Vencarm XL 225mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Venlafaxine hydrochloride

Available from:

Aspire Pharma Ltd

ATC code:

N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

225mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5060209731612

Patient Information leaflet

IMPORTANT THINGS YOU SHOULD KNOW ABOUT VENCARM XL
Please read all of this leaflet before you start to take your
medicine as it contains important information about
Vencarm XL
•
VENCARM XL IS USED TO TREAT DEPRESSION, SEVERE AND
PERSISTENT ANXIETY KNOWN AS GENERALISED ANXIETY
DISORDER (GAD), SOCIAL ANXIETY DISORDER (ALSO KNOWN AS
SOCIAL PHOBIA) AND PANIC DISORDER (PANIC ATTACKS)
•
VENCARM XL IS NOT FOR USE IN CHILDREN AND ADOLESCENTS
• See section 2 ‘use in 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 or suffering from an anxiety disorder, and that you
have been prescribed this medication; it may be useful to
show them this leaflet.
•
Vencarm XL may not start to work immediately.
Some people taking antidepressants may feel worse before
feeling 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 to feel better.
•
Some people who are depressed may think of harming
or killing themselves. If this happens you should see
your doctor or go to a hospital straight away – see
section 2 ‘Thoughts of suicide and worsening of your
depression or anxiety disorder’.
•
If you take too many capsules, 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 Vencarm XL or change your dose
without the advice of your doctor even if you feel
better. If you stop taking Vencarm XL abruptly you may get
withdrawal reactions – see in section 3 ‘If you stop taking
Vencarm XL’.
•
If you have heart problems such as fast or irregular
heart rate or high blood pressure you should talk to your
doctor before taking Vencarm XL - see in section 2 ‘What
you need to know before you tak

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vencarm XL 225mg prolonged-release capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains 254.70mg of Venlafaxine
Hydrochloride,
equivalent to 225mg of venlafaxine free base.
Excipient(s) with known effect
Each 225 mg prolonged release capsule contains 0.02 mg of Carmoisine
(E122).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release capsule, hard (prolonged-release capsules)
Pink opaque size '00' hard gelatin capsules filled with film-coated
mini tablets having
radial circular bands on the body in blue ink and radial circular band
on the cap in
blue ink filled with mini tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes
For prevention of recurrence of major depressive episodes.
Treatment of generalised anxiety disorder.
Treatment of social anxiety disorder.
Treatment of panic disorder, with or without agoraphobia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxine is
75mg given
once daily. Patients not responding to the initial 75mg/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 cases, the recommended dose in
prevention of
recurrence of MDE is the same as the