SUNVENIZ XL 150 MG PROLONGED-RELEASE TABLETS

Active substance: VENLAFAXINE HYDROCHLORIDE

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Thoughts of suicide and worsening of your depression
If you are depressed 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
think like this:
- If you have previously had thoughts about killing or harming
yourself.
- If you are a young adult. Information from clinical trials has shown
an increased risk of suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were treated with an
antidepressant.

Sunveniz XL 37.5 mg prolonged-release
tablets
Sunveniz XL 75 mg prolonged-release
tablets
Sunveniz XL 150 mg prolonged-release
tablets

Driving and using machines
Sunveniz XL may impair mental concentration and alertness.
Therefore, you should be careful when driving motor vehicles or
operating machinery. Your doctor will evaluate your ability to drive or
use machines by taking into account the degree of the underlying
disease, response to treatment and possible undesirable effects.

If you have thoughts of harming or killing yourself at any time, contact
your doctor or go to a hospital straight away.

Sunveniz XL contains lactose
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

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.

Venlafaxine
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. 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.

3. How to take Sunveniz XL

Dental hygiene
Dry mouth is reported in 10% of patients treated with Sunveniz XL.
This may increase the risk of caries. Therefore, you should take
special care in your dental hygiene.
Children and adolescents under 18 years of age
Sunveniz XL should normally not be used for children and adolescents
under 18 years. The long-term safety effects concerning growth,
maturation and behavioural development of Sunveniz XL in this age
group have not yet been demonstrated. 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
medicines such as Sunveniz XL. Despite this, your doctor may
prescribe Sunveniz XL for patients under 18 because he/she decides
that this is in their best interests. If your doctor has prescribed
Sunveniz XL 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 Sunveniz XL.

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

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
It may take several days or more before you feel your medicine is
working. You may need to take Sunveniz XL for several months.
Dosage
The recommended starting dose for treatment of depression 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.
Method of administration
Take this medicine at approximately the same time each day, either in
the morning or in the evening. Tablets must be swallowed whole with
fluid and not crushed, chewed or dissolved.
If you take more Sunveniz XL than you should
If you may have taken more Sunveniz XL than you should you must
seek immediate medical attention. Remember to take the packet with
you.
The symptoms of a possible overdose may include a rapid heartbeat,
changes in level of alertness (ranging from sleepiness to coma),
blurred vision, seizures or fits, and vomiting.

Other medicines and Sunveniz XL
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

1. What Sunveniz XL is and what it is used for
Sunveniz 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. It is thought that
people who are depressed have lower levels of serotonin and
noradrenalin in the brain. It is not fully understood how antidepressants
work, but they may help by increasing the levels of serotonin and
noradrenalin in the brain.
Sunveniz XL is a medicine to treat adults with depression. Treating
depression 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.
Venlafaxine which is contained in Sunveniz XL is also authorised to
treat other conditions which are not mentioned in this leaflet. Ask your
doctor or pharmacist if you have any further questions.

2. What you need to know before you take Sunveniz XL
Do not take Sunveniz XL
- if you are allergic (hypersensitive) to venlafaxine or to any of the
other ingredients of this medicine (listed in section 6)
- if you are also taking or have taken any time within the last 14 days
any medicines known as irreversible monoamine oxidase inhibitors
(irreversible MAOIs), used to treat depression or Parkinson's
disease. Taking an irreversible MAOI together with other medicines,
including Sunveniz XL, can cause serious or even life-threatening
side effects. Also, you must wait at least 7 days after you stop
taking Sunveniz XL before you take any irreversible MAOI (see also
“Taking other medicines”).
If you think any of these apply to you, do not take the tablets. Talk to
your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sunveniz XL
- if you use other medicines that taken concomitantly with Sunveniz
XL could increase the risk of developing serotonin syndrome (see
the section “ Other medicines and Sunveniz 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 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
- if your cholesterol levels get higher
- if you have a history of, or if someone in your family has had, mania
(feeling over-excited or euphoric) or bipolar disorder
- if you have a history of aggressive behaviour
- if you have liver or kidney problems.
If any of these conditions apply to you, please talk with your doctor
before taking Sunveniz XL.

If you forget to take Sunveniz XL
If you miss a dose, take it as soon as you remember. However, if it is
time for your next dose, skip the missed dose and take only a single
dose as usual. Do not take more than the daily amount of Sunveniz XL
that has been prescribed for you in one day.

