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EFEXOR XL 75MG PROLONGED RELEASE HARD CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

EFEXOR XL 75MG
PROLONGED-RELEASE HARD CAPSULES
(venlafaxine hydrochloride)

Efexor XL prolonged-release hard capsules are available in the
following strengths: 75mg & 150mg. Efexor XL 75mg prolongedrelease hard capsules will be referred to as Efexor XL throughout
this leaflet.

IMPORTANT THINGS YOU SHOULD KNOW ABOUT
EFEXOR XL

Please read all of this leaflet before you start to take your
medicine as it contains important information about Efexor
XL
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Efexor XL is used to treat depression, severe and
persistent anxiety known as generalised anxiety
disorder (GAD), social anxiety disorder (also known as
social phobia) and panic disorder (panic attacks)
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Efexor XL is not for use in children and adolescents –
see in section 2 ‘Use in children and adolescents’

Efexor XL is a treatment for adults with depression. It is also a
treatment for adults with the following anxiety disorders:
generalised anxiety disorder, social anxiety disorder (fear or
avoidance of social situations) and panic disorder (panic attacks).
Treating depression or anxiety disorders 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.

Taking other medicines

2. Before you take Efexor XL

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.
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Monoamine oxidase inhibitors which are used to treat
depression or Parkinson’s disease must not be taken with
Efexor XL. Tell your doctor if you have taken these
medicines within the last 14 days. (MAOIs: see the section
“Before you take Efexor XL”).
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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:
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Triptans (used for migraine)
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Other medicines to treat depression, for instance
SNRIs, SSRIs, tricyclics, or medicines containing
lithium
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Medicines containing linezolid, an antibiotic (used to
treat infections)
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Medicines containing moclobemide, a MAOI (used to
treat depression)
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Medicines containing sibutramine (used for weight
loss)
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Medicines containing tramadol, fentanyl, tapentadol,
pethidine, or pentazocine (used to treat severe pain)
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Medicines containing dextromethorphan (used to treat
coughing)
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Medicines containing methadone (used to treat opioid
drug addiction or severe pain)
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Medicines containing methylene blue (used to treat
high levels of methaemoglobin in the blood)
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Products containing St. John’s Wort (also called
Hypericum perforatum, a natural or herbal remedy
used to treat mild depression)
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Products containing tryptophan (used for problems
such as sleep and depression)
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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)

Do not take Efexor XL
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If you are allergic to venlafaxine or any of the other
ingredients of this medicine (Section 6 contains a full list).
If you are also taking, or have taken within the last 14 days,
any medicines known as irreversible monoamine oxidase
inhibitors (MAOIs), used to treat depression or Parkinson’s
disease. Taking an irreversible MAOI together with Efexor
XL, can cause serious or even life-threatening side effects.
Also, you must wait at least 7 days after you stop taking
Efexor XL before you take any MAOI (see also the section
entitled “Taking other medicines” and the information in that
section about ‘Serotonin Syndrome’).

Take special care with Efexor XL

If you have any concerns about how you feel, or about this
medication, it is important that you talk to your doctor –
even if you feel anxious or worried about doing so.
You may find it helpful to tell a friend or relative that you are
depressed or suffering from an anxiety disorder, and that you
have been prescribed this medication; it might be useful to show
them this leaflet.
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Efexor XL may not start to work immediately.Some
people taking antidepressants may feel worse before feeling
better. Your doctor may ask to see you again a couple of
weeks after you start treatment and then regularly until you
start to feel well again. Tell your doctor if you do not start to
feel better.
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Some people who are depressed may think of harming
or killing themself. If this happens you should see
your doctor or go to a hospital straight away – see in
section 2 ‘Thoughts of suicide and worsening of your
depression or anxiety disorder’
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If you take too many capsules it is important to seek
immediate medical attention, even if you feel well,
because of the risk of serious side effects
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Do not stop taking Efexor XL or change your dose
without the advice of your doctor even if you feel
better. If you stop taking Efexor XL abruptly you may get
withdrawal reactions – see in section 3 ‘If you stop taking
Efexor XL’
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If you have heart problems such as fast or irregular
heart rate or high blood pressure you should talk to
your doctor before taking Efexor XL – see in section 2
‘Before you take Efexor XL’
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Taking certain other medicines with Efexor XL may
cause problems. You should tell your doctor if you are
taking any other medicines – see in section 2 ‘Before you
take Efexor XL’
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See your doctor without delay if you feel restless and feel
like you can’t keep still, feel ‘high’ or very over-excited, have
jerky muscle movements which you can’t control. See
section 4 – ‘Possible side effects’ for other important
information

