Tonpular XL 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Venlafaxine hydrochloride

Available from:

Wockhardt UK Ltd

ATC code:

N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

150mg

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: 5012727905785

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PACKAGE LEAFLET: INFORMATION FOR THE USER
TONPULAR XL 75MG PROLONGED-RELEASE HARD CAPSULES
TONPULAR XL 150MG PROLONGED-RELEASE HARD CAPSULES
Venlafaxine Hydrochloride
READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU
START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may
need to read it again.
- If you have any further
questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT TONPULAR XL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TONPULAR XL
3. HOW TO TAKE TONPULAR XL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TONPULAR XL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT TONPULAR XL IS AND WHAT IT IS USED FOR
Tonpular XL contains the active substance venlafaxine
hydrochloride.
Tonpular XL is an antidepressant that belongs to a group of
medicines called Serotonin and Noradrenaline Reuptake
Inhibitors (SNRIs). This group of medicines is used to treat
depression and other conditions such as anxiety disorders. It is
thought that people who are depressed and/or anxious have
lower levels of serotonin and noradrenaline in the brain. It is not
fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Tonpular XL is a treatment for adults with depression. It is also a
treatment for adults with the following anxiety disorders:
generalised anxiety disorder, social anxiety disorder (fear or
avoidance of social situations) and panic disorder (panic
attacks). Treating depression or anxiety disorders properly is
important to help you get bett

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tonpular XL 150mg Prolonged-Release Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
prolonged
release
hard
capsule
contains
169.7mg
of
venlafaxine
hydrochloride, equivalent to 150mg of venlafaxine.
Excipients:
Sunset yellow FCF (E110) 0.2286mg
Tartrazine (E102) 0.0304mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Size '0' hard gelatin capsule with orange opaque cap and orange opaque
body
filled with white to off white pellets. The capsule is imprinted with
_W_
on cap in
white colour.
718
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 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.
_ _
Antidepressive medicinal products should continu