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VENAXX XL 75 MG PROLONGED-RELEASE CAPSULES
Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE
To be implemented by:
Venaxx XL® 75mg & 150mg PR Capsules, hard KBR
101079_80LF Venaxx 75_150mg v3_1 AMCo.CRF.133.2013
Quark Xpress 9
Minimum Font Size & Typeface:
9pt Swiss 721BT
170 x 500mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Venaxx XL® 75 mg prolonged-release capsules, hard
Venaxx XL® 150 mg prolonged-release capsules, hard
IMPORTANT THINGS YOU SHOULD KNOW ABOUT Venaxx XL
Please read all of this leaflet before you start to take your medicine as it contains important information about Venaxx XL
• This medicine is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD)
and social anxiety disorder (also known as social phobia)
• This medicine is not for use in children and adolescents – see in section 2 ‘Venaxx XL is not recommended for use in Children’
This leaflet describes two strengths of the Capsule. For simplicity they will both be referred to as Venaxx XL hereafter.
Venaxx XL may cause a sensation of restlessness or an
If you have any concerns about how you feel, or about this
inability to sit or stand still. You should tell your doctor if this
medicine, it is important that you talk to your doctor - even
happens to you.
if you feel anxious or worried about doing so.
If any of these conditions apply to you, please talk with your
You may find it helpful to tell a friend or relative that you are
doctor before taking this medicine.
depressed or suffering from an anxiety disorder, and that you
have been prescribed this medicine; it might be useful to
Thoughts of suicide and worsening of your depression or
show them this leaflet.
• Venaxx XL may not start to work immediately. Some
If you are depressed and/or have anxiety disorders, you can
people taking antidepressants may feel worse before
sometimes have thoughts of harming or killing yourself.
feeling better. Your doctor may ask to see you again a
These may be increased when you first start taking
couple of weeks after you start treatment and then
antidepressants, since these medicines all take time to work,
regularly until you start to feel well again. Tell your doctor
usually about two weeks, but sometimes longer.
if you do not start to feel better.
You may be more likely to think like this:
• Some people who are depressed may think of harming
• If you have previously had thoughts about killing yourself
or killing themself. If this happens you should see your
or harming yourself.
doctor or go to a hospital straight away – see in section
• If you are a young adult. Information from clinical trials
2 ‘Thoughts of suicide and worsening of your depression
has shown an increased risk of suicidal behaviour in
or anxiety disorder’
young adults (less than 25 years old) with psychiatric
• If you take too many capsules it is important to seek
conditions who were treated with an antidepressant.
immediate medical attention, even if you feel well,
have thoughts of harming or killing yourself at any time,
because of the risk of serious side effects
contact your doctor or go to a hospital straight away.
• Do not stop taking Venaxx XL or change your dose
You may find it helpful to tell a relative or close friend that you
without the advice of your doctor even if you feel better.
are depressed or have an anxiety disorder, and ask them to
If you stop taking this medicine abruptly you may get
read this leaflet. You might ask them to tell you if they think
withdrawal reactions – see in section 3 ‘When and how to
your depression or anxiety is getting worse, or if they are
stop taking this medicine’
worried about changes in your behavior.
• If you have heart problems or high blood pressure you
Dry mouth is reported in 10% of patients treated with this
should talk to your doctor before taking Venaxx XL –
medicine. This may increase the risk of caries. Therefore, you
see in section 2 ‘Before you take this medicine’
should take special care in your dental hygiene.
• Taking certain other medicines with Venaxx XL may cause
Use in children and adolescents under 18 years of age
problems. You should tell your doctor if you are taking any
Venaxx XL should normally not be used for children and
other medicines – see in section 2 ‘Before you take
adolescents under 18 years. Also, you should know that
patients under 18 have an increased risk of side effects, such
• See your doctor without delay if you feel restless and feel
as suicide attempt, suicidal thoughts and hostility
like you can’t keep still, feel ‘high’ or very overexcited,
(predominantly aggression, oppositional behaviour and anger)
have jerky muscle movements which you can’t control.
when they take this class of medicines. Despite this, your
See section 4 – ‘Possible side effects’ for other important
doctor may prescribe this medicine for patients under 18
because he/she decides that this is in their best interests. If
• If you are pregnant, or intend to become pregnant, or
your doctor has prescribed this medicine for a patient under
18, and you want to discuss this, please go back to your
breast feeding, you should talk to your doctor – see in
doctor. You should inform your doctor if any of the symptoms
section 2 ‘Pregnancy, breastfeeding and Venaxx XL’
listed above develop or worsen when patients under 18 are
More information on all of these points is provided in the
taking this medicine. Also, the longterm safety effects
rest of the leaflet.
concerning growth, maturation and cognitive and behavioural
• Keep this leaflet. You may need to read it again.
development of this medicine in this age group has not yet
• If you have any further questions, ask your doctor or
Taking other medicines
• This medicine has been prescribed for you. Do not pass
Please tell your doctor or pharmacist if you are taking or have
it on to others. It may harm them, even if their symptoms
recently taken any other medicines, including medicines
are the same than yours.
obtained without a prescription.
