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VENLASOV XL 75 MG PROLONGED-RELEASE CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Package leaflet: Information for the user

Venlasov XL 75 mg and 150 mg
Prolonged-release Capsules
Venlafaxine Hydrochloride
IMPORTANT THINGS YOU SHOULD KNOW ABOUT VENLASOV
XL
Please read all of this leaflet before you start to take your
medicine as it contains important information about Venlasov
XL.




Venlasov XL is used to treat depression, severe and
persistent anxiety known as generalised anxiety disorder
(GAD), social anxiety disorder (also known as social phobia)
and panic disorder (panic attacks)
Venlasov XL is not for use in children and adolescents under
18 years of age – see section 2 ‘Use in children and adolescents
under 18 years of age’

If you have any concerns about how you feel, or about this
medication, it is important that you talk to your doctor - even if
you feel anxious or worried about doing so. You may find it helpful
to tell a friend or relative that you are depressed or suffering from an
anxiety disorder, and that you have been prescribed this medication; it
might be useful to show them this leaflet.


Venlasov XL may not start to work immediately. Some people
taking antidepressants may feel worse before feeling better. Your
doctor may ask to see you again a couple of weeks after starting
your treatment and then regularly until you start to feel well again.
Tell your doctor if you do not start to feel better.



Some people who are depressed may think of harming or
killing themself. If this happens you should see your doctor or
go to a hospital straight away – see in section 2 ‘Thoughts of
suicide and worsening of your depression or anxiety disorder’





If you take too many capsules it is important to seek
immediate medical attention, even if you feel well, because of
the risk of serious side effects
Do not stop taking Venlasov XL or change your dose without
talking to your doctor even if you feel better. If you stop taking
Venlasov XL abruptly you may get withdrawal reactions – see in
section 3 ‘If you stop taking Venlasov XL’



If you have heart problems such as fast or irregular heart rate
or high blood pressure you should talk to your doctor before
taking Venlasov XL – see in section 2 ‘What you need to know
before you take Venlasov XL’



Taking certain other medicines with Venlasov XL may cause
problems. You should tell your doctor if you are taking any
other medicines – see in section 2 ‘What you need to know
before you take Venlasov XL’



See your doctor without delay if you feel restless and feel like
you can’t keep still, feel ‘high’ or very over-excited, have jerky
muscle movements which you can’t control. See section 4 –
‘Possible side effects’ for other important information

If you are pregnant, or intend to become pregnant, or
breast-feeding, you should talk to your doctor – see section 2
‘Pregnancy and breast-feeding’
More information on all of these points is provided in the rest of
this leaflet.
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 any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. 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. See
section 4.
What is in this leaflet
1. What Venlasov XL Capsules are and what they are used for
2. What you need to know before you take Venlasov XL Capsules
3. How to take Venlasov XL Capsules
4. Possible side effects
5. How to store Venlasov XL Capsules
6. Contents of the pack and other information

1. What Venlasov XL Capsules are and what they
are used for
The name of this medicine is Venlasov XL 75 mg Capsules and
Venlasov XL 150 mg Capsules (referred to as Venlasov XL Capsules
throughout this leaflet).
Venlasov XL Capsules contain the active ingredient venlafaxine
hydrochloride, which belongs to a group of medicines called
antidepressants. They are one of a group of medicines called
Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs). It is thought
that people who are depressed may have lower levels of serotonin
and noradrenaline in their brain. Whilst it is not fully understood how
antidepressants work, Venlasov XL Capsules may help by increasing
the levels of serotonin and noradrenaline in the brain.
Venlasov XL Capsules are used to treat adults who are suffering from
the symptoms of depressive illness and anxiety disorders such as
generalised anxiety disorder (GAD), social anxiety disorder (fear and
avoidance of social situations) and panic disorder (panic attacks).
Venlasov XL is a treatment which can relieve these symptoms and
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.
Your doctor may continue to give you Venlasov XL Capsules when
you are feeling better to prevent your symptoms from returning or
prevent you from becoming depressed in the future.

2. What you need to know before you take
Venlasov XL Capsules
Do not take Venlasov XL Capsules
• 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 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 Venlasov XL Capsules, can
cause serious or even life-threatening side effects. Also, you must
wait at least 7 days after you stop taking Venlasov XL Capsules
before you take any MAOI (see also the section entitled ‘Other
medicines and Venlasov XL Capsules’ and the information in that
section about ‘Serotonin Syndrome’).
If any of the above apply to you, tell your doctor or pharmacist
immediately, as Venlasov XL Capsules may not be suitable for you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlasov XL Capsules
• if you use other medicines that taken together with Venlasov XL
Capsules could increase the risk of developing serotonin
syndrome (see the section ‘Other medicines and Venlasov XL
Capsules’).
• 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 been told you have an abnormal heart rhythm.
• 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.
This medicine 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.

