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VENLADEX XL 75 MG PROLONGED RELEASE TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

VENLADEX® XL 75 mg PROLONGED-RELEASE TABLETS
VENLADEX® XL 150 mg PROLONGED-RELEASE TABLETS
Venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW
ABOUT VENLADEX XL
Please read all of this leaflet before you start
to take your medicine as it contains important
information about Venladex XL.
Venladex 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).
Venladex 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.
Venladex 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 in 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 themselves. 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 tablets 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 Venladex XL or change your
dose without the advice of your doctor even
if you feel better. If you stop taking Venladex XL
abruptly you may get withdrawal reactions – see in
section 3 'If you stop taking Venladex XL'.
If you have heart problems such as fast or
irregular heart rate or high blood pressure
you should talk to your doctor before taking
Venladex XL - see in section 2 'Before you take
Venladex XL'.
Taking certain other medicines with Venladex
XL may cause problems. You should tell your
doctor if you are taking any other medicines see in section 2 'What you need to know before you
take Venladex XL'.
See your doctor without delay if you feel restless
and feel like you can't keep still, feel 'high' or very
over-excited, have jerky muscle movements which
you can't control. See section 4 'Possible side
effects' for other important information.
If you are pregnant, or intend to become
pregnant, or breast-feeding, you should talk
to your doctor - see in section 2 'Pregnancy and
breast-feeding'.

What is in this leaflet:
1. What VENLADEX XL is and what it is used for
2. What you need to know before you take
VENLADEX XL
3. How to take VENLADEX XL
4. Possible side effects
5. How to store VENLADEX XL
6. Contents of the pack and other information

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More information on all of these points is provided
in the rest of this leaflet. 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. This
includes any possible side effects not listed in this
leaflet. See section 4.

1. WHAT VENLADEX XL IS AND WHAT IT IS
USED FOR
The name of your medicine is VENLADEX XL 75
mg or VENLADEX XL 150 mg Prolonged-Release
Tablets (referred to as VENLADEX XL throughout
this leaflet).
VENLADEX 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.
VENLADEX XL is a treatment for adults with
depression. VENLADEX 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 VENLADEX XL
Do not take VENLADEX XL
• If you are allergic to venlafaxine or any of the other
ingredients of VENLADEX XL (section 6 contains
a full list).
• If you are also taking, or have taken within the
last 14 days, any medicines known as irreversible
monoamine oxidase inhibitors (MAOIs), used to
treat depression or Parkinson’s disease. Taking an
irreversible MAOI together with VENLADEX XL,
can cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after
you stop taking VENLADEX XL before you take
any MAOI (see also the section entitled “Other
medicines and Venladex XL” and the information
in that section about “Serotonin syndrome”).
Warnings and precautions
If any of the following apply to you, please tell your
doctor before taking VENLADEX XL:
• If you use other medicines that, if taken
concomitantly with VENLADEX XL, could increase
the risk of developing serotonin syndrome (see
the section “Other medicines and Venladex XL”).
• If you have eye problems, such as certain kinds of
glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told you have an abnormal heart
rhythm.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your
blood (hyponatraemia).
• If you have a tendency to develop bruises or a
tendency to bleed easily (history of bleeding