Your doctor should decide whether you can take this medicine
In this leaflet:
with other medicines.
1 What Venaxx XL is and what it is used for
Do not start or stop taking any medicines, including those
2 Before you take Venaxx XL
bought without a prescription, natural and herbal remedies,
3 How to take Venaxx XL
before checking with your doctor or pharmacist.
4 Possible side effects
• Monoamine oxidase inhibitors (MAOIs: see the section
5 How to store Venaxx XL
“Before you take Venaxx XL”).
6 Further information
• Serotonin syndrome:
1. WHAT Venaxx XL IS AND WHAT IT IS USED FOR
Venaxx 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
Venaxx XL is a treatment for adults with depression. This
medicine is also a treatment for adults with social anxiety
disorder (fear or avoidance of social situations).
Treating depression or social anxiety disorder 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.
Venlafaxine which is contained in Venaxx XL may also be
authorised to treat conditions which are not mentioned in
2. BEFORE YOU TAKE Venaxx XL
Do not take Venaxx XL
• If you are allergic to this medicine or any of the other
ingredients of this medicine.
• 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 other medicines, including this
medicine, can cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after you stop
taking this medicine before you take any MAOI (see also
the sections “Serotonin syndrome” and “Taking other
Take special care with Venaxx XL
• If you use other medicines that taken concomitantly with
this medicine could increase the risk of developing
serotonin syndrome (see the section “Taking other
• 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
• 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
• 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 over-excited or
• If you have a history of aggressive behaviour
• Serotonin syndrome, a potentially life-threatening
condition (see the section “Possible Side Effects”), may
occur with this medicine 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
• 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 this medicine
and should be used with caution. It is especially important to
mention to your doctor or pharmacist if you are taking
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure
and heart problems)
Taking Venaxx XL with food and drink
Venaxx XL should be taken with food (see section 3 “HOW TO
TAKE Venaxx XL”).
You should avoid alcohol while you are taking this medicine.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to
become pregnant. You should use this medicine 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 this
medicine. When taken during pregnancy, similar drugs
(SSRIs) may increase the risk of 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.
Venaxx XL passes into breast milk. There is a risk of an effect
on the baby. Therefore, you should discuss the matter with
your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with this medicine.
Driving and using machines
Do not drive or use any tools or machines until you know how
this medicine affects you.
3. HOW TO TAKE Venaxx 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 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.
The maximum dose for social anxiety disorder is 225 mg/day.
Take this medicine at approximately the same time each day,
either in the morning or in the evening. Capsules must be
swallowed whole with fluid and not opened, crushed, chewed
Venaxx XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since
your dose of this medicine may need to be different.
Do not stop taking this medicine without talking to your doctor
(see the section “If you stop taking Venaxx XL”).
If you take more Venaxx XL than you should
Call your doctor or pharmacist immediately if you take more
than the amount of this medicine 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
If you forget to take Venaxx 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 this medicine that has been prescribed for
you in one day.
If you stop taking Vennax 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 [Venlafaxine], he/she may ask
you to reduce your dose slowly before stopping treatment
altogether. Side effects are known to occur when people stop
using this medicine, especially when this medicine is stopped
suddenly or the dose is reduced too quickly. Some patients
may experience symptoms such as tiredness, dizziness,
light-headedness, headache, sleeplessness, nightmares, dry
mouth, loss of appetite, nausea, diarrhoea, nervousness,
agitation, confusion, ringing in the ears, tingling or rarely
electric shock sensations, weakness, sweating, seizures, or
Your doctor will advise you on how you should gradually
discontinue this medicine 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, Venaxx XL can cause side effects,
although not everybody gets them.
If any of the following happen, do not take more Venaxx XL.
Tell your doctor immediately, or go to the casualty department
at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing
sensations, sudden reddening of the skin and/or a warm
• 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
• 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
Venaxx XL, if you stop taking Venaxx XL”).
