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VENLANEO XL 75 MG PROLONGED RELEASE CAPSULES
Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE
VENLANEO® XL 75 mg & 150 mg Prolonged Release Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If you get any side effects, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
What is in this leaflet:
1. What Venlaneo XL Prolonged Release Capsules are and what they are used for
2. What you need to know before you take Venlaneo XL Prolonged Release Capsules
3. How to take Venlaneo XL Prolonged Release Capsules
4. Possible side effects
5. How to store Venlaneo XL Prolonged Release Capsules
6. Contents of the pack and other information
1. WHAT VENLANEO XL PROLONGED RELEASE CAPSULES ARE AND WHAT
THEYARE USED FOR
Venlaneo XL Prolonged Release Capsules contain the active ingredient venlafaxine
hydrochloride. Venlafaxine hydrochloride 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.
Venlaneo XL Prolonged Release Capsules are used to treat adults with depression.
Venlaneo XL Prolonged Release Capsules are 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 VENLANEO XL PROLONGED
Do not take Venlaneo XL Prolonged Release Capsules if:
• You are allergic (hypersensitive) to venlafaxine hydrochloride, or to any of the other
ingredients of Venlaneo XL Prolonged Release Capsules.
• 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 Venlaneo XL
Prolonged Release Capsules, can cause serious or even life-threatening side effects. Also,
you must wait at least 7 days after you stop taking Venlaneo XL Prolonged Release
Capsules before you take any MAOI (see also the sections “Serotonin syndrome” and
“Taking other medicines”).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Venlaneo XL Prolonged Release Capsules.
Take special care with Venlaneo XL Prolonged Release Capsules
• If you use other medicines that taken concomitantly with Venlaneo XL Prolonged Release
Capsules could increase the risk of developing serotonin syndrome (see the section “Taking
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the
• If you have a history of high blood pressure.
• If you have a history of heart problems.
. If you have been told you have an abnormal heart rhythm.• If you have a history of fits
• 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.
• If you have been told by your doctor that you have intolerance to some sugars (e.g.
Venlaneo XL Prolonged Release Capsules may cause a sensation of restlessness or an
inability to sit or stand still. 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
Venlaneo XL Prolonged Release Capsules.
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
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
Dry mouth is reported in 10% of patients treated withVenlaeno XL. This may increase the risk
of tooth decay (caries). Therefore, you should take special care in your dental hygiene.
Your blood glucose levels may be altered due to Venlaneo XL. Therefore, the dosage of
your diabetes Medicines may need to be adjusted.
Children and Adolescents
Venlaneo XL Prolonged Release Capsules 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 Venlaneo XL Prolonged Release
Capsules 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 Venlaneo XL Prolonged
Release Capsules. 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
Other medicines and Venlaneo XL Prolonged Release Capsules
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 Venlaneo XL Prolonged Release Capsules
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
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease
must not be taken with Venlaneo XL. Tell your doctor if you have taken these medicines
within the last 14 days. (MAOIs: see the section “Before you take Venlaneo XL Prolonged
• Serotonin syndrome:
Serotonin syndrome- a potentially life threatening condition or Neuroleptic Malignant
Syndrome (NMS)-like reaction (see the section “Possible Side Effects”), may occur with
venlafaxine treatment, particularly when taken with other medicines. Examples of these
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRIs, SSRIs, tricyclics, or medicines
• 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, fentanyl, tapentadol, pethidine, or pentazocine (used to
treat severe pain)
. Medicines containing dextromethorphan (used to treat coughing)
. Medicines containing methadone (used to treat opioid drug addiction or severe pain)
. Medicines containing methylene blue (used to treat high levels of methaemoglobin in the
• 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) or other dopamine antagonists.
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,
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
Tell your doctor immediately, or go to the casualty department at your nearest
hospital if you think serotonin syndrome is happening to you.
You must tell your doctor if you are taking medicines that can affect your heart rhythm.
Examples of these medicines include:
. Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal
. Antipsychotics such as thioridazine (See also Serotonin syndrome above)
. Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
. Antihistamines (used to treat allergy)
The following medicines may also interact with Venlaneo XL Prolonged Release Capsules
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)
Venlaneo XL Prolonged Release Capsules with food and drink
Venlaneo XL Prolonged Release Capsules should be taken with food (see section 3 “HOW
TO TAKE VENLANEO XL PROLONGED RELEASE CAPSULES”).
You should avoid alcohol while you are taking Venlaneo XL Prolonged Release Capsules.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. You should take
Venlaneo XL Prolonged Release Capsules only after discussing the potential benefits and
the potential risks to your unborn child with your doctor.
If you are taking Venlaneo XL Prolonged Release Capsules 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
not feeding properly and trouble with breathing. 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
Make sure your midwife and/or doctor know you are on Venlaneo XL Prolonged Release
Capsules. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a
serious condition in babies, called persistent pulmonary hypertension of the new born
(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.
Venlafaxine hydrochloride passes into breast milk. There is a risk of an effect on the baby.
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 Venlaneo XL Prolonged Release
Driving and using machines
Do not drive or use any tools or machines until you know how Venlaneo XL Prolonged
Release Capsules affects you.
Important information about some of the ingredients of Venlaneo XL Prolonged
Some of the colorants in Venlaneo XL Prolonged Release Capsules may cause allergic
reactions. 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 VENLANEO XL PROLONGED RELEASE CAPSULES
The recommended Dose:
Always take Venlaneo XL Prolonged Release Capsules exactly as your doctor or pharmacist
has told you. You should check with your doctor or pharmacist if you are not sure.