disorders), or if you are taking other medicines
that may increase the risk of bleeding e.g.,
warfarin (use to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your
family has had, mania or bipolar disorder (feeling
over-excited or euphoric).
• If you have a history of aggressive behaviour.
VENLADEX XL may cause a sensation of
restlessness or an inability to sit or stand still during
the first few weeks of treatment. You should tell your
doctor if this happens to you.
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorders,
you can sometimes have thoughts of harming
or killing yourself. These may be increased when
you first start taking antidepressants, since these
medicines all take time to work, usually about two
weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing
yourself or harming yourself.
• If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in young adults (less than 25 years old)
with psychiatric conditions who were treated with
an antidepressant.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close
friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might
ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about
changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated
with venlafaxine. This may increase the risk of tooth
decay (caries). Therefore, you should take special
care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to
VENLADEX XL. Therefore, the dosage of your
diabetes medicines may need to be adjusted.
Children and adolescents
VENLADEX XL should normally not be used
for children and adolescents under 18 years.
Also, you should know that patients under 18
have an increased risk of side effects, such as
suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour
and anger) when they take this class of medicines.
Despite this, your doctor may prescribe VENLADEX
XL for patients under 18 because he/she decides
that this is in their best interests. If your doctor has
prescribed VENLADEX XL for a patient under 18,
and you want to discuss this, please go back to
your doctor. You should inform your doctor if any
of the symptoms listed above develop or worsen
when patients under 18 are taking VENLADEX
XL. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of VENLADEX XL in this age group
has not yet been demonstrated.
Other medicines and Venladex XL
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Do not start or stop taking any medicines, including
those bought without a prescription, natural and
herbal remedies, before checking with your doctor
or pharmacist.
Your doctor should decide whether you can take
VENLADEX XL with other medicines, such as:
• Monoamine oxidase inhibitors which are used to
treat depression or Parkinson’s disease must not
be taken with VENLADEX XL. Tell your doctor if
you have taken these medicines within the last 14
days. (MAOIs: see the section “What you need to
know before you take VENLADEX XL”).
• Products associated with serotonin syndrome:
Serotonin syndrome:
A potentially life threatening condition or Neuroleptic
Malignant Syndrome (NMS)-like reactions (see the
section “Possible Side Effects”), may occur with
venlafaxine treatment, particularly when taken with
other medicines. Examples of these medicines
include:
• Triptans (used for migraine)
• Other medicines to treat depression, for instance
SNRI, SSRIs, tricyclics, or medicines containing
lithium
• Medicines containing linezolid, an antibiotic (used
to treat infections)
• Medicines containing moclobemide, a reversible
MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight
loss)
• Medicines containing tramadol (a pain killer),
fentanyl, tapentadol, pethidine, or pentazocine
(used to treat severe pain)
• Medicines containing dextromethorphan (used to
treat coughing)
• Medicines containing methadone (used to treat
opioid drug addiction or severe pain)
• Medicines containing methylene blue (used to
treat high levels of methaemoglobin in the blood)
• Products containing St. John’s Wort (also called
Hypericum perforatum, a natural or herbal remedy
used to treat mild depression)
• Products containing tryptophan (used for
problems such as sleep and depression)
• Antipsychotics (used to treat a disease with
symptoms such as hearing, seeing or sensing
things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and
becoming withdrawn)
Signs and symptoms of serotonin syndrome may
include a combination of the following:
restlessness, hallucinations, loss of coordination,
fast heart beat, increased body temperature, fast
changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome
can resemble Neuroleptic Malignant Syndrome
(NMS). Signs and symptoms of NMS may include
a combination of fever, fast heart beat, sweating,
severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the
casualty department at your nearest hospital if
you think serotonin syndrome is happening to
you.
You must tell your doctor if you are taking medicines
that can affect your heart rhythm.
Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone,
sotalol or dofetilide (used to treat abnormal heart
rhythm)
• Antipsychotics such as thioridazine (See also
Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin
(used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with
VENLADEX XL and should be used with caution. It
is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole (an antifungal medicine)

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• Haloperidol or risperidone (to treat psychiatric
conditions)
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems)
• Oral contraceptives
Taking VENLADEX XL with food and drink
VENLADEX XL should be taken with food (see
section 3 “How to take VENLADEX XL”).
You should avoid alcohol while you are taking
VENLADEX XL.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine. You should use VENLADEX XL only
after discussing the potential benefits and the
potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor know you are
on VENLADEX XL. When taken during pregnancy,
similar drugs (SSRIs) may increase the risk of
a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24
hours after the baby is born. If this happens to your
baby you should contact your midwife and/or doctor
immediately.
If you are taking VENLADEX XL during pregnancy,
other symptoms your baby might have when it is
born is not feeding properly, in addition to having
trouble breathing. If your baby has these symptoms
when it is born and you are concerned, contact your
doctor and/or midwife who will be able to advise
you.
VENLADEX XL passes into breast milk. There is a
risk of an effect on the baby. Therefore, you should
discuss the matter with your doctor, and he/she will
decide whether you should stop breast feeding or
stop the therapy with VENLADEX XL.
Driving and operating machinery
Venlafaxine can cause impaired judgement,
thinking, and movement and coordination as well
as problems with vision. If you are affected by any
of these you should not drive, operate machinery or
take part in any activities where such effects could
put you or others at risk.
3. HOW TO TAKE VENLADEX XL
Always take VENLADEX XL exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual recommended starting dose for treatment
of depression, generalised anxiety disorder and
social anxiety disorder is 75 mg per day. The
dose can be raised by your doctor gradually, and
if needed, even up to a maximum dose of 375
mg daily for depression. If you are being treated
for panic disorder, your doctor will start with a
lower dose (37.5 mg) and then increase the dose
gradually. The maximum dose for generalised
anxiety disorder, social anxiety disorder and panic
disorder is 225 mg/day.
Take VENLADEX XL at approximately the same
time each day, either in the morning or in the
evening. The tablets must be swallowed whole with
fluid and not crushed, divided, chewed or dissolved.
VENLADEX XL should be taken with food.
If you have liver or kidney problems, talk to your
doctor, since your dose of VENLADEX XL may
need to be different.
Do not stop taking VENLADEX XL without talking
to your doctor (see the section “If you stop taking
VENLADEX XL”).
If you take more VENLADEX XL than you should
Call your doctor or pharmacist immediately if you
take more than the amount of VENLADEX XL
prescribed by your doctor.
The symptoms of a possible overdose may include
a rapid heart beat, changes in level of alertness
(ranging from sleepiness to coma), blurred vision,
seizures or fits, and vomiting.

