VENSIR XL 225MG PROLONGED RELEASE CAPSULES
Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE
75mg, 150mg & 225mg Prolonged-Release Capsules
Read all of this leaflet carefully before you
start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
See section 4.
In this leaflet:
1. What Vensir XL is and what it is used for
2. What you need to know before you use Vensir XL
3. How to use Vensir XL
4. Possible side effects
5. How to store Vensir XL
6. Contents of the pack and other information
1. What Vensir XL is and what it is used for
Vensir XL is an antidepressant and 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, Vensir XL may help to
relieve the symptoms of depression by increasing
the levels of these substances (neurotransmitters)
in the brain.
Vensir XL is used for:
• Major depression
Venlafaxine which is contained in Vensir XL is
also authorised to treat other illnesses, which
are not mentioned in this leaflet. Ask your doctor,
pharmacist or other healthcare professional if
you have further questions and always follow
you need to know before you use
Do not use Vensir XL if:
• You have had any allergic reaction to
venlafaxine or to any of the other ingredients in
• 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 Vensir XL, can cause
serious or even life-threatening side effects.
Also, you must wait at least 7 days after you
stop taking Vensir XL before you take any MAOI
(see also the section entitled “Taking other
medicines” and the information in that section
about ‘Serotonin Syndrome’).
Take special care with Vensir XL if:
If any of the following apply to you, please tell your
doctor before taking Vensir XL if you:
• use other medicines that taken together
with Vensir XL could increase the risk of
developing serotonin syndrome (see the
section “Taking other medicines”)
• have eye problems, such as certain kinds of
glaucoma (increased pressure in the eye)
• have a history of high blood pressure
• have a history of heart problems
• have a history of fits (seizures)
• have a history of low sodium levels in your
• 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)
• have a history of, or if someone in your family
has had, mania or bipolar disorder (feeling
over-excited or euphoric)
• have a history of aggressive behaviour
• have diabetes.
Vensir XL may cause a sensation of restlessness
or an inability to sit or stand still during the first few
weeks of treatment. You should tell your doctor if this
happens to you.
Thoughts of suicide and worsening of your
If you are depressed 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
• 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
You may find it helpful to tell a relative or close
friend that you are depressed, and ask them to
read this leaflet. You might ask them to tell you if
they think your depression is getting worse, or if
they are worried about changes in your behaviour.
Use in children and adolescents under 18 years
Vensir 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 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 Vensir XL.
Also, the long-term safety effects of this medicine
concerning growth, maturation and cognitive and
behavioural development of this medicine in this
age group has not yet been demonstrated.
Dry mouth is reported in 10% of patients treated
with venlafaxine. This may increase the risk of
tooth decay (caries). Therefore, you should take
special care in your dental hygiene.
Using other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Your doctor should decide whether you can take
Vensir XL with other medicines.
Do not start or stop taking any medicines,
including those bought without a prescription,
natural and herbal remedies, before checking with
your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used
to treat depression or Parkinson’s disease must
not be taken with Vensir XL. Tell your doctor if
you have taken these medicines within the last
14 days. (MAOIs: see the section “Before you
take Vensir XL”).
Serotonin syndrome: A potentially life•
threatening condition or Neuroleptic Malignant
Syndrome (NMS)-like reactions (see the
section “Possible Side Effects”), may occur
with venlafaxine treatment, particularly when
taken with other medicines. Examples of these
• 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
• Medicines containing tramadol (a pain-killer)
• Products containing St. John’s Wort
(also called Hypericum perforatum, a natural
or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for
problems such as sleep and depression)
Antipsychotics, such as clozapine (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
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)
such as erythromycin or
moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with
Vensir XL and should be used with caution. It is
especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems).
If you are having Electroconvulsive therapy (ECT),
please inform your doctor.
Taking Vensir XL with food and drink
The capsules should be taken with food.
