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TONPULAR XL 150MG PROLONGED-RELEASE HARD CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Package leaflet: Information for the user
Tonpular XL 75mg Prolonged-Release Hard Capsules
Tonpular XL 150mg Prolonged-Release Hard Capsules
Venlafaxine Hydrochloride
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 Tonpular XL is and what it is used for
2. What you need to know before you take Tonpular XL
3. How to take Tonpular XL
4. Possible side effects
5. How to store Tonpular XL
6. Contents of the pack and other information

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1. What Tonpular XL is and what it is used for
Tonpular XL contains the active substance venlafaxine
hydrochloride. Tonpular XL is an antidepressant that
belongs to a group of medicines called Serotonin and
Noradrenaline Reuptake Inhibitors (SNRIs). Everyone
has substances in their brain called serotonin and
noradrenaline. It is thought that people suffering from
depression (and associated conditions) have less of
these substances compared to people who do not have
depression (and associated conditions). It is not fully
understood how antidepressants work, but they may help
by increasing the amount of serotonin and noradrenaline
in the brain.
Tonpular XL is used to treat:
• Depression (including anxiety symptoms)
If you are depressed, you may have feelings of extreme
sadness. These feelings can interfere with your everyday
life and last a long time (e.g. weeks and months).
• Panic Disorder (panic attacks)
Venlafaxine, which is contained in Tonpular XL, is also
authorised to treat other conditions which are not
mentioned in this leaflet. Ask your doctor or pharmacist if
you have further questions.

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2. What you need to know before you take Tonpular XL
Do not take Tonpular XL if:
• you are allergic (hypersensitive) to venlafaxine
hydrochloride or to any of the other ingredients in
Tonpular XL (see section 6, Further information)
• you are taking, or have taken within the last 14 days
any medicine called monoamine oxidase inhibitors
(MAOIs). These medicines can be used to treat
depression or Parkinson’s disease. Taking an
irreversible MAOI together with other medicines,
including Tonpular XL, can cause serious or even
life-threatening side effects. Also, you must wait at least
7 days after you stop taking Tonpular XL before you
take any MAOI (see also the sections “Serotonin
syndrome” and “Taking other medicines”).
Warning and precautions
Talk to your doctor or pharmacist before taking
Tonpular XL if:
• you have or have had a history of, or if someone in your
family has ever had, mania or bipolar affective disorder
(feeling 'high' or over excited alternated with low mood
or depression)
• you have a history of high blood pressure or heart
problems
• you have a history of fits (seizures)
• you have glaucoma (an increased pressure in the eye)
• you have increased risk of bleeding or suffer from any
bleeding disorders or if you are taking other medicines
that may increase the risk of bleeding
• you have a history of low sodium levels in your blood
(hyponatraemia).
• your cholesterol levels get higher
• you use other medicines that taken concomitantly with
Tonpular XL could increase the risk of developing
serotonin syndrome (see the section “Taking other
medicines”). Serotonin syndrome can be life-threatening
• you have a history of aggressive behaviour
• you have diabetes
Tonpular XL may cause a sensation of restlessness or an
inability to sit or stand still. You should tell your doctor if
this happens to you.
Do not be concerned if you see small white granules or
balls in your stools after taking Tonpular XL. Inside
Tonpular XL capsules are spheroids or small white balls
that contain the venlafaxine active ingredient. These
spheroids are released from the capsule into your
gastrointestinal tract. As the spheroids travel the length of
your gastrointestinal tract, venlafaxine is slowly released.
The spheroid “shell” remains undissolved and is
eliminated in your stools. Therefore, even though you
may see spheroids in your stools, your dose of
venlafaxine has been absorbed.
Use in children and adolescents under 18 years of age
This medicine should not be prescribed for children and
adolescents under 18 years of age who have major
depressive disorders. This is because the long term
effects of Tonpular XL have not yet been established in
this age group. It has been found that patients under 18
years of age have an increased risk of experiencing some
of the side effects associated with taking Tonpular XL.
These side effects include feelings of self harm, thoughts
of/or attempted suicide and feelings of hostility (mainly
aggression, anger and negative or hostile behaviour).
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 first starting
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to have these kind of thoughts if:
• you have previously had thoughts about killing or
harming yourself
• you are a young adult. Information from clinical trials
has shown an increased risk in suicidal behaviour in
adults aged less than 25 years with psychiatric
conditions who were treated with an antidepressant.
If you have thoughts about harming or killing
yourself at any time, contact your doctor or go to
hospital straight away.