If any of the following apply to you, please tell your doctor before
taking Efexor XL:
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If you use other medicines that taken together with Efexor
XL could increase the risk of developing serotonin syndrome
(see the section “Taking other medicines”).
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If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).
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If you have a history of high blood pressure.
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If you have a history of heart problems.
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If you have a history of fits (seizures).
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If you have a history of low sodium levels in your blood
(hyponatraemia).
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If you have a tendency to develop bruises or a tendency to
bleed easily (history of bleeding disorders), or if you are
taking other medicines that may increase the risk of
bleeding e.g., warfarin (used to prevent blood clots).
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If you have a history of, or if someone in your family has
had, mania or bipolar disorder (feeling over-excited or
euphoric).
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If you have a history of aggressive behaviour.

If you are pregnant, or intend to become pregnant, or
breast-feeding, you should talk to your doctor – see in
section 2 ‘Pregnancy, breast-feeding and Efexor XL’

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

More information on all of these points is provided in the
rest of this leaflet.

Read all of this leaflet carefully before you
start taking this medicine.
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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.
2.
3.
4.
5.
6.

What Efexor XL is and what it is used for
Before you take Efexor XL
How to take Efexor XL
Possible side effects
How to store Efexor XL
Further information

1. What Efexor XL is and what it is used for
Efexor XL 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.

Efexor XL may cause a sensation of restlessness or an inability to
sit or stand still during the first few weeks of treatment. You
should tell your doctor if this happens to you.

Thoughts of suicide and worsening of your depression or
anxiety 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:
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If you have previously had thoughts about killing yourself or
harming yourself.
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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.

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

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 Efexor XL with
other medicines.

Signs and symptoms of serotonin syndrome may include a
combination of the following: restlessness, hallucinations, loss of
coordination, fast heart beat, increased body temperature, fast
changes in blood pressure, overactive reflexes, diarrhoea, coma,
nausea, vomiting.
In its most severe form, serotonin syndrome can resemble
Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of
NMS may include a combination of fever, fast heart beat,
sweating, severe muscle stiffness, confusion, increased muscle
enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty
department at your nearest hospital if you think serotonin
syndrome is happening to you.
The following medicines may also interact with Efexor XL and
should be used with caution. It is especially important to mention
to your doctor or pharmacist if you are taking medicines
containing:
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Ketoconazole (an antifungal medicine)
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Haloperidol or risperidone (to treat psychiatric conditions)
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Metoprolol (a beta blocker to treat high blood pressure and
heart problems)

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.

Taking Efexor XL with food and drink

Diabetes

You should avoid alcohol while you are taking Efexor XL.

Your blood glucose levels may be altered due to Efexor XL.
Therefore, the dosage of your diabetes medicines may need to be
adjusted.

Use in children and adolescents under 18 years of age

Efexor XL 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
this medicine for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed this
medicine 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 Efexor XL. Also, the long-term safety
effects concerning growth, maturation and cognitive and
behavioural development of this medicine in this age group has
not yet been demonstrated.

Page 1 of 2

Efexor XL should be taken with food (see section 3 “How to take
Efexor XL”).

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to
become pregnant. You should use Efexor XL 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
Efexor XL. When taken during pregnancy, similar drugs (SSRIs)
may increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your
midwife and/or doctor immediately.
If you are taking 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.

Efexor XL 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 breastfeeding or stop the therapy with this medicine.

Driving and using machines

Do not drive or use any tools or machines until you know how this
medicine affects you.

3. How to take Efexor XL
Always take Efexor XL 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 for treatment of
depression, generalised anxiety disorder and social anxiety
disorder is 75mg per day. The dose can be raised by your doctor
gradually, and if needed, even up to a maximum dose of 375mg
daily for depression. If you are being treated for panic disorder,
your doctor will start with a lower dose (37.5mg) and then
increase the dose gradually. The maximum dose for generalised
anxiety disorder, social anxiety disorder and panic disorder is
225mg/day.
Take Efexor XL at approximately the same time each day, either
in the morning or in the evening.
Capsules must be swallowed whole with fluid and not opened,
crushed, chewed or dissolved.
Efexor XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since
your dose of this medicine may need to be different.
Do not stop taking this medicine without talking to your doctor
(see the section “If you stop taking Efexor XL”).

If you take more Efexor XL than you should

Call your doctor or pharmacist immediately if you take more of
this medicine than the amount 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 Efexor XL

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
Efexor XL that has been prescribed for you in one day.

