VENLALIC XL 225MG PROLONGED RELEASE TABLETS

Active substance: VENLAFAXINE HYDROCHLORIDE

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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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

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• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Store in the original package.
• Protect from moisture
• Do not take use medicine after the expiry date shown on the carton and



blister label. If your doctor tells you to stop taking this medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep
this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6

Venlalic ® XL 225mg Prolonged Release Tablets

How to store Venlalic XL

Contents of the pack and other information

Your medicine
The active substance is venlafaxine. Each prolonged-release tablet contains
225mg venlafaxine (as hydrochloride).
The other ingredients are Core: mannitol (E421), povidone K-90,
macrogol 400, cellulose microcrystalline, colloidal anhydrous silica,
magnesium stearate.
Coat: cellulose acetate, opradry Y 30 18037 (mixture of hypromellose,
lactose mononohydrate, titanium dioxide (E172), triacetin).
What is in your medicine
Each tablet is round, biconvex and white.
Avaliable in blister pack of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratorios LICONSA, S.A, Avda,
Miralcampo, N°7, Poligono Industrial Miralcampo 19200 Azuqueca de
Henares (Guadalajara), Spain and is procured from within the EU. Product
Licence Holder LTT Pharma Limited, B98 0RE and repackaged by Lexon
(UK) Limited Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM PL Number:

33723/0188

Venlalic XL is a registered trademark of Dallas Burston Ashbourne
Holdings Limited.
Leaflet revision date: 19/03/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:LTT0188/190313/1/F

(venlafaxine hydrochloride)

Patient Information 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.
Your medicine is called Venlalic XL 225mg Prolonged Release Tablets and
will be referred to as Venlalic XL throughout the rest of this leaflet. Please
note that the leaflet also contains information about other strengths of the
medicine, Venlalic XL 37.5mg Prolonged Release tablets, Venlalic XL 75mg
Prolonged Release Tablets and Venlalic XL 150mg Prolonged Release
Tablets.
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

• 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.

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 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 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.

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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
Venlalic XL 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.

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 should be taken with food.

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

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.

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.

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.

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

Driving and using machines
Do not drive or use any tools or machines until you know how Venlalic XL
affects you.

Like all medicines, Venlalic XL can cause side effects, although not
everybody gets them.

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.

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.

3

How to take Venlalic XL

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).

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you.

The usual recommended starting dose for treatment of depression and social
anxiety disorder is 75 mg per day. The dose can be raised by your doctor
gradually, and if needed, even up to a maximum dose of 375 mg daily for
depression. The maximum dose for social anxiety disorder is 225 mg/day.

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If you have liver or kidney problems, talk to your doctor, since your dose of
Venlalic XL may need to be different.

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.

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 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

Ref:LTT0188/190313/1/B

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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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