You may find it helpful to tell a close friend or relative 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 caries. Therefore,
you should take special care in your dental hygiene.
Other medicines and Tonpular XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. The
following medicines can affect or be affected by treatment
with Tonpular XL
• Monoamine oxidase inhibitors (MAOIs: see the section
“Before you take Tonpular XL”)
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 used to treat depression such as 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)
• 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)
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, hyperthermia, muscle rigidity, unstable nervous
system with possible rapid change in vital signs and
mental status. Get medical care right away if you think
serotonin syndrome is happening to you.
The following medicines may also interact with Tonpular
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)
Diabetes
If you are diabetic and taking venlafaxine, talk to your
doctor, as it may alter glycaemic control. Your dosage
may need to be adjusted.
Tonpular XL with food and drink
Tonpular XL should be taken with food (see section 3
“How to take Tonpular XL”). As with all medicines that act
on the central nervous system, alcohol should be avoided
while taking this medicine.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying
to become pregnant. You should use Tonpular XL only
after discussing the potential benefits and the potential
risks to your unborn child with your doctor.
If you are taking Tonpular 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 not feeding properly and trouble with
breathing. If your baby has these symptoms when it is
born and you are concerned, contact your doctor and/or
midwife who will be able to advise you.
Make sure your midwife and/or doctor know you are on
Tonpular 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 doctor
immediately.
Tonpular 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
Tonpular XL.
Driving and using machines
It is possible that Tonpular XL may make you feel drowsy.
Do not drive or operate machinery if affected.
Tonpular XL 75mg capsules contain sunset yellow
FCF (E110), carmoisine (E122) and allura red AC (E129).
These azo colouring agents may cause allergic reactions.
Tonpular XL 150mg capsules contain sunset yellow
FCF (E110) and tartrazine (E102). These azo colouring
agents may cause allergic reactions.
3. How to take Tonpular XL
Always take Tonpular XL as your doctor has told you.
Your doctor will decide the right dose for you; this will be
on the pharmacist’s label. Check this carefully, it will tell
you how many capsules to take and how often to take
them. Do not crush or chew the capsule or any of the
pellets. The required dose should be swallowed whole
with a glass of water, taken at the same time every day
either with evening meal or breakfast. The dose of
Tonpular XL depends on your condition:
Treatment of Depression (including anxiety symptoms)
• one 75mg capsule per day
• your doctor will monitor your treatment. If there is no
improvement in your condition your dose may be
increased to 375mg per day.
Panic Disorder
• one 37.5mg capsule per day which may be increased
gradually. The maximum dose is 225mg per day
For elderly patients the dosage should be carefully
monitored by your doctor. For patients with moderate
kidney and liver problems only half of the above dose
should be taken.
If you take more Tonpular XL than you should
If you (or anybody else including a child) take more
Tonpular XL than you should, contact your nearest
hospital casualty department or doctor immediately.
Always take the blister pack of capsules and this leaflet
with you. The symptoms of a possible overdose may
include a rapid heart beat, changes in level of alertness

ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
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ARTWORK (DETAILS)
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Process
Black

Venlafaxine 75 & 150mg - 28 Capsules
Wockhardt UK
FP3284; FP3285
L1
(w)148 x (h)420mm
2548
222402
8 pt. (10% condensed)
Venlafaxine_Leaflet_104176-7.ai
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31st March, 2016

