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DEPEFEX 75MG XL CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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567_FR02232_V3_DEPEFEX_567_FR02232_V3 16/06/15 08:28 Page1

INFORMATION FOR THE USER

Depefex® 75 mg XL Capsules
Depefex® 150 mg XL Capsules

(Venlafaxine)

SIX IMPORTANT THINGS YOU NEED TO KNOW ABOUT DEPEFEX
Ŷ Depefex treats depression. Like all medicines it can also have unwanted effects. It is important
that you and your doctor discuss the benefits of taking Depefex and the harmful effects before
you start treatment.
Ŷ Depefex are not for use in children and adolescents under 18. See section 2 of the leaflet.
Ŷ Some people who are depressed think of harming or killing themselves. If you start to feel
worse, or think of harming or killing yourself, see your doctor or go to a hospital straightaway.
See section 2, Thoughts of harming yourself.
Ŷ Depefex will not work straightaway. Some people taking the medicine feel worse before
feeling better. Your doctor should see you a few weeks after starting treatment. Tell your
doctor if you do not feel better. See section 3, How to take Depefex.
Ŷ Do not stop taking Depefex without talking to your doctor. If you stop taking Depefex
suddenly or miss a dose, you may get withdrawal effects. See section 3, If you stop taking
Depefex.
Ŷ If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy
and Breast-feeding.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Ƈ Keep this leaflet. You may need to read it again.
Ƈ If you have any further questions, ask your doctor or pharmacist.
Ƈ 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.
Ƈ 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.
What is in this leaflet:
1. What Depefex is and what it is used for
2. What you need to know before you take Depefex
3. How to take Depefex
4. Possible side effects
5. How to store Depefex
6. Contents of the pack and other information
The name of this medicine is Depefex 75 mg XL Capsules and Depefex 150 mg XL
Capsules. For convenience, this leaflet will call it Depefex.

1. WHAT DEPEFEX IS AND WHAT
IT IS USED FOR
Depefex belongs to a group of medicines called
antidepressants. They are one of a group of
medicines called a selective serotonin and
noradrenaline reuptake inhibitor (SNRI). It is
thought that people who are depressed 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.
Depefex are used for the treatment of depression.
Your doctor may continue to give you Depefex
when you are feeling better to stop your
symptoms coming back or stop you becoming
depressed in the future. Treating your depression
properly is important to help you get better. If not
treated your condition may not go away or may
be more difficult to treat.
You may find it helpful to tell a friend or relative
that you are depressed and ask them to read
this leaflet as well. You might ask them to tell you
if they are worried about any changes in your
behaviour.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE DEPEFEX
! DO NOT TAKE DEPEFEX IF:
‡ you have previously had an allergic reaction to
venlafaxine or any of the other ingredients listed
in section 6 at the end of this leaflet.
‡ 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 Parkinson’s
disease. Taking an irreversible MAOI together
with other medicines, including Depefex can
cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after
you stop taking Depefex before you take any
MAOI (see also the section “Taking Depefex
with other medicines”).
‡ you suffer from heart disease
‡ you have high blood pressure (hypertension)
which is not being lowered by treatment
‡ you have severe liver or kidney problems
If any of these apply to you, tell your doctor or
pharmacist immediately, as the capsules may not
be suitable for you.

! USE IN CHILDREN AND ADOLESCENTS
UNDER 18 YEARS OF AGE
Depefex should not normally be used in children
and adolescents under the age of 18 years.
‡ Also, you should know that patients under 18
have an increased risk of side effects such as
suicidal attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional
behaviour and anger) when they take this type
of medicine. Despite this, your doctor may
occasionally prescribe Depefex for patients
under 18 because he/she decides that this is in
their best interests.
‡ If your doctor has prescribed Depefex for
someone 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 these capsules.
‡ The long-term safety effects of Depefex
on growth, maturation and cognitive and
behavioural development in this age group has
not yet been demonstrated.

Take special care and tell your doctor or
pharmacist before taking Depefex if:
‡ You use other medicines that taken
concomitantly with Depefex could increase
the risk of developing serotonin syndrome
(see the section “Taking Depefex with other
medicines”).
‡ You have a history of epilepsy, fits or seizures.
‡ You suffer from, or have a history of, mania or
bipolar disorder (feeling over-excited or euphoric).
‡ You have eye problems or suffer from, or have
a history of, narrow angle glaucoma (increased
pressure in the eye).
‡ 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.
‡ Your cholesterol levels get higher.
‡ You have high blood pressure which is being
treated.
‡ You have a history of aggressive behaviour.
‡ You have a history of low sodium levels in your
blood (hyponatraemia).

‡ You have a history of heart problems.
‡ You have diabetes.
Depefex 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 you have any of the above, please talk with your
doctor before taking Depefex.

