Venlablue XL 150mg Prolonged Release Capsules, Hard

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Venlafaxine hydrochloride

Inapatikana kutoka:

Bluefish Pharmaceuticals AB

ATC kanuni:

N06AX; N06AX16

INN (Jina la Kimataifa):

Venlafaxine hydrochloride

Kipimo:

150 milligram(s)

Dawa fomu:

Prolonged-release capsule, hard

Dawa ya aina:

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

Eneo la matibabu:

Other antidepressants; venlafaxine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2010-04-09

Taarifa za kipeperushi

1
PACKAGE LEAFLET
IE-PIL
1.3.1.EN-PL-IE.1 Pg. 12
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLABLUE XL 75 MG PROLONGED RELEASE CAPSULES, HARD
VENLABLUE XL 150 MG PROLONGED RELEASE CAPSULES, HARD
venlafaxine
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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Venlablue XL is and what it is used for
2.
What you need to know before you take Venlablue XL
3.
How to take Venlablue XL
4.
Possible side effects
5.
How to store Venlablue XL
6.
Contents of the pack and other information
1.
WHAT VENLABLUE XL AND WHAT IT IS USED FOR
Venlablue 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 not fully understood
how antidepressants work, but
they may help by increasing the levels of serotonin and noradrenaline
in the brain.
Venlablue XL is a treatment for adults with depression. Venlablue XL
is also a treatment for adults
with social anxiety disorder (fear or avoidance of social situations).
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENLABLUE XL
DO NOT TAKE VENLABLUE XL
-
If you are allergic to venlafaxine or any of the other ingredients of
this medicine (listed in
section 6)
-
If you are also taking or have taken any time

Tabia za bidhaa

Health Products Regulatory Authority
04 July 2023
CRN00DKNH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlablue XL 150mg Prolonged Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains: Venlafaxine hydrochloride, corresponding to 150
mg Venlafaxine.
Excipients with known effect: allura red (E129) 0.198 mg, brillant
blue (E133) 0.009 mg and sunset yellow (E110) 0.396 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Dark orange / dark orange opaque, size ‘0’ hard gelatin capsules
having thick and thin radial circular band on the body in white
ink and thick and thin radial circular band on the cap in white ink.
The capsule is filled with 12 white to off-white, round,
biconvex, film coated mini tablets of 12.5 mg each
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes
Treatment of social anxiety disorder
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
Venlafaxine Bluefish is not recommended for use in children and
adolescents under the age of 18 years.
Controlled clinical studies in children and adolescents with major
depressive disorder failed to demonstrate efficacy and do not
support the use of venlafaxine in these patients (see sections 4.4 and
4.8).
The safety and efficacy of Venlablue XL for other indications in
children and adolescents under the age of 18 have not been
established.
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