R 1st PDF sent on - 7TH APRIL 2016
R 2nd PDF sent on - 8TH APRIL 2016
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This is a service provided by the Royal National Institute
of Blind People
For the Republic of Ireland please call +44 1978 669272
This leaflet was last revised in 03/2016

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What Tonpular XL contains
The active ingredient is venlafaxine: Each prolonged
release hard capsule contains 84.8mg of venlafaxine
hydrochloride, equivalent to 75mg venlafaxine or
169.7mg venlafaxine hydrochloride, equivalent to 150mg
venlafaxine.
The other ingredients are:
Contents of the capsule: microcrystalline cellulose,
povidone K 30, ethylcellulose, triethyl citrate, talc,
methacrylic acid copolymer Type C, sodium bicarbonate,
colloidal anhydrous silica, sodium laurilsulfate
Capsule shell: titanium dioxide (E171), sunset yellow
FCF (E110), brilliant blue FCF (E133), gelatin, sodium
laurilsulfate, shellac.
75mg strength capsule shell also contain: carmoisine
(E122), povidone and allura red (E129).
150mg strength capsule shell also contain: tartrazine
(E102).
What Tonpular XL look like and the contents of the
pack
Tonpular XL 75mg Prolonged-Release Hard Capsules
are a hard gelatine capsule with light pink opaque cap
and light pink opaque body filled with white to off white
pellets, imprinted with W
717 on cap in red colour.
Tonpular XL 150mg Prolonged-Release Hard
Capsules are a hard gelatine capsule with orange
opaque cap and orange opaque body filled with white to
off white pellets, imprinted with W
718 on cap in white colour.
Both strengths are supplied in a blister pack and outer
cardboard carton, and are available in pack size of 14 or
28 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road
North, Wrexham LL13 9UF, UK. These medicinal
products are authorised in the Member States of the EEA
under the following names:
UK: Tonpular XL 75mg or 150mg Prolonged-Release
Hard Capsules
Ireland: Tonpular XL 75mg or 150mg Prolonged-Release
Hard Capsules
Poland: Tonpular XL 75mg or Tonpular XL 150mg
Cyprus: Tonpular XL 75mg or 150mg Prolonged-Release
Hard Capsules
Malta: Tonpular XL 75mg or 150mg Prolonged-Release
Hard Capsules
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name
Reference number
Tonpular XL 75mg
Prolonged-Release Hard Capsules
29831/0364
Tonpular XL 150mg
Prolonged-Release Hard Capsules
29831/0365

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6. Contents of the pack and other information

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• 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 pack and carton. The expiry date
refers to the last day of that month.
• Store below 25°C. Store in the original package to
protect from moisture.
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.

