PAROXETINE 40 MG TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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PATIENT INFORMATION LEAFLET

Paroxetine 20mg and 40mg Tablets
Paroxetine
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
2
3

What Paroxetine is and what it is used for
Before you take Paroxetine
How to take Paroxetine

4
5
6

Possible side effects
How to store Paroxetine
Further information

Using other medicines
Certain other medicines may influence the effect of
Paroxetine, or Paroxetine may influence their effects. Some
Paroxetine belongs to a group of medicines called selective
of the medicines in question are listed below:
serotonin reuptake inhibitors (SSRIs), which are antidepressants.
Tricyclic antidepressant (against depression) e.g.
clomipramine, nortriptyline and desipramine
Paroxetine is used in the treatment of:
SSRI’s e.g. citalopram and fluoxetine
Depressive illness (major depressive episodes)
L−tryptophan (against sleep disturbances)
Obsessive compulsive disorder (compulsive thoughts
MAO−inhibitors (e.g. against depression or Parkinson)
and compulsive actions) OCD
Lithium (antipsychotic)
Panic disorder with or without agoraphobia (e.g. fear of
St. John’s Wort (Hypericum perforatum)
leaving the house, entering shops, or fear of public places)
Triptans (against migraine)
Social phobia
Tramadol and pethidine (potent painkiller)
Generalised anxiety disorder
Fentanyl (used in anaesthesia or to treat chronic pain)
Post−traumatic stress disorder
Linezolid (antibiotic)
Concomitant use of above mentioned medicinal products
2
Before you take Paroxetine
may e.g. lead to "serotonine syndrome" by potentiating
serotonergic effects of Paroxetine (see "Do not take
Do not take Paroxetine
Paroxetine" and "Take special care with Paroxetine").
if you are allergic to paroxetine, or any of the other
Your doctor will want to monitor you more closely.
ingredients of the product.
Perphenazine, risperidone, thioridazine, pimozide and
if you are taking the medicines MAO−inhibitors (e.g.
clozapine (antipsychotics)
against depression) concomitantly or have taken
Propafenone and flecainide (against irregular heart rhythm)
MAO−inhibitors within the two last weeks.
Metoprolol (heart medicines)
An exception is moclobemide and linezolid where
Concomitant use of above mentioned medicinal
Paroxetine treatment can be initiated after 24 hours. At
products may lead to an increased rate of side effects
least one week should elapse between discontinuation of
of these such as cardiac effects, which in some cases
Paroxetine and initiation of therapy with any MAO−inhibitor.
may be severe (see "Do not take Paroxetine").
if you take thioridazine (antipsychotic agent) concomitantly
Phenobarbital, carbamazepine and phenytoin (against
if you take pimozide (antipsychotic agent) concomitantly
epilepsy)
Rifampicin (antibiotic)
Take special care with Paroxetine:
Concomitant use of above mentioned medicinal
Use in children and adolescents under 18 years of age
products may weaken the effect of Paroxetine by
Paroxetine should not normally be used for children and
increasing the metabolism of paroxetine.
adolescents under 18. Clinical trials have shown that
NSAIDs (e.g. ibuprofen, diclofenac), COX−2 inhibitors
patients under 18 have an increased risk of side effects
and acetylsalicylic acid (aspirin) (painkillers)
such as suicide attempt, suicidal thoughts and hostility
Warfarin or other medicines used to prevent blood clotting
(predominantly aggression, oppositional behaviour and
Clozapine, phenothiazines (antipsychotics) and most
anger) when they take this class of medicines.
tricyclic antidepressants (against depression)
Despite this, your doctor may prescribe Paroxetine for
Concomitant use of above mentioned medicinal
patients under 18 because he/she decides that this is
products may lead to increased/prolonged bleeding
in their best interest. If your doctor has prescribed
(see "Take special care with Paroxetine").
