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VANLALUPEN XL 150MG PROLONGED RELEASE CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VANLALUPEN XL
37.5 mg, 75 mg AND 150 mg
PROLONGED RELEASE CAPSULES
Venlafaxine Hydrochloride
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, 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 symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed on this
leaflet, please tell your doctor or pharmacist.
In This Leaflet:
1 What Vanlalupen XL is and what it is used for.
2 Before you take Vanlalupen XL.
3 How to take Vanlalupen XL.
4 Possible side effects.
5 How to store Vanlalupen XL.
6 Further information.
1. WHAT VANLALUPEN XL IS AND WHAT IT IS USED FOR
Vanlalupen 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 (a chemical that can affect your mood) and noradrenaline in
the brain. While it is not fully understood how antidepressants work, Vanlalupen
XL may help to relieve the symptoms of depression by increasing the levels of
serotonin and noradrenaline in the brain.
This medicine is a treatment
• For adults with depression.
• 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. BEFORE YOU TAKE VANLALUPEN XL
Do not take Vanlalupen XL
• If you are allergic (hypersensitive) to venlafaxine or any of the other ingredients
of Vanlalupen XL (see 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 other medicines, including Vanlalupen XL can cause serious or
even life-threatening side effects. Also, you must wait at least 7 days after you
stop taking Vanlalupen XL before you take any MAOI (see also the sections
entitled “Taking other medicines” and the information in that section about
“Serotonin syndrome”).
Take special care with Vanlalupen XL
If any of the following apply to you, please tell your doctor before taking this
medicine:
• If you use other medicines that taken together with Vanlalupen XL could
increase the risk of developing serotonin syndrome (see the section “Taking
other medicines”).
• 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 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.
Vanlalupen 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 anxiety disorder
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.
Contact your doctor or go to a hospital straight away if you have thoughts of
harming or killing yourself at any time.
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 Vanlalupen XL. Therefore, the
dosage of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Vanlalupen XL should normally not be used by children and adolescents under
18 years of age. 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 this
medicine 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 Vanlalupen XL. Also,
the long-term safety effects concerning growth, maturation and cognitive and
behavioural development of this medicine in this age group has not yet been
demonstrated.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Your doctor should decide whether you can take Vanlalupen 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 Vanlalupen XL. Tell your doctor if you have
taken these medicines within the last 14 days. (MAOIs: see the section “Before
you take Vanlalupen XL”).
• Serotonin syndrome:
A potentially life-threatening condition or Neuroleptic Malignant Syndrome
(NMS)-like reactions (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)
• Other 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)
• 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 Vanlalupen 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 (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Taking Vanlalupen XLwith food and drink
Vanlalupen XL should be taken with food (see section 3 “HOW TO TAKE
VANLALUPEN XL”).
Do not drink alcohol while you are taking Vanlalupen XL.
Pregnancy and lactation
Tell your doctor if you become pregnant, or you are trying to become pregnant.
You should use Vanlalupen XL only after discussing the potential benefits and the
potential risks to your unborn child with your doctor.
When taken during pregnancy, this medicine may increase the risk of a serious
condition in babies, called persistent pulmonary hypertension of the newborn
(PPHN). This makes 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 contact your doctor immediately.
If you are taking this medicine during pregnancy, other symptoms your baby
might have when it is born is not feeding properly, in addition to having trouble
breathing. If your baby has these symptoms when it is born and you are concerned,
contact your doctor who will be able to advise you.
Vanlalupen XL passes into breast milk. There is a risk of an effect on the baby. Ask
your doctor for advice. He/she will decide whether you should stop breast-feeding
or stop the therapy with Vanlalupen XL.
Driving and using machines
This medicine may impair judgement, thinking and motor skills.
Do not drive or use any tools or machines until you know how Vanlalupen XL
affects you.
3. HOW TO TAKE VANLALUPEN XL
Always take Vanlalupen XL 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 Vanlalupen XL at approximately the same time each day, either in the
morning or in the evening. Capsules must be swallowed whole with fluid and not
opened, crushed, chewed or dissolved.
Vanlalupen XL should be taken with food.
If you suffer from liver or kidney problems, talk to your doctor. He may reduce
your dose.
Do not stop taking this medicine without talking to your doctor (see the section
“If you stop taking Vanlalupen XL”).
If you take more Vanlalupen XL than you should
Contact your doctor or pharmacist immediately if you take more of this medicine
than the amount 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 Vanlalupen 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 Vanlalupen XL that has been prescribed
for you in one day.
If you stop taking Vanlalupen 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
Vanlalupen XL, he/she may ask you to reduce your dose slowly before stopping
treatment altogether. When you stop taking this medicine, side effects may
occur especially when it is stopped suddenly or the dose is reduced too quickly.
Some patients may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite,
nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling
or rarely electric shock sensations, weakness, sweating, seizures, or flu-like
symptoms.
Your doctor will advise you on how you should gradually discontinue Vanlalupen
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, Vanlalupen XL can cause side effects, although not everybody
gets them.
Tell your doctor immediately, or go to the casualty department at your nearest
hospital if you have any of the following symptoms:
• 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 possible 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 VANLALUPEN XL, if you
stop taking Vanlalupen XL”).
Do not be concerned if you see small white balls or granules in your stools
after taking this medicine. Inside Vanlalupen XL capsules are spheroids (small
white balls) that contain the active ingredient (venlafaxine). These spheroids
are released from the capsule into your stomach. As they travel through your
stomach and intestines, venlafaxine is slowly released. The spheroid “shell”
does not dissolve and is passed out in your stools. So, even though you may
see spheroids in your stools, your dose of medicine has been absorbed.
Complete side effect listing
If any of the following symptoms are severe or become troublesome, you should
tell your doctor or pharmacist.
Very common (affects more than 1 in 10 users)
• Headache; dry mouth; sweating (including night sweats)
• Nausea
Common (affects 1 to 10 users in 100)
• Weight loss; appetite decreased; constipation; vomiting; increased cholesterol

