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AXYVEN XL 75 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE / VENLAFAXINE / VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Axyven XL® 37.5 mg ProlongedRelease Tablets
Axyven XL® 75 mg Prolonged-Release
Tablets
Axyven XL® 150 mg ProlongedRelease Tablets
(venlafaxine hydrochloride)
The name of your medicine is Axyven XL 37.5 mg
Prolonged-Release Tablets or Axyven XL 75 mg
Prolonged-Release Tablets or Axyven XL 150 mg
Prolonged-Release Tablets but will be referred to as
Axyven XL throughout 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 please 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
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.
What is in this leaflet:
1. What Axyven XL is and what it is used for
2. What you need to know before you take Axyven XL
3. How to take Axyven XL
4. Possible side effects
5. How to store Axyven XL
6. Contents of the pack and other information

1. WHAT AXYVEN XL IS AND WHAT IT IS
USED FOR
Axyven 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.
Axyven XL is a treatment for adults with depression.
Axyven XL 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. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AXYVEN XL
Do not take Axyven XL
 If you are allergic to venlafaxine or any of the other
ingredients of this medicine (listed in section 6).
 If 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 Axyven XL, can cause
serious or even life-threatening side effects. Also, you
must wait at least 7 days after you stop taking Axyven
XL before you take any MAOI (see also the sections
entitled “Taking other medicines” and the information
in that section about “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor before taking Axyven XL
 If you use other medicines that taken concomitantly
with Axyven XL could increase the risk of developing
serotonin syndrome (see the section “Taking other
medicines”).
 If you have a swallowing, stomach or intestinal
disorder that reduces your ability to swallow or pass
foods by normal bowel movements.
 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 your cholesterol levels get higher.
 If you have a history of, or if someone in your family
has had, mania or bipolar disorder (feeling overexcited or euphoric).
 If you have a history of aggressive behaviour.
Axyven 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.
If any of these conditions apply to you, please talk with
your doctor before taking Axyven XL.
Thoughts of suicide and worsening of your
depression or feelings of anxiety
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:
 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.
If you have thoughts of harming or killing yourself at any
time, contact your doctor or go to a hospital straight
away.
You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder and
ask them to read this leaflet. You might ask them to tell
you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your
behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with
venlafaxine. This may increase the risk of caries.
Therefore, you should take special care in your dental
hygiene.
Diabetes
Your blood glucose levels may be altered due to Axyven
XL. Therefore, the dosages of your diabetes medicines
may need to be adjusted.
Use in children and adolescents under 18 years of
age
Axyven 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 Axyven XL
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 Axyven XL.

Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development
of Axyven XL in this age group has not yet been
demonstrated.
Other medicines and Axyven XL
Tell your doctor or pharmacist if you are taking, have
recently taken any other medicines.
Your doctor should decide whether you can take Axyven
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 Axyven XL. Tell your doctor if you have taken
these medicines within the last 14 days. (MAOIs: see
the section “Before you take Axyven XL”).
 Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening
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)
 Medicines containing methylene blue (used to treat
high levels of methaemoglobin in the blood)
 Products containing St. John’s Wort (also called
Hypericum perforatum, a natural or herbal remedy
used to treat mild depression)
 Products containing tryptophan (used for problems
such as sleep and depression)
 Antipsychotics (used to treat a disease with symptoms
such as hearing, seeing or sensing things which are
not there, mistaken beliefs, unusual suspiciousness,
unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may
include a combination of the following:
restlessness, hallucinations, loss of coordination, fast
heart beat, increased body temperature, fast changes in
blood pressure, overactive reflexes, diarrhoea, 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 Axyven
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, Itraconazole, Voriconazole,
Posaconazole (antifungal medicines)
 Clarithromycin, telithromycin (antibiotics used to treat
infections)
 Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir
(used to treat HIV infection)
 Haloperidol or risperidone (to treat psychiatric
conditions)
 Metoprolol (a beta blocker to treat high blood pressure
and heart problems)
Axyven XL with food, drink and alcohol
Axyven XL should be taken with food (see section 3
“How to take Axyven XL”).
You should avoid alcohol while you are taking Axyven
XL.

Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are
trying to become pregnant. You should use Axyven 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
Axyven 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 Axyven XL during pregnancy, let your
midwife and/or doctor know, as your baby might have
some symptoms when it is born. These symptoms
usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia,
constant crying, sleeping difficulties and, not feeding
properly. 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.
Venlafaxine passes into breast milk. There is a risk of an
effect on the baby, which may cause symptoms such as
crying, irritabilty and abnormal sleep patterns.
Symptoms consistent with venlafaxine drug
discontinuation can also occur after stopping breastfeeding. 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 Axyven XL.
Driving and using machines
Do not drive or use any tools or machines until you
know how Axyven XL affects you.
Important information about some of the ingredients
of Axyven XL
This medicine contains lactose. 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 AXYVEN XL
Always take this medicine 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 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.
Take Axyven XL at approximately the same time each
day, either in the morning or in the evening. Tablets
must be swallowed whole with fluid and not opened,
crushed, chewed or dissolved.
Axyven XL should be taken with food.
If you have liver or kidney problems, talk to your doctor,
since your dose of Axyven XL may need to be different.
Do not stop taking Axyven XL without talking to your
doctor (see the section “If you stop taking Axyven XL”).
If you take more Axyven XL than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Axyven XL 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 Axyven 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 Axyven XL that has been
prescribed for you in one day.
If you stop taking Axyven 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 Axyven 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 Axyven XL, especially
when Axyven XL is stopped suddenly or the dose is
reduced too quickly. Some patients may experience
symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, sensation that
everything around you is spinning or moving (vertigo),
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 Axyven 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, Axyven XL can cause side effects,
although not everybody gets them.
Do not be concerned if you see a tablet in your stools
after taking Axyven XL. As the tablet travels the length
of your gastrointestinal tract, venlafaxine is slowly
released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though
you may see a tablet in your stools, your dose of
venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axyven
XL. 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)
 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).

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)
 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
Axyven XL, if you stop taking Axyven XL”)
 Prolonged bleeding - if you cut or injure yourself, it
may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
 Dizziness; headache
 Nausea; dry mouth
 Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
 Appetite decreased
 Confusion; feeling separated (or detached) from
yourself; lack of orgasm; decreased libido;
nervousness; insomnia; abnormal dreams
 Drowsiness; tremor; pins and needles; increased
muscle tonus
 Visual disturbance including blurred vision; dilated
pupils; inability of the eye to automatically change
focus from distant to near objects
 Ringing in the ears (tinnitus)
 Palpitations
 Increase in blood pressure; flushing
 Yawning
 Vomiting; constipation; diarrhoea
 Increased frequency in urination; difficulties passing
urine
 Menstrual irregularities such as increased bleeding or
increased irregular bleeding; abnormal
ejaculation/orgasm (males); erectile dysfunction
(impotence)
 Weakness (asthenia); fatigue; chills
 Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
 Hallucinations; feeling separated (or detached) from
reality; agitation; abnormal orgasm (females); lack of
feeling or emotion; feeling over-excited; grinding of the
teeth
 A sensation of restlessness or an inability to sit or
stand still; fainting; involuntary movements of the
muscles; impaired coordination and balance; altered
taste sensation
 Fast heart beat; feeling dizzy (particularly when
standing up too quickly)
 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 (may affect up to 1 in 1,000 people)
 Seizures or fits
 Inability to control urination
 Over activity, racing thoughts and decreased need for
sleep (mania)

