; GTIN: 5060013943188

Información para el usuario

Package leaflet: Information for the user
Venlafaxine 37.5 mg Tablets
Venlafaxine 75 mg Tablets
Important things you need to know about Venlafaxine
Please read all of this leaflet before you start to take your medicine
as it contains
important information about Venlafaxine
•
Venlafaxine is used to treat depression
•
Venlafaxine should not be given to anyone under 18 years of age-see in
section 2
‘Children and adolescents’
If you have any concerns about how you feel, or about this medication,
it is important
that you talk to your doctor - even if you feel anxious or worried
about doing so.
You may find it helpful to tell a friend or relative that you are
depressed, and that you have
been prescribed this medication; it might be useful to show them this
leaflet.
•
Venlafaxine may not work straight away. After you start treatment, you
may feel worse
before you feel better. Your doctor may ask to see you again a couple
of weeks after
you start treatment, and then regularly until you start to feel well
again. Tell your
doctor if you do not start feel better
•
Some people who are depressed may think of harming or killing
themselves.
If you have these thoughts at any time, tell your doctor or go to a
hospital straight
away. – see in section 2 ‘Thoughts of suicide and worsening of
your depression or
anxiety disorder’
•
If you have taken too many tablets it is important to seek immediate
medical attention,
even if you feel well, because of the risk of serious side effects
•
Do not stop taking your tablets or change the amount you take without
checking with
your doctor first. Keep taking them even if you feel better. If you
stop taking Venlafaxine
suddenly you may get withdrawal reactions-see in section 3 ‘If you
stop taking
Venlafaxine tablets’
•
Taking some other medicines with Venlafaxine may cause problems. Tell
your doctor
if you are taking or have recently taken any other medicines- see in
‘Other medicines
and Venlafaxine Tablets’
•
Tell your doctor straight away if you feel restless

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Venlafaxine 75 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of Venlafaxine as Venlafaxine Hydrochloride
as the
active substance.
Excipients of known effect: Also contains 104.16 mg of Lactose
Monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Peach coloured, circular, flat faced, bevelled edged, uncoated tablets
having ‘75’
debossed on one side and ‘BL’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Venlafaxine tablets are indicated for the
•
treatment of major depressive disorder
•
prevention of the recurrence of major depressive episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAJOR DEPRESSIVE EPISODES:
The recommended starting dose 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, 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.Anti-depressive medicinal products
should
continue for at least 6 months following remission.
ELDERLY
No specific dose adjustments of venlafaxine are considered necessary
based
on patient age alone. However, caution should be exercised in treating
the
elderly (e.g. due to the possibility of