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VENLAFAXINE 37.5MG TABLETS

Active substance: VENLAFAXINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-68935-ZB LEA VENLAFAXINE A/S TAB TUK
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LINE.

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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 or
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
been taking Venlafaxine for a long time.

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

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).

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.

HOW TO STORE VENLAFAXINE

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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CONTENTS OF THE PACK AND
OTHER INFORMATION

6

Reporting of side effects
If you get any side effects, talk to your
This leaflet was last revised in July 2015
doctor or pharmacist. This includes any
PL 00289/0711-0714
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

09 July 2015

WHAT VENLAFAXINE IS AND
WHAT IT IS USED FOR

Venlafaxine is an antidepressant that belongs
to a group of medicines called serotonin
and norepinephrine reuptake inhibitors
Important things you should know about
(SNRIs). This group of medicines is used to
Venlafaxine
treat depression and other conditions, such
• Venlafaxine is for depression
• Venlafaxine should not be given to anyone as anxiety disorders. It is thought that people
under 18 years of age - see Section 2 ‘Use who are depressed and/or anxious have
in children and adolescents under 18 years lower levels of serotonin and noradrenaline
in the brain. It is not fully understood how
of age’
antidepressants work, but they may help by
• Venlafaxine may not work straight away.
increasing the levels of serotonin and
After you start treatment, you may feel
noradrenaline in the brain.
worse before you feel better. It may take
between two and four weeks before you
Venlafaxine is a treatment for adults with
start to feel better. Tell your doctor if you
depression. Treating depression properly is
do not start to feel better
important to help you get better. If it is not
• Some people who are depressed may think treated, your condition may not go away
of harming or killing themselves. If this
and may become more serious and more
happens you should tell your doctor or go difficult to treat.
to a hospital straight away - see Section 2
‘Thoughts of suicide and worsening of
2 WHAT YOU NEED TO KNOW
your depression or anxiety disorder’
BEFORE YOU TAKE VENLAFAXINE
• If you have taken too many tablets tell
DO NOT take Venlafaxine
your doctor or go to a hospital straight
• If you are allergic to Venlafaxine or any of
away. Do this even if you feel well as
the other ingredients of medicine (listed in
taking too much of this medicine can be
section 6)
dangerous
• Do not stop taking your tablets or change • If you are also taking or have taken any
time within the last 14 days any medicines
the amount you take without checking
known as irreversible monoamine oxidase
with your doctor first. Keep taking them
inhibitors (MAOIs), used to treat depression
even if you feel better. If you stop taking
or Parkinson’s disease. Taking an irreversible
Venlafaxine suddenly you may get
MAOI together with other medicines,
withdrawal reactions – see Section 3 ‘If
including Venlafaxine, can cause serious
you stop taking Venlafaxine’
or even life-threatening side effects. Also,
• Taking certain other medicines with
you must wait at least 7 days after you
Venlafaxine may cause problems. Tell your
stop taking Venlafaxine before you take
doctor if you are taking or have recently
any irreversible MAOI (see also the section
taken any other medicines – see Section 2
“Other medicines and venlafaxine”).
‘Taking other medicines’
• Tell your doctor straight away if you feel
Warnings and precautions
restless and can’t keep still, feel ‘high’ or
Talk to your doctor or pharmacist before
over-excited or have jerky muscle
taking venlafaxine
movements which you can’t control - see • If you use other medicines that taken
Section 4 ‘Possible side effects’
concomitantly with Venlafaxine could
• If you have problems with your heart or
increase the risk of developing serotonin
have high blood pressure, talk to your
syndrome (see the section “Other
doctor before taking Venlafaxine – see
medicines and venlafaxine”)
Section 2 'Take special care with Venlafaxine’ • If you have eye problems, such as certain
• If you are pregnant, planning to become
kinds of glaucoma (increased pressure in
pregnant, or are breast-feeding, talk to
the eye)
your doctor before taking Venlafaxine - see • If you have a history of high blood pressure
section 2 ‘Pregnancy and breast-feeding’. • If you have a history of heart problems
• If you have a history of fits (seizures)
There is more information on all of these
• If you are diabetic, as your insulin or oral
points in the rest of this leaflet.
antidiabetic dosage may need to be
Read all of this leaflet carefully before you
changed
start taking this medicine because it
• If you have a history of low sodium levels
contains important information for you.
in your blood (hyponatraemia)
• Keep this leaflet. You may need to read it
• If you have a tendency to develop bruises
again.
or a tendency to bleed easily (history of
• If you have any further questions, ask your
bleeding disorders), or if you are taking
doctor or pharmacist.
other medicines that may increase the risk
• This medicine has been prescribed for you
of bleeding
only. Do not pass it on to others. It may
• If your cholesterol levels get higher
harm them, even if their signs of illness
• If you have a history of, or if someone in
are the same as yours.
your family has had, mania or bipolar
• If you get any side effects, talk to your
disorder (feeling over-excited or euphoric)
doctor or pharmacist. This includes any
• If you have a history of aggressive
possible side effects not listed in this
behaviour.
leaflet. See section 4.
Venlafaxine may cause a sensation of
WHAT IS IN THIS LEAFLET:
restlessness or an inability to sit or stand
1. What Venlafaxine is and what it is used for still. You should tell your doctor if this
happens to you.
2. What you need to know before you take
Venlafaxine
If any of these conditions apply to you,
3. How to take Venlafaxine
please talk with your doctor before taking
4. Possible side effects
Venlafaxine.
5. How to store Venlafaxine
6. Contents of the pack and other information

