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VENLECOSSE XL 75 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Package leaflet: Information for the user

Venlalic® XL 75 mg prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this
medicine.
This product is available in other strengths
• 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.
Your medicine is called Venlalic XL 75 mg prolonged-release tablets
but throughout this leaflet will be referred to as Venlalic XL.
What is in this leaflet:
1. What Venlalic XL is and what it is used for
2. What you need to know before you take Venlalic XL
3. How to take Venlalic XL
4. Possible side effects
5. How to store Venlalic XL
6. Contents of the pack and other information
1. What Venlalic XL is and what it is used for
Venlalic XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This
group of medicines is used to treat depression and other conditions
such as anxiety disorders. It is thought that people who are depressed
and/or anxious have lower levels of serotonin and noradrenaline in the
brain. It is not fully understood how antidepressants work, but they
may help by increasing the levels of serotonin and noradrenaline in the
brain.
Venlalic XL is a treatment for adults with depression. Venlalic XL is
also a treatment for adults with the following anxiety disorders:
generalised anxiety disorder, social anxiety disorder (fear or avoidance
of social situations) and panic disorder (panic attacks). Treating
depression or anxiety disorders properly is important to help you get
better. If it is not treated, your condition may not go away and may
become more serious and more difficult to treat.
2. What you need to know before you take Venlalic XL
Do not take Venlalic XL
• If you are allergic to venlafaxine or any of the other ingredients of
this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14
days any medicines known as irreversible monoamine oxidase
inhibitors (MAOIs), used to treat depression or Parkinson’s
disease. Taking an irreversible MAOI together with Venlalic XL,
can cause serious or even life-threatening side effects. Also, you
must wait at least 7 days after you stop taking Venlalic XL before
you take any MAOI (see also the sections entitled “Taking other
medicines” and the information in that section about “Serotonin
syndrome”).
Warnings and precautions
Talk to your doctor before taking Venlalic XL
• If you use other medicines that taken concomitantly with
Venlalic XL could increase the risk of developing serotonin
syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that
reduces your ability to swallow or pass foods by normal bowel
movements.
• If you have eye problems, such as certain kinds of glaucoma
(increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood
(hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed
easily (history of bleeding disorders), or if you are taking other
medicines that may increase the risk of bleeding e.g. warfarin
(used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had,
mania or bipolar disorder (feeling 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.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this
leaflet. You might ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about changes in your
behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This
may increase the risk of caries. Therefore, you should take special
care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlalic XL.
Therefore, the dosages of your diabetes medicines may need to be
adjusted.

Use in children and adolescents under 18 years of age
Venlalic XL should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have an
increased risk of side effects, such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional
behaviour and anger) when they take this class of medicines. Despite
this, your doctor may prescribe this medicine for patients under 18
because he/she decides that this is in their best interests. If your
doctor has prescribed Venlalic XL for a patient under 18, and you want
to discuss this, please go back to your doctor. You should inform your
doctor if any of the symptoms listed above develop or worsen when
patients under 18 are taking Venlalic XL. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Venlalic XL in this age group has not yet been
demonstrated.
Other medicines and Venlalic XL
Tell your doctor or pharmacist if you are taking, have recently taken
any other medicines.
Your doctor should decide whether you can take Venlalic XL with other
medicines.
Do not start or stop taking any medicines, including those bought
without a prescription, natural and herbal remedies, before checking
with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression
or Parkinson’s disease must not be taken with Venlalic XL. Tell
your doctor if you have taken these medicines within the last 14
days. (MAOIs: see the section “Before you take Venlalic XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see
the section “Possible Side Effects”), may occur with venlafaxine
treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs,
tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat
infections)
• Medicines containing moclobemide, a reversible MAOI (used
to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels
of methaemoglobin in the blood)
• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild
depression)
• Products containing tryptophan (used for problems such as
sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there,
mistaken beliefs, unusual suspiciousness, unclear reasoning
and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a
combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include
a combination of fever, fast heart beat, sweating, severe muscle
stiffness, confusion, increased muscle enzymes (determined by a
blood test).
Tell your doctor immediately, or go to the casualty department at
your nearest hospital if you think serotonin syndrome is
happening to you
The following medicines may also interact with Venlalic XL and should
be used with caution. It is especially important to mention to your
doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole
(antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat
HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Venlalic XL with food, drink and alcohol
Venlalic XL should be taken with food (see section 3 “How to take
Venlalic XL”).
You should avoid alcohol while you are taking Venlalic XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Venlalic XL only after discussing the
potential benefits and the potential risks to your unborn child with your
doctor.
Make sure your midwife and/or doctor knows you are on Venlalic XL.
When taken during pregnancy, similar drugs (SSRIs) may increase the
risk of a serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe faster
and appear bluish. These symptoms usually begin during the first 24
hours after the baby is born. If this happens to your baby you should
contact your midwife and/or doctor immediately.
If you are taking Venlalic XL during pregnancy, let your midwife and/or
doctor know, as your baby might have some symptoms when it is born.
These symptoms usually begin during the first 24 hours after the baby
is born. They include irritability, tremor, hypotonia, constant crying,
sleeping difficulties and, not feeding properly. If your baby has these
symptoms when it is born and you are concerned, contact your doctor
and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the
baby, which may cause symptoms such as crying, 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. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Venlalic XL
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per
day. The dose can be raised by your doctor gradually, and if needed,
even up to a maximum dose of 375 mg daily for depression. If you are
being treated for panic disorder, your doctor will start with a lower dose
(37.5 mg) and then increase the dose gradually. The maximum dose
for generalised anxiety disorder, social anxiety disorder and panic
disorder is 225 mg/day.
Take Venlalic XL at approximately the same time each day, either in
the morning or in the evening. Tablets must be swallowed whole with
fluid and not opened, crushed, chewed or dissolved.
Venlalic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your
dose of Venlalic XL may need to be different.
Do not stop taking Venlalic XL without talking to your doctor (see the
section “If you stop taking Venlalic XL”).
If you take more Venlalic XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Venlalic XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma),
blurred vision, seizures or fits, and vomiting.
If you forget to take Venlalic XL
If you miss a dose, take it as soon as you remember. However, if it is
time for your next dose, skip the missed dose and take only a single
dose as usual. Do not take more than the daily amount of Venlalic XL
that has been prescribed for you in one day.
If you stop taking Venlalic XL
Do not stop taking your treatment or reduce the dose without the
advice of your doctor even if you feel better. If your doctor thinks that
you no longer need Venlalic XL, he/she may ask you to reduce your
dose slowly before stopping treatment altogether. Side effects are
known to occur when people stop using Venlalic XL, especially when
Venlalic XL is stopped suddenly or the dose is reduced too quickly.
Some patients may experience symptoms such as tiredness,
dizziness, light-headedness, headache, sleeplessness, sensation that
everything around you is spinning or moving (vertigo), nightmares, dry
mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation,
confusion, ringing in the ears, tingling or rarely electric shock
sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue
Venlalic XL treatment. If you experience any of these or other
symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Venlalic XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venlalic
XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine
is slowly released. The shape of the tablet remains undissolved and is
eliminated in your stools. Therefore, even though you may see a tablet in
your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venlalic XL. Tell your
doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations,
sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin
that often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include
a combination of fever, fast heart beat, sweating, severe muscle
stiffness, confusion, increased muscle enzymes (determined by a
blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be
symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased
blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Venlalic XL, if you
stop taking Venlalic XL”).
• Prolonged bleeding - if you cut or injure yourself, it may take
slightly longer than usual for bleeding to stop.
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of
orgasm; decreased libido; nervousness; insomnia; abnormal
dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of
the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased
irregular bleeding; abnormal ejaculation/orgasm (males); erectile
dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol

Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality;
agitation; abnormal orgasm (females); lack of feeling or emotion;
feeling over-excited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still;
fainting; involuntary movements of the muscles; impaired
coordination and balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too
quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which
can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue,
throat area or hands and feet and/or a raised itchy rash (hives)
may be present; sensitivity to sunlight; bruising; rash; abnormal
hair loss
• Inability to pass urine;
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep
(mania)
Not known (frequency cannot be estimated from the available
data)
• Reduced number of platelets in your blood, leading to an
increased risk of bruising or bleeding; blood disorders which may
lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing,
often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal
ideation and suicidal behaviours have been reported during
venlafaxine therapy or early after treatment discontinuation (see
section 2, Before you take Venlalic XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you
can't control, these may be symptoms of serious conditions known
as neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling
of being drunk, sweating or rigid muscles, which are symptoms of
serotonin syndrome; stiffness, spasms and involuntary movements
of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart
beat, which could lead to fainting; unexpected bleeding, e.g.
bleeding gums, blood in the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature,
which are symptoms of inflammation of the lungs associated with
an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms,
which are symptoms of inflammation of the liver (hepatitis); slight
changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the
skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
• Abnormal breast milk production
Venlalic XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat;
slight changes in blood levels or liver enzymes, sodium or cholesterol.
More rarely, Venlalic XL may reduce the function of platelets in your
blood, leading to an increased risk of bruising or bleeding. Therefore,
your doctor may wish to do blood tests occasionally, particularly if you
have been taking Venlalic XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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
Do not store above 30°C.
Store in the original container to protect from moisture
Keep out of the sight and reach of children
Do not use after the expiry date which is stated on the packaging. The
expiry date refers to the last day of the month.
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.
Contents of the pack and other information
What Venlalic XL contains
Each prolonged-release tablet contains 75 mg of the active ingredient
venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol (E421), Povidone K-90, Macrogol 400, Microcrystalline
cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coat: Cellulose acetate, Macrogol 400, hypromellose, lactose
monohydrate, titanium dioxide (E171), triacetin.
What Venlalic XL looks like and contents of the pack
Venlalic XL 75 mg prolonged-release tablets round, white biconvex,
tablets with a laser hole on one side.
Venlalic XL 75 mg prolonged-release tablets are available in pack size
30 tablets.
Manufacturer: Laboratorios LICONSA, S.A.
Avda. Miralcampo, No7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain.
Procured within the EU
Product licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Repackaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride G75 0TD.
POM
PL 19065/0406
This leaflet was revised 09/03/2015
E0406/2/Venlalic
Venlalic® XL is a registered trade mark of DALLAS BURSTON
ASHBOURNE HOLDINGS LIMITED

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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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