Medication Guide App

POLITID XL 75MG PROLONGED-RELEASE CAPSULES

Active substance: VENLAFAXINE HYDROCHLORIDE

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Politid XL 75mg Prolonged-release capsules
Politid XL 150mg Prolonged-release capsules
Venlafaxine
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1 What Politid XL is and what it is used for
2 Before you take Politid XL
3 How to take Politid XL
4 Possible side effects
5 How to store Politid XL
6 Further information

1 What Politid XL is and what it is used for

Politid 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.
Politid XL is a treatment for adults with depression. Politid XL 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 atttacks). 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 Before you take Politid XL
Do not take Politid XL:

• If you are allergic to venlafaxine or any of the other ingredients of Politid
XL.
• If you are also taking or have taken any time 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 other medicines, including Politid XL, can cause serious or
even life-threatening side effects. Also, you must wait at least 7 days after
you stop taking Politid XL before you take any MAOI (see also the sections
“Serotonin syndrome” and “Taking other medicines”).

Take special care with Politid XL:

• If you use other medicines that taken concomitantly with Politid XL
could increase the risk of developing serotonin syndrome (see the section
“Taking other medicines”).
• 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 or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
• If you have diabetes. Your treatment for diabetes may have to be adjusted.
Politid 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.
If any of these conditions apply to you, please talk with your doctor before
taking Politid XL.

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 you
first start taking antidepressants, since these medicines all take time to work,
usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• 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.
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.

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.

• Monoamine oxidase inhibitors (MAOIs: see the section “Before you take
Politid 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 to treat depression, for instance 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. Get medical care right away if
you think serotonin syndrome is happening to you.
The following medicines may also interact with Politid 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)
• aloperidol or risperidone (to treat psychiatric conditions)
H
• etoprolol (a beta blocker to treat high blood pressure and heart
M
problems)

Taking Politid XL with food and drink

Politid XL should be taken with food (see section 3 “How to take Politid XL”).
You should avoid alcohol while you are taking
Politid XL.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Politid XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
If you are taking Politid 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 irritability, tremor, floppy muscles (hypotonia) constant crying,
sleeping difficulties, 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 knows you are on Politid 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.
Politid 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
Politid XL.

Driving and using machines

Do not drive or use any tools or machines until you know how Politid XL
affects you.

Important information about some of the ingredients of Politid
XL
The excipient sunset yellow FCF (E110) included in the capsules shell may
cause allergic reactions.
Furthermore this medicine contains sucrose. If you have been told by your
doctor that you have intolerance to some sugars, contact your doctor before
taking this medicinal product.

3 How to take Politid XL
Always take Politid XL exactly as your doctor has told you. You should 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 75mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225mg/day.
Take Politid 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.
Politid XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of
Politid XL may need to be different.
Do not stop taking Politid XL without talking to your doctor (see the section
“If you stop taking Politid XL”).

If you take more Politid XL than you should

Call your doctor or pharmacist immediately if you take more than the
amount of Politid XL prescribed by your doctor.
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, and vomiting.

If you forget to take Politid XL

Use in children and adolescents under
18 years of age

Politid 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 Politid
XL for patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Politid 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 Politid XL. Also, the long-term safety effects
concerning growth, maturation and cognitive and behavioural development
of Politid XL in this age group has not yet been demonstrated.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Your doctor should decide whether you can take Politid 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.

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 Politid XL that has been prescribed
for you in one day.

If you stop taking Politid 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 Politid 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 Politid XL, especially when Politid XL is stopped suddenly or the
dose is reduced too quickly. Some patients may experience symptoms such
as tiredness, dizziness, light-headedness, spinning sensation, 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.
Your doctor will advise you on how you should gradually discontinue Politid
XL treatment. 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 product, ask your doctor
or pharmacist.

Continued top of next column
AAAG2372

Continued over page

Venlafaxine SR (PHARMAPACK TRANSFER) All Strengths, PIL, United Kingdom
item no:

AAAG2372

dimensions:

print proof no:

3

pharmacode:

origination date: 29.11.12

min pt size:

190 x 380

2.
3.
4.