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Do not be concerned if you see small white balls or
granules in your stools after taking this medicine. Inside
Efexor XL capsules are spheroids (small white balls) that
contain the active ingredient (venlafaxine). These
spheroids are released from the capsule into your stomach.
As they travel through your stomach and intestines,
venlafaxine is slowly released. The spheroid “shell” does
not dissolve and is passed out in your stools. So, even
though you may see spheroids in your stools, your dose of
medicine has been absorbed.

Complete side effect listing
Very common (affects more than 1 in 10 users)
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Your doctor will advise you on how you should gradually
discontinue Efexor XL 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, Efexor XL can cause side effects, although not
everybody gets them.
If any of the following happen, do not take more Efexor XL. Tell
your doctor immediately, or go to the casualty department
at your nearest hospital:
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Chest tightness, wheezing, trouble swallowing or breathing
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Swelling of the face, throat, hands, or feet
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Feeling nervous or anxious, dizziness, throbbing sensations,
sudden reddening of the skin and/or a warm feeling
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Severe rash, itching, or hives (elevated patches of red or
pale skin that often itch)
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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.
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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).
Other side effects that you should tell your doctor about
include:
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Coughing, wheezing, shortness of breath and a high
temperature
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Black (tarry) stools or blood in stools
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Yellow skin or eyes, itchiness or dark urine, which may be
symptoms of inflammation of the liver (hepatitis)

Dizziness; headache
Nausea; dry mouth
Sweating (including night sweats)

Common (affects 1 to 10 users in 100)
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If you stop taking Efexor XL

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 Efexor XL, he/she may ask you to reduce
your dose slowly before stopping treatment altogether. Side
effects are known to occur when people stop using this medicine,
especially when it 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.

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, seizures or fits
Psychiatric problems, such as hyperactivity and euphoria
(feeling unusually overexcited).
Withdrawal effects (see the section “How to take Efexor XL,
if you stop taking Efexor XL”).
Prolonged bleeding - if you cut or injure yourself, it may
take slightly longer than usual for bleeding to stop.

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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

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Efexor XL 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, Efexor XL 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 Efexor XL
for a long time.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the safety of
this medicine.

5. How to store Efexor XL
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Uncommon (affects 1 to 10 users in 1,000)
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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
General swelling of the skin especially the face, mouth,
tongue, throat area or hands and feet and/or a raised itchy
rash (hives) may be present; sensitivity to sunlight;
bruising; rash; abnormal hair loss
Inability to pass urine
Weight gain; weight loss

Rare (affects 1 to 10 users in 10,000)
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Seizures or fits
Inability to control urination
Over activity, racing thoughts and decreased need for sleep
(mania)

Frequency not known
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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
Swollen face or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a serious
allergic reaction)
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, Before you take Efexor XL)
Disorientation and confusion often accompanied by
hallucination (delirium); aggression
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 serotonin syndrome; stiffness, spasms and
involuntary movements of the muscles
Page 2 of 2

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
Skin rash, which may lead to severe blistering and peeling of
the skin; itching; mild rash
Unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
Abnormal breast milk production

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Keep out of the sight and reach of children.
Do not use Efexor XL after the expiry date shown on the
packaging.
Do not store above 25°C.
Store in the original package in order to protect from light
and moisture.
If your doctor decides to stop treatment, return any leftover
capsules to your pharmacist. Only keep them if your doctor
tells you to.
If your capsules appear to be discoloured or show any other
signs of deterioration, please return them to your
pharmacist who will advise you further.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information
What Efexor XL contains

Each capsule contains venlafaxine 75mg as the hydrochloride salt.
Other ingredients are:
Capsule contents: microcrystalline cellulose, hypromellose 2208,
hypromellose 2910 and ethylcellulose
Capsule shell: gelatin, red iron oxide (E172),
yellow iron oxide (E172), titanium dioxide (E171), talc and
red printing ink.

What Efexor XL looks like and contents of the pack

Efexor XL are opaque, peach, hard, gelatin capsules printed in red
with "W" and "75".
Efexor XL comes in calendar blister packs of 14, 28 and 56
capsules.

Manufacturer

Manufactured by: Wyeth Medica Ireland, Little Connell,
Newbridge, County Kildare, Republic of Ireland.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0532

POM

Leaflet revision and issue date (Ref): 01.04.14
Efexor® is a registered trademark of Wyeth LLC.

Other formats:

This leaflet can be made available in large print, audio or Braille
on request. To request this, please contact 01302 365000 and ask
for the Regulatory Department, quoting the following number:
21828/0532.

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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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