Your doctor should decide whether you can take Sunveniz XL with
other medicines. When Sunveniz XL is taken in combination with other
medicines, this may lead to the so-called 'serotonin syndrome'. For
information about the symptoms of this syndrome, see section 4
under 'Other serious side effects'. The serotonin syndrome is a
potentially life-threatening condition which may be caused when
Sunveniz XL is used in combination with other medicines such as:

If you stop taking Sunveniz XL
Do not stop taking this medicine or reduce the dose without the advice
of your doctor even if you feel better. If your doctor thinks that you no
longer need Sunveniz XL, he/she may reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when
people stop using Sunveniz XL, especially when Sunveniz XL is
stopped suddenly or the dose is reduced too quickly. Some patients
may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of
appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing
in the ears, tingling or rarely electric shock sensations, weakness,
sweating, seizures, or flu-like symptoms.

- irreversible monoamine oxidase inhibitors (see also under “Do not
take Sunveniz XL”)
- medicines containing moclobemide, which is a newer, reversible
MAOI (used to treat depression)
- triptans (used for migraine)
- medicines to treat depression, for instance SNRIs, SSRIs, tricyclic
antidepressants, or medicines containing lithium
- medicines containing linezolid, an antibiotic (used to treat
infections)
- 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).

Your doctor will advise you on how you should gradually discontinue
Sunveniz XL. If you experience any of these or other symptoms that
are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Certain other medicines may also interact with Sunveniz XL and should
be used with caution. It is especially important to mention to your
doctor or pharmacist if you are taking medicines containing:

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

- ketoconazole (an antifungal medicine)
- haloperidol or risperidone (to treat psychiatric conditions)
- metoprolol (a beta blocker to treat high blood pressure and heart
problems).

Serious allergic reactions
If you notice any of the following symptoms, stop taking Sunveniz XL .
Tell your doctor immediately, or go to the casualty department at your
nearest hospital:
- chest tightness, wheezing, trouble swallowing or breathing
- swelling of the face, tongue, throat, hands, or feet
- feeling nervous or anxious, dizziness, throbbing sensations in the
head, 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)

Sunveniz XL with food, drink and alcohol
Take Sunveniz XL with food. Do not drink alcohol during treatment with
Sunveniz XL.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.

Other serious side effects
If you notice any of the following symptoms, you may need urgent
medical attention as this may be an indication of very serious
conditions, such as the serotonin syndrome or the neuroleptic
malignant syndrome:
- heart problems, such as fast or irregular heart rate, increased blood
pressure
- eye problems, such as blurred vision, dilated pupils, sustained rapid
eye movements
- nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
- other physical symptoms, such as high temperature, sweating,
feeling of being drunk, rigid muscles or jerky muscle movements
- psychiatric problems, such as euphoric feelings, confusion,
agitation, or restlessness
- treatment withdrawal (see the information under 'If you stop taking
Sunveniz XL ' in the section “How to take Sunveniz XL ”).

Pregnancy
Tell your doctor if you are pregnant, or if you are trying to become
pregnant. You should use Sunveniz 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 knows you are on Sunveniz 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.

Folding
375--2--93.75 mm
248--2 --62 mm

248 mm

Name of Product:
Sunveniz XL 37,5 , 75 , 150 mg

AWS TYPE

[V001 & V003]

Language

Country
EUUK - UNITED KINGDOM

PIL

044BP1191B

Void artwork Code No: 044BP1191A

CD-PDD-

Actual Size

248 x 375 mm

Reason: change in text from EU > RA

REMARKS:

Barcode Area

41 x 16 mm

No. of Colors : 1

Specification / Type of paper

Color codes:
BLACK

Super Fine 40 GSM Tissue Paper ITC

Folding
375--2--93.75 mm
248--2 --62 mm

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Development Department [PDD]
SPIL - Vadodara

Prepared by
Sign

Checked by
Date

Sign

Patient info. Leaflet

Swiss 721 CN BT - 10 pt

Title and Tiltle Heading

Swiss 721 CN BT - 13 pt and 11 pt

Body Text

08/03/2013 9:36:00 AM

Approved by

Date Sign

FONTS SPECIFICATION

Sunveniz XL-37_5-75-150mg-PIL-248x375mm-EUUK-carved out-REV1-08-03-13

Location
SPIL - Halol

ENGLISH

Code

Size: 248x375 mm
Patient Information
SUN EUROPE
EUUK - UNITED KINGDOM

Swiss 721 CN BT - 8 pt

Approved by RA
Date Sign

Date

375 mm

Package leaflet: Information for the user

Breast-feeding
Sunveniz XL passes into breast milk. There is a risk of an effect on the
baby. Therefore, you should discuss breast-feeding with your doctor,
and he/she will decide whether you should stop breast-feeding or stop
taking Sunveniz XL.

Other side effects
If any of the following side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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.

Very common: may affect more than 1 in 10 people
- dry mouth
- headache
- nausea
- sweating (including night sweats).