7 pt

5.
6.

originated by:
approved for print/date

colours/plates:
1. black

db

revision date:

13.12.13

Technical Approval

revised by:

db

date sent:

supplier:

Dupnitsa

technically app. date: 10.12.13

29.11.13

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

4 Possible side effects

5 How to store Politid XL

Like all medicines, Politid XL can cause side effects, although not everybody
gets them.
Do not be concerned if you see small white granules or balls in your
stools after taking Politid XL. Inside Politid 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.

6 Further information
What Politid XL contains

The active substance is venlafaxine.
[For 75mg strength]: Each capsule contains venlafaxine hydrochloride
equivalent to 75mg of venlafaxine.
[For 150mg strength]: Each capsule contains venlafaxine hydrochloride
equivalent to 150mg of venlafaxine.
The other ingredients are:
Contents of the capsule:
Sugar spheres (contains sucrose, maize starch), Hydroxypropylcellulose,
Hypromellose, Talc,
Ethyl cellulose, Dibutyl sebacate, Oleic acid,
Colloidal anhydrous silica.

Allergic reactions

If any of the following happen, do not take more Politid 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, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)

Serious side effects

If you notice any signs of the following, you may need urgent medical
attention:
• 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 euphoria
• Treatment withdrawal (see the section “How to take Politid XL, if you stop
taking Politid XL”).

Capsule shell:
Gelatin, Sodium lauryl sulphate, Sunset yellow FCF (E110), Quinoline yellow
(E104), Titanium dioxide (E171).
150mg strength also contains Patent Blue V (E131)

What Politid XL looks like and contents of the pack

Politid XL 75mg Prolonged-release Capsules:
White to off-white granules in a capsule size “1” with a yellow cap and
transparent body.
Politid XL 150mg Prolonged-release Capsules:
White to off-white granules in a capsule size “0” with a buff cap and
transparent body.
Available in packs of 28 prolonged-release capsules, packed in PVC/
aluminium blister.

Complete side effect listing

The frequency (likelihood of occurring) of side effects is classified as follows:
Very common
Common
Uncommon
Rare
Not known

Keep out of the reach and sight of children.
Do not use Politid XL after the expiry date which is stated on the pack. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
F
requency cannot be estimated from the available data

• Blood disorders
Uncommon: bruising; black tarry stools (faeces) or blood in stools, which
can be a sign of internal bleeding
Not known: reduced number of platelets in your blood, leading to an
increased risk of bruising or bleeding; blood disorders which may lead to
an increased risk of infection
• Metabolism/nutritional disorders
Common: weight loss; increased cholesterol
Uncommon: weight gain
Not known: 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
• Nervous system disorders
Very common: dry mouth; headache
Common: abnormal dreams; decreased libido; dizziness; increased
muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor;
confusion; feeling separated (or detached) from yourself and reality
Uncommon: lack of feeling or emotion; hallucinations; involuntary
movement of the muscles; agitation; impaired coordination and balance
Rare: a sensation of restlessness or an inability to sit or stand still; seizures
or fits; feeling overexcited or euphoric
Not known: 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, spinning sensation, (vertigo),
aggression
• Sight and hearing disorders
Common: blurred vision
Uncommon: altered taste sensation; ringing in the ears (tinnitus)
Not known: severe eye pain and decreased or blurred vision
• Heart or circulation disorders
Common: increase in blood pressure; flushing; palpitations
Uncommon: feeling dizzy (particularly when standing up too quickly),
fainting, fast heartbeat
Not known: decrease in blood pressure; abnormal, rapid or irregular heart
beat, which could lead to fainting
• Breathing disorders
Common: yawning
Not known: 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)
• Digestive disorders
Very common: nausea
Common: appetite decreased; constipation; vomiting
Uncommon: grinding of the teeth; diarrhoea
Not known: severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
• Skin disorders
Very common: sweating (including night sweats)
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe blistering and peeling of
the skin; itching; mild rash
• Muscle disorders
Not known: unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
• Urinary system disorders
Common: difficulties passing urine; increased frequency in urination
Uncommon: inability to pass urine
Rare: involuntary passing of urine
• Reproductive and sexual disorders
Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile
dysfunction (impotence); menstrual irregularities such as increased
bleeding or increased irregular bleeding
Uncommon: abnormal orgasm (females)
• General
Common: weakness (asthenia); chills
Uncommon: swelling caused by fluid build up, sensitivity to sunlight
Not known: swollen face or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a serious allergic reaction)
Politid 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, Politid 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 Politid XL for a long
time.

