Venlafaxine 37.5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Venlafaxine hydrochloride

Dostępny od:

Sun Pharma UK Ltd

Kod ATC:

N06AX16

INN (International Nazwa):

Venlafaxine hydrochloride

Dawkowanie:

37.5mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04030400; GTIN: 5015525223228 5015525223235

Ulotka dla pacjenta

Top of page cut-off to middle of registration mark = 44 mm
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Pharma code 854
First bar is 105mm from top edge.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself
• If you are a young adult. Information from
clinical trials has shown an increased risk
of suicidal behaviour in young adults (less
than 25 years old) with psychiatric
conditions who were treated with an
antidepressant.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or
go to a hospital straight away.
You may find it helpful to tell a relative or
close friend that you are depressed or have
an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if
they think your depression or anxiety is
getting worse, or if they are worried about
changes in your behaviour.
DRY MOUTH
Dry mouth is reported in 10% of patients
treated with Venlafaxine. This may increase
the risk of tooth decay (caries). Therefore,
you should take special care in your dental
hygiene.
DIABETES
Your blood glucose levels may be altered due
to Venlafaxine. Therefore, the dosage of your
diabetes medicines may need to be adjusted.
CHILDREN AND ADOLESCENTS
Venlafaxine should normally not be used for
children and adolescents under 18 years.
Also, you should know that patients under 18
have an increased risk of side-effects such as
suicide attempt, suicidal thoughts and
hostility (predominantly aggression,
oppositional behaviour and anger) when they
take this class of medicines. Despite this, your
doctor may prescribe Venlafaxine for patients
under 18 because he/she decides that this is
in their best interests. If your doctor has
prescribed Venlafaxine for a patient under 18
and you want to discuss this, please go back
to your doctor. You should inform your doctor
if any of the symptoms listed above develop

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Venlafaxine 37.5 mg Tablets
Almus Venlafaxine 37.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the equivalent of 37.5 mg of venlafaxine as
42.426 mg
venlafaxine hydrochloride.
_ _
_Excipients _
Each tablet contains 92.18 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Mottled peach, round, flat bevelled tablet, on one side scored and
debossed “9” on
one side of the score and “3” on the other side of the score.
Debossed with “7380” on
the opposite side of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
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
The recommended starting dose of immediate-release venlafaxine is 75
mg/day in two or three 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). 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