GB 724-9576-APIL

You may be more likely to think like this:
• if you have previously had thoughts about killing yourself or
harming yourself.
• if you are a young adult. Information from clinical trials has shown
an increased risk of suicidal behaviour in young adults (less than
25 years old) with psychiatric conditions who were treated with an
antidepressant.
If you have thoughts of harming or killing yourself at any time, contact
your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about changes in your
behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine.
This may increase the risk of dental caries (tooth decay). Therefore,
you should take special care with your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlasov XL
Capsules. Therefore, the dosage of your diabetes medicines may
need to be adjusted.
If any of these apply to you, or if you are not sure, tell your doctor.
Use in children and adolescents under 18 years of age
Venlasov XL 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 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 Venlasov XL
Capsules.
• 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.

3. How to take Venla

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PIP CODE:
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DATE: 12/09//2016
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Other medicines and Venlasov XL Capsules
Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other medicines, including any medicines obtained
without prescription.
Your doctor should decide whether you can take Venlasov XL
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 pharmacist.


Monoamine oxidase inhibitors which are used to treat depression
or Parkinson’s disease must not be taken with Venlasov XL
Capsules. Tell your doctor if you have taken these medicines
within the last 14 days. (MAOIs: see the section ‘what you need to
know before you take Venlasov XL Capsules’).

• 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 SNRIs,
SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat
infections)
• Medicines containing moclobemide, a 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 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.
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 heart rhythm)
• 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 Venlasov XL 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)
Taking Venlasov XL Capsules with food and drink
Food
The capsules should be taken with food.
Alcohol
The combination of Venlasov XL Capsules and alcohol should be
avoided.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before taking
this medicine.
Pregnancy
You should use Venlasov XL Capsules only after discussing the
potential benefits and risks to your unborn child with your doctor.
Make sure your midwife and/or doctor know you are on Venlasov XL
Capsules. 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 this medicine during pregnancy, in addition to having
trouble breathing, another symptom your baby might have when it is
born is 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.
Breast-feeding
Venlafaxine 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 this medicine.
Driving and using machines
Do not drive or operate any tools or machines until you know how this
medicine affects you.
Venlasov XL Capsules contain Allura Red (E129) and Sunset
Yellow (E110)
Venlasov XL 150 mg Capsules contain the colours allura red (E129)
and sunset yellow (E110) which may cause allergic reactions.

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PAGE 1 OF 2

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3. How to take Venlasov XL Capsules



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






Recommended dose
The usual recommended starting dose for the treatment of
depression, generalised anxiety disorder and social anxiety disorder
is 75 mg taken once daily. 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.
You should swallow each capsule whole with a drink of water at
approximately the same time each day, either in the morning or in the
evening. Do not break open, crush or chew the capsules, or put them
in water before swallowing.
Venlasov XL Capsules should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your
dose of this medicine may need to be different.
Do not stop taking this medicine without talking to your doctor (see
the section ‘If you stop taking Venlasov XL Capsules’).
Use in children
Venlasov XL Capsules are not recommended for use in children and
adolescents (under the age of 18). See also section 2.
If you take more Venlasov XL Capsules than you should
If you realise you have taken more Venlasov XL Capsules than your
doctor has recommended (or if someone else has taken some of your
Venlasov XL Capsules), contact your doctor right away. If you cannot
reach your doctor, go to the nearest hospital and take the pack with
you.
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 Venlasov XL Capsules
If you forget to take a dose, take it as soon as you remember unless it
is nearly time for your next dose. Do not take a double dose to make
up for the forgotten dose.
Do not take more than the daily amount of Venlasov XL Capsules that
has been prescribed for you in one day.
If you stop taking Venlasov XL Capsules
Do not discontinue the treatment or reduce the dose without
consulting your doctor, even if you feel better.
If your doctor thinks that you no longer need Venlasov XL Capsules,
he/she may ask you to reduce your dose slowly before stopping
treatment altogether. Side effects are known to occur when people
stop using this medicine, especially when it 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, tinnitus (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
Venlasov XL Capsules 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 medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine may cause side effects, although not
everybody gets them.
Serious side effects
If any of the following happen, do not take more Venlasov XL
Capsules. Tell your doctor immediately, or go to the casualty
department at your nearest hospital:
Uncommon (may affect up to 1 in 100 people)
• Swelling of the face, mouth, tongue, throat, hands, or feet and/or a
raised itchy rash (hives), trouble swallowing or breathing
Rare (may affect up to 1 in 1,000 people)
• Chest tightness, wheezing, trouble swallowing or breathing
• Severe skin 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).
• Signs of infection, such as high temperature, chills, shivering,
headaches, sweating, flu-like symptoms. This may be the result of
a blood disorder which leads to an increased risk of infection.
• Severe rash, which may lead to severe blistering and peeling of
the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a
sign of rhabdomyolysis.
Other side effects that you should tell your doctor about include
(the frequency of these side effects are included in the list ‘Other side
effects that may occur’ below):
• Coughing, wheezing and shortness of breath which may be
accompanied by 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 (muscle spasms or stiffness), seizures or fits
• Psychiatric problems, such as hyperactivity and feeling unusually
overexcited
• Withdrawal effects (see the section ‘How to take Venlasov XL
Capsules, If you stop taking Venlasov XL Capsules’).
• Prolonged bleeding - if you cut or injure yourself, it may take
slightly longer than usual for bleeding to stop.