Complete side effect listing
The frequency (likelihood of occurring) of side effects is
classified as follows:
Very common Affects more than 1 user in 10
Common Affects 1 to 10 users in 100
Uncommon Affects 1 to 10 users in 1,000
Rare Affects 1 to 10 users in 10,000
Not known Frequency cannot be estimated from
the available data
• Blood disorders
Uncommon: bruising; black tarry stools (faeces) or blood in
stools, which can be a sign of internal bleeding
Not known : reduced number of platelets in your blood,
leading to an increased risk of bruising or bleeding; blood
disorders which may lead to an increased risk of infection
• Metabolism/nutritional disorders
Common: weight loss; increased cholesterol
Uncommon: weight gain
Not known: 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
• Nervous system disorders
Very common : dry mouth; headache
Common: abnormal dreams; decreased libido; dizziness;
increased muscle tonus; insomnia; nervousness; pins and
needles; sedation; tremor; confusion; feeling separated (or
detached) from yourself and reality Uncommon : lack of
feeling or emotion; hallucinations; involuntary movement of
the muscles; agitation; impaired coordination and balance
Rare: a sensation of restlessness or an inability to sit or stand
still; seizures or fits; feeling over excited or euphoric
Not known : 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
• Sight and hearing disorders
Common: blurred vision
Uncommon: altered taste sensation; ringing in the ears
Not known: severe eye pain and decreased or blurred vision
• Heart or circulation disorders
Common: increase in blood pressure; flushing; palpitations
Uncommon: feeling dizzy (particularly when standing up too
quickly), fainting, fast heartbeat
Not known: decrease in blood pressure; abnormal, rapid or
irregular heart beat, which could lead to fainting
• Breathing disorders
Not known: 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
• Digestive disorders
Very common: nausea
Common: appetite decreased; constipation; vomiting
Uncommon: grinding of the teeth; diarrhoea
Not known: severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or pancreas)
• Skin disorders
Very common: sweating (including night sweats)
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe blistering
and peeling of the skin; itching; mild rash
• Muscle disorders
Not known: unexplained muscle pain, tenderness or
• Urinary system disorders
Common: difficulties passing urine; increased frequency in
Uncommon: inability to pass urine
• Reproductive and sexual disorders
Common: abnormal ejaculation/orgasm (males); lack of
orgasm; erectile dysfunction (impotence); menstrual
irregularities such as increased bleeding or increased irregular
Uncommon: abnormal orgasm (females)
Common: weakness (asthenia); chills
Uncommon: sensitivity to sunlight
Not known: swollen face or tongue, shortness of breath or
difficulty breathing, often with skin rashes (this may be a
serious allergic reaction)
Venaxx 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, this medicine
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 this medicine for a long time.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
5. HOW TO STORE Venaxx XL
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated
on the packaging.
The expiry date refers to the last day of that month.
Store below 30˚C .
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required.
6. FURTHER INFORMATION
What Venaxx XL contains
The active substance is Venlafaxine.
Each prolonged-release capsule, hard contains 75 mg and
150 mg of Venlafaxine as venlafaxine hydrochloride.
The other ingredients are:
75 mg prolonged-release capsules, hard:
Capsule content: Hypromellose, ammonio methacrylate
copolymer (type B), sodium larilsulfate, magnesium stearate
Coating: Basic butylated methacrylate copolymer 12.5%
Capsule shell: Gelatin, titanium dioxide (E 171), red iron
Printing ink: Shellac, black iron oxide (E172), propylene
150 mg prolonged-release capsules, hard:
Capsule content: Hypromellose, ammonio methacrylate
copolymer (type B), sodium larilsulfate, magnesium stearate
Coating: Basic butylated methacrylate copolymer 12.5%
Capsule shell: Gelatin, titanium dioxide (E 171), erythrosine
(E127), indigotin I (E 132)
Printing ink: Shellac, black iron oxide (E172), propylene
What Venaxx XL looks like and contents of the pack
75 mg prolonged-release capsules, hard: flesh opaque – flesh
opaque size 0 hard gelatin capsules containing two round,
bivonvex film-coated tablets, with imprint VEN on cap and 75
on body 150 mg prolonged-release capsules, hard: scarlet
opaque – scarlet opaque size 00 hard gelatin capsules
containing three round, bivonvex film-coated tablets, with
imprint VEN on cap and 150 on body.
75 mg: 14, 28, 30, 56, 98 and 100 prolonged-release
150 mg: 10, 28, 30, 56, 98 and 100 prolonged-release
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Pharmathen SA, Dervenakion 6, Pallini 15351
This leaflet was last revised in December 2013.
There are a number of organisations that provide help,
information and advice for people with depression and their
families or carers. You may wish to contact:
(National Association for Mental
PO Box 277, Manchester
Mind infoline: 0300 123 3393
212 Spitfire Studios
63 – 71 Collier Street
Telephone: 0845 123 23 20
120 – 122 Broadway
CF 24 1NJ
Telephone: 029 2069 2891
1st Floor, Cityside House
40 Adler Street
SANE line: 0845 767 8000
Venaxx is the registered trademark of
Mercury Pharma Group Ltd.
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.