Paroxetine for a patient under 18 and you want to discuss
Procyclidine (against Parkinson disease). Increased
this, please go back to your doctor.
side effects of procyclidine may occur by increasing the
You should inform your doctor if any of the listed above
concentration of procyclidine in the blood.
develop or worsen when patients under 18 are taking
Tamoxifen, (to treat breast cancer or fertility problems).
Paroxetine. Also, the long−term safety effects concerning
Concomitant use may reduce the effectiveness of
growth, maturation and cognitive and behavioural
tamoxifen.
development of this age group have not yet been
Combination of fosamprenavir and ritonavir (to treat HIV
demonstrated.
infection)
Thoughts of suicide and worsening of your
Atomoxetine (to treat attention deficit hyperactivity
depression or anxiety disorder
disorder (ADHD))
If you are depressed and/or have anxiety disorders you
Please tell your doctor or pharmacist if you are taking or
can sometimes have thoughts of harming or killing
have recently taken any other medicines, including
yourself. These may be increased when first starting
medicines obtained without a prescription.
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
Taking Paroxetine with food and drink
You may be more likely to think like this:
Alcohol: The combination of Paroxetine and alcohol is not
− if you have previously had thoughts about killing or
recommended.
harming yourself.
Pregnancy and breast−feeding
− if you are a young adult.
Information from clinical trials has shown an increased Ask your doctor or pharmacist for advice before taking any
medicine.
risk of suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were treated with Pregnancy:
Talk to your doctor as soon as possible if you are planning to
an antidepressant.
− If you have thoughts of harming or killing yourself at any get pregnant or if you are already pregnant.
time, contact your doctor or go to a hospital straight In babies whose mothers took Paroxetine during the first few
away.
months of pregnancy, there have been some reports showing
an increased risk of birth defects, in particular those affecting
You may find it helpful to tell a relative or close friend that
the heart. In the general population, about 1 in 100 babies are
you are depressed or have an anxiety disorder, and ask
born with a heart defect. This increased to about 2 in 100
them to read this leaflet. You might ask them to tell you if
babies in mothers who took Paroxetine. You and your doctor
they think your depression or anxiety is getting worse, or if
may decide that it is better for you to gradually stop taking
they are worried about changes in your behaviour.
Paroxetine while you are pregnant. However, depending on
Withdrawal symptoms seen on a discontinuation of a
your circumstances, your doctor may suggest that it is better for
selective serotonin reuptake inhibitor (SSRI)
you to keep taking Paroxetine.
When you stop taking Paroxetine, especially if it is abruptly,
Make sure your midwife and/or doctor know you are on
you may feel discontinuation symptoms (see "How to
take Paroxetine" and "Possible side effects"). These are Paroxetine. When taken during pregnancy, particularly in the
last 3 months of pregnancy, medicines like Paroxetine may
common when treatment is stopped. The risk is higher,
increase the risk of a serious condition in babies, called
when Paroxetine has been used for a long time or in a
persistent pulmonary hypertension of the new born (PPHN),
high doses or when the dose is reduced too quickly.
making the baby breathe faster and appear bluish. These
Most people find that the symptoms are mild and go
symptoms usually begin during the first 24 hours after the
away on their own within two weeks. However, in some
baby is born. If this happens to your baby you should contact
patients they may be severe in intensity or they may be
your midwife and/or doctor immediately.
prolonged (2−3 months or more).