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symptoms of inflammation of the lungs
associated with an increase in white blood
cells
severe abdominal or back pains (which
could indicate a serious problem in the
gut, liver or pancreas)
decrease in blood pressure; abnormal,
rapid or irregular heart beat which could
lead to fainting
slight changes in blood levels of liver
enzymes; decrease in blood sodium
levels; itchiness, yellow skin or eyes, dark
urine, or flu-like symptoms, which are
symptoms of inflammation of the liver
(hepatitis); excessive water intake (known
as SIADH); abnormal breast milk
production
unexplained muscle pain, tenderness or
weakness (rhabdomyolysis)
a high temperature with rigid muscles,
confusion or agitation, and sweating, or if
you experience jerky muscle movements
which you can't control; these may be
symptoms of a serious condition known
as neuroleptic malignant syndrome
a feeling of euphoria, drowsiness,
sustained rapid eye movement,
clumsiness, restlessness, a feeling of
being drunk, and sweating or rigid
muscles; these may be symptoms of a
condition known as serotonergic
syndrome
stiffness, spasms and involuntary
movements of the muscles
disorientation and confusion often
accompanied by hallucinations, vertigo (a
feeling of dizziness or “spinning”),
aggression
thoughts of harming or killing yourself
skin rash which may lead to severe
blistering and peeling of the skin, itching,
mild rash
swollen face or tongue, shortness of
breath or difficulty breathing, often with
skin rashes (this may be a serious allergic
reaction)
life threatening irregular heartbeat
nose bleeds.

Version:

TEVA UK Ref:

231-30-68935-ZB LEA VENLAFAXINE A/S TAB TUK

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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 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 caries. Therefore, you should take
special care in your dental hygiene.
Children and adolescents under 18 years of
age
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.

• 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)
• 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)
Get medical care right away if you think
serotonin syndrome is happening to you.
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
• Tell your doctor if you become pregnant,
or you are trying to become pregnant. You
should use Venlafaxine only after
discussing the potential benefits and the
potential risks to your unborn child with
Other medicines and Venlafaxine
your doctor
Tell your doctor or pharmacist if you are
• Make sure your midwife and/or doctor
taking, have recently taken or might take
know you are on Venlafaxine. When taken
any other medicines.
during pregnancy, similar drugs (SSRIs)
may increase the risk of a serious
Your doctor should decide whether you can
condition in babies, called persistent
take Venlafaxine with other medicines.
pulmonary hypertension of the new born
Do not start or stop taking any medicines,
(PPHN), making the baby breathe faster
including those bought without a prescription,
and appear bluish. These symptoms
natural and herbal remedies, before
usually begin during the first 24 hours
checking with your doctor or pharmacist.
after the baby is born. If this happens to
your baby you should contact your
• Monoamine oxidase inhibitors (MAOIs:
midwife and/or doctor immediately
see the section “What you need to know
• Venlafaxine passes into breast milk. There
before you take Venlafaxine”)
is a risk of an effect on the baby.
• Serotonin syndrome:
Therefore, you should discuss the matter
Serotonin syndrome, a potentially
with your doctor and he/she will decide
life-threatening condition or Neuroleptic
whether you should stop breast-feeding
Malignant Syndrome (NMS)-like reactions
or stop the therapy with Venlafaxine.
(see the section “Possible Side Effects”),
may occur with Venlafaxine treatment,
Driving and using machines
particularly when taken with other
• Do not drive or use any tools or machines
medicines. Examples of these medicines
until you know how Venlafaxine affects
include:
you.
• Triptans (used for migraine)

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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

• Chest tightness, wheezing, trouble
swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness,
throbbing sensations, sudden reddening
of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated
patches of red or pale skin that often itch).

Always take this medicine exactly as your
Other side effects that you should tell your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure. doctor about include:
• Eye problems, such as blurred vision,
The recommended dose is 75 mg per day in
dilated pupils
divided doses, two or three times a day. The
• Nerve problems, such as dizziness, pins
dose can be raised by your doctor gradually
and needles, movement disorder, seizures
and, if needed, even up to a maximum dose
or fits
of 375 mg daily for depression.
• Psychiatric problems, such as hyperactivity
and euphoria
Take Venlafaxine at approximately the same
• Treatment withdrawal (see the section
time each day, in the morning and in the
“How to take Venlafaxine, If you stop
evening.
taking Venlafaxine”).
Venlafaxine should be taken with food.
The following side effects have been reported
If you have liver or kidney problems, talk to
at the approximate frequencies shown:
your doctor, since your dose of Venlafaxine
may need to be different.
Very common (affecting more than one
person in 10):
Do not stop taking Venlafaxine without
• nausea
talking to your doctor (see the section “If
• headache, dry mouth
you stop taking Venlafaxine”).
• sweating (including night sweats).
If you take more Venlafaxine than you should
Common (affecting fewer than one person
Call your doctor or pharmacist immediately
in 10 but more than one person in 100):
if you take more than the amount of
• yawning
Venlafaxine prescribed by your doctor.
• loss of appetite, constipation, vomiting,
The symptoms of a possible overdose may
weight loss, increase in cholesterol levels
include a rapid heart beat, changes in level
• weakness, chills
of alertness (ranging from sleepiness to
• increase in blood pressure, flushing,
coma), blurred vision, seizures or fits, and
palpitations
vomiting.
• abnormal dreams, sleepiness, difficulty
sleeping
If you forget to take Venlafaxine
• feeling detached from yourself and reality
If you miss a dose, take it as soon as you
• loss of sexual desire
remember. However, if it is time for your
• abnormal ejaculation/orgasm (males),
next dose, skip the missed dose and take
inability to achieve orgasm or erectile
only a single dose as usual. Do not take
dysfunction (impotence)
more than the daily amount of Venlafaxine
that has been prescribed for you in one day. • abnormal periods in women including
increased bleeding or irregular bleeding
If you stop taking Venlafaxine
difficulties passing urine, increased desire
Do not stop taking your treatment or reduce
to urinate
the dose without the advice of your doctor
• ringing in the ears.
even if you feel better. If your doctor thinks
that you no longer need Venlafaxine, he/she Uncommon (affecting fewer than one
person in 100 but more than one person in
may ask you to reduce your dose slowly,
1000):
before stopping treatment altogether. Side
• bruising
effects are known to occur when people
• black tarry faeces or blood in the faeces
stop using Venlafaxine, especially when
(which can be a sign of internal bleeding),
Venlafaxine is stopped suddenly or the dose
diarrhoea
is reduced too quickly. Some patients may
• feeling dizzy (particularly when standing
experience symptoms such as tiredness,
up quickly), fainting, fast heartbeat
dizziness, light-headedness, headache,
sleeplessness, nightmares, dry mouth, loss • sensitivity to sunlight
of appetite, nausea, diarrhoea, nervousness, • grinding of the teeth
• weight gain
agitation, confusion, ringing in the ears,
tingling or rarely, electric shock sensations, • lack of feeling or emotion, hallucinations,
agitation
weakness, sweating, seizures or flu-like
• involuntary movement of the muscles,
symptoms.
problems with co-ordination and loss of
Your doctor will advise you on how you
balance
should gradually discontinue Venlafaxine
• abnormal orgasm in women
treatment. If you experience any of these or • rash, abnormal hair loss
other symptoms that are troublesome, ask
• tinnitus (ringing in the ears), altered taste
your doctor for further advice.
sensation
If you have any further questions on the use • inability to pass urine.
of this product, ask your doctor or
Rare (affecting fewer than one person in
pharmacist.
1000 but more than one person in 10,000):
• restlessness or an inability to keep still
POSSIBLE SIDE EFFECTS
4
• fits
• urinary incontinence.
Like all medicines, Venlafaxine can cause
Frequency not known
side effects, although not everybody gets
• blood disorders leading to increased
them.
bruising or bleeding or risk of infection
If any of the following happen, do not take
• coughing, wheezing, shortness of breath
more Venlafaxine. Tell your doctor
and a high temperature, which are
immediately, or go to the casualty
department at your nearest hospital:

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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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