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SIGVEN XL 225MG 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
Venlalic® XL 150 mg prolonged-release tablets
Venlalic® XL 225 mg prolonged-release tablets
(venlafaxine hydrochloride)
This product is available as any of the above names but will be referred to as Venlalic XL
throughout this leaflet. Please note this leaflet also contains information about other
strength (37.5 mg).
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.

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.

What is in this leaflet:

Your doctor should decide whether you can take Venlalic XL with other medicines.

1.
2.
3.
4.
5.
6.

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.

What Venlalic XL is and what it is used for
What you need to know before you take Venlalic XL
How to take Venlalic XL
Possible side effects
How to store Venlalic XL
Contents of the pack and other information

1. What Venlalic XL is and what it is used for
Venlalic XL is an antidepressant that belongs to a group of medicines called serotonin and
norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat
depression and other conditions such as anxiety disorders. It is thought that people who
are depressed and/or anxious have lower levels of serotonin and noradrenaline in the
brain. It is not fully understood how antidepressants work, but they may help by increasing
the levels of serotonin and noradrenaline in the brain.
Venlalic XL is a treatment for adults with depression. Venlalic XL is also a treatment for
adults with the following anxiety disorders: generalised anxiety disorder, social anxiety
disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating
depression or anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious and more difficult
to treat.
2. What you need to know before you take Venlalic XL
Do not take Venlalic XL
 If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in
section 6).
 If you are also taking or have taken any time within the last 14 days any medicines
known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression
or Parkinson’s disease. Taking an irreversible MAOI together with Venlalic XL, can
cause serious or even life-threatening side effects. Also, you must wait at least 7 days
after you stop taking Venlalic XL before you take any MAOI (see also the sections
entitled “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.

 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, irritabilty and abnormal sleep patterns. Symptoms
consistent with venlafaxine drug discontinuation can also occur after stopping breastfeeding. 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.

Dry mouth

Important information about some of the ingredients of Venlalic XL

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.

This medicine contains lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product.

3. How to take Venlalic XL
Always take this medicine exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression generalised anxiety
disorder and social anxiety disorder is 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 heartbeat, changes in level of
alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Venlalic XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next
dose, skip the missed dose and take only a single dose as usual. Do not take more than
the daily amount of Venlalic XL that has been prescribed for you in one day.
If you stop taking Venlalic XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even
if you feel better. If your doctor thinks that you no longer need Venlalic XL, he/she may ask
you to reduce your dose slowly before stopping treatment altogether. Side effects are known
to occur when people stop using Venlalic XL, especially when Venlalic XL is stopped
suddenly or the dose is reduced too quickly. Some patients may experience symptoms such
as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that
everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of
appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or
rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venlalic XL treatment.
If you experience any of these or other symptoms that are troublesome, ask your doctor for
further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Venlalic XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venlalic XL. As the tablet
travels the length of your 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 heartbeat, which could lead to
fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the
appearance of unexpected bruises or broken blood vessels (broken veins)
 Coughing, wheezing, shortness of breath and a high temperature, which are symptoms
of inflammation of the lungs associated with an increase in white blood cells (pulmonary
eosinophilia)
 Severe abdominal or back pains (which could indicate a serious problem in the gut, liver
or pancreas)
 Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of
inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
 Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
 Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
 Abnormal breast milk production
Venlalic XL sometimes causes unwanted effects that you may not be aware of, such as
increases in blood pressure or abnormal 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 possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Venlalic XL
 Keep out of the sight and reach of children.
 Do not use Venlalic XL after the expiry date which is stated on the packaging. The expiry
date refers to the last day of that month.
 Do not store above 30°C. Store in the original package in order to protect from moisture.
 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.
 If your medicine becomes discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Venlalic XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 75, 150 or 225 mg 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, Opadry Y 30 18037 (mixture of hypromellose,
lactose monohydrate, titanium dioxide (E172), triacetin).
What Venlalic XL looks like and contents of the pack
Venlalic XL are round, white, biconvex, prolonged-release tablets with a laser hole on one
side.
Venlalic XL is available in blister pack of 30 tablets.
PL: 15814/1205 Venlalic® XL 75 mg prolonged-release tablets
PL: 15814/1206 Venlalic® XL 150 mg prolonged-release tablets
PL: 15814/1207 Venlalic® XL 225 mg prolonged-release tablets

POM

Manufactured by Laboratorios Liconsa, S.A., Azuqueca de Henares (Guadalajara), Spain.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 24.06.2016.
Venlalic XL is a registered trademark of Dallas Burston Ashbourne Holdings Ltd.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Package leaflet: Information for the user

SigVen XL 75 mg prolonged-release tablets
SigVen XL 150 mg prolonged-release tablets
SigVen XL 225 mg prolonged-release tablets
(venlafaxine hydrochloride)
This product is available as any of the above names but will be referred to as SigVen XL
throughout this leaflet. Please note this leaflet also contains information about other
strength (37.5 mg).
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.