1

What Paroxetine is and what it
is used for

If you get severe discontinuation symptoms when you
stop taking Paroxetine, please contact your doctor. He or
she may ask you to start taking your tablets again and
come off them more slowly.
Check with your doctor if:
you develop symptoms such as inner sense of
restlessness and psychomotor agitation such as an
inability to sit or stand still usually associated with
subjective distress (akathisia). This is most likely to
occur within the first few weeks of treatment. Increasing
the dose of Paroxetine may make these feelings worse
(see section "Possible side effects").
you develop symptoms such as high fever, muscle
cramps, confusion and anxiety since these symptoms
could be a sign of so called "serotonin syndrome".
Therefore Paroxetine should not be used in combination
with other medicines with serotonergic effects such as
sumatriptan or other triptans (certain migraine medicines),
tramadol, linezolid, other SSRIs, lithium and St. John’s
Wort (Hypericum perforatum), oxitriptan and tryptophan.
you have a history of mania (overactive behaviour or
thoughts). If you are entering a manic phase, you should
stop taking Paroxetine.
Ask your doctor for advice.
you have heart, liver or kidney problems. In patients
with severe kidney disorder or those with liver disorder
a dose reduction is recommended.
you have diabetes. Paroxetine can raise or lower your
blood sugar. The dose of your insulin or anti−diabetes
medicine taken orally may need to be adjusted.
you have epilepsy. If you develop seizures during treatment
with Paroxetine, you should contact your doctor.
your treatment for depression is electro convulsive
therapy, (ECT).
you have glaucoma (elevated pressure in your eyes)
you are at risk of a decreased sodium level in the blood
(hyponatraemia) e.g. from concomitant medications and
cirrhosis. Hyponatraemia has been reported rarely during
treatment with Paroxetine, predominantly in the elderly.
you have a history of bleeding disorder e.g. cutaneous
bleeding abnormalities, gynaecological or haemorrhage
from the stomach or if you use medicines which possibly
increase tendency to bleed (see section "Taking other
medicines").
Please consult your doctor, even if these statements were
applicable to you at any time in the past.

If you are taking Paroxetine in the last 3 months of pregnancy
your newborn baby might also have other conditions which
usually begin during the first 24 hours after birth. Symptoms
include not being able to sleep or feed properly, trouble with
breathing, a blue−ish skin or being too hot or cold, being sick,
crying a lot, stiff or floppy muscles, tiredness, lack of energy,
trembling of the body, jitters or fits. If your baby has any of
these symptoms when it is born, contact your doctor who will
be able to advise you.
Breast−feeding:
Although small amounts of Paroxetine pass into breast milk,
studies did not show any effect on babies. You and your
doctor may decide that you can breast−feed while you are
taking Paroxetine.
Fertility:
Paroxetine has been shown to reduce the quality of sperm
in animal studies. Theoretically, this could affect fertility,
but impact on human fertility has not been observed as yet.
Driving and using machines
Paroxetine may cause side effects (such as feeling dizzy,
sleepy, or confused) that affect how well you concentrate
and how quickly you can react. If you get these side effects,
do not drive or operate machines, or anything else where
you need to be alert and concentrate.

3

How to take Paroxetine

Always take Paroxetine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
The tablets should be taken in the morning with your breakfast.
Drink a glass of water with your medicine. The tablet or
tablet halves should be swallowed rather than chewed.
The usual dose is:
Adults
Depression
The recommended dose is 20 mg daily. Depending on your
response, the dose may be increased gradually up to a
maximum dose of 50 mg daily in 10 mg steps. In general,
improvement in patients starts after one week but may only
become evident from the second week of therapy. The
treatment should be continued for several months.
continued....

