VENLAFAXINE 37.5 MG TABLETS

Active substance: VENLAFAXINE

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Venlafaxine 37.5 mg Tablets
Venlafaxine 75 mg Tablets
Venlafaxine Hydrochloride
Important things you need to know about Venlafaxine
• Venlafaxine is used to treat depression
• Venlafaxine should not be given to anyone under 18 years of age-see in section 2
‘Use in children and adolescents under 18 years of age’
• Venlafaxine may not work straight away. After you start treatment, you may feel worse
before you feel better. It may take between two to four weeks before you start feeling
better. Tell your doctor if you do not feel better
• Some people who are depressed may think of harming or killing themselves.
If you have these thoughts at any time, tell 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 have taken 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 your tablets or change the amount you take without checking with
your doctor first. Keep taking them even if you feel better. If you stop taking Venlafaxine
suddenly you may get withdrawal reactions-see in section 3 ‘If you stop taking
Venlafaxine tablets’
• Taking some other medicines with Venlafaxine may cause problems. Tell your doctor
if you are taking or have recently taken any other medicines- see in ‘Other medicines
and Venlafaxine Tablets’
• Tell your doctor straight away if you feel restless and can’t keep still, feel ‘high’ or
over-excited or have jerky muscle movements which you can’t control- see section
4 ‘Possible side effects’
• If you have problems with your heart or have high blood pressure, talk to your doctor
before taking Venlafaxine-see in section 2 ‘What you need to know before you take
Venlafaxine Tablets’
• If you are pregnant, planning to become pregnant, or are breast-feeding, talk to
your doctor before taking Venlafaxine- see section 2 ‘Pregnancy and breast feeding’
There is more information on all of these points in the rest of this leaflet.
Read this entire 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 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.

VENLAFAXINE HYDROCHLORIDE
SAME SIZE ARTWORK
480 mm x 140 mm

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

1. What Venlafaxine Tablets are and what they are used for
Venlafaxine Tablets contain Venlafaxine Hydrochloride as the active ingredient.
Venlafaxine belongs to the class of medicines called “antidepressants” which are
used to relieve the symptoms of depressive illness and any associated anxiety.
People who are depressed may have lower levels than usual of substances called
“serotonin” and “noradrenaline” in their brain. While it is not fully understood how
anti-depressants work, Venlafaxine may help by increasing the levels of these
substances in your brain.

2. What you need to know before you take Venlafaxine Tablets
Do not take Venlafaxine tablets if
• you are allergic to venlafaxine or any of the other ingredients of this medicine (see
section 6)
• 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 Venlafaxine can
cause serious or even life- threatening side effects. Also you must wait at least one
week after you stop taking Venlafaxine tablets before you can take an MAOI.
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine if you:
• use other medicines that taken together with Venlafaxine could increase the risk of
developing serotonin syndrome (see the section “Other medicines and Venlafaxine
tablets”).
• have eye problems, such as certain kinds of glaucoma (increased pressure in the
eye).
• have a history of high blood pressure.
• have a history of heart problems.
• have a history of fits (seizures).
• have a history of low sodium levels in your blood (hyponatraemia).
• 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 (used to prevent blood clots).

• have a history of, or if someone in your family has had, mania or bipolar disorder
(feeling over-excited or euphoric).
• have a history of aggressive behaviour.
Venlafaxine 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.
If you are not sure whether any of the above applies to you, talk to your doctor or
pharmacist before taking this medicine.
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 first starting
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 1 in 10 patients treated with Venlafaxine. This may increase the
risk of tooth decay (dental caries). Therefore, you should take special care with 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.
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 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 concerning growth, maturation
and development of the brain in this age group have not yet been demonstrated.
Other medicines and Venlafaxine Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines obtained without a prescription, including herbal
medicines. This is because Venlafaxine can affect the way some other medicines work.
Also, some other medicines can affect the way Venlafaxine works.
Do not start or stop taking any medicines, before checking with your doctor or
pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s
disease must not be taken with Venlafaxine. Tell your doctor if you have taken
these medicines within the last 14 days. (MAOIs: see section 2).
• 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:
• Medicines for migraine such as sumatriptan (triptans)
• Medicines for depression such as SNRI, SSRIs, tricyclics, or medicines containing
lithium
• Antibiotics, such as linezolid, used to treat infections
• Medicines used to treat depression such as moclobemide (called reversible MAOIs)
• Medicines to help with weight loss such as sibutramine
• 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)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used
to treat severe pain)
• 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, nausea,
coma, 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).
Get medical care straight away if you think this is happening to you. If you are not sure
if any of the above applies to you, talk to your doctor or pharmacist before taking
Venlafaxine.
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 (to treat fungal infections)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venlafaxine Tablets with food and drink
• Take Venlafaxine with food (see section 3)
• You should avoid alcohol while you are taking Venlafaxine Tablets.
Pregnancy
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.
If you are taking this medicine and you find out that you are pregnant, make sure your
midwife and/or doctor know you are on Venlafaxine Tablets. 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, 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.
Breast-feeding
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 this medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant
or breast-feeding.
Driving and using machines
Make sure your judgement or coordination is not affected before you drive or use
machinery.

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PACKAGE LEAFLET: INFORMATION FOR USER

3. How to take Venlafaxine Tablets
Always take this medicine exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Adults aged 18 years and over
The usual recommended starting dose is 75mg per day in divided doses, two or three
times a day. If needed, your doctor may increase the dose gradually up to a maximum
of 375mg daily.
If you have liver or kidney problems, talk to your doctor, as your dose may need to be
different.
Take Venlafaxine tablets at approximately the same time each day, in the morning and
in the evening, with food. Tablets must be swallowed whole with fluid and not opened,
crushed, chewed or dissolved.
Do not stop taking Venlafaxine tablets without talking to your doctor (see section ‘If you
stop taking Venlafaxine Tablets’)
If you take more Venlafaxine Tablets than you should
If you take too many tablets you must seek immediate medical attention, even if you feel
well, because of the risk of serious side effects. Remember to take the packet with you,
even if it is empty.
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 Tablets
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 a double
dose to makeup for a forgotten dose
If you stop taking Venlafaxine Tablets
Do not stop taking your tablets or change the dose without the advice of your doctor
even if you feel better. If your doctor thinks that you no longer need Venlafaxine Tablets
he/she will ask you to reduce your dose slowly before stopping treatment altogether.
This should help reduce the chance of withdrawal symptoms.
If Venlafaxine Tablets are 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, feeling or being
sick, diarrhoea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling
or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.

SAME SIZE ARTWORK
480 mm x 140 mm

6. Contents of the pack and other information

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 may cause side effects, although not everybody gets
them.
Stop taking Venlafaxine and see a doctor or go to a hospital straight away if:
• You get unexplained muscle pain, tenderness or weakness called “rhabdomyolysis”
• You get swelling of your hands, feet, ankles, face, lips or throat which may cause
difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives)
or nettle rash (utricaria). You may be having an allergic reaction to Venlafaxine
• You get blistering or peeling of skin around your lips, eyes, mouth, nose and genitals,
with flu-like symptoms and fever. These could be signs of an illness called “StevensJohnson syndrome”
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)
Tell your doctor straight away if
• You notice yellowing of your skin or eyes and your urine becomes darker in colour.
You may also have a high temperature, feel tired, lose your appetite, have stomach
pain or feel sick. These could be signs of a liver problem, such as jaundice or hepatitis
• You notice blood in your vomit or pass black tarry stools
• You have nerve problems, such as dizziness, pins and needles, movement disorder,
seizures or fits
• You have heart problems, such as fast or irregular heartbeat, increased blood
pressure
• You feel ‘high’ or over-excited, see or hear things which are not there (hallucinations)
and have difficulty concentrating or staying still (mania, hypomania or delirium)
• You have painful eyes with blurred vision and dilated pupils
• You have withdrawal effects (see ‘If you stop taking Venlafaxine Tablets’)
• You have prolonged bleeding - if you cut or injure yourself, it may take slightly longer
than usual for bleeding to stop.
If any of the following side effects gets serious or lasts longer than a few days, tell
your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
• Nausea, dizziness
• Headache, sweating, dry mouth

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 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
• 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)
Not known: frequency cannot be estimated from the available data
• 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
• 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)

• 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)
• Abnormal breast milk production
Blood tests
The following side effects also affect blood. They are only found in blood test results:
• Increase in blood cholesterol levels
• Changes to some of the cells or other parts of your blood
• Slight changes in blood levels or liver enzymes
• Increase in blood pressure or abnormal heart beat
• Reduced platelet count in your blood which leads to increased risk of bruising and
bleeding
Your doctor may wish to do blood tests occasionally, particularly if you have been
taking Venlafaxine for a long time.
Reporting of side effects
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. 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.

What Venlafaxine Tablets contain
Each tablet contains Venlafaxine Hydrochloride Ph.Eur equivalent to Venlafaxine
37.5 mg or 75 mg as the active ingredient.
The other ingredients are lactose, microcrystalline cellulose, sodium starch glycollate,
pregelatinised starch, magnesium stearate, yellow iron oxide (E172) and red iron oxide
(E172).
What Venlafaxine Tablets look like and contents of the pack
Venlafaxine Tablets 75 mg are Peach colour, circular, flat bevelled edged uncoated
tablets having embossed ‘75’ on one side and ‘BL’ on other side.
Venlafaxine Tablets 37.5 mg are Peach colour, circular, flat bevelled edged uncoated
tablets having embossed ’37.5’ on one side and ‘BL’ on other side.
Venlafaxine Tablets 75 mg and 37.5 mg are packed in blister pack of 28 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Venlafaxine 37.5 mg Tablets: PL 17907/0250
Venlafaxine 75 mg Tablets: PL 17907/0251
This leaflet was last revised in July 2014
To request a copy of this leaflet in Braille, large print or audio format, contact the
licence holder at the address (or telephone, fax, email) above.

5. How to store Venlafaxine Tablets
• Keep out of the sight and reach of children.
• Do not store above 250C. Store in the original package.
• Do not put the tablets into another container, they might get mixed up. Do not remove
the tablets from the blister pack or open the blister pack until you are ready to take
the medicine.
• Do not use these Tablets after the “Expiry Date” which is stated on the carton or
blister. The expiry date refers to the last day of that month.
• Do not throw away any medicines via waste water or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
V3 11-07-14 D0

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Do not drive or use any tools or machines until you know how this medicine affects you.
Venlafaxine Tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact
your doctor before taking these tablets.

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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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