Thoughts of harming yourself:
People who are depressed can sometimes have
thoughts of harming or killing themselves. These
may be increased when you first start taking
antidepressants since these medicines 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 adults aged less than 25
years with psychiatric conditions who were
treated with an antidepressant.
If you get these thoughts at any time, contact
your doctor or go to the nearest hospital straight
away.
You may find it helpful to tell a relative or close
friend that you are depressed, and ask them to
read this leaflet. You might ask them to tell you if
they think your depression 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.

Taking Depefex with 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
Depefex 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 Depefex”).
‡ Serotonin syndrome:
‡ Serotonin syndrome, a potentially lifethreatening condition (see the section
“Possible Side Effects”), may occur with
venlafaxine treatment, particularly when taken
with other medicines. Examples of these
medicines include:
‡ 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. John’s Wort (also
called Hypericum perforatum, a natural or
herbal remedy used to treat mild depression)
‡ Products containing tryptophan (used for
problems such as sleep and depression)
Signs and symptoms of serotonin syndrome
may include a combination of the following:
restlessness, hallucinations, loss of coordination,
fast heart beat, increased body temperature, fast
changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting. Get medical
care right away if you think serotonin syndrome is
happening to you.
The following medicines may also interact with
Depefex and should be used with caution. It is
especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
‡ Ketoconazole (an antifungal medicine)
‡ Haloperidol or risperidone (to treat psychiatric
conditions)
‡ Metoprolol (a beta blocker to treat high blood
pressure and heart problems)
Taking Depefex with food, drink and alcohol
You should swallow each capsule whole with food
and with a drink of water.
You should avoid drinking alcohol while you
are taking the capsules. Alcohol may make your
symptoms or side effects worse.

567_FR02232_V3_DEPEFEX_567_FR02232_V3 16/06/15 08:28 Page2

Pregnancy, breast-feeding and fertility
You must tell your doctor if you are pregnant
or plan to become pregnant, so that another
medicine can be considered. You should use
Depefex only after discussing the potential
benefits and the potential risks to your unborn
child with your doctor.
Make sure your midwife and/or doctor know
you are on Depefex. 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 or if your
baby is not feeding properly, you should
contact your midwife and/or doctor immediately.
Breast-feeding is not recommended as
venlafaxine in Depefex can pass into the breast
milk, and there would be risk of an effect on the
baby. Therefore, you should discuss this matter
with your doctor, and he/she will decide whether
you should stop breast-feeding or stop the
therapy with Depefex.

Driving and using machines
Possible side effects of Depefex are dizziness,
confusion and eye sight changes such as
blurred vision. If you get these or feel that your
judgement, thinking or co-ordination is affected
when you take Depefex do not drive or use
machines.

Important information about some of the
ingredients of Depefex
This product contains sucrose. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicinal product.

3. HOW TO TAKE DEPEFEX
Always take Depefex exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual starting dose is one 75 mg capsule
a day. However, your doctor may start with a
different dose, particularly if you are elderly or
have liver or kidney problems. Your doctor may
also change your dose during the course of your
treatment. Your dose can be raised by your doctor
gradually, and if needed, even up to a maximum
dose of 375 mg daily for depression.
You should swallow each capsule whole at
approximately the same time each day, either in
the morning or evening. Do not break open, crush
or chew the capsules, or put them in water before
swallowing.
Depefex should be taken with food.
Do not stop taking Depefex without talking to
your doctor (see the section “If you stop taking
Depefex”).

If you take more Depefex than you should
Never take more capsules than your doctor tells
you. If you accidentally take too many capsules
contact your doctor or hospital immediately.
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 Depefex
If you forget to take a capsule, you can take it up
to 12 hours after you usually take it, and then take
your next capsule at the usual time. If the period
after the missed dose is more than 12 hours, you
should miss the dose altogether and just take
your next capsule at the usual time.
Do not take a double dose to make up for a
forgotten capsule.

If you stop taking Depefex
Do not stop taking your capsules or reduce the
dose without the advice of your doctor, even
if you feel better. If your doctor thinks you no
longer need Depefex, your dose will be reduced
gradually before stopping treatment altogether.
Side effects are known to occur when people stop
using Depefex, especially when the capsules
are stopped suddenly or the dose 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, weakness, sweating, fits/
seizures, or flu-like symptoms. These symptoms
are generally non-serious and disappear within a
few days.
Your doctor will advise you on how you should
gradually stop Depefex and if you suffer any of
these or other symptoms that are troublesome,
return to your doctor for further advice.
If you require any further information on Depefex
please consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Depefex can cause side
effects, although not everybody gets them.
Do not be concerned if you see small white
granules or balls in your stools after taking
Depefex. Inside Depefex capsules are
spheroids or small white balls that contain
the venlafaxine active ingredient. These
spheroids are released from the capsule into
your gastrointestinal tract. As the spheroids
travel the length of your gastrointestinal tract,
venlafaxine is slowly released. The spheroid
“shell” remains undissolved and is eliminated
in your stools. Therefore, even though you
may see spheroids in your stools, your dose of
venlafaxine has been absorbed.