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer:
BALKANPHARMA – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
or
PharmaPack International B.V.
Bleiswijkseweg 51
2712 PB Zoetermeer
The Netherlands
This leaflet was last revised in December 2013.

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

Continued top of next column
AAAG2372

Actavis, Barnstaple, EX32 8NS, UK

Venlafaxine SR (PHARMAPACK TRANSFER) All Strengths, PIL, United Kingdom
item no:

AAAG2372

dimensions:

print proof no:

3

pharmacode:

origination date: 29.11.12

min pt size:

190 x 380

2.
3.
4.

7 pt

5.
6.

originated by:
approved for print/date

colours/plates:
1. black

db

revision date:

13.12.13

Technical Approval

revised by:

db

date sent:

supplier:

Dupnitsa

technically app. date: 10.12.13

29.11.13

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Politid XL 75mg Prolonged-release capsules
Politid XL 150mg Prolonged-release capsules
Venlafaxine

Read all of this leaflet carefully before you start
taking this medicine.
· Keep this leaflet. You may need to read it again.
· If you have any further questions, ask your
doctor or pharmacist.
· This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
· If any of the side effects gets serious or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Use in children and adolescents under
18 years of age

Politid 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 Politid XL for patients under 18 because
he/she decides that this is in their best interests. If
your doctor has prescribed Politid 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 Politid
XL. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Politid XL in this age group has not
yet been demonstrated.

In this leaflet:
1 What Politid XL is and what it is used
for
2 Before you take Politid XL
3 How to take Politid XL
4 Possible side effects
5 How to store Politid XL
6 Further information

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Your doctor should decide whether you can take
Politid 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 (MAOIs: see the
section “Before you take Politid 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 to treat depression, for instance 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. Get medical care right away if you
think serotonin syndrome is happening to you.
The following medicines may also interact with
Politid 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)

1 What Politid XL is and what it is used
for

Politid 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.
Politid XL is a treatment for adults with depression.
Politid XL 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 atttacks).
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 Before you take Politid XL
Do not take Politid XL:

· If you are allergic to venlafaxine or any of the other
ingredients of Politid XL.
· If you are also taking or have taken any time
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 other
medicines, including Politid XL, can cause serious
or even life-threatening side effects. Also, you
must wait at least 7 days after you stop taking
Politid XL before you take any MAOI (see also the
sections “Serotonin syndrome” and “Taking other
medicines”).

Take special care with Politid XL:

· If you use other medicines that taken
concomitantly with Politid XL could increase the
risk of developing serotonin syndrome (see the
section “Taking other medicines”).
· 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 or bipolar disorder (feeling overexcited or euphoric).
· If you have a history of aggressive behaviour.
· If you have diabetes. Your treatment for diabetes
may have to be adjusted.

Taking Politid XL with food and drink

Politid XL should be taken with food (see section 3
“How to take Politid XL”).
You should avoid alcohol while you are taking
Politid XL.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are
trying to become pregnant. You should use Politid XL
only after discussing the potential benefits and the
potential risks to your unborn child with your doctor.
If you are taking Politid 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 irritability, tremor,
floppy muscles (hypotonia) constant crying, sleeping
difficulties, 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 knows you
are on Politid 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.
Politid 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 Politid XL.

Politid 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.
If any of these conditions apply to you, please talk
with your doctor before taking Politid XL.

