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VANLALIC XL 150MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE

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Assessed against the UK PIL dated October 2014
PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlalic® XL 150mg prolonged-release tablets
(venlafaxine hydrochloride)

Your medicine is available using the name Venlalic XL 150mg
prolonged-release tablets but will be referred to as Venlalic XL
throughout this leaflet. Other strengths 37.5mg, 75mg and
225mg are also available.

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. 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 “Other
medicines and Venlalic XL” 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 “Other medicines
and Venlalic XL”).

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.
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.

Mock‐Up 
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 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 “What you need to know 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
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

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.
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By hussainal at 3:10 pm, Jul 26, 2016

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, irritability 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, generalised anxiety disorder 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. If you are being treated for
panic disorder, your doctor will start with a lower dose
(37.5mg) and then increase the dose gradually. The
maximum dose for generalised anxiety disorder, social
anxiety disorder and panic 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
gastro-intestinal 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.

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 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, “What you
need to know 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

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 150mg 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: 21828/0599

POM

Leaflet revision and issue date: 15.07.16
Venlalic® is a registered trademark of Dallas Burston
Ashbourne Holdings Ltd.

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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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