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TONPULAR XL 150MG PROLONGED-RELEASE HARD CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / 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
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)
• if 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 use other medicines that taken together with Tonpular
XL could increase the risk of developing serotonin syndrome
(see the section “Other medicines and Tonpular 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.
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.
Children and adolescents
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.
Diabetes
Your blood glucose levels may be altered due to Tonpular XL.
Therefore, the dosage of your diabetes medicines may need to
be adjusted.
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 which are used to treat
depression or Parkinson’s disease must not be taken with
Tonpular 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 Tonpular 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 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, 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 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)
Tonpular XL with food, drink and alcohol
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 this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. 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 (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.

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For the Republic of Ireland please call +44 1978 669272
This leaflet was last revised in 11/2016
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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 on cap in red colour.
717
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 on cap in white colour.
718
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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5. How to store Tonpular 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 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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4. Possible Side Effects
Like all medicines, this medicine 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:
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 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, shortness of breath and a high
temperature
• Black (tarry) stools or blood in stools
• Itchiness, yellow skin or eyes, 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 Tonpular XL,
if you stop taking Tonpular XL”).
• Prolonged bleeding - if you cut or injure yourself, it may take
slightly longer than usual for bleeding to stop.
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.
Other side effects that may occur
Very common (may affect more than 1 in 10 people)
• dizziness, headache
• dry mouth; nausea
• sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• decreased appetite
• 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
• difficulties passing urine; increased frequency in urination
• menstrual irregularities such as increased bleeding or
increased irregular bleeding; abnormal ejaculation/orgasm
(males); erectile dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• hallucinations; feeling separated (or detached) from reality;
agitation; abnormal orgasm (females); lack of feeling or
emotion; feeling over-excited; grinding of the teeth
• a sensation of restlessness or an inability to sit or stand still;
fainting; involuntary movement of the muscles; impaired
coordination and balance; altered taste sensation;
• fast heartbeat; feeling dizzy (particularly when standing up too
quickly);
• shortness of breath
• vomiting blood, black tarry stools (faeces) or blood in stools,
which can be a sign of internal bleeding
• sensitivity to sunlight; bruising; rash; abnormal hair loss
• inability to pass urine
• weight gain; weight loss
Rare (may affect up to 1 in 1000 people)
• seizures or fits
• inability to control urination
• over activity, racing thoughts and decreased need for sleep
(mania)
Not known (frequency cannot be estimated from the
available data)
• Prolonged bleeding, which may be a sign of reduced number
of platelets in your blood, leading to an increased risk of
bruising or bleeding
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels

• Suicidal ideation and suicidal behaviours; cases of suicidal
ideation and suicidal behaviours have been reported during
venlafaxine therapy or early after treatment discontinuation
(see section 2, What you need to know before you take
Tonpular XL)
• Disorientation and
confusion often
accompanied by
hallucination (delirium);
aggression
• Stiffness, spasms and
involuntary movements
of the muscles
• Severe eye pain and
decreased or blurred
vision
• Vertigo
• Decrease in blood
pressure; abnormal,
rapid or irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood in the urine or
in vomit, or the appearance of unexpected bruises or broken
blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high
temperature, which are symptoms of inflammation of the lungs
associated with an increase in white blood cells (pulmonary
eosinophilia)
• Severe abdominal or back pains (which could indicate a
serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms,
which are symptoms of inflammation of the liver (hepatitis);
slight changes in blood levels of liver enzymes
• Itching; mild rash
• Abnormal breast milk production
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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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
• light-headedness
(e.g. pins and needles/
• tiredness
feelings of 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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