Depefex XL 75mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Venlafaxine hydrochloride

Mevcut itibaren:

Chiesi Ltd

ATC kodu:

N06AX16

INN (International Adı):

Venlafaxine hydrochloride

Doz:

75mg

Farmasötik formu:

Modified-release capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04030400; GTIN: 5028613002810

Bilgilendirme broşürü

DEPEFEX
® 75 MG XL CAPSULES
DEPEFEX
® 150 MG XL CAPSULES
(Venlafaxine)
SIX IMPORTANT THINGS YOU NEED TO KNOW ABOUT DEPEFEX
■
Depefex treats depression. Like all medicines it can also have
unwanted effects. It is important that you
and your doctor discuss the benefits of taking Depefex and the harmful
effects before you start treatment.
■
Depefex are not for use in children and adolescents under 18. See
section 2 of the leaflet.
■
Some people who are depressed think of harming or killing themselves.
If you start to feel worse, or think
of harming or killing yourself, see your doctor or go to a hospital
straight away. See section 2, Thoughts
of harming yourself.
■
Depefex will not work straightaway. Some people taking the medicine
feel worse before feeling better.
Your doctor should see you a few weeks after starting treatment. Tell
your doctor if you do not feel better.
See section 3, How to take Depefex.
■
Do not stop taking Depefex without talking to your doctor. If you stop
taking Depefex suddenly or miss a
dose, you may get withdrawal effects. See section 3, If you stop
taking Depefex.
■ If you are pregnant or planning to get pregnant, talk to your
doctor. See section 2 Pregnancy and Breast-
feeding
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 DEPEFEX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPEFEX
3.
HOW TO TAKE DEPEFEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPEFEX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
The name of this medicine

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Depefex 75mg XL Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 75mg of venlafaxine as
venlafaxine hydrochloride.
Venlafaxine is chemically defined as
(R/S)-1-[(2-dimethylamino)-1-(4-methoxy phenyl)
ethyl] cyclohexanol hydrochloride.
Depefex Capsules contain sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release capsules, hard
Depefex 75mg XL Capsules are white opaque capsules containing white or
whitish
pellets
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
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 375mg/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 six
months following
remission.
USE IN OLDER PEOPLE:
No specific dose adjustments of venlafaxine are considered necessary
based on
patient age alone. However, caution should be exercised in treating
the old