Diabetes
Your blood glucose levels may be altered due to SigVen XL. Therefore, the dosages of
your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
SigVen 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 SigVen 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 SigVen XL.
Also, the long-term safety effects concerning growth, maturation and cognitive and
behavioural development of SigVen XL in this age group has not yet been demonstrated.
Other medicines and SigVen XL
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines.

What is in this leaflet:

Your doctor should decide whether you can take SigVen XL with other medicines.

1.
2.
3.
4.
5.
6.

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.

What SigVen XL is and what it is used for
What you need to know before you take SigVen XL
How to take SigVen XL
Possible side effects
How to store SigVen XL
Contents of the pack and other information

1. What SigVen XL is and what it is used for
SigVen 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.
SigVen XL is a treatment for adults with depression. SigVen 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 SigVen XL
Do not take SigVen 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 SigVen XL, can cause
serious or even life-threatening side effects. Also, you must wait at least 7 days after you
stop taking SigVen 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 SigVen XL
 If you use other medicines that taken concomitantly with SigVen 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.
SigVen 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 SigVen
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.

 Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease
must not be taken with SigVen XL. Tell your doctor if you have taken these medicines
within the last 14 days. (MAOIs: see the section “Before you take SigVen 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 SigVen 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)

SigVen XL with food, drink and alcohol
SigVen XL should be taken with food (see section 3 “How to take SigVen XL”).
You should avoid alcohol while you are taking SigVen XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should
use SigVen 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 SigVen 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 SigVen 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 breastfeeding. 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 SigVen XL.
Driving and using machines
Do not drive or use any tools or machines until you know how SigVen XL affects you.

Dry mouth

Important information about some of the ingredients of SigVen XL

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.

This medicine contains lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product.

3. How to take SigVen 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 SigVen 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.
SigVen XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of SigVen XL may
need to be different.
Do not stop taking SigVen XL without talking to your doctor (see the section “If you stop
taking SigVen XL”).
If you take more SigVen XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of SigVen XL
prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heartbeat, changes in level of
alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take SigVen 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 SigVen XL that has been prescribed for you in one day.
If you stop taking SigVen 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 SigVen 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 SigVen XL, especially when SigVen 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 SigVen 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, SigVen XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking SigVen 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 SigVen 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 SigVen XL, if you stop taking SigVen 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 SigVen XL)
 Disorientation and confusion often accompanied by hallucination (delirium); aggression
 A high temperature with rigid muscles, confusion or agitation, and sweating, or if you
experience jerky muscle movements which you can’t control, these may be symptoms of
serious conditions known as neuroleptic malignant syndrome; euphoric feelings,
drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness,
spasms and involuntary movements of the muscles
 Severe eye pain and decreased or blurred vision
 Vertigo
 Decrease in blood pressure; abnormal, rapid or irregular heartbeat, which could lead to
fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the
appearance of unexpected bruises or broken blood vessels (broken veins)
 Coughing, wheezing, shortness of breath and a high temperature, which are symptoms
of inflammation of the lungs associated with an increase in white blood cells (pulmonary
eosinophilia)
 Severe abdominal or back pains (which could indicate a serious problem in the gut, liver
or pancreas)
 Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of
inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
 Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
 Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
 Abnormal breast milk production
SigVen 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, SigVen 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 SigVen
XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 SigVen XL
 Keep out of the sight and reach of children.
 Do not use SigVen XL after the expiry date which is stated on the packaging. The expiry
date refers to the last day of that month.
 Do not store above 30°C. Store in the original package in order to protect from moisture.
 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.
 If your medicine becomes discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do.
6. Contents of the pack and other information
What SigVen XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 75, 150 or 225 mg 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, Opadry Y 30 18037 (mixture of hypromellose,
lactose monohydrate, titanium dioxide (E172), triacetin).
What SigVen XL looks like and contents of the pack
SigVen XL are round, white, biconvex, prolonged-release tablets with a laser hole on one
side.
SigVen XL is available in blister pack of 30 tablets.
PL: 15814/1205 SigVen XL 75 mg prolonged-release tablets
PL: 15814/1206 SigVen XL 150 mg prolonged-release tablets
PL: 15814/1207 SigVen XL 225 mg prolonged-release tablets

POM

Manufactured by Laboratorios Liconsa, S.A., Azuqueca de Henares (Guadalajara), Spain.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 24.06.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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