Venlalic XL 37.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Venlafaxine hydrochloride

Available from:

Ethypharm UK Ltd

ATC code:

N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

37.5mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5060078671569

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXYVEN XL 37.5MG
PROLONGED-RELEASE TABLETS
(venlafaxine hydrochloride)
Your medicine is available using the name Axyven XL 37.5mg
prolonged-release tablets but will be referred to as Axyven XL
throughout this leaflet. Other strengths 75mg, 150mg and
225mg are also available.
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, please 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 Axyven XL is and what it is used for
2.
What you need to know before you take Axyven XL
3.
How to take Axyven XL
4.
Possible side effects
5.
How to store Axyven XL
6.
Contents of the pack and other information
1.
WHAT AXYVEN XL IS AND WHAT IT IS USED FOR
Axyven XL contains the active substance venlafaxine.
Axyven XL is an antidepressant that belongs to a group of
medicines called serotonin and norepinephrine 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.
Axyven XL is a treatment for adults with depression.
Axyven XL 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 import

Summary of Product characteristics

OBJECT 1
VENLALIC XL PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 05-Jun-2018 | Ethypharm UK
Ltd
1. Name of the medicinal product
Venlalic XL 37.5 mg prolonged-release tablets
Venlalic XL 75 mg prolonged-release tablets
Venlalic XL 150 mg prolonged-release tablets
Venlalic XL 225 mg prolonged-release tablets
2. Qualitative and quantitative composition
Venlalic XL 37.5 mg prolonged-release tablets
Each prolonged-release tablet contains 37.5 mg venlafaxine (as
hydrochloride).
Venlalic XL 75 mg prolonged-release tablets
Each prolonged-release tablet contains 75 mg venlafaxine (as
hydrochloride).
Venlalic XL 150 mg prolonged-release tablets
Each prolonged-release tablet contains 150 mg venlafaxine (as
hydrochloride).
Venlalic XL 225 mg prolonged-release tablets
Each prolonged-release tablet contains 225 mg venlafaxine (as
hydrochloride).
Excipient with known effect: lactose 3.0 / 3.4 / 5.7 / 6.5 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
37.5 mg prolonged-release tablets: 7 mm round, biconvex, white
tablets.
75 mg prolonged-release tablets: 7.5 mm round, biconvex, white
tablets.
150 mg prolonged-release tablets: 9.5 mm round, biconvex, white
tablets.
225 mg prolonged-release tablets: 11 mm round, biconvex, white tablets
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 fr