Active substance: VENLAFAXINE

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Venlafaxine 37.5 mg Tablets
Venlafaxine 75 mg Tablets


Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• 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.

In this leaflet:
1. What Venlafaxine is and what it is used for
2. Before you take Venlafaxine
3. How to take Venlafaxine
4. Possible side effects
5. How to store Venlafaxine
6. Further information


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 (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.
Venlafaxine 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.


Before you take Venlafaxine

Do not take Venlafaxine
• if you are allergic (hypersensitive) to
venlafaxine or any of the other ingredients of
• if you are also taking or have taken any time
within the last 14 days any medicines known as
irreversible monoamine oxidase inhibitors
(MAOIs), used to treat depression or Parkinsonʼs
disease. Taking an irreversible MAOI together
with other medicines, including Venlafaxine, can
cause serious or even life-threatening side effects.
Also, you must wait at least 7 days after you stop
taking Venlafaxine before you take any irreversible
MAOI (see also the sections “Serotonin
syndrome” and “Taking other medicines”).
Take special care with Venlafaxine
• If you use other medicines that taken
concomitantly with Venlafaxine could increase
the risk of developing serotonin syndrome (see
the section “Taking other medicines”)
• 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 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
• 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
• If you have diabetes.
Venlafaxine may cause a sensation of
restlessness or an inability to sit or stand still. You
should tell your doctor if this happens to you.

If any of these conditions apply to you, please talk
with your doctor before taking Venlafaxine.

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
caries. Therefore, you should take special care in
your dental hygiene.

If you have diabetes, your doctor might need to
adjust your insulin and/or oral antidiabetic dosage
after starting treatment with venlafaxine.

Use in 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
• 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.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

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 “Before you take Venlafaxine”)
• Serotonin syndrome, a potentially life
threatening condition (see the section “Possible
Side Effects”), may occur with venlafaxine
treatment, particularly when taken with other
medicines. Examples of these medicines
- 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)
- Products containing St. Johnʼs 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 and vomiting. 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
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems).
Taking Venlafaxine with food and drink
Venlafaxine should be taken with food (see
section 3 “How to take Venlafaxine”).
You should avoid alcohol while you are taking

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 your doctor.

Make sure your midwife and/or doctor knows you
are on Venlafaxine.

If you are taking Venlafaxine during pregnancy
your baby might have some symptoms when it is
born. These symptoms usually begin during the
first 24 hours after the baby is born. They include
not feeding properly and trouble with 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.
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.

Venlafaxine passes into breast milk. There is a
risk of an effect on the baby e.g. constant crying,
irritability and abnormal sleep-patterns. 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
Driving and using machines
Do not drive or use any tools or machines until
you know how Venlafaxine affects you.

Important information about some of the
ingredients of Venlafaxine
This medicine 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.


How to take Venlafaxine

Always take Venlafaxine 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, 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.

Continued on the next page >>

Do not stop taking Venlafaxine without talking to
your doctor (see the section “If you stop taking

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
If you have any further questions on the use of
this product, ask your doctor or pharmacist.


Possible side effects

Like all medicines, Venlafaxine can cause side
effects, although not everybody gets them.

Allergic reactions
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:
• 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).
Serious side effects
If you notice any signs of the following, you may
need urgent medical attention:
• Heart problems, such as fast or irregular heart
rate, increased blood pressure
• Eye problems, such as blurred vision, dilated
• Nerve problems, such as dizziness, pins and
needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and
• Treatment withdrawal (see the section “How to
take take Venlafaxine, If you stop taking
Complete side effect listing
The frequency (likelihood of occurring) of side
effects is classified as follows:
Very common
Not known

Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
Frequency cannot be estimated
from the available data

• Blood disorders
Uncommon: bruising, black tarry stools (faeces)
or blood in stools, which can be a sign of
internal bleeding
Not known: reduced number of platelets in your
blood, leading to an increased risk of bruising or
bleeding, blood disorders which may lead to an
increased risk of infection
• Metabolism/nutritional disorders
Common: weight loss, increased cholesterol
Uncommon: weight gain
Not known: 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), confusion,
excessive water intake (known as SIADH),
abnormal breast milk production

