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VIEPAX 75MG TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ViePax® 37.5 mg TABLETS
ViePax® 75 mg TABLETS
Venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW
ABOUT ViePax

Please read all of this leaflet before you start
to take your medicine as it contains important
information about ViePax.
ViePax is used to treat depression and social
anxiety disorder (also known as social phobia).
ViePax 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.
ViePax 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 ViePax or change your dose
without the advice of your doctor even if you
feel better. If you stop taking ViePax abruptly you
may get withdrawal reactions – see in section 3 'If
you stop taking ViePax'.
If you have heart problems such as fast or
irregular heart rate or high blood pressure you
should talk to your doctor before taking ViePax
– see in section 2 'Before you take ViePax'.
Taking certain other medicines with ViePax 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
ViePax'.
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'.
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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What ViePax is and what it is used for
2. What you need to know before you take ViePax
3. How to take ViePax
4. Possible side effects
5. How to store ViePax
6. Contents of the pack and other information

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1. WHAT ViePax IS AND WHAT IT IS USED FOR
The name of your medicine is ViePax 37.5 mg
Tablets or ViePax 75 mg Tablets (referred to as
ViePax throughout this leaflet).
ViePax 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. 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.
ViePax is a treatment for adults with depression.
Treating depression 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 ViePax
Do not take ViePax
• If you are allergic to venlafaxine or any of the
other ingredients of ViePax (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 ViePax, can cause
serious or even life-threatening side effects. Also,
you must wait at least 7 days after you stop taking
ViePax before you take any MAOI (see also the
section entitled “Other medicines and ViePax” 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 ViePax:
• If you use other medicines that, if taken
concomitantly with ViePax, could increase the
risk of developing serotonin syndrome (see the
section “Other medicines and ViePax”).
• 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.
ViePax 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
If you are depressed and/or anxious, 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 anxious, 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
ViePax. Therefore, the dosage of your diabetes
medicines may need to be adjusted.
Children and adolescents
ViePax 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 ViePax for patients under 18
because he/she decides that this is in their best
interests. If your doctor has prescribed ViePax 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 ViePax. Also, the long-term safety effects
concerning growth, maturation and cognitive and
behavioural development of ViePax in this age
group has not yet been demonstrated.
Other medicines and ViePax
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
ViePax with other medicines, such as:
• Monoamine oxidase inhibitors which are used to
treat depression or Parkinson’s disease must not
be taken with ViePax. 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 ViePax”).
• 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
ViePax 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)
• Haloperidol or risperidone (to treat psychiatric
conditions)
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems)
• Oral contraceptives
Taking ViePax with food and drink
ViePax should be taken with food (see section 3
“How to take ViePax”).
You should avoid alcohol while you are taking
ViePax.
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 ViePax 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 ViePax. 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 ViePax 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.
ViePax 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 ViePax.
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.
Important information about some of the
ingredients of ViePax
This product contains lactose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE ViePax
Always take ViePax 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 is 75 mg
per day in divided doses. The dose can be raised
by your doctor gradually and, if needed, even up to
a maximum dose of 375 mg daily for depression.
Take ViePax at approximately the same time each
day, in the morning and in the evening.
ViePax should be taken with food.
If you have liver or kidney problems, talk to your
doctor, since your dose of ViePax may need to be
different.
The 37.5mg tablets and 75mg tablets come in
special "calendar" packs which help you remember
to take your tablets when you should.
The following instructions will help you:
1. Remove a card.
2. Go to the correct day of the week.
3. Take the tablet from the card or part of the
card, marked "AM", in the morning.
4. Your next tablet should be taken in the evening
from the card or part of the card, marked "PM".
5. Continue taking a tablet every morning and
evening.
6. When you have finished a card, move on to
the next one.
Do not stop taking ViePax without talking to your
doctor (see the section “If you stop taking ViePax”).
If you take more ViePax than you should
Call your doctor or pharmacist immediately if you
take more than the amount of ViePax 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.
If you forget to take ViePax
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 ViePax
that has been prescribed for you in one day.

4. POSSIBLE SIDE EFFECTS

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If you stop taking ViePax
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 ViePax, he/she may ask you to reduce your
dose slowly before stopping treatment altogether.
Side effects are known to occur when people
stop using ViePax, especially when ViePax 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 ViePax 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.

Like all medicines, ViePax can cause side effects,
although not everybody gets them.
If any of the following happen, do not take more
ViePax. 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
ViePax, if you stop taking ViePax”)
• 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 ViePax)
• 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
ViePax 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, ViePax 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 ViePax 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 ViePax
Keep out of the reach and sight of children.
Do not use ViePax 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
What ViePax contains
The active substance is venlafaxine.
Each tablet contains either 37.5 mg or 75 mg
venlafaxine as venlafaxine hydrochloride.
Other ingredients in these tablets are: lactose
monohydrate, microcrystalline cellulose, sodium
starch glycolate, povidone, magnesium stearate,
ferric oxide yellow (E-172), ferric oxide red (E-172)
and ferric oxide black (E-172).
What ViePax looks like and contents of the pack
ViePax37.5 mg and ViePax 75 mg are mottledbeige, round tablets.
ViePax 37.5 mg and ViePax 75 mg come in
calendar packs of 28 and 56 tablets.
Not all pack sizes may be marketed.
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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