6. Contents of the pack and other information

Uncommon: may affect up to 1 in 100 people
- bruising, black tarry stools (faeces) or blood in stools, which can
be a sign of internal bleeding
- weight gain
- lack of feeling or emotion; hallucinations; involuntary movement of
the muscles; agitation; impaired coordination and balance
- altered taste sensation; ringing in the ears (tinnitus)
- feeling dizzy (particularly when standing up too quickly), fainting,
fast heartbeat
- grinding of the teeth; diarrhoea
- rash; abnormal hair loss
- inability to pass urine
- abnormal orgasm (females)
- sensitivity to sunlight.
Rare: may affect up to 1 in 1,000 people
- a sensation of restlessness or an inability to sit or stand still
- seizures or fits
- feeling over-excited or euphoric.
Frequency not known: frequency cannot be estimated from the
available data
- 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); confusion, excessive water intake (known as SIADH);
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
serotonergic 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 vision
- 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; mild rash
- unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
· swollen face or tongue, shortness of breath or difficulty breathing,
often with skin rashes (this may be a serious allergic reaction; if this
occurs, contact your doctor immediately).
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy.

5. How to store Sunveniz XL

What Sunveniz XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 37.5 mg, 75 mg or 150 mg
venlafaxine (as venlafaxine hydrochloride).
The other ingredients are:
Tablet core
Sustained release layer:
hypromellose,
povidone (K-30),
lactose monohydrate,
methacrylic acid-ethyl acrylate (1:1) co-polymer,
talc,
magnesium stearate.
Openable layer:
silicified microcrystalline cellulose,
crospovidone Type A,
colloidal anhydrous silica,
sodium lauryl sulphate,
lake allura red (E129),
talc,
magnesium stearate.
Coating
ethyl cellulose aqueous dispersion,
mannitol,
povidone (K-30),
dibutyl sebacate,
triethyl citrate,
polysorbate 20,
opadry II 85F 19250 clear, which consists of
talc,
macrogol 3350,
polysorbate 80,
polyvinyl alcohol.

375 mm

Common: may affect up to 1 in 10 people
- weight loss
- increased cholesterol
- abnormal dreams, decreased libido, dizziness, increased muscle
tonus, insomnia, nervousness, pins and needles, sedation, tremor,
confusion, feeling separated (or detached) from yourself and reality
- blurred vision
- increase in blood pressure, flushing, palpitations
- yawning
- decreased appetite, constipation, vomiting
- difficulties passing urine, increased frequency in urination
- abnormal ejaculation/orgasm (males), lack of orgasm, erectile
dysfunction (impotence), menstrual irregularities such as increased
bleeding or increased irregular bleeding
- weakness (asthenia), chills.

Barcode

Printing ink (opacode-s-1-17823 black)
shellac,
black iron oxide (E172),
propylene glycol.
What Sunveniz XL looks like and contents of the pack
Sunveniz XL 37.5 mg: This medicinal product is presented as a round,
pink and white coloured biconvex bilayer coated prolonged-release
tablet imprinted with “760” with black ink on one side and plain on the
other side.
Sunveniz XL 75 mg: This medicinal product is presented as a round,
pink and white coloured bilayer coated prolonged-release tablet
imprinted with “759” with black ink on one side and plain on other
side.
Sunveniz XL 150 mg: This medicinal product is presented as an oval,
pink and white coloured biconvex bilayer coated tablet imprinted with
“758” with black ink on one side and plain on other side.
Blister: Pack sizes 14, 15, 20, 28, 30, 50 or 100 prolonged-release
tablets.
Tablet container: Pack sizes: 30 and 1000 (for dispensing only)
prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the
EEA under the following names:
France:
Venlafaxine SUN LP 37,5 mg / 75 mg / 150 mg,
comprimé à libération prolongée
Germany:
Venlafaxin SUN 37,5 mg / 75 mg/ 150 mg,
Retardtabletten
Italy:
Venlafaxina SUN 37,5 mg / 75 mg / 150 mg,
compressa a rilascio prolungato
Spain:
Venlafaxina SUN 37,5 mg / 75 mg / 150 mg,
comprimido de liberación prolongada
The Netherlands:
Venlafaxine SUN 37,5 mg / 75 mg / 150 mg,
tablet met verlengde afgifte
United Kingdom:
Sunveniz XL 37.5 mg / 75 mg / 150 mg,
prolonged-release tablets
This leaflet was last revised in 03/2013.

044BP1191B

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
carton after “EXP”. The expiry date refers to the last day of that month.
Blisters: Store in the original package in order to protect from moisture.
Tablet container: Keep the tablet container tightly closed in order to
protect from moisture.

Folding
375--2--93.75 mm
248--2 --62 mm

Sunveniz XL-37_5-75-150mg-PIL-248x375mm-EUUK-carved out-REV1-08-03-13
08/03/2013 9:36:00 AM

248 mm

Size: 248x375 mm
Patient Information
SUN EUROPE
EUUK - UNITED KINGDOM

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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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