Venlalic XL 225mg 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:

225mg

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: 5060078671194

Patient Information leaflet

D50057-B
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 Venlalic XL is and what it is used for
2.
What you need to know before you take Venlalic XL
3.
How to take Venlalic XL
4.
Possible side effects
5.
How to store Venlalic XL
6.
Contents of the pack and other information
1.
What Venlalic XL is and what it is used for
Venlalic XL contains the active substance venlafaxine. Venlalic 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.
Venlalic XL is a treatment for adults with depression. Venlalic 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
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 Venlalic XL
Do not take Venlalic XL
•
If you are allergic to venlafaxine or any of the other ingredients of
this medicine (

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