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VENLAFAXINE TEVA XL 225 MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE

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TEVA UK Ref:

Version:

6

16 September 2016
Template
PANTONE® GREEN C
BLACK

VENLAFAXINE XL 225 mg
PROLONGED-RELEASE CAPSULES, HARD
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Venlafaxine XL is and what it is used for
2. What you need to know before you take Venlafaxine XL
3. How to take Venlafaxine XL
4. Possible side effects
5. How to store Venlafaxine XL
6. Contents of the pack and other information

1

What Venlafaxine XL is and what it is used for

Venlafaxine XL contains the active substance venlafaxine.
Venlafaxine 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.
Venlafaxine XL is a treatment for adults with depression. It
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
Venlafaxine XL

Do NOT take Venlafaxine 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 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 Venlafaxine XL, can cause serious or even
life-threatening side effects. Also, you must wait at least
7 days after you stop taking Venlafaxine XL before you
take any MAOI (see also the section entitled “Other
medicines and Venlafaxine XL” and the information in
that section about ‘Serotonin Syndrome’).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Venlafaxine XL:
• if you use other medicines that taken together with
Venlafaxine XL could increase the risk of developing
serotonin syndrome (see the section “Other medicines
and Venlafaxine XL”)
• 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.

Other medicines and Venlafaxine XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Your doctor should decide whether you can take
Venlafaxine 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 Venlafaxine XL. 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
Venlafaxine XL”).
• Serotonin syndrome:
A potentially life-threatening condition or Neuroleptic
Malignant Syndrome (NMS)-like reactions (see the
section “Possible Side Effects”) may occur with
venlafaxine treatment, particularly when taken with
other medicines.
Examples of these medicines include:
- triptans (used for migraine)
- other medicines to treat depression, for instance 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
heartbeat, increased body temperature, fast changes in
blood pressure, overactive reflexes, diarrhoea, coma,
nausea, vomiting.
In its most severe form, serotonin syndrome can resemble
Neuroleptic Malignant Syndrome (NMS). Signs and
symptoms of NMS may include a combination of fever,
fast heartbeat, sweating, severe muscle stiffness, confusion,
increased muscle enzymes (determined by a 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
Venlafaxine XL and should be used with caution. It is
especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (to treat psychiatric conditions)
• metoprolol (a beta blocker to treat high blood pressure
and heart problems).
Tell your doctor if you are taking oral contraceptives.
Venlafaxine XL with food, drink and alcohol
Venlafaxine XL should be taken with food (see section 3
“How to take Venlafaxine XL”).

Venlafaxine XL may cause a sensation of restlessness or
an inability to sit or stand still during the first few weeks of
You should avoid alcohol while you are taking Venlafaxine
treatment. You should tell your doctor if this happens to
XL. This is to minimise side effects and to help the capsule
you.
work until the next one is due.
Thoughts of suicide and worsening of your depression or
Pregnancy and breast-feeding
anxiety disorder
If you are pregnant or breast-feeding, think you may be
If you are depressed and/or have anxiety disorders, you
pregnant or are planning to have a baby, ask your doctor
can sometimes have thoughts of harming or killing
for advice before taking this medicine. You should use
yourself. These may be increased when you first start
taking antidepressants, since these medicines all take time Venlafaxine XL only after discussing the potential benefits
to work, usually about two weeks, but sometimes longer. and the potential risks to your unborn child with your doctor.
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.

Make sure your midwife and/or doctor knows you are on
Venlafaxine 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.

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.

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.

Dry mouth
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.

Venlafaxine XL 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.

Diabetes
Your blood glucose levels may be altered due to
Venlafaxine XL. Therefore, the dosages of our diabetes
medicines may need to be adjusted.

Driving and using machines
Do not drive or use any tools or machines until you know
how this medicine affects you.

Children and adolescents
Venlafaxine 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 Venlafaxine XL. Also, the long-term safety effects
concerning growth, maturation and cognitive and
behavioural development of this medicine in this age
group has not yet been demonstrated.

Venlafaxine XL contains Carmoisine (E122)
Carmoisine (E122) may cause allergic reactions.

3

How to take Venlafaxine XL

Always take this medicine exactly as your doctor has told
you. 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.

TEVA UK Ref:

Version:

6

16 September 2016
Template
PANTONE® GREEN C
BLACK

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
Venlafaxine XL should be taken with food.
• a sensation of restlessness or an inability to sit or stand
still; fainting; involuntary movements of the muscles;
If you have liver or kidney problems, talk to your doctor,
impaired coordination and balance; altered taste
since your dose of this medicine may need to be different.
sensation
• fast heartbeat; feeling dizzy (particularly when standing
Do not stop taking this medicine without talking to your
up too quickly)
doctor (see the section “If you stop taking Venlafaxine XL”).
• shortness of breath
• vomiting blood, black tarry stools (faeces) or blood in
If you take more Venlafaxine XL than you should
stools; which can be a sign of internal bleeding
Call your doctor or pharmacist immediately if you take

sensitivity
to sunlight; bruising; rash; abnormal hair loss
more of this medicine than the amount prescribed by your
• inability to pass urine;
doctor.
• weight gain; weight loss.
The symptoms of a possible overdose may include a rapid
Rare (may affect up to 1 in 1000 people)
heartbeat, changes in level of alertness (ranging from
• seizures or fits
sleepiness to coma), blurred vision, seizures or fits, and
• inability to control urination
vomiting.
• over activity, racing thoughts and decreased need for
sleep (mania).
If you forget to take Venlafaxine XL
If you miss a dose, take it as soon as you remember.
Frequency not known (cannot be estimated from the
However, if it is time for your next dose, skip the missed
available data)
dose and take only a single dose as usual. Do not take
• prolonged bleeding, which may be a sign of reduced
more than the daily amount of Venlafaxine XL that has
number of platelets in your blood, leading to an
been prescribed for you in one day.
increased risk of bruising or bleeding
Do not take a double dose to make up for a forgotten