Not known (frequency cannot be estimated from the
available data)
 Reduced number of platelets in your blood, leading to
an increased risk of bruising or bleeding; blood
disorders which may lead to an increased risk of
infection
 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 Axyven 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
 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
Axyven 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, Axyven 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
Axyven XL for a long time.
Reporting of side effects
If you get any of the side effects, talk to your doctor or
pharmacist. 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 AXYVEN XL
Keep out of the reach and sight of children.
Do not use Axyven XL after the expiry date which is
stated on the packaging. The expiry date refers to the
last day of that month.
Do not store above 30ºC.
Store in the original package in order to protect from
moisture.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Axyven XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 37.5, 75 or 150
mg of venlafaxine (as hydrochloride).
The other ingredients are
Core: Mannitol, Povidone K-90, Macrogol 400,
Microcrystalline cellulose, Colloidal anhydrous silica,
Magnesium stearate.
Coat: Cellulose acetate 320S, Cellulose acetate 398-10,
Macrogol 400, Opadry White Y-30-18037 (mixture of
hypromellose, lactose monohydrate, titanium dioxide
(E172) and triacetin).
What Axyven XL looks like and contents of the pack
37.5 mg prolonged-release tablets: 7 mm round,
biconvex, white tablets.
75 mg prolonged-release tablets: 7.5 mm round,
biconvex, white tablets.
150 mg prolonged-release tablets: 9.5 mm round,
biconvex, white tablets.
Available in blister packs containing 28 tablets.
Manufactured by Laboratorios LICONSA, S.A., Avda.
Miralcampo no 7, Poligono Industrial Miralcampo, 19200
Azuqueca de Henares, Spain and procured from within
the EU and repackaged in the UK by the Product
Licence holder: CD Pharma Ltd, Unit 3, Manor Point,
Manor Way, Borehamwood, Herts WD6 1EE.
Axyven XL 37.5 mg Prolonged-Release Tablets
PL: 20492/0554
Axyven XL 75 mg Prolonged-Release Tablets
PL: 20492/0555
Axyven XL 150 mg Prolonged-Release Tablets
PL: 20492/0556
POM
Axyven is a registered trademark
Date of preparation: 02nd February 2017

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Venlalic® XL 37.5 mg ProlongedRelease Tablets
®
Venlalic XL 75 mg Prolonged-Release
Tablets
Venlalic® XL 150 mg ProlongedRelease Tablets
(venlafaxine hydrochloride)
The name of your medicine is Venlalic XL 37.5 mg
Prolonged-Release Tablets or Venlalic XL 75 mg
Prolonged-Release Tablets or Venlalic XL 150 mg
Prolonged-Release Tablets but will be referred to as
Venlalic XL throughout 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 please 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
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.
What is in this leaflet:
1. What Venlalic XL is and what it is used for
2. What you need to know before you take Venlalic XL
3. How to take Venlalic XL
4. Possible side effects
5. How to store Venlalic XL
6. Contents of the pack and other information

1. WHAT VENLALIC XL IS AND WHAT IT IS
USED FOR
Venlalic 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.
Venlalic XL is a treatment for adults with depression.
Venlalic XL 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. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE VENLALIC XL
Do not take Venlalic XL
 If you are allergic to venlafaxine or any of the other
ingredients of this medicine (listed in section 6).
 If 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 Venlalic XL, can cause
serious or even life-threatening side effects. Also, you
must wait at least 7 days after you stop taking Venlalic
XL before you take any MAOI (see also the sections
entitled “Taking other medicines” and the information
in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venlalic XL
 If you use other medicines that taken concomitantly
with Venlalic XL could increase the risk of developing
serotonin syndrome (see the section “Taking other
medicines”).