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
you first start taking antidepressants, since these
medicines all take time to work, usually about two
weeks, but sometimes longer.
You may be more likely to think like this:
· If you have previously had thoughts about killing
yourself or harming yourself.
· 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.
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.

Driving and using machines

Do not drive or use any tools or machines until you
know how Politid XL affects you.

Important information about some of the
ingredients of Politid XL
The excipient sunset yellow FCF (E110) included in
the capsules shell may cause allergic reactions.
Furthermore this medicine contains sucrose. If
you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicinal product.

3 How to take Politid XL
Always take Politid XL exactly as your doctor has told
you. You should 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 75mg per day. The dose can be
raised by your doctor gradually, and if needed, even
up to a maximum dose of 375mg daily for depression.
If you are being treated for panic disorder, your
doctor will start with a lower dose (37.5mg) and then
increase the dose gradually. The maximum dose for
generalised anxiety disorder, social anxiety disorder
and panic disorder is 225mg/day.
Take Politid 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.
Politid XL should be taken with food.
If you have liver or kidney problems, talk to your
doctor, since your dose of Politid XL may need to be
different.

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.

Continued top of next column
AAAE5975

Continued over page

Venlafaxine SR (Politid XL) 75mg & 150mg 28 Capsules PIL - UK
item no:
print proof no:
origination date:

AAAE5975
2
29.11.12

originated by:
approved for print/date

17.12.12

160x420

revised by:
supplier:

DR
Pharmapack

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

colours/plates:
1. Black

Non Printing Colours

Technical Approval
date sent:

29.11.12

technically app. date:

17.12.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

• Heart or circulation disorders
Common: increase in blood pressure; flushing;
palpitations
Uncommon: feeling dizzy (particularly when
standing up too quickly), fainting, fast heartbeat
Not known: decrease in blood pressure; abnormal,
rapid or irregular heart beat, which could lead to
fainting
• Breathing disorders
Common: yawning
Not known: 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)
• Digestive disorders
Very common: nausea
Common: appetite decreased; constipation;
vomiting
Uncommon: grinding of the teeth; diarrhoea
Not known: severe abdominal or back pains (which
could indicate a serious problem in the gut, liver or
pancreas)
• Skin disorders
Very common: sweating (including night sweats)
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe
blistering and peeling of the skin; itching; mild rash
• Muscle disorders
Not known: unexplained muscle pain, tenderness or
weakness (rhabdomyolysis)
• Urinary system disorders
Common: difficulties passing urine; increased
frequency in urination
Uncommon: inability to pass urine
Rare: involuntary passing of urine
• Reproductive and sexual disorders
Common: abnormal ejaculation/orgasm (males);
lack of orgasm; erectile dysfunction (impotence);
menstrual irregularities such as increased bleeding
or increased irregular bleeding
Uncommon: abnormal orgasm (females)
• General
Common: weakness (asthenia); chills
Uncommon: swelling caused by fluid build up,
sensitivity to sunlight
Not known: swollen face or tongue, shortness of
breath or difficulty breathing, often with skin rashes
(this may be a serious allergic reaction)
Politid 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, Politid 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 Politid XL for a long time.

Do not stop taking Politid XL without talking to your
doctor (see the section “If you stop taking Politid XL”).

If you take more Politid XL than you should
Call your doctor or pharmacist immediately if you
take more than the amount of Politid XL prescribed
by your doctor.
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, and vomiting.

If you forget to take Politid 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 Politid XL that
has been prescribed for you in one day.

If you stop taking Politid 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 Politid 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 Politid XL, especially when Politid XL is stopped
suddenly or the dose is reduced too quickly. Some
patients may experience symptoms such as tiredness,
dizziness, light-headedness, spinning sensation,
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.
Your doctor will advise you on how you should
gradually discontinue Politid XL treatment. 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
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Politid XL can cause side effects,
although not everybody gets them.
Do not be concerned if you see small white
granules or balls in your stools after taking Politid
XL. Inside Politid 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.