Vomiting blood, black tarry stools (faeces) or blood in stools; which
can be a sign of internal bleeding
Sensitivity to sunlight; bruising; abnormal hair loss
Inability to control urination
Stiffness, spasms and involuntary movements of the muscles
Slight changes in blood levels of liver enzymes

Rare: may affect up to 1 in 1,000 people
• Seizures or fits
• Coughing, wheezing and shortness of breath which may be
accompanied by a high temperature
• Disorientation and confusion often accompanied by hallucination
(delirium)
• Excessive water intake (known as SAIDH)
• Decrease in blood sodium levels
• Severe eye pain and decreased or blurred vision
• Abnormal, rapid or irregular heartbeat, which could lead to fainting
• 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)
Very rare: may affect up to 1 in 10,000 people
• Prolonged bleeding, which may be a sign of reduced number of
platelets in your blood, leading to an increased risk of bruising or
bleeding
• Abnormal breast milk production
• Unexpected bleeding, e.g. bleeding gums, blood in the urine or
vomit, or the appearance of unexpected bruises or broken blood
vessels (broken veins)
Frequency not known: (cannot be estimated from the available
data)
• 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, ‘What you need to know before you take Venlasov XL
Capsules’)
• Aggression
• Vertigo

12/09/2016
63214
15/09/2016

PRODUCT NAME: Venlasov XL 75 mg

and 150 mg
Prolonged-release
Capsules
PIP CODE:
GB 724-9576-APIL
COMPONENT: Leaflet
SIZE:
200x600 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE: 100%
COLOURS: Black

Cutter
DATE: 12/09//2016
FONT SIZE:
8 pt
VERSION NO:
3
AMENDED BY:
VK
PROJECT:
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.

Venlasov XL Capsules sometimes cause 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, Venlasov XL 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 Venlasov
XL Capsules for a long time.

Accept Artwork .................................................................

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

Date ...................................................................................

By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to Store Venlasov XL Capsules
Do not store above 25°C. Store in the original package in order to
protect from moisture.
Keep out of the sight and reach of children
Do not use Venlasov XL Capsules after the expiry date which is
stated on the carton after EXP. The expiry date refers to the last day
of that month.
Do not use Venlasov XL Capsules if you notice that the capsules are
sticky or show any other visible signs of deterioration.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Venlasov XL Capsules contain
The active substance is venlafaxine hydrochloride equivalent to
75 mg or 150 mg venlafaxine. Other ingredients are:
microcrystalline cellulose, copovidone, ethylcellulose, magnesium
stearate, povidone, silica- colloidal anhydrous, talc.
The capsule shell for 75mg capsules contains gelatin, titanium dioxide
(E171), black iron oxide (E172), red iron oxide (E172). The printing
ink contains the following: shellac, propylene glycol, dehydrated
alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, red
iron oxide (E172).
The capsule shell for 150mg capsules contains gelatin, titanium
dioxide (E171), brilliant blue FCF (E 133), allura red (E129), sunset
yellow FCF (E110). The printing ink contains the following: shellac,
propylene glycol, dehydrated alcohol, isopropyl alcohol, butyl alcohol,
sodium hydroxide, povidone, titanium dioxide (E171).
What Venlasov XL Capsules look like and contents of the pack
The 75 mg capsules are opaque, peach coloured, prolonged-release
hard capsules having red coloured, thick and thin radial circular bands
on both ends of the capsules.
The 150 mg capsules are opaque, dark orange hard gelatin capsules
having white coloured, thick and thin radial circular bands on both
ends of the capsules.
Venlasov XL 75mg and 150mg Capsules are available in blister packs
of 7, 14, 28 or 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical,
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
Manufacturer
Waymade Plc,
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
The leaflet was last revised in October 2016

Do not be concerned if you see small white balls or granules in
your stools after taking this medicine. Inside Venlasov 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.
Other side effects that may occur
Very common: may affect more than 1 in 10 people
• Dizziness; headache; drowsiness
• Insomnia
• Nausea; dry mouth; constipation
• 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; agitation; nervousness; abnormal
dreams
• Tremor; a sensation of restlessness or an inability to sit or stand
still; pins and needles; altered taste sensation; 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)
• Fast heartbeat; palpitations
• Increase in blood pressure; flushing
• Shortness of breath; yawning
• Vomiting; diarrhoea
• Mild rash; itching
• Increased frequency in urination; inability to pass urine; difficulties
passing urine
• Menstrual irregularities such as increased bleeding or increased
irregular bleeding; abnormal ejaculation/orgasm (males); erectile
dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Weight gain; weight loss
• Increased cholesterol
Uncommon: may affect up to 1 in 100 people
• Over activity, racing thoughts and decreased need for sleep
(mania)
• Hallucinations; feeling separated (or detached) from reality;
abnormal orgasm; lack of feeling or emotion; feeling over-excited;
grinding of the teeth
• Fainting; involuntary movements of the muscles; impaired
coordination and balance
• Feeling dizzy (particularly when standing up too quickly); decrease
in blood pressure

Received Date:
CDL JOB No. :
Required By :

GB 724-9576-APIL

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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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