 If you have a swallowing, stomach or intestinal
disorder that reduces your ability to swallow or pass
foods by normal bowel movements.
 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 your cholesterol levels get higher.
 If you have a history of, or if someone in your family
has had, mania or bipolar disorder (feeling overexcited or euphoric).
 If you have a history of aggressive behaviour.
Venlalic 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.
If any of these conditions apply to you, please talk with
your doctor before taking Venlalic XL.
Thoughts of suicide and worsening of your
depression or feelings of anxiety
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:
 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.
If you have thoughts of harming or killing yourself at any
time, contact your doctor or go to a hospital straight
away.
You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder and
ask them to read this leaflet. You might ask them to tell
you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your
behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with
venlafaxine. This may increase the risk of caries.
Therefore, you should take special care in your dental
hygiene.
Diabetes
Your blood glucose levels may be altered due to
Venlalic XL. Therefore, the dosages of your diabetes
medicines may need to be adjusted.
Use in children and adolescents under 18 years of
age
Venlalic 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 Venlalic XL
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 Venlalic XL.
Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development
of Venlalic XL in this age group has not yet been
demonstrated.

Other medicines and Venlalic XL
Tell your doctor or pharmacist if you are taking, have
recently taken any other medicines.
Your doctor should decide whether you can take
Venlalic 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 Venlalic XL. Tell your doctor if you have taken
these medicines within the last 14 days. (MAOIs: see
the section “Before you take Venlalic XL”).
 Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening
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)
 Medicines containing methylene blue (used to treat
high levels of methaemoglobin in the blood)
 Products containing St. John’s Wort (also called
Hypericum perforatum, a natural or herbal remedy
used to treat mild depression)
 Products containing tryptophan (used for problems
such as sleep and depression)
 Antipsychotics (used to treat a disease with symptoms
such as hearing, seeing or sensing things which are
not there, mistaken beliefs, unusual suspiciousness,
unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may
include a combination of the following:
restlessness, hallucinations, loss of coordination, fast
heart beat, increased body temperature, fast changes in
blood pressure, overactive reflexes, diarrhoea, 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 Venlalic
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, Itraconazole, Voriconazole,
Posaconazole (antifungal medicines)
 Clarithromycin, telithromycin (antibiotics used to treat
infections)
 Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir
(used to treat HIV infection)
 Haloperidol or risperidone (to treat psychiatric
conditions)
 Metoprolol (a beta blocker to treat high blood pressure
and heart problems)
Venlalic XL with food, drink and alcohol
Venlalic XL should be taken with food (see section 3
“How to take Venlalic XL”).
You should avoid alcohol while you are taking Venlalic
XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are
trying to become pregnant. You should use Venlalic 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
Venlalic 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 Venlalic XL during pregnancy, let your
midwife and/or doctor know, as your baby might have
some symptoms when it is born. These symptoms
usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia,
constant crying, sleeping difficulties and, not feeding
properly. 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.
Venlafaxine passes into breast milk. There is a risk of an
effect on the baby, which may cause symptoms such as
crying, irritabilty and abnormal sleep patterns.
Symptoms consistent with venlafaxine drug
discontinuation can also occur after stopping breastfeeding. 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 Venlalic XL.
Driving and using machines
Do not drive or use any tools or machines until you
know how Venlalic XL affects you.
Important information about some of the ingredients
of Venlalic XL
This medicine contains lactose. 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 VENLALIC XL
Always take this medicine 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 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.
Take Venlalic XL at approximately the same time each
day, either in the morning or in the evening. Tablets
must be swallowed whole with fluid and not opened,
crushed, chewed or dissolved.
Venlalic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor,
since your dose of Venlalic XL may need to be different.
Do not stop taking Venlalic XL without talking to your
doctor (see the section “If you stop taking Venlalic XL”).
If you take more Venlalic XL than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Venlalic XL 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 Venlalic 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 Venlalic XL that has been
prescribed for you in one day.
If you stop taking Venlalic 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 Venlalic
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 Venlalic XL,
especially when Venlalic XL is stopped suddenly or the
dose is reduced too quickly. Some patients may
experience symptoms such as tiredness, dizziness,
light-headedness, headache, sleeplessness, sensation
that everything around you is spinning or moving
(vertigo), 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 Venlalic 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, Venlalic XL can cause side effects,
although not everybody gets them.
Do not be concerned if you see a tablet in your stools
after taking Venlalic XL. As the tablet travels the length
of your gastrointestinal tract, venlafaxine is slowly
released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though
you may see a tablet in your stools, your dose of
venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venlalic
XL. 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)
 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).