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If you forget to take VENLADEX XL
If you miss a dose, take it as soon as you
remember. However, if it is time for your next dose,
skip the missed dose and take only a single dose
as usual. Do not take more than the daily amount
of VENLADEX XL that has been prescribed for you
in one day.
If you stop taking VENLADEX XL
Do not stop taking your treatment or reduce the dose
without the advice of your doctor even if you feel
better. If your doctor thinks that you no longer need
VENLADEX XL, he/she may ask you to reduce your
dose slowly before stopping treatment altogether.
Side effects are known to occur when people stop
using VENLADEX XL, especially when VENLADEX
XL is stopped suddenly or the dose is reduced too
quickly. Some patients may experience symptoms
such as tiredness, dizziness, light-headedness,
headache, sleeplessness, nightmares, dry mouth,
loss of appetite, nausea, diarrhoea, nervousness,
agitation, confusion, ringing in the ears, tingling
or rarely electric shock sensations, weakness,
sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should
gradually discontinue VENLADEX XL treatment.
If you experience any of these or other symptoms
that are troublesome, ask your doctor for further
advice.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VENLADEX XL can cause side
effects, although not everybody gets them.
If any of the following happen, do not take more
VENLADEX XL. Tell your doctor immediately, or
go to the casualty department at your nearest
hospital:
Uncommon (may affect up to 1 in 100 people)
• Swelling of the face, mouth, tongue, throat, hands,
or feet and/or a raised itchy rash (hives), trouble
swallowing or breathing
Frequency not known (cannot be estimated
from the available data)
• Chest tightness, wheezing, trouble swallowing or
breathing
• Severe rash, itching, or hives (elevated patches of
red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome
which may include restlessness, hallucinations,
loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea,
vomiting. In its most severe form, serotonin
syndrome can resemble Neuroleptic Malignant
Syndrome (NMS). Signs and symptoms of NMS
may include a combination of fever, fast heart beat,
sweating, severe muscle stiffness, confusion,
increased muscle enzymes (determined by a
blood test).
• Signs of infection, such as high temperature,
chills, shivering, headaches, sweating, flu-like
symptoms. This may be the result of a blood
disorder which leads to an increased risk of
infection.
• Severe rash, which may lead to severe blistering
and peeling of the skin.
• Unexplained muscle pain, tenderness or
weakness. This may be a sign of rhabdomyolysis.
Other side effects that you should tell your doctor
about include (The frequency of these side effects
are included in the list “Other side effects that may
occur” below):
• Coughing, wheezing, shortness of breath and a
high temperature
• Black (tarry) stools or blood in stools
• Itchiness, yellow skin or eyes, or dark urine, which
may be symptoms of inflammation of the liver
(hepatitis)

