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VENLAFAXINE 50MG TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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5

How to store Venlafaxine

6

Contents of the pack and other
information

What Venlafaxine contains
• The active substance is venlafaxine. Each
tablet contains 25 mg, 37.5 mg, 50 mg,
75 mg of venlafaxine (as hydrochloride)
• The other ingredients are lactose
monohydrate, lactose spray-dried, sodium
starch glycolate (type A), colloidal silica
anhydrous, magnesium stearate, yellow
iron oxide (E172) and red iron oxide (E172).
What Venlafaxine looks like and contents of
the pack
• 25 mg tablets: Mottled peach, round, flat
beveled tablet, scored on one side and
debossed "9" on one side of the score and
"3" on the other side, debossed "199" on
the opposite side of the tablet. The tablet
can be divided into equal halves and is
available in pack sizes of 30 and 60 tablets.
A hospital pack size of 50 tablets is also
available
• 37.5 mg tablets: Mottled peach, round, flat
beveled tablet, scored on one side and
debossed "9" on one side of the score and
"3" on the other side, debossed "7380" on
the opposite side of the tablet. The score line
is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
The tablets are available in pack sizes of 10,
20, 28, 30, 50, 56, 60 and 100 tablets. A
hospital pack size of 50 tablets is also available
• 50 mg tablets: Mottled peach, round, flat
beveled tablet, scored on one side and
debossed "9" on one side of the score and
"3" on the other side, debossed with "7381"
on the opposite side of the tablet. The tablet
can be divided into equal halves and is
available in pack sizes of 28, 30, 42, 56, 60
and 100 tablets. A hospital pack size of 50
tablets is also available
• 75 mg tablets: Mottled peach, round, flat
beveled tablet, scored on one side and
debossed "9" on one side of the score and
"3" on the other side, debossed with "7382"
on the opposite side of the tablet. The tablet
can be divided into equal halves and is
available in pack sizes of 20, 28, 30, 50, 56,
60 and 100 tablets. Hospital pack sizes of 50
and 500 tablets are also available.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Brampton Road,
Hampden Park, Eastbourne, East Sussex,
BN22 9AG.
This leaflet was last revised in June 2016
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anxiety disorders. It is thought that people
who are depressed and/or anxious have
lower levels of serotonin and noradrenaline
PACKAGE LEAFLET:
in the brain. It is not fully understood how
INFORMATION FOR THE USER
antidepressants work, but they may help by
increasing the levels of serotonin and
Important things you should know about
noradrenaline in the brain.
Venlafaxine
• Venlafaxine is for depression
Venlafaxine is a treatment for adults with
• Venlafaxine should not be given to anyone depression. Treating depression properly is
under 18 years of age - see Section 2 ‘Use important to help you get better. If it is not
in children and adolescents under 18 years treated, your condition may not go away
of age’
and may become more serious and more
• Venlafaxine may not work straight away.
difficult to treat.
After you start treatment, you may feel
you need to know before
worse before you feel better. It may take
2 What
you take Venlafaxine
between two and four weeks before you
start to feel better. Tell your doctor if you
DO NOT take Venlafaxine
do not start to feel better
• If you are allergic to Venlafaxine or any of
• Some people who are depressed may think
the other ingredients of medicine (listed in
of harming or killing themselves. If this
section 6)
happens you should tell your doctor or go • If you are also taking or have taken any
to a hospital straight away - see Section 2
time within the last 14 days any medicines
‘Thoughts of suicide and worsening of
known as irreversible monoamine oxidase
your depression or anxiety disorder’
inhibitors (MAOIs), used to treat depression
• If you have taken too many tablets tell your
or Parkinson’s disease. Taking an
doctor or go to a hospital straight away. Do
irreversible MAOI together with other
this even if you feel well as taking too
medicines, including Venlafaxine, can
much of this medicine can be dangerous
cause serious or even life-threatening side
• Do not stop taking your tablets or change
effects. Also, you must wait at least 7 days
the amount you take without checking
after you stop taking Venlafaxine before
with your doctor first. Keep taking them
you take any irreversible MAOI (see also the
even if you feel better. If you stop taking
section “Other medicines and venlafaxine”).
Venlafaxine suddenly you may get
Warnings
and precautions
withdrawal reactions – see Section 3 ‘If you
stop taking Venlafaxine’
Talk to your doctor or pharmacist before
• Taking certain other medicines with
taking venlafaxine
Venlafaxine may cause problems. Tell your • If you use other medicines that taken
doctor if you are taking or have recently
together with Venlafaxine could increase
taken any other medicines – see Section 2
the risk of developing serotonin syndrome
‘Taking other medicines’
(see the section “Other medicines and
• Tell your doctor straight away if you feel
venlafaxine”)
restless and can’t keep still, feel ‘high’ or
• If you have eye problems, such as certain
over-excited or have jerky muscle
kinds of glaucoma (increased pressure in
movements which you can’t control - see
the eye)
Section 4 ‘Possible side effects’
• If you have a history of high blood pressure
• If you have problems with your heart or
• If you have a history of heart problems
have high blood pressure, talk to your
• If you have a history of fits (seizures)
doctor before taking Venlafaxine – see
• If you are diabetic, as your insulin or oral
Section 2 'Take special care with Venlafaxine’
antidiabetic dosage may need to be changed
• If you are pregnant, planning to become
• If you have a history of low sodium levels
pregnant, or are breast-feeding, talk to
in your blood (hyponatraemia)
your doctor before taking Venlafaxine – see • If you have a tendency to develop bruises
section 2 ‘Pregnancy and breast-feeding’.
or a tendency to bleed easily (history of
bleeding disorders), or if you are taking
There is more information on all of these
other medicines that may increase the risk
points in the rest of this leaflet.
of bleeding e.g., warfarin (used to prevent
Read all of this leaflet carefully before you
blood clots)
start taking this medicine because it
• If your cholesterol levels get higher
contains important information for you.
• If you have a history of, or if someone in
• Keep this leaflet. You may need to read it
your family has had, mania or bipolar
again.
disorder (feeling over-excited or euphoric)
• If you have any further questions, ask your • If you have a history of aggressive
doctor or pharmacist.
behaviour.
• This medicine has been prescribed for you
If any of these conditions apply to you,
only. Do not pass it on to others. It may
please talk with your doctor before taking
harm them, even if their signs of illness
Venlafaxine.
are the same as yours.
• If you get any side effects, talk to your
Venlafaxine may cause a sensation of
doctor or pharmacist. This includes any
restlessness or an inability to sit or stand
possible side effects not listed in this
still during the first few weeks of treatment.
leaflet. See section 4.
You should tell your doctor if this happens
to you.
What is in this leaflet
Thoughts of suicide and worsening of your
1. What Venlafaxine is and what it is used for depression or anxiety disorder
If you are depressed and/or have anxiety
2. What you need to know before you take
disorders you can sometimes have thoughts
Venlafaxine
of harming or killing yourself. These may be
3. How to take Venlafaxine
increased when you first start taking
4. Possible side effects
antidepressants, since these medicines all
5. How to store Venlafaxine
6. Contents of the pack and other information take time to work, usually about two weeks
but sometimes longer.
Venlafaxine is and what it is You may be more likely to think like this:
1 What
used for
• If you have previously had thoughts about
killing or harming yourself
Venlafaxine is an antidepressant that belongs
to a group of medicines called serotonin and • If you are a young adult. Information from
clinical trials has shown an increased risk
norepinephrine reuptake inhibitors (SNRIs).
This group of medicines is used to treat
Peel Here To Open
depression and other conditions, such as