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)
 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
Venlalic XL, if you stop taking Venlalic XL”)
 Prolonged bleeding - if you cut or injure yourself, it
may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
 Dizziness; headache
 Nausea; dry mouth
 Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
 Appetite decreased
 Confusion; feeling separated (or detached) from
yourself; lack of orgasm; decreased libido;
nervousness; insomnia; abnormal dreams
 Drowsiness; tremor; pins and needles; increased
muscle tonus
 Visual disturbance including blurred vision; dilated
pupils; inability of the eye to automatically change
focus from distant to near objects
 Ringing in the ears (tinnitus)
 Palpitations
 Increase in blood pressure; flushing
 Yawning
 Vomiting; constipation; diarrhoea
 Increased frequency in urination; difficulties passing
urine
 Menstrual irregularities such as increased bleeding or
increased irregular bleeding; abnormal
ejaculation/orgasm (males); erectile dysfunction
(impotence)
 Weakness (asthenia); fatigue; chills
 Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
 Hallucinations; feeling separated (or detached) from
reality; agitation; abnormal orgasm (females); lack of
feeling or emotion; feeling over-excited; grinding of the
teeth
 A sensation of restlessness or an inability to sit or
stand still; fainting; involuntary movements of the
muscles; impaired coordination and balance; altered
taste sensation
 Fast heart beat; feeling dizzy (particularly when
standing up too quickly)
 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 (may affect up to 1 in 1,000 people)
 Seizures or fits
 Inability to control urination
 Over activity, racing thoughts and decreased need for
sleep (mania)

Not known (frequency cannot be estimated from the
available data)
 Reduced number of platelets in your blood, leading to
an increased risk of bruising or bleeding; blood
disorders which may lead to an increased risk of
infection
 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 Venlalic 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
 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
Venlalic 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, Venlalic 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
Venlalic XL for a long time.
Reporting of side effects
If you get any of the side effects, talk to your doctor or
pharmacist. 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 VENLALIC XL
Keep out of the reach and sight of children.
Do not use Venlalic XL after the expiry date which is
stated on the packaging. The expiry date refers to the
last day of that month.
Do not store above 30ºC.
Store in the original package in order to protect from
moisture.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Venlalic XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 37.5, 75 or 150
mg of venlafaxine (as hydrochloride).
The other ingredients are
Core: Mannitol, Povidone K-90, Macrogol 400,
Microcrystalline cellulose, Colloidal anhydrous silica,
Magnesium stearate.
Coat: Cellulose acetate 320S, Cellulose acetate 398-10,
Macrogol 400, Opadry White Y-30-18037 (mixture of
hypromellose, lactose monohydrate, titanium dioxide
(E172) and triacetin).
What Venlalic XL looks like and contents of the pack
37.5 mg prolonged-release tablets: 7 mm round,
biconvex, white tablets.
75 mg prolonged-release tablets: 7.5 mm round,
biconvex, white tablets.
150 mg prolonged-release tablets: 9.5 mm round,
biconvex, white tablets.
Available in blister packs containing 28 tablets.
Manufactured by Laboratorios LICONSA, S.A., Avda.
Miralcampo no 7, Poligono Industrial Miralcampo, 19200
Azuqueca de Henares, Spain and procured from within
the EU and repackaged in the UK by the Product
Licence holder: CD Pharma Ltd, Unit 3, Manor Point,
Manor Way, Borehamwood, Herts WD6 1EE.
Venlalic XL 37.5 mg Prolonged-Release Tablets
PL: 20492/0554
Venlalic XL 75 mg Prolonged-Release Tablets
PL: 20492/0555
Venlalic XL 150 mg Prolonged-Release Tablets
PL: 20492/0556
POM
Venlalic is a registered trademark
Date of preparation: 02nd February 2017

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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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