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5. How to store Tonpular XL

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Like all medicines, Tonpular XL can cause side effects,
although not everybody gets them.
Allergic reactions
If any of the following happen, do not take more Tonpular
XL. Tell your doctor immediately, or go to the casualty
department at your nearest hospital:
• Chest tightness, wheezing,
• Swelling of the face,
trouble swallowing or breathing throat, hands, or feet
• Feeling nervous or anxious,
• Severe rash, itching, or
dizziness, throbbing sensations, hives (elevated patches
sudden reddening of the skin
of red or pale skin that
and/or a warm feeling
often itch)
Serious side effects
If you notice any signs of the following, you may need
urgent medical attention:
• Heart problems, such as fast • Eye problems, such as
or irregular heart rate,
blurred vision, dilated
increased blood pressure
pupils
• Nerve problems, such as
• Psychiatric problems,
dizziness, pins and needles,
such as hyperactivity
movement disorder, seizures
and euphoria
or fits
• Treatment withdrawal (see the
section “How to take Tonpular XL,
Stopping Tonpular XL”).
You should tell your doctor or pharmacist if you have any
of the following side effects, or if you think this medicine
is making you feel unwell in any other way.
Very common (may affect more than 1 in 10 people)
• headache
• dry mouth; nausea
• sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• decreased appetite
• Abnormal dreams; insomnia; nervousness; confusion;
feeling separated (or detached) from yourself and
reality); decreased libido; abnormal orgasm (male); lack
of orgasm
• palpitations
• increase in blood pressure; flushing
• yawning
• constipation; vomiting
• difficulties passing urine; increased frequency in
urination
• abnormal ejaculation erectile dysfunction (impotence);
menstrual irregularities such as increased bleeding or
increased irregular bleeding
• weakness (aesthesia); chills
• increased cholesterol; weight loss
Uncommon (may affect up to 1 in 100 people)
• lack of feeling or emotion; hallucinations; agitation;
grinding of the teeth
• involuntary movement of the muscles; impaired
coordination and balance; altered taste sensation;
fainting
• ringing in the ears (tinnitus)
• fast heartbeat
• feeling dizzy (particularly when standing up too quickly);
• shortness of breath or trouble breathing
• diarrhoea; black tarry stools (faeces) or blood in stools,
which can be a sign of internal bleeding
• swelling of the skin; rash; abnormal hair loss; bruising;
sensitivity to sunlight
• inability to pass urine
• abnormal orgasm (females)
• weight gain
Rare (may affect up to 1 in 1000 people)
• feeling over excited or euphoric
• a sensation of restlessness or an inability to sit or stand
still; seizures or fits
• inability to control urination
Not known (frequency cannot be estimated from the
available data)
• reduced number of platelets in your blood, blood
disorders which may lead to an increased risk of infection.
• decrease in blood sodium levels; confusion
• euphoric feelings; thoughts of harming or killing
yourself; aggression
• Excessive water intake (known as SIADH)
• a high temperature with rigid muscles, disorientation
and confusion often accompanied by hallucination
(delirium); 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; drowsiness;
sustained rapid eye movement; clumsiness;
restlessness; feeling of being drunk; sweating or rigid
muscles, which are symptoms of serotonergic
syndrome; stiffness, spasms and involuntary
movements of the muscles
• severe eye pain; decreased or blurred vision; vertigo
(dizziness and balancing trouble when standing up)
• abnormal, rapid or irregular heartbeat which could lead
to fainting
• decrease in blood pressure
• 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

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4. Possible Side Effects

• itchiness, yellow skin or eyes, dark urine, or flu-like
symptoms, which are symptoms of inflammation of the
liver (hepatitis)
• skin rash which may lead to severe blistering and
peeling of the skin; itching; mild rash
• unexplained muscle
pain; tenderness or
weakness
(rhabdomyolysis)
• bleeding under the
skin
• prolonged bleeding
time; abnormal
breast milk
production; abnormal
heartbeat; slight
changes in blood
levels of liver
enzymes
Tonpular 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, Tonpular 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
Tonpular XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the national reporting systems listed below.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:medsafety@hpra.ie
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.

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(ranging from sleepiness to coma), blurred vision,
seizures or fits, muscle deterioration and vomiting.
If you forget to take Tonpular XL
If you forget a dose, take another as soon as you
remember. If it is almost time for your next dose, then do
not take the missed dose at all. NEVER take a double
dose to make up for the one missed.
If you stop taking Tonpular 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 Tonpular 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 Tonpular XL especially
when Tonpular XL is stopped suddenly or the dose is
reduced too quickly. If you suddenly stop taking this
medicine you may experience:
• difficulty sleeping
• diarrhoea
• agitation
• dizziness, headache
• sweating
• feeling and/or being sick
• weakness
• flu-like symptoms
• tingling or numbness
• ringing in the ears
of the skin
• dry mouth
• loss of appetite
• feeling nervous or confused
• sensory changes (e.g. pins • light-headedness
and needles/feelings of
• tiredness
electric shock)
• fits
Your doctor will advise you on how you should gradually
discontinue Tonpular XL treatment.
If you are at all concerned about your treatment or if you
have any questions, please speak to your doctor or
pharmacist.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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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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