The combination of Vensir XL and alcohol is not
recommended. Alcohol should be avoided to
prevent the rapid release of drug from the capsule
and to minimize side effects.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you
are trying to become pregnant. You should use
Vensir 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 know you
are on Vensir XL. 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
If you are taking this medicine during pregnancy,
other symptoms your baby might have when
it is born is not feeding properly, in addition to
having trouble breathing. If your baby has these
symptoms when it is born and you are concerned,
contact your doctor and/or midwife who will be
able to advise you.
Vensir XL passes into breast milk. There is a risk of
an effect on the baby. Your baby may experience
irritability, shaking, floppiness, persistent crying and
difficulty in sleeping. 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.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Vensir XL may make you feel drowsy. Be careful
driving or operating dangerous machinery until
you know how it affects you
Important information about some of the
ingredients of Vensir XL
The colour carmoisine (E122) in Vensir XL
225 mg prolonged release capsules may cause
3. How to use Vensir XL
Always take Vensir XL exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The usual starting dose for the treatment of
depression is 75mg taken once daily. If necessary,
after three-four weeks, your doctor may increase
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.
This may damage the film coating of the
mini-tablets inside the capsule, which slow
down release of the drug.
Children and adolescents
The use of Vensir XL in children and
adolescents (under the age of 18) is not
recommended (see also section 2).
Impairment of the liver or kidneys
If you suffer from liver or kidney problems,
the dosage may be reduced by your doctor.
If you take more Vensir XL than you should
If you have taken too much Vensir XL you
should contact your doctor or a hospital.
Symptoms of overdose: 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 Vensir XL
Do not take a double dose to make up for a
If you stop taking Vensir XL
Do not discontinue the treatment without
consulting your doctor.
When one stops taking Vensir XL , withdrawal
reactions may occur e.g. tiredness, dizziness,
light-headedness, headache, sleeplessness,
nightmares, dry mouth, loss of appetite, feeling
or being sick, diarrhoea, nervousness, agitation,
confusion, tinnitus (ringing in the ears), tingling
or rarely electric shock sensations, weakness,
poor co-ordination, tremor, sweating or seizures.
These disorders are mild and temporary.
Vensir XL should not be stopped abruptly.
In order to avoid withdrawal effects, the dose
should be reduced gradually, under the doctor’s
supervision. If you have any further questions
on the use of this product, ask your doctor or
4. Possible side effects
Like all medicines, Vensir XL can cause side
effects, although not everybody gets them.
If any of the following happen, do not take more
Vensir XL. Tell your doctor immediately, or go
to the casualty department at your nearest
• Chest tightness, wheezing, trouble swallowing
• 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
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
• Nerve problems, such as dizziness, pins and
needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity
and euphoria (feeling unusually overexcited).
• Muscle stiffness, weakness or aching and
producing less urine than usual.
• Sudden fever, sore throat, mouth ulcers or
• Withdrawal effects (see the section “HOW TO
TAKE VENSIR XL, if you stop taking Vensir XL”).
Complete side effect listing
Very common (affects more than 1 in 10 users)
• Headache, dry mouth, sweating (including
Common (affects 1 to 10 users in 100)
• Weight loss, appetite decreased, constipation,
vomiting, increased cholesterol
• Feeling separated (or detached) from
yourself and reality, nervousness, confusion,
abnormal dreams, insomnia
• Tremor, increase in muscle tension
• Pins and needles
• Increase in blood pressure, flushing,
• Increased frequency in urination, difficulties
• Decreased libido, abnormal ejaculation/
orgasm (males), lack of orgasm, erectile
• Menstrual irregularities such as increased
bleeding or increased irregular bleeding
• Weakness (asthenia), dizziness, sedation,
• Blurred vision
Uncommon (affects 1 to 10 users in 1,000)
• Bruising, black tarry stools (faeces) or blood
in stools, which can be a sign of internal
• Grinding of the teeth, involuntary movement
of the muscles
• 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
• Sensitivity to sunlight, abnormal hair loss, rash
• Impaired coordination and balance, feeling
dizzy (particularly when standing up too
quickly), fainting, fast heartbeat
• Weight gain, diarrhoea
• Altered taste sensation
• Lack of feeling or emotion, agitation
• Ringing in the ears (tinnitus)
• Inability to pass urine
• Abnormal orgasm (females).