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Obsessive thoughts and obsessive actions (OCD)
The initial dose is 20 mg daily. Depending on your
response, the dose may be increased gradually to 40 mg
daily in 10 mg steps. The recommended dose is 40 mg
daily. The maximum dose is 60 mg daily. The treatment
should be continued for several months.
Panic disorder
The initial dose is 10 mg daily. Depending on your
response, the dose may be gradually increased to 40 mg
daily in 10 mg steps. The recommended dose is 40 mg
daily. The maximum dose is 60 mg daily. The treatment
should be continued for several months.
Social phobia, generalised anxiety disorder and post−
traumatic stress disorder
The recommended dose is 20 mg daily. Depending on your
response, the dose may be increased gradually to 50 mg in
10 mg steps. The maximum dose is 50 mg daily.
Elderly (more than 65 years)
Depending on your response the dose may be increased to
40 mg daily. The maximum dose is 40 mg daily.
Severe decreased kidney function
Your doctor prescribes a suitable dose for you.
Decreased liver function
Your doctor prescribes a suitable dose for you.
If you take more Paroxetine than you should
If you have taken more Paroxetine than you should, talk to
your doctor or pharmacist, or contact with the nearest
hospital. Symptoms of overdose are e.g. being sick, fever,
headache and involuntary muscle contractions.
If you forget to take Paroxetine
If you forget to take a dose, and you remember before you
go to bed, take it straight away. Carry on as usual the next
day.
If you only remember during the night, or the next day,
leave out the missed dose. You may possibly get
withdrawal effects, but these should go away after you take
your next dose at the usual time.
If you stop taking Paroxetine
Do not stop taking Paroxetine until your doctor tells you to,
even if you feel better.
If you stop suddenly after taking this medicine for a long
time you can experience withdrawal effects.
When stopping treatment with Paroxetine the dose should
be gradually reduced over a period of several weeks or 2 −
3 months or more in order to reduce the risk of withdrawal
reactions (for withdrawal symptoms see section "Possible
side effects"). One way of doing this is to gradually reduce
the dose of Paroxetine you take by 10 mg a week. If
intolerable symptoms occur following a decrease in the
dose or upon discontinuation of treatment, your doctor may
ask you to start taking you tablets again and come off them
more slowly. If you have any further questions on the use of
this product, ask your doctor or pharmacist.
What to do if you feel no better
Paroxetine will not relieve your symptoms straight away − all
antidepressants take time to work. Some people will start to
feel better within a couple of weeks, but for others it may
take a little longer. Some people taking antidepressants
feel worse before feeling better. If you do not start to feel
better after a couple of weeks, go back to your doctor who
will advise you. Your doctor should ask to see you again a
couple of weeks after you first start treatment. Tell your
doctor if you have not started to feel better.

4

Possible side effects

Like all medicines, Paroxetine can cause side effects,
although not everybody gets them.
You should see your doctor immediately if you experience
symptoms such as:
swollen face, tongue and/or throat and/or difficulty
to swallow or itchy rash together with difficulties to
breathe (angioedema)
high fever, muscle cramps, confusion and anxiety
since these symptoms could be a sign of so called
"serotonin syndrome"
If you develop suicidal thoughts or suicidal ideation
during treatment with Paroxetine, especially in the first
2−4 weeks, you should contact your doctor immediately.
Other side effects
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.
Frequencies are defined as:
very common (occurs in more than one in 10 patients),
common (occurs in more than one in 100, but less than one
in 10 patients),
uncommon (occurs in more than one in 1000, but less than
one in 100 patients),
rare (occurs in more than one in 10,000, but less than one
in 1000 patients),
very rare (occurs in less than one in 10,000 patients,
including isolated reports).
not known (cannot be estimated from the available data).
Blood and lymphatic system disorders
Uncommon: abnormal bleeding, predominantly of the skin
and mucous membranes (mostly ecchymosis)
Very rare: deficiency of blood platelets
Immune system disorders
Very rare: allergic reactions including nettle rash (urticaria)
and swelling of the face, lips, tongue or throat with difficulty
to breathe or swallow (angioedema)
Hormone (endocrine) disorders
Very rare: syndrome of inappropriate anti−diuretic hormone
secretion (SIADH)
Metabolism and nutrition disorders
Common: decreased appetite, increase in cholesterol levels
Rare: reduced sodium level in the blood (hyponatraemia).
Hyponatraemia has been reported predominantly in elderly
patients and is sometimes due to syndrome of inappropriate
anti−diuretic hormone secretion (SIADH).
Psychiatric disorders
Common: somnolence, insomnia, agitation, abnormal
dreams (including nightmares)
Uncommon: confusion, hallucinations
Rare: overactive behaviour or thoughts (manic reactions),
anxiety, feeling detached from yourself (depersonalisation),
panic attacks, feeling restless and unable to sit or stand still
(akathisia)
Frequency not known: Cases of suicidal ideation and
suicidal behaviours have been reported during paroxetine
therapy or early after treatment discontinuation (see section
’Take special care with Paroxetine’). These symptoms may
also be due to the underlying disease.

Cardiac disorders
Uncommon: rapid heart rate
Rare: slow heart rate
Vascular disