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EFEXOR XL 150 CAPSULES

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S 1433 LEAFLET Efexor XL 20120223

Uncommon (affects 1 to 10 users in 1,000)


Bruising; black tarry stools (faeces) or blood in stools, which
can be a sign of internal bleeding



Grinding of the teeth; involuntary movement of the muscles



Hallucinations



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; abnormal hair loss; rash



Impaired coordination and balance; feeling dizzy (particularly
when standing up too quickly), fainting, fast heartbeat



Weight gain; diarrhoea



Altered taste sensation



Lack of feeling or emotion; agitation



Ringing in the ears (tinnitus)



S 1433 LEAFLET Efexor XL 20120223

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.



A sensation of restlessness or an inability to sit or stand still;
seizures or fits; feeling over-excited or euphoric.

 Inability to control urination
Frequency 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; slight changes in
blood levels of liver enzymes; decrease in blood sodium levels

EFEXOR XL 150mg CAPSULES
(venlafaxine hydrochloride)
Your medicine is known as Efexor XL 150mg Capsules but will be
referred to as Efexor XL throughout the following patient information
leaflet.

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.

Information for other strengths of Efexor XL (Efexor XL 75mg
Capsules) may also be present in this leaflet.
IMPORTANT THINGS YOU SHOULD KNOW ABOUT
EFEXOR XL

5. How to store Efexor XL

Please read all of this leaflet before you start to take your
medicine as it contains important information about Efexor XL



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.





Do not store your capsules above 25°C.



Do not use Efexor XL after the expiry date which is stated on
the carton and blister strip. The expiry date refers to the last day
of that month.

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)



Efexor XL is not for use in children and adolescents – see
in section 2 ‘Use in children and adolescents’



Capsules should not be thrown in your bin or put down the
drain. If they are out of date, or no longer suitable for you, return
them to your pharmacist.

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.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do

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.

Inability to pass urine;

 Abnormal orgasm (females)
Rare (affects 1 to 10 users in 10,000)

PACKAGE LEAFLET: INFORMATION FOR THE USER



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.



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)

6. Further information



Abnormal breast milk production

What Efexor XL contains



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



Disorientation and confusion often accompanied by
hallucination (delirium)





Stiffness, spasms and involuntary movements of the muscles



Thoughts of harming or killing yourself



Severe eye pain and decreased or blurred vision



Decrease in blood pressure; abnormal, rapid or irregular heart
beat, which could lead to fainting



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)



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’

Each capsule contains 150mg of the active ingredient
venlafaxine (as the hydrochloride) in a modified release
formulation.



The other ingredients in these capsules are microcrystalline
cellulose, ethylcellulose, methylhydroxypropyl cellulose, gelatin,
talc, red iron oxide (E172) and yellow iron oxide (E172),
titanium dioxide (E171), and printing inks.



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’



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’

What Efexor XL looks like and contents of the pack
Efexor XL 150 Capsules are opaque dark orange capsules printed
in white with ‘W’ on one end and ’150’ on the other.
The capsules are available in blister packs containing 30 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
This product is manufactured by Wyeth Medica Ireland, Newbridge,
Ireland.
POM



Skin rash, which may lead to severe blistering and peeling of
the skin; itching; mild rash

Leaflet revision date: 23 February 2012.



Unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)

Efexor is a registered trade mark of Wyeth, USA.



Vertigo



Aggression



PL No. 19488/1433

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’
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 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’
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.


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.

S1433 LEAFLET Efexor XL 20120223

Confusion





Manufacturer

Severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)

Swollen face or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a serious allergic
reaction)

2. Before you take Efexor XL
3. How to take Efexor XL
4. Possible side effects
5. How to store Efexor XL
6. Further information
1. What Efexor XL is and what 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 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.
2. Before you take Efexor XL
Do not take Efexor XL


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’).

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





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.

In this leaflet:
1. What Efexor XL is and what it is used for

Take special care with Efexor XL
If any of the following apply to you, please tell your doctor before
taking Efexor XL:


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”).



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 e.g.,
warfarin (used to prevent blood clots).



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.

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

Examples of these medicines include:

Driving and using machines



Chest tightness, wheezing, trouble swallowing or breathing

o

Triptans (used for migraine)



Swelling of the face, throat, hands, or feet

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.

o

Other medicines to treat depression, for instance SNRIs,
SSRIs, tricyclics, or medicines containing lithium

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



Feeling nervous or anxious, dizziness, throbbing sensations,
sudden reddening of the skin and/or a warm feeling

o

Medicines containing linezolid, an antibiotic (used to treat
infections)

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.

Severe rash, itching, or hives (elevated patches of red or pale
skin that often itch)



Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart
beat, increased body temperature, fast changes in blood
pressure, overactive reflexes, diarrhoea, coma, nausea,
vomiting.

o

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.

Medicines containing moclobemide, a MAOI (used to treat
depression)

o

Medicines containing sibutramine (used for weight loss)

o

Medicines containing tramadol (a pain-killer)

o

Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild
depression)

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

o

Products containing tryptophan (used for problems such as
sleep and depression)

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.

o

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)

Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine.
This may increase the risk of tooth decay (caries). Therefore, you
should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to 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.

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:


Ketoconazole (an antifungal medicine)



Metoprolol (a beta blocker to treat high blood pressure and
heart problems)

Taking Efexor XL with food and drink
Efexor XL should be taken with food (see section 3 “How to take
Efexor XL”).
You should avoid alcohol while you are taking Efexor XL.
Pregnancy and breast-feeding

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 Efexor XL 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 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”).

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.

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.

Serotonin syndrome:

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.

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.

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 breast-feeding or
stop the therapy with this medicine.

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:


Coughing, wheezing, shortness of breath and a high
temperature



Black (tarry) stools or blood in stools



Yellow skin or eyes, itchiness or dark urine, which may be
symptoms of inflammation of the liver (hepatitis)

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.

Heart problems, such as fast or irregular heart rate, increased
blood pressure

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”).



Eye problems, such as blurred vision, dilated pupils

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.



Nerve problems, such as dizziness, pins and needles,
movement disorder, seizures or fits



Psychiatric problems, such as hyperactivity and euphoria
(feeling unusually overexcited).

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.

Haloperidol or risperidone (to treat psychiatric conditions)



The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg
per 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. If you are being treated for panic disorder, your doctor
will start with a lower dose (37.5 mg) and then increase the dose
gradually. The maximum dose for generalised anxiety disorder,
social anxiety disorder and panic disorder is 225 mg/day.

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.
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:

Withdrawal effects (see the section “How to take Efexor XL, if
you stop taking Efexor XL”).
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)


Headache; dry mouth; sweating (including night sweats)



Nausea

Common (affects 1 to 10 users in 100)


Weight loss; appetite decreased; constipation; vomiting;
increased cholesterol



Feeling separated (or detached) from yourself and reality;
nervousness; confusion; abnormal dreams; insomnia



Tremor; increased muscle tonus



Pins and needles



Increase in blood pressure; flushing; palpitations



Increased frequency in urination; difficulties passing urine



Decreased libido; abnormal ejaculation/orgasm (males); lack of
orgasm; erectile dysfunction (impotence)



Menstrual irregularities such as increased bleeding or increased
irregular bleeding



Weakness (asthenia); dizziness; sedation; chills



Blurred vision



Yawning

S 1433 LEAFLET Efexor XL 20120223

+ Expand Transcript

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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