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POLITID XL 75MG PROLONGED-RELEASE CAPSULES

Active substance(s): 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 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 Politid XL is and what it is used for
2 What you need to know before you take Politid XL
3 How to take Politid XL
4 Possible side effects
5 How to store Politid XL
6 Contents of the pack and oher 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 attacks). Treating depression or anxiety disorders properly is important to
help you get better. If it is not treated, your condition may not go away and may
become more serious and more difficult to treat.

2 What you need to know before you take Politid XL
Do not take Politid XL:

• I f you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6)..
• If you are also taking or have taken within the last 14 days any medicines
known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat
depression or Parkinson’s disease. Taking an irreversible MAOI together with
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 “Other medicines and Politid
XL”).

Warnings and precautions

If any of the following apply to you, please tell your doctor before taking:
• If you use other medicines that taken together with Politid XL could increase
the risk of developing serotonin syndrome (see the section “Other medicines
and Politid 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.
Politid XL may cause a sensation of restlessness or an inability to sit or stand
still during the first few weeks of treatment. You should tell your doctor if this
happens to you.

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

Other medicines and Politid XL

Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Your doctor should decide whether you can take 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 which are used to treat depression or Parkinson’s
disease must not be taken with Politid 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 Politid XL).
• Serotonin syndrome:
Serotonin syndrome, a potentially life•threatening condition or Neuroleptic
Malignant Syndrome (NMS)-like reactions (see the section “Possible side
effects”), may occur with venlafaxine treatment, particularly when taken with
other medicines. Examples of these medicines include:
- Triptans (used for migraine)
- Other medicines to treat depression, for instance 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 methadone (used to treat opioid drug addiction or
severe pain)
- Medicines containing dextromethorphan (used to treat coughing)
- Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)
- Products containing St. John’s Wort (also called Hypericum perforatum, a
natural or herbal remedy used to treat mild depression)
- Products containing tryptophan (used for problems such as sleep and
depression)
- Antipsychotics (used to treat a disease with symptoms such as hearing,
seeing or sensing things which are not there, mistaken beliefs, unusual
suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of
the following: restlessness, hallucinations, loss of coordination, fast heartbeat,
increased body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant
Syndrome (NMS). Signs and symptoms of NMS may include a combination of
fever, fast heartbeat, sweating, severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you.
You must tell your doctor if you are taking medicines that can affect your heart
rhythm. Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to
treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (See also Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial
infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with 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)
•M
 etoprolol (a beta blocker to treat high blood pressure and heart problems)

Taking Politid XL with food, drink and alcohol

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

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.
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 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.
If you are taking this medicine during pregnancy, other symptoms your baby
might have when it is born is not feeding properly, in addition to having
trouble breathing. If your baby has these symptoms when it is born and you are
concerned, contact your doctor and/or midwife who will be able to advise you.
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.
Politid XL 75mg and 150mg contains sunset yellow FCF (E110)
The excipient sunset yellow FCF (E110) included in the capsules shell may cause
allergic reactions.

Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of tooth decay (caries). Therefore, you should take special care in
your dental hygiene.

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.

Diabetes

3 How to take Politid XL

Your blood glucose levels may be altered due to Politid XL. Therefore, the dosage
of your diabetes medicines may need to be adjusted.

Children and adolescents

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 this medicine for
patients under 18 because he/she decides that this is in their best interests. If
your doctor has prescribed this medicine for a patient under 18, and you want
to discuss this, please go back to your doctor. You should inform your doctor
if any of the symptoms listed above develop or worsen when patients under
18 are taking Politid XL. Also, the long•term safety effects concerning growth,
maturation and cognitive and behavioural development of this medicine in this
age group has not yet been demonstrated.

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression, generalised
anxiety disorder and social anxiety disorder is 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.

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AAAH4412

Continued over page

Venlafaxine SR All Strengths Capsules PIL UK

1. black

item no:

AAAH4412

dimensions: 190 x 380

print proof no:

2

pharmacode:

origination date: 21.11.14
approved for print/date

colours/plates:

min pt size:

2.
3.
4.

7 pt

originated by:

db

revision date:

28.11.14

Technical Approval

revised by:

db

date sent:

21.11.14

supplier:

Dupnitsa

approved:

24.11.14

5.
6.
Non Printing Colours
1.
2.
3.

Politid XL should be taken with food.

Not known (frequency cannot be estimated from the available data)

If you have liver or kidney problems, talk to your doctor, since your dose of
Politid XL may need to be different.

• 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
• Swollen face or tongue, shortness of breath or difficulty breathing, often with
skin rashes (this may be a serious allergic reaction)
• 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 Politid XL’)
• Disorientation and confusion often accompanied by hallucination (delirium);
aggression
• 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 serotonin syndrome; 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 heartbeat, 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
• Skin rash, which may lead to severe blistering and peeling of the skin; itching;
mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production

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
a double dose to make up for the forgotten dose.

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 medicine, ask your doctor or
pharmacist.

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 Politid XL. Tell your doctor
immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• S welling 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)
• Signs and symptoms of serotonin syndrome which may include restlessness,
hallucinations, loss of coordination, fast heartbeat, increased body temperature,
fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea,
vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant
Syndrome (NMS). Signs and symptoms of NMS may include a combination of
fever, fast heartbeat, sweating, severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).
Serious side effects
• Other side effects that you should tell your doctor about include: Coughing,
wheezing, shortness of breath and high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder,
seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria
• Withdrawal effects (see the section “How to take Politid XL, if you stop taking
Politid XL”).
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 stomach. As the spheroids travel
the length of your stomach, 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.

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 of 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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of
this medicine.

5 How to store Politid 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 carton,
blister and bottle. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.

6 Contents of the pack and other information
What 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

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

Very common (may affects more than 1 in 10 people)

150mg strength also contains Patent Blue V (E131)

• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)

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.

Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to
automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
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 movements 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 General swelling of the skin especially the face, mouth,
tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be
present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss

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 2014.

Rare (may affect up to 1 in 1,000 people)
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)

Continued top of next column
AAAH4412

Actavis, Barnstaple, EX32 8NS, UK

Venlafaxine SR All Strengths Capsules PIL UK

1. black

item no:

AAAH4412

dimensions: 190 x 380

print proof no:

2

pharmacode:

origination date: 21.11.14
approved for print/date

colours/plates:

min pt size:

2.
3.
4.

7 pt

originated by:

db

revision date:

28.11.14

Technical Approval

revised by:

db

date sent:

21.11.14

supplier:

Dupnitsa

approved:

24.11.14

5.
6.
Non Printing Colours
1.
2.
3.

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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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