Take Venlaneo XL Prolonged Release Capsules 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. Venlaneo XL Prolonged Release Capsules should
be taken with food.
The usual adult doses for different conditions are as follows:
The usual recommended starting dose for treatment of depression 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 per day.
Generalised Anxiety Disorder and Social Disorder:
The usual recommended starting dose for treatment of generalised anxiety disorder
and social anxiety disorder is 75mg per day. The maximum dose is 225mg per day.
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 is 225mg per
If you have liver or kidney problems, talk to your doctor, since your dose of Venlaneo XL
Prolonged Release Capsules may need to be different.
Do not stop taking Venlaneo XL Prolonged Release Capsules without talking to your doctor
(see the section “If you stop taking Venlaneo XL Prolonged Release Capsules”).
If you take more Venlaneo XL Prolonged Release Capsules than you should:
Call your doctor or pharmacist immediately if you take more Venlaneo XL Prolonged
Release Capsules than 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 Venlaneo XL Prolonged Release Capsules:
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 a double dose
to make up for a forgotten dose. Do not take more than the daily amount of Venlaneo XL
Prolonged Release Capsules that have been prescribed for you in one day.
If you stop taking Venlaneo XL Prolonged Release Capsules:
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 to take Venlaneo XL
Prolonged Release Capsules, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people stop taking
Venlaneo XL Prolonged Release Capsules, especially when treatment is stopped suddenly
or the dose is reduced too quickly. Some patients may experience symptoms such as
tiredness, dizziness, light-headedness, 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
Your doctor will advise you on how you should gradually discontinue treatment with
Venlaneo XL Prolonged Release Capsules. 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, Venlaneo XL Prolonged Release Capsules can cause side effects,
although not everybody gets them.
Do not be concerned if you see small white granules or balls in your stools after taking
Venlaneo XL Prolonged Release Capsules. Inside Venlaneo XL Prolonged Release
Capsules are spheroids or small white balls that contain the venlafaxine active ingredient.
These spheroids are released from the capsule into your gastrointestinal tract. As the
spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. The
spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even
though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.
Serious side effects
If you notice any signs of the following, you may need urgent medical attention:
. 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
• 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 usually overexcited)
• Treatment withdrawal (see the section “HOW TO TAKE VENLANEO XL PROLONGED
RELEASE CAPSULES, if you stop taking Venlaneo XL Prolonged Release Capsules”).
. Prolonged bleeding- if you cut or injure yourself, it may take slightly longer than usual for
bleeding to stop.
If any of the following happen, do not take more Venlaneo XL Prolonged Release Capsules.
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
The frequency (likelihood of occurring) of side effects is classified as follows:
Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
Frequency cannot be estimated from the available data
. Dizziness, Headache
. Nausea, Dry mouth
. Sweating (including night sweats)
. 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, sedation
. 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)
. Blood pressure increase, flushing (mostly hot flashes)
. 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
. 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)
. Shortness of breath
. Vomiting blood, black tarry stools (faeces) or blood in stools which can be a sign of internal
. 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
. Seizures or fits
. Inability to control urination
. Over activity, racing thoughts and decreased need for sleep (mania)
Frequency not known
. Reduced number of platelets in your blood, leading to an increased risk of bruising or
bleeding, blood disorder which may lead to an increased risk of infection
. Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes
. 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 Venlafaxine XL prolonged release capsules)
. 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
. 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
. Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or
. 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
Venlaneo XL Prolonged Release Capsules 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 of liver enzymes, sodium or cholesterol. More rarely, Venlaneo XL
Prolonged Release Capsules 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 Venlaneo XL Prolonged Release Capsules
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 VANLANEO XL PROLONGED RELEASE CAPSULES
Keep your capsules in the pack in which they are supplied to protect them from moisture.
Store the pack below 30ºC. Do not use them after the expiry date which is shown on the
pack after EXP. The expiry date refers to the last day of that month.
Keep all medicines out of the reach and sight of children.
Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Venlaneo XL Prolonged Release Capsules contain:
The active ingredient in Venlaneo XL Prolonged Release Capsules is venlafaxine
The inactive ingredients are: sucrose, maize starch, hydroxypropyl cellulose,
hydroxypropylmethyl cellulose, talc, ethyl cellulose, dibutyl sebacate, oleic acid, colloidal
anhydrous silica, sodium lauryl sulphate and gelatin (capsule shell only). Colouring agents
included in the 75 mg capsule shells are sunset yellow (E110), quinoline yellow and
titanium dioxide. Colouring agents included in the
150 mg shells are sunset yellow, quinoline yellow, patent blue (E131) and titanium dioxide.
What Venlaneo XL Prolonged Release Capsules look like and contents of the pack:
Venlaneo XL Prolonged Release Capsules come in three strengths. Venlaneo XL 75 mg
Capsules are yellow/clear capsules. Venlaneo XL 150 mg Capsules are buff/clear capsules.
All three strengths of capsules are filled with white to off-white pellets. Your medicine is
available in blister packs containing 14 or 28 capsules. Not all pack sizes may be marketed
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, NN8 6GT, UK
Manufacturer responsible for batch release: Fannin (UK) Limited,
57 High Street, Odiham, Hampshire, RG29 1LF.
Product licence number: PL 20417/0085 or PL 20417/0087
This leaflet was last approved in February 2016.
Source: Medicines and Healthcare Products Regulatory Agency