• Feeling separated (or detached) from yourself and reality; nervousness;
confusion; abnormal dreams; insomnia
• Tremor; increased muscle tonus
• Pins and needles
• Increase in blood pressure; flushing; palpitations
• Increased frequency in urination; difficulties passing urine
• Decreased libido; abnormal ejaculation/orgasm (males); lack of orgasm;
erectile dysfunction (impotence)
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding
• Weakness (asthenia); dizziness; sedation; chills
• Blurred vision
• Yawning
Uncommon (affects 1 to 10 users in 1,000)
• Bruising; black tarry stools (faeces) or blood in stools, which can be a sign of
internal bleeding
• Grinding of the teeth; involuntary movement of the muscles
• Hallucinations
• 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; abnormal hair loss; rash
• Impaired coordination and balance; feeling dizzy (particularly when standing up
too quickly), fainting, fast heartbeat
• Weight gain; diarrhoea
• Altered taste sensation
• Lack of feeling or emotion; agitation
• Ringing in the ears (tinnitus)
• Inability to pass urine;
• Abnormal orgasm (females)
Rare (affects 1 to 10 users in 10,000)
• A sensation of restlessness or an inability to sit or stand still; seizures or fits;
feeling over-excited or euphoric.
• Inability to control urination
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; slight changes in blood levels of liver enzymes; decrease in blood
sodium levels
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis)
• Excessive water intake (known as SIADH)
• Abnormal breast milk production
• 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
• Disorientation and confusion often accompanied by hallucination (delirium)
• Stiffness, spasms and involuntary movements of the muscles
• Thoughts of harming or killing yourself
• Severe eye pain and decreased or blurred vision
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which
could lead to fainting
• 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)
• Skin rash, which may lead to severe blistering and peeling of the skin; itching;
mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Swollen face or tongue, shortness of breath or difficulty breathing, often with
skin rashes (this may be a serious allergic reaction)
• Confusion
• Vertigo
• Aggression
Vanlalupen 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, Vanlalupen
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 Vanlalupen XL for a long time.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE VANLALUPEN XL
Keep out of the reach and sight of children.
Do not use Vanlalupen XL after the expiry date, which is stated on the carton. The
expiry date refers to the last date of that month.
Store below 25°C.
If your doctor decides to stop treatment, return any leftover capsules to your
pharmacist. Only keep them if your doctor tells you to.
REMEMBER this medicine is only for you. Only a doctor can prescribe it for you.
Never give it to others. It may harm them even if their symptoms are the same
as yours.
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. FURTHER INFORMATION
What Vanlalupen XL contains
The active substance is Venlafaxine Hydrochloride
The other ingredients are:
Povidone, calcium hydrogen phosphate dihydrate, magnesium stearate (E470b),
ethylcellulose, hypromellose, gelatin, red iron oxide (E172), yellow iron oxide
(E172) and black iron oxide (E172), Titanium dioxide (E171) and printing inks.
What Vanlalupen XL look like and the contents of the pack
Hard prolonged-release capsules
Vanlalupen XL is available in three strengths.
- 37.5 mg are size 3, light grey coloured cap and flesh coloured body, imprinted
with ‘VENLA’ in red ink on cap and ‘37.5 mg’ in red ink on body, containing four
white to off white tablets, which contain venlafaxine 37.5 mg.
- 75 mg are size 1, flesh coloured cap and flesh coloured body, imprinted with
‘VENLA’ in red ink on cap and ‘75 mg’ in red ink on body, containing eight white
to off white tablets which contain venlafaxine 75 mg.
- 150  mg are size 0, with brown coloured cap and brown coloured body,
imprinted with ‘VENLA’ in white ink on cap and ‘150 mg’ on body, containing
sixteen white to off white tablets, which contain venlafaxine 150 mg.
Vanlalupen XL is available in the following pack sizes:
37.5 mg: 7, 10, 14, 20, 28, 30, 50, 56, 100 
75 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100
150 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire, WA16 0PF,
United Kingdom
This leaflet was last approved in
Date of preparation: March 2012
Code No. GO/DRUGS/654

ID#: xxxxxx

Expand Transcript

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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