Tonpular XL 75 mg prolonged-release hard capsules

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Venlafaxine

Tillgänglig från:

Wockhardt UK Limited

ATC-kod:

N06AX; N06AX16

INN (International namn):

Venlafaxine

Dos:

75 milligram(s)

Läkemedelsform:

Prolonged-release capsule, hard

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Other antidepressants; venlafaxine

Bemyndigande status:

Not marketed

Tillstånd datum:

2010-01-08

Bipacksedel

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 better. If it is not treated, your condition
may not go away and may become
more serious and more difficult to treat. _

Produktens egenskaper

Health Products Regulatory Authority
17 October 2019
CRN00983S
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tonpular XL 75 mg prolonged-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release hard capsule contains 84.8mg of venlafaxine
hydrochloride, equivalent to 75mg of venlafaxine.
Excipients:
Sunset yellow FCF (E110) 0.0079mg
Carmoisine (E122) 0.0028mg
Allura red AC (E129) 0.0528mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Size '1' hard gelatin capsule with light pink opaque cap and light
pink opaque body filled with white to off white pellets. The
capsule is imprinted with _W_
717
on cap in red colour.
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