Rare (affects 1 to 10 users in 10,000)
• A sensation of restlessness or an inability to
sit or stand still, seizures or fits, feeling
over-excited or euphoric
• Inability to control urination.
Frequency not known
• Reduced number of platelets in your blood,
leading to an increased risk of bruising
or bleeding, blood disorders which may
lead to an increased risk of infection, slight
changes in blood levels of liver enzymes,
decrease in blood sodium levels
• Itchiness, yellow skin or eyes, dark urine,
or flu-like symptoms, which are symptoms
of inflammation of the liver (hepatitis)
• Excessive water intake leading to low blood
• Abnormal breast milk production
• A high temperature with rigid muscles,
confusion or agitation, and sweating, or if
you experience jerky muscle movements
which you can’t control, these may be
symptoms of serious conditions known as
neuroleptic malignant syndrome
• Euphoric feelings, drowsiness, sustained
rapid eye movement, clumsiness,
restlessness, feeling of being drunk,
sweating or rigid muscles, which are
symptoms of serotonin syndrome
• Disorientation and confusion often
accompanied by hallucination (delirium)
• Stiffness, spasms and involuntary
movements of the muscles
• Thoughts of harming or killing yourself
• Severe eye pain and decreased or blurred
• Decrease in blood pressure, abnormal,
rapid or irregular heartbeat, which could
lead to fainting
• Coughing, wheezing, shortness of breath
and a high temperature, which are
symptoms of inflammation of the lungs
associated with an increase in white blood
cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which
could indicate a serious problem in the gut,
liver or pancreas)
• Skin rash, which may lead to severe
blistering and peeling of the skin, itching,
• Unexplained muscle pain, tenderness or
face or tongue, shortness of breath
or difficulty breathing, often with skin rashes
(this may be a serious allergic reaction)
Vensir 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, Vensir 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 Vensir XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or
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 Vensir XL
Do not store above 25°C.
Store in the original container to protect from
Keep out of the reach and sight of children.
Do not use Vensir XL after the expiry date which
is stated on the carton. The expiry date refers to
the last day of that month.
Do not use Vensir XL if you notice that the
capsules are sticky or other visible signs of
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.
ontents of the pack and other information
What Vensir XL capsules contains
The active substance is venlafaxine hydrochloride
equivalent to 75mg, 150mg or 225mg venlafaxine.
The other ingredients are: microcrystalline
cellulose, copovidone, ethyl cellulose,
magnesium stearate, povidone, colloidal silicon
The capsule shell for 75mg contains gelatine,
titanium dioxide (E171), Black iron oxide (E172),
Red iron oxide (E172).The printing ink contains
the following: shellac, propylene glycol, red iron
The capsule shell for 150mg contains gelatine,
titanium dioxide (E171), Brilliant blue FCF
(E133), Allura red (E129), Sunset yellow FCF
(E110). The printing ink contains the following:
shellac, propylene glycol, sodium hydroxide,
povidone, titanium dioxide (E171)
The capsule shell for 225mg contains gelatin,
carmoisin (E122) and titanium dioxide (E171).
The printing ink contains the following: shellac,
strong ammonia solution (E527), propylene glycol,
and FD & C Blue # 2 Aluminium Lake (E132).
The active substance and ingredients are used
to make white to off-white round biconvex film
coated mini tablets of 12.5mg. The 75mg capsule
contains 6 mini tablets, 150mg capsule contains
12 mini tablets and the 225mg capsule contains
18 mini tablets.
What Vensir XL capsules look like and
contents of the pack
The 75mg 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
The 225mg capsules are opaque, pink coloured,
prolonged release hard capsules having blue
coloured thick and thin radial circular bands on
both ends of the capsules.
Vensir XL capsules are available in blister packs
of 10, 14, 15 20, 28, 30, 56, 60 or 100 capsules.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
LE3 0PA. U.K.
Morningside Pharmaceuticals Ltd
5 Pavilion Way
LE11 5GW. U.K.
This leaflet was revised in July 2015
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.