• Heart problems, such as fast or irregular heart
rate, increased blood pressure
• Eye problems, such as blurred vision, dilated
pupils
• Nerve problems, such as dizziness, pins and
needles, movement disorder (muscle spasms or
stiffness), seizures or fits
• Psychiatric problems, such as hyperactivity and
euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take
VENLADEX XL, if you stop taking VENLADEX
XL”).
• Prolonged bleeding – if you cut or injure yourself,
it may take slightly longer than usual for bleeding
to stop.
Other side effects that may occur
Very common: may affect more than 1 in 10
people
• dizziness; headache
• nausea; dry mouth
• sweating (including night sweats)
Common: may affect up to 1 in 10 people
• appetite decreased
• confusion; feeling separated (or detached)
from yourself; lack of orgasm; decreased libido;
nervousness; insomnia; abnormal dreams
• drowsiness; tremor; pins and needles; increased
muscle tonus
• visual disturbance including blurred vision; dilated
pupils; inability of the eye to automatically change
focus from distant to near objects
• ringing in the ears (tinnitus)
• palpitations
• increase in blood pressure; flushing
• yawning
• vomiting; constipation; diarrhoea
• increased frequency in urination; difficulties
passing urine
• menstrual irregularities such as increased
bleeding or increased irregular bleeding;
abnormal ejaculation/orgasm (males); erectile
dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• increased cholesterol
Uncommon: may affect up to 1 in 100 people
• hallucinations; feeling separated (or detached)
from reality; agitation; abnormal orgasm
(females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• a sensation of restlessness or an inability to sit
or stand still; fainting; involuntary movements of
the muscles; impaired coordination and balance;
altered taste sensation
• fast heartbeat; feeling dizzy (particularly when
standing up too quickly)
• shortness of breath
• vomiting blood, black tarry stools (faeces) or blood
in stools; which can be a sign of internal bleeding
• sensitivity to sunlight; bruising; rash; abnormal
hair loss
• inability to pass urine;
• weight gain; weight loss
Rare: may affect up to 1 in 1,000 people
• seizures or fits
• inability to control urination
• over activity, racing thoughts and decreased need
for sleep (mania)
Frequency not known (cannot be estimated
from the available data)
• prolonged bleeding, which may be a sign of
reduced number of platelets in your blood, leading
to an increased risk of bruising or bleeding
• excessive water intake (known as SIADH)
• decrease in blood sodium levels
• suicidal ideation and suicidal behaviours; cases
of suicidal ideation and suicidal behaviours
have been reported during venlafaxine therapy
or early after treatment discontinuation (see
section 2, What you need to know before you take
VENLADEX XL)
• disorientation and confusion often accompanied
by hallucination (delirium); aggression
• stiffness, spasms and involuntary movements of
the muscles
• severe eye pain and decreased or blurred vision
• vertigo
• decrease in blood pressure; abnormal, rapid or
irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood
in the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels
(broken veins)
• coughing, wheezing, shortness of breath and
a high temperature, which are symptoms of
inflammation of the lungs associated with
an increase in white blood cells (pulmonary
eosinophilia)
• severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or
pancreas)
• itchiness, yellow skin or eyes, dark urine, or flu-like
symptoms, which are symptoms of inflammation
of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• itching; mild rash
• abnormal breast milk production
VENLADEX XL sometimes causes unwanted
effects that you may not be aware of, such as
increases in blood pressure or abnormal heart beat;
slight changes in blood levels or liver enzymes,
sodium or cholesterol. More rarely, VENLADEX XL
may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding.
Therefore, your doctor may wish to do blood tests
occasionally, particularly if you have been taking
VENLADEX XL for a long time.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE VENLADEX XL
Keep out of the sight and reach of children.
Do not use VENLADEX XL after the expiry date,
which is stated on the packaging.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
The active substance is venlafaxine.
Each tablet contains 75 mg or 150 mg venlafaxine
as venlafaxine hydrochloride.
Other ingredients in these tablets are:
microcrystalline
cellulose,
hypromellose,
ethylcellulose, magnesium stearate, silica colloidal
anhydrous, dibutyl sebacate and macrogol 400.
VENLADEX XL 150 mg Tablets also contain
carnauba wax.
What VENLADEX XL looks like and contents of
the pack
VENLADEX XL 75 mg and VENLADEX XL 150 mg
are white, convex, capsule-shaped coated tablets.
VENLADEX XL 75 mg and VENLADEX XL 150 mg
come in calendar packs of 28 tablets.
Marketing Authorisation Holder and
Manufacturer:
DEXCEL® -PHARMA LTD., 7 Sopwith Way, Drayton
Fields, Daventry, Northamptonshire,
NN11 8PB, UK.
This leaflet was last revised in January 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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