excessive
water intake (known as SIADH)
dose.
• decrease in blood sodium levels
• suicidal ideation and suicidal behaviours; cases of
If you stop taking Venlafaxine XL
suicidal ideation and suicidal behaviours have been
Do not stop taking your treatment or reduce the dose
reported during venlafaxine therapy or early after
without the advice of your doctor even if you feel better. If
treatment discontinuation (see section 2, What you need
your doctor thinks that you no longer need Venlafaxine
to know before you take Venlafaxine XL)
XL, he/she may ask you to reduce your dose slowly before
• disorientation and confusion often accompanied by
stopping treatment altogether. Side effects are known to
hallucination (delirium); aggression
occur when people stop using this medicine, especially
• stiffness, spasms and involuntary movements of the
when it is stopped suddenly or the dose is reduced too
muscles
quickly. Some patients may experience symptoms such as
• severe eye pain and decreased or blurred vision
tiredness, dizziness, light-headedness, headache,
• vertigo
sleeplessness, nightmares, dry mouth, loss of appetite,
• decrease in blood pressure; abnormal, rapid or irregular
nausea, diarrhoea, nervousness, agitation, confusion,
heartbeat, which could lead to fainting; unexpected
ringing in the ears, tingling or rarely electric shock
bleeding, e.g. bleeding gums, blood in the urine or in
sensations, weakness, sweating, seizures, or flu-like
vomit, or the appearance of unexpected bruises or
symptoms.
broken blood vessels (broken veins)
Your doctor will advise you on how you should gradually • coughing, wheezing, shortness of breath and a high
discontinue Venlafaxine XL treatment. If you experience
temperature, which are symptoms of inflammation of
any of these or other symptoms that are troublesome, ask
the lungs associated with an increase in white blood
your doctor for further advice.
cells (pulmonary eosinophilia)
• severe abdominal or back pains (which could indicate a
If you have any further questions on the use of this
serious problem in the gut, liver or pancreas)
medicine, ask your doctor or pharmacist.
• 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
4 Possible side effects
enzymes

itching;
mild rash
Like all medicines, this medicine can cause side effects,
• abnormal breast milk production.
although not everybody gets them.
Take Venlafaxine XL at approximately the same time each
day, either in the morning or in the evening. Capsules
must be swallowed whole with fluid and not opened,
crushed, chewed or dissolved.

If any of the following happen, do not take more
Venlafaxine XL. 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.
Frequency not known (cannot be estimated from the
available data)
• chest tightness, wheezing, trouble swallowing or
breathing
• severe rash, itching, or hives (elevated patches of red or
pale skin that often itch)
• signs and symptoms of serotonin syndrome which may
include restlessness, hallucinations, loss of
coordination, fast heartbeat, increased body
temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can
resemble Neuroleptic Malignant Syndrome (NMS).
Signs and symptoms of NMS may include a
combination of fever, fast heartbeat, sweating, severe
muscle stiffness, confusion, increased muscle enzymes
(determined by a 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 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, shortness of breath and a high
temperature
• black (tarry) stools or blood in stools
• itchiness, 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 feeling
unusually overexcited.
• withdrawal effects (see the section “How to take
Venlafaxine XL, If you stop taking Venlafaxine XL”).
• prolonged bleeding - if you cut or injure yourself, it may
take slightly longer than usual for bleeding to stop.
Other side effects that may occur
Very common (may affect more than 1 in 10 people)
• dizziness; headache
• nausea; dry mouth
• sweating (including night sweats).
Common (may affect up 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.

Venlafaxine 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 of liver enzymes, sodium or cholesterol. More
rarely, Venlafaxine 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
Venlafaxine 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 Venlafaxine XL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is
stated on the blister and carton after “EXP”.The expiry date
refers to the last day of that month.
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
protect the environment.

6

Contents of the pack and other information

What Venlafaxine XL contains
• The active substance is venlafaxine.
Each prolonged-release capsule, contains 225 mg of
venlafaxine, as venlafaxine hydrochloride.
• The other ingredients are:
Capsule contents: Microcrystalline Cellulose, Povidone
(K-90), Talc, Colloidal Silicon Dioxide, Magnesium
Stearate, Ethyl cellulose, Copovidone.
Capsule shell: Gelatin, Carmoisine (E122), Titanium
Dioxide (E171), Water.
Capsule printing ink: Shellac, Propylene glycol, Strong
ammonia solution, Indigo Carmine Aluminium Lake
(E132).
What Venlafaxine XL looks like and contents of the pack
Venlafaxine XL 225 mg are pink opaque, hard gelatin
capsules having blue thick and thin radial circular bands
on the body and cap, filled with mini tablets.
Venlafaxine XL 225 mg is available in:
Cold-forming aluminium (OPA/Alu/PVC) and aluminium
blisters containing 28, 30, 30x1 prolonged-release
capsules, hard.
White opaque PVC/PVdC and aluminium blisters
containing 28, 30, 30x1 prolonged-release capsules, hard.
White opaque PVC/Aclar and aluminium blisters
containing 28, 30, 30x1 prolonged-release capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren,
Baden-Wuerttemberg, 89143, Germany
This leaflet was last revised in 09/2016
PL 00289/2049

32536-A
281409.01-GB

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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