Allergic reactions
If any of the following happen, do not take more
Depefex. 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
pupils
‡ Nerve problems, such as dizziness, pins and
needles, movement disorder, seizures or fits
‡ Psychiatric problems, such as hyperactivity and
euphoria
‡ Treatment withdrawal (see the section “How to
take Depefex”, if you stop taking Depefex).

Other reported side effects
Very common (affects more than 1 person in 10
users):

‡ dry mouth; headache
‡ nausea
‡ sweating (including night sweats)
Common (affects less than 1 person in 10
users):

‡ weight loss; increased cholesterol
‡ abnormal dreams; decreased libido;
dizziness; increased muscle tonus; insomnia;
nervousness; pins and needles; sedation;
tremor; confusion; feeling separated (or
detached) from yourself and reality
‡ blurred vision
‡ increase in blood pressure; flushing; palpitations
‡ yawning
‡ appetite decreased; constipation; vomiting
‡ difficulties passing urine; increased frequency
in urination
‡ abnormal ejaculation/orgasm (males); lack
of orgasm; erectile dysfunction (impotence);
menstrual irregularities such as increased
bleeding or increased irregular bleeding
‡ weakness (asthenia); chills
Uncommon (affects less than 1 person in 100
users):

‡ bruising; black tarry stools (faeces) or blood in
stools, which can be a sign of internal bleeding
‡ weight gain
‡ lack of feeling or emotion; hallucinations;
involuntary movement of the muscles; agitation;
impaired coordination and balance
‡ altered taste sensation; ringing in the ears (tinnitus)
‡ feeling dizzy (particularly when standing up too
quickly), fainting, fast heartbeat
‡ grinding of the teeth; diarrhoea
‡ rash; abnormal hair loss
‡ inability to pass urine
‡ abnormal orgasm (females)
‡ sensitivity to sunlight
‡ serious allergic reaction which causes swelling
of the face and throat
Rare (affects less than 1 person in 1000 users):

‡ a sensation of restlessness or an inability to sit or
stand still; seizures or fits; feeling overexcited
or euphoric
‡ inability to control your bladder
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
‡ 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
‡ 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; thoughts of
harming or killing yourself; a feeling of
dizziness or “spinning”; aggression
‡ 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)
‡ severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or
pancreas)
‡ skin rash, which may lead to severe blistering
and peeling of the skin; itching; mild rash
‡ unexplained muscle pain, tenderness or
weakness (rhabdomyolysis)
‡ swollen face or tongue, shortness of breath or
difficulty breathing, often with skin rashes (this
may be a serious allergic reaction)
Depefex sometimes causes unwanted effects
which you may not be aware of, such as increases
in blood pressure or abnormal heart beat, or slight
changes in blood levels of liver enzymes, sodium
or rarely cholesterol (fats). More rarely, Depefex
may reduce the function of platelets in your
blood, leading to increased chance of bruising or
bleeding. Therefore, your doctor may wish to do
blood tests occasionally, particularly if you have
been taking the capsules for a long time.
!TELL YOUR DOCTOR OR PHARMACIST IF:

‡ Any side effect gets serious
‡ You notice any side effects which are not listed
in this leaflet
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 YellowCard
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 DEPEFEX
!KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN
Do not use Depefex after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Do not store Depefex above 25°C. Store in the
original package in order to protect from light.
Medicines should not be disposed of via
wastewater or household waste. Ask your
Pharmacist how to dispose of medicines no
longer required.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Depefex Capsules contain
Each Capsule contains 75 mg or 150 mg of
venlafaxine as venlafaxine hydrochloride.
The other ingredients in the capsules are: stearic
acid, ethylcellulose, talc, gelatin, sucrose and maize
starch. The 75mg capsules also contain Titanium dioxide
What Depefex Capsules look like and contents of the pack
Depefex Capsules come in two strengths.
Depefex 75 mg XL Capsules are white opaque
capsules containing white or whitish pellets.
Depefex 150 mg XL Capsules are natural
transparent capsules cbontaining white or whitish pellets.
They come in packs containing 28 capsules.
Marketing Authorisation Holder and Manufacturer
Chiesi Limited, 333 Styal Road, Manchester,
M22 5LG, UK.
This leaflet was last approved in 07/2015
FR02232.V3 / CP0034/7

“Is this leaflet hard to see or read? Telephone: 0161 488 5555 for help”

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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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