Pill Identifier App

VENLALIC XL 37.5MG PROLONGED-RELEASE TABLETS

Active substance: VENLAFAXINE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlalic® XL 37.5mg
prolonged-release tablets
(venlafaxine hydrochloride)

Venlalic XL prolonged-release tablets are available in the following
strengths: 37.5mg, 75mg, 150mg and 225mg.
Venlalic XL 37.5mg prolonged-release tablets 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.
2.
3.
4.
5.
6.

What Venlalic XL is and what it is used for
What you need to know before you take Venlalic XL
How to take Venlalic XL
Possible side effects
How to store Venlalic XL
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 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 over-excited 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.

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.

Signs and symptoms of serotonin syndrome may include a
combination of the following:
restlessness, hallucinations, loss of coordination, fast heartbeat,
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 heartbeat,
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

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 or 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)

If any of these conditions apply to you, please talk with your
doctor before taking Venlalic XL.
Page 1 of 2

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
breast-feeding. 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 monohydrate. 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
and social anxiety disorder is 75mg per day. The dose can be
raised by your doctor gradually, and if needed, even up to a
maximum dose of 375mg daily for depression. The maximum
dose for social anxiety disorder is 225mg/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
heartbeat, 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
heartbeat, 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 heartbeat,
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

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 heartbeat; 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
heartbeat, 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

Complete side effect listing
Very common (may affect more than 1 in 10
people)
Dizziness; headache
Nausea; dry mouth
Sweating (including night sweats)

Page 2 of 2

Venlalic XL sometimes causes unwanted effects that you may not
be aware of, such as increases in blood pressure or abnormal
heartbeat; 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 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
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 SIGHT AND REACH OF CHILDREN.
Do not use Venlalic XL after the expiry date which is stated
on the packaging (‘Exp’). 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.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if your
doctor tells you to.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
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 37.5mg venlafaxine
(as hydrochloride).
The other ingredients are:
Core: mannitol (E421), povidone K90, macrogol 400,
microcrystalline cellulose, colloidal anhydrous silica and
magnesium stearate.
Coat: cellulose acetate (320SNF), cellulose acetate (398-10NF),
macrogol 400 and Opadry White Y-30-18037 (hypromellose,
lactose monohydrate, titanium dioxide (E171) and triacetin).

What Venlalic XL looks like and contents of the pack
Venlalic XL are white, round, biconvex, prolonged-release tablets.
Venlalic XL is available in blisters of 28 tablets.

Manufacturer

Manufactured by: Laboratorios LICONSA S.A.,
Avda. Miralcampo no 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0600

POM

Leaflet revision and issue date: 12.02.14
Venlalic® is a registered trademark of Dallas Burston Ashbourne
Holdings Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Axyven XL 37.5mg prolonged-release tablets
(venlafaxine hydrochloride)

Axyven XL prolonged-release Tablets are available in the following
strengths: 37.5mg, 75mg, 150mg and 225mg.
Axyven XL 37.5mg prolonged-release tablets will be referred to as
Axyven 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.
2.
3.
4.
5.
6.

What Axyven is and what it is used for
What you need to know before you take Axyven
How to take Axyven
Possible side effects
How to store Axyven
Contents of the pack and other information

1. What Axyven is and what it is used for
Axyven 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 is a treatment for adults with depression 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
Do not take Axyven

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, can cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after you stop
taking Axyven 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
If you use other medicines that taken concomitantly with
Axyven 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 over-excited or
euphoric).
If you have a history of aggressive behaviour.
Axyven may cause a sensation of restlessness or an inability to sit
or stand still during the first few weeks of treatment. You should
tell your doctor if this happens to you.

Thoughts of suicide and worsening of your
depression or 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.
Therefore, the dosages of your diabetes medicines may need to
be adjusted.

Use in children and adolescents under 18 years of
age

Axyven 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 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. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of Axyven
in this age group has not yet been demonstrated.

Other medicines and Axyven

Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines.
Your doctor should decide whether you can take Axyven 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. Tell your doctor if you have taken these medicines
within the last 14 days. (MAOIs: see the section “Before you
take Axyven”).
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)

If any of these conditions apply to you, please talk with your
doctor before taking Axyven.

Page 1 of 2

Signs and symptoms of serotonin syndrome may include a
combination of the following:
restlessness, hallucinations, loss of coordination, fast heartbeat,
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 heartbeat,
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 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 with food, drink and alcohol

Axyven should be taken with food (see section 3 “How to take
Axyven”).
You should avoid alcohol while you are taking Axyven.

Pregnancy, breast-feeding and fertility

Tell your doctor if you become pregnant, or you are trying to
become pregnant. You should use Axyven 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.
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 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
breast-feeding. 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.

Driving and using machines

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

Important information about some of the
ingredients of Axyven

This medicine contains lactose monohydrate. 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
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 75mg per day. The dose can be
raised by your doctor gradually, and if needed, even up to a
maximum dose of 375mg daily for depression. The maximum
dose for social anxiety disorder is 225mg/day.
Take Axyven 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 should be taken with food.
If you have liver or kidney problems, talk to your doctor, since
your dose of Axyven may need to be different.

Do not stop taking Axyven without talking to your doctor (see the
section “If you stop taking Axyven”).

If you take more Axyven than you should

Call your doctor or pharmacist immediately if you take more than
the amount of Axyven prescribed by your doctor.
The symptoms of a possible overdose may include a rapid
heartbeat, changes in level of alertness (ranging from sleepiness
to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Axyven

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 that has been prescribed for you in one day.

If you stop taking Axyven

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, 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,
especially when Axyven 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 Axyven 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 can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Axyven. 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. 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
heartbeat, 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 heartbeat,
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,
if you stop taking Axyven”)
Prolonged bleeding – if you cut or injure yourself, it may
take slightly longer than usual for bleeding to stop

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 heartbeat; 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)
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
heartbeat, 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

Complete side effect listing
Very common (may affect more than 1 in 10
people)
Dizziness; headache
Nausea; dry mouth
Sweating (including night sweats)

Page 2 of 2

Axyven sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal
heartbeat; slight changes in blood levels or liver enzymes, sodium
or cholesterol. More rarely, Axyven 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 for a
long time.

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
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
Keep out of the sight and reach of children.
Do not use Axyven 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.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if your
doctor tells you to.
If your tablets appear to be discoloured or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
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 contains

The active substance is venlafaxine.
Each prolonged-release tablet contains 37.5mg venlafaxine
(as hydrochloride).
The other ingredients are:
Core: mannitol (E421), povidone K90, macrogol 400,
microcrystalline cellulose, colloidal anhydrous silica and
magnesium stearate.
Coat: cellulose acetate (320SNF), cellulose acetate (398-10NF),
macrogol 400 and Opadry White Y-30-18037 (hypromellose,
lactose monohydrate, titanium dioxide (E171) and triacetin).

What Axyven looks like and contents of the pack

Axyven are white, round, biconvex, prolonged-release tablets.
Axyven is available in blisters of 28 tablets.

Manufacturer

Manufactured by: Laboratorios LICONSA S.A.,
Avda. Miralcampo no 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0600

POM

Leaflet revision and issue date: 12.02.14

Expand view ⇕

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.

Hide
(web3)