• Nervous system disorders
Very common: dry mouth, headache
Common: abnormal dreams, decreased libido,
dizziness, increased muscle tonus, insomnia,
nervousness, pins and needles, sedation,
tremor, confusion, feeling separated (or
detached) from yourself and reality
Uncommon: lack of feeling or emotion,
hallucinations, involuntary movement of the
muscles, agitation, impaired coordination and
Rare: a sensation of restlessness or an inability
to sit or stand still, seizures or fits, feeling
over-excited or euphoric
Not known: 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 serious conditions known as
neuroleptic malignant syndrome, euphoric
feelings, drowsiness, sustained rapid eye
movement, clumsiness, restlessness, feeling of
being drunk, sweating or rigid muscles, which
are symptoms of serotonergic syndrome,
disorientation and confusion often accompanied
by hallucination (delirium), stiffness, spasms
and involuntary movements of the muscles;
cases of suicidal ideation and suicidal
behaviours have been reported during
venlafaxine therapy or early after treatment
discontinuation (see section 2 “Take special
care with Venlafaxine): aggression; spinning
• Sight and hearing disorders
Common: blurred vision
Uncommon: altered taste sensation, ringing in
the ears (tinnitus)
Not known: severe eye pain and decreased or
blurred vision

• Heart or circulation disorders
Common: increase in blood pressure, flushing,
Uncommon: feeling dizzy (particularly when
standing up too quickly), fainting, fast heartbeat
Not known: decrease in blood pressure,
abnormal, rapid or irregular heart beat, which
could lead to fainting
• Breathing disorders
Common: yawning
Not known: 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)
• Digestive disorders
Very common: nausea
Common: appetite decreased, constipation,
Uncommon: grinding of the teeth, diarrhoea
Not known: severe abdominal or back pains
(which could indicate a serious problem in the
gut, liver or pancreas)

• Skin disorders
Very common: sweating (including night sweats)
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe
blistering and peeling of the skin, itching, mild
• Muscle disorders
Not known: unexplained muscle pain,
tenderness or weakness (rhabdomyolysis)

• Urinary system disorders
Common: difficulties passing urine, increased
frequency in urination
Uncommon: inability to pass urine
Rare: inability to control urination
• Reproductive and sexual disorders
Common: abnormal ejaculation/orgasm
(males), lack of orgasm, erectile dysfunction
(impotence), menstrual irregularities such as
increased bleeding or increased irregular
Uncommon: abnormal orgasm (females)

• General
Common: weakness (asthenia), chills
Uncommon: sensitivity to sunlight, swollen face
or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a
serious allergic reaction called angioedema)

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.
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.


How to store Venlafaxine

Keep out of the reach and sight of children.

Do not use Venlafaxine after the expiry date
stated on the packaging. The expiry date is the
last day of the stated month.

This medicinal product does not require any
special storage conditions (tablet container and

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


Further information

What Venlafaxine contains
• The active substance is venlafaxine.

Venlafaxine 37.5 mg Tablets:
One tablet contains 37.5 mg venlafaxine as
venlafaxine hydrochloride.
Venlafaxine 75 mg Tablets:
One tablet contains 75 mg venlafaxine as
venlafaxine hydrochloride.

• The other ingredients are microcrystalline
cellulose, lactose monohydrate, sodium starch
glycollate (type A), magnesium stearate,
anhydrous, colloidal silicon dioxide and brown
ferric oxide (E172).
What Venlafaxine looks like and contents of
the pack
Venlafaxine 37.5 mg Tablets: Pale, red-brown or
brownish, oblong tablet coded 3.

Venlafaxine 75 mg Tablets: Pale, red-brown or
brownish, oblong tablet, scored and coded 7 on
each half. The tablet can be divided into two
equal halves.

Polyethylene tablet container and closure (tamper
Pack sizes: 28, 30, 42, 50, 56, 60, 90, 98, 100,

Blister (Al/PVC)
Pack sizes: 10, 14, 15, 20, 28, 30, 42, 45, 50, 56,
60, 90, 98, 98 x 1, 100, 100 x 1, 250
Not all package sizes or types may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Salutas Pharma GmbH, Otto-van-Guericke-Allee,
D-39179 Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or Lek Pharmaceuticals d.d.,
Verovškova 57, SL- 1526 Ljubljana, Slovenia or
LEK S.A., ul. Domaniewska 50 C, 02-672
Warsaw, Poland or Rowa Pharmaceuticals Ltd,
Bantry, Co. Cork, Ireland.
This leaflet was last approved in 03/2012.


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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.