VENLAFAXINE 25 mg, 37.5 mg,
50 mg AND 75 mg TABLETS

Pharma code 20 (0101)
First bar is 105mm from top edge.

Keep out of the sight and reach of children.
Do not use Venlafaxine after the expiry date
which is stated on the blister and carton
after EXP. The expiry date refers to the last
day of the month.
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.

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been taking Venlafaxine for a long time.
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.

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• 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 over-excited; 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 Venlafaxine)
• 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
Venlafaxine 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 of
liver enzymes, sodium or cholesterol. More
rarely, Venlafaxine 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

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• Medicines containing methylene blue
(used to treat high levels of
methaemoglobin in the blood)
• 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)
• 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).
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 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 Venlafaxine 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).
Venlafaxine with food, drink and alcohol
• Venlafaxine should be taken with food
(see section 3 “How to take Venlafaxine”)
• You should avoid alcohol while you are
taking Venlafaxine.
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 Venlafaxine 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 Venlafaxine. When taken
during pregnancy, similar drugs (SSRIs)
may increase the risk of a serious
condition in babies, called persistent
pulmonary hypertension of the new born
(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 this medicine during
pregnancy, in addition to having trouble
breathing, another symptom your baby
might have when it is born is not feeding
properly. If your baby has these
symptoms when it is born and you are

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concerned, contact your doctor and/or
midwife who will be able to advise you.
• Venlafaxine 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 Venlafaxine.
Driving and using machines
• Do not drive or use any tools or machines
until you know how Venlafaxine affects you.
Venlafaxine 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 Venlafaxine

Always take this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The recommended dose is 75 mg per day in
divided doses, two or three times a 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.
Take Venlafaxine at approximately the same
time each day, in the morning and in the
evening.
Venlafaxine should be taken with food.
If you have liver or kidney problems, talk to
your doctor, since your dose of Venlafaxine
may need to be different.
Do not stop taking Venlafaxine without
talking to your doctor (see the section “If
you stop taking Venlafaxine”).
If you take more Venlafaxine than you
should
Call your doctor or pharmacist immediately if
you take more than the amount of
Venlafaxine 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 Venlafaxine
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 Venlafaxine
that has been prescribed for you in one day.
If you stop taking Venlafaxine
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 Venlafaxine, he/she
may ask you to reduce your dose slowly,
before stopping treatment altogether. Side
effects are known to occur when people
stop using Venlafaxine, especially when
Venlafaxine 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 Venlafaxine
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, this medicine can cause
side effects, although not everybody gets
them.
If any of the following happen, do not take

more Venlafaxine. 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 skin 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 feeling unusually overexcited
• Withdrawal effects (see the section “How
to take Venlafaxine, if you stop taking
Venlafaxine”).
• 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

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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 Venlafaxine. Therefore, the dosage of your
diabetes medicines may need to be adjusted.
Children and adolescents
Venlafaxine 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 Venlafaxine for patients
under 18 because he/she decides that this is
in their best interests. If your doctor has
prescribed Venlafaxine 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
Venlafaxine. Also, the long-term safety effects
concerning growth, maturation and cognitive
and behavioural development of Venlafaxine
in this age group has not yet been
demonstrated.
Other medicines and Venlafaxine
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Your doctor should decide whether you can
take Venlafaxine with other medicines.
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.
• Monoamine oxidase inhibitors (MAOIs:
see the section “What you need to know
before you take Venlafaxine”)
• 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)
• 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)
• Medicines containing dextromethorphan
(used to treat coughing)
• Medicines containing methadone (used
to treat opioid drug addiction or severe
pain)

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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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