Allergic reactions

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

If any of the following happen, do not take more
Politid 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, throat, hands, or feet
· Feeling nervous or anxious, dizziness, throbbing
sensations, sudden reddening of the skin and/or a
warm feeling
· Severe rash, itching, or hives (elevated patches of
red or pale skin that often itch)

5 How to store Politid XL

Keep out of the reach and sight of children.
Do not use Politid XL after the expiry date which is
stated on the pack. The expiry date refers to the last
day of that month.
This medicine does not require any special storage
conditions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

Serious side effects

If you notice any signs of the following, you may need
urgent medical attention:
· 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
euphoria
· Treatment withdrawal (see the section “How to take
Politid XL, if you stop taking Politid XL”).

6 Further information
What Politid XL contains

The active substance is venlafaxine.
[For 75mg strength]: Each capsule contains
venlafaxine hydrochloride equivalent to 75mg of
venlafaxine.
[For 150mg strength]: Each capsule contains
venlafaxine hydrochloride equivalent to 150mg of
venlafaxine.
The other ingredients are:
Contents of the capsule:
Sugar spheres (contains sucrose, maize starch),
Hydroxypropylcellulose, Hypromellose, Talc,
Ethyl cellulose, Dibutyl sebacate, Oleic acid,
Colloidal anhydrous silica.

Complete side effect listing

The frequency (likelihood of occurring) of side effects
is classified as follows:
Very common
Common
Uncommon
Rare
Not known

Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
Frequency cannot be estimated from
the available data

Capsule shell:
Gelatin, Sodium lauryl sulphate, Sunset yellow FCF
(E110), Quinoline yellow (E104), Titanium dioxide
(E171).

• Blood disorders
Uncommon: bruising; black tarry stools (faeces)
or blood in stools, which can be a sign of internal
bleeding
Not known: reduced number of platelets in your
blood, leading to an increased risk of bruising or
bleeding; blood disorders which may lead to an
increased risk of infection
• Metabolism/nutritional disorders
Common: weight loss; increased cholesterol
Uncommon: weight gain
Not known: 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
• Nervous system disorders
Very common: dry mouth; headache
Common: abnormal dreams; decreased libido;
dizziness; increased muscle tonus; insomnia;
nervousness; pins and needles; sedation; tremor;
confusion; feeling separated (or detached) from
yourself and reality
Uncommon: lack of feeling or emotion;
hallucinations; involuntary movement of the
muscles; agitation; impaired coordination and
balance
Rare: a sensation of restlessness or an inability to sit
or stand still; seizures or fits; feeling overexcited or
euphoric
Not known: 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, spinning sensation,
(vertigo), aggression
• Sight and hearing disorders
Common: blurred vision
Uncommon: altered taste sensation; ringing in the
ears (tinnitus)
Not known: severe eye pain and decreased or
blurred vision

150mg strength also contains Patent Blue V (E131)

What Politid XL looks like and contents of
the pack

Politid XL 75mg Prolonged-release Capsules:
White to off-white granules in a capsule size “1” with a
yellow cap and transparent body.
Politid XL 150mg Prolonged-release Capsules:
White to off-white granules in a capsule size “0” with a
buff cap and transparent body.
Available in packs of 28 prolonged-release capsules,
packed in PVC/ aluminium blister.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer:
BALKANPHARMA – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
or
PharmaPack International B.V.
Bleiswijkseweg 51
2712 PB Zoetermeer
The Netherlands
This leaflet was last revised in November 2012.

Continued top of next column
AAAE5975

Actavis, Barnstaple, EX32 8NS, UK

Venlafaxine SR (Politid XL) 75mg & 150mg 28 Capsules PIL - UK
item no:
print proof no:
origination date:

AAAE5975
2
29.11.12

originated by:
approved for print/date

17.12.12

160x420

revised by:
supplier:

DR
Pharmapack

2.
3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:

dimensions:

colours/plates:
1. Black

Non Printing Colours

Technical Approval
date sent:

29.11.12

technically app. date:

17.12.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Expand view ⇕

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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