Efexor XL 225mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Venlafaxine hydrochloride

זמין מ:

Viatris UK Healthcare Ltd

קוד ATC:

N06AX16

INN (שם בינלאומי):

Venlafaxine hydrochloride

כמות:

225mg

טופס פרצבטיות:

Modified-release capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04030400; GTIN: 5013457021097

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE USER
EFEXOR XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
EFEXOR XL 150 MG PROLONGED-RELEASE CAPSULES, HARD
EFEXOR XL 225 MG PROLONGED-RELEASE CAPSULES, HARD
venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW ABOUT EFEXOR XL
PLEASE READ ALL OF THIS LEAFLET BEFORE YOU START TO TAKE YOUR MEDICINE
AS IT CONTAINS IMPORTANT
INFORMATION ABOUT EFEXOR XL
•
EFEXOR 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)
•
EFEXOR XL IS NOT FOR USE IN CHILDREN AND ADOLESCENTS
– see in section 2 ‘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 might
be useful to show them this leaflet.
•
EFEXOR 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
THEMSELF. IF THIS HAPPENS
YOU SHOULD SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY
– see in 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 EFEXOR XL OR CHANGE YOUR DOSE WITHOUT THE ADVICE OF
YOUR DOCTOR EVEN IF
YOU FEEL BETTER.
If you stop taking Efexor XL abruptly you may get withdrawal reactions
– see in
section 3 ‘If you stop taking Efexor XL’
•

מאפייני מוצר

OBJECT 1
EFEXOR XL 225MG CAPSULES
Summary of Product Characteristics Updated 14-Aug-2019 | Pfizer
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Efexor XL 225 mg prolonged-release capsules, hard
2. Qualitative and quantitative composition
Each prolonged-release capsule contains 254.52 mg of venlafaxine
hydrochloride, equivalent to 225 mg of
venlafaxine free base.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release capsule, hard.
Light grey opaque cap and dark orange opaque body capsules printed in
white with 'W' and '225', hard gelatin
capsule, size 00el (25.3 mm x 8.53 mm).
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 depressi