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DEPEFEX 75MG XL CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE

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10100_FR02232_V4_DEPEFEX_10100_FR02232_V4 24/03/17 08:36 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
■ 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.
■ Depefex are not for use in children and adolescents under 18. See section 2 of the leaflet.
■ 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.
■ 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.
■ 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.
■ 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.
♦ 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.
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”).
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, or if someone
in your family has had, 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.
• You have a history of high blood pressure.
• 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 been told you have an abnormal heart
rhythm
• You have diabetes (your blood glucose levels may
be altered due to Depefex, therefore the dosage of
your diabetes medicines may need to be adjusted).
Depefex 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 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
(tooth decay). 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 which are used to
treat depression or Parkinson’s disease must not
be taken with Depefex XL. Tell your doctor if you
have taken these medicines within the last
14 days. (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 MAOI
(used to treat depression)
• Medicines containing sibutramine (used for
weight loss)
• Medicines containing tramadol, fentanyl,
tapentadol, pethidine, or pentazocine (a painkiller)
• 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)
• 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)
• 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, 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). Get medical care right
away if you think serotonin syndrome is happening
to you.
You must tell your doctor if you are taking medicines
that can affect your heart rhythm.
Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone,
sotalol or dofetilide (used to treat abnormal
heart rhythm)
• Antipsychotics such as thioridazine (See also
Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin
(used to treat bacterial infections)
• Antihistamines (used to treat allergy)
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)

10100_FR02232_V4_DEPEFEX_10100_FR02232_V4 24/03/17 08:36 Page2

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.

Pregnancy, breast-feeding and fertility
You must tell your doctor if you are pregnant or
breast-feeding, think you may be 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 or has trouble
breathing, 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 breastfeeding 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.
Although the frequency cannot be estimated from
the available data cases of suicidal ideation and
suicidal behaviours have been reported during
venlafaxine therapy or early after treatment
discontinuation (see section 2, What you need to
know before you take Depefex XL).
If any of the following happen, do not take more
Depefex XL. Tell your doctor immediately, or go
to the casualty department at your nearest
hospital:
Uncommon (may affect up to 1 in 100 people)
• Swelling of the face, mouth, tongue, throat, hands,
or feet, and/or a raised itchy rash (hives), trouble
swallowing or breathing
Rare (may affect up to 1 in 1,000 people)
• Chest tightness, wheezing, trouble swallowing or
breathing
• Severe skin 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.
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).
• Signs of infection, such as high temperature,
chills, shivering, headaches, sweating, flu-like
symptoms. This may be the result of a blood
disorder which leads to an increased risk of
infection.
• Severe rash, which may lead to severe blistering
and peeling of the skin.
• Unexplained muscle pain, tenderness or
weakness. This may be a sign of rhabdomyolysis.
Other reported side effects
Very common (affects more than 1 person in 10 users):

• headache; dizziness; drowsiness
• insomnia
• nausea; dry mouth; constipation
• sweating (including night sweats)
Common (affects less than 1 person in 10 users):

• weight loss; weight gain; increased cholesterol
• abnormal dreams; decreased libido; increased
muscle tonus; nervousness; pins and needles;
tremor; confusion; feeling separated (or detached)
from yourself ; agitation; a sensation of
restlessness or an inability to sit or stand still;
altered taste sensation
• blurred vision; dilated pupils; inability of the eye to
automatically change focus from distant to near
objects
• increase in blood pressure; flushing; palpitations;
fast heartbeat
• yawning; shortness of breath
• appetite decreased; vomiting; diarrhoea
• difficulties passing urine; increased frequency in
urination; inability to pass urine
• abnormal ejaculation/orgasm (males); lack of
orgasm; erectile dysfunction (impotence);
menstrual irregularities such as increased
bleeding or increased irregular bleeding
• weakness (asthenia); chills; fatigue
• ringing in the ears (tinnitus)
• mild rash; itching
Uncommon (affects less than 1 person in 100 users):

• bruising; vomiting blood; black tarry stools (faeces)
or blood in stools, which can be a sign of internal
bleeding
• lack of feeling or emotion; hallucinations;
involuntary movement of the muscles; impaired
coordination and balance
• feeling dizzy (particularly when standing up too
quickly), fainting, decrease in blood pressure
• grinding of the teeth; feeling separated (or
detached) from reality; feeling over-excited
• abnormal hair loss
• abnormal orgasm (females)
• sensitivity to sunlight
• over activity, racing thoughts and decreased need
for sleep (mania)
• inability to control urination
• stiffness, spasms and involuntary movements of
the muscles
• slight changes in blood levels of liver enzymes
Rare (affects less than 1 person in 1000 users):

• seizures or fits
• coughing, wheezing and shortness of breath which
may be accompanied by a high temperature
• disorientation and confusion often accompanied
by hallucination (delirium)
• excessive water intake (known as SIADH)
• decrease in blood sodium levels
• severe eye pain and decreased or blurred vision
• abnormal, rapid or irregular heartbeat, which could
lead to fainting
• 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)
• Dystonia - muscle disorder causing twisting
movements (dystonia)
Very rare (may affect up to 1 in 10,000 people):
• prolonged bleeding, which may be a sign of
reduced number of platelets in your blood, leading
to an increased risk of bruising or bleeding
• abnormal breast milk production
• 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)
• Tardive dyskinesia - uncontrollable movements of
mouth, tongue and limbs(tardive dyskinesia)
Not known (frequency cannot be estimated
from the available data):

• aggression
• vertigo
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 01/2017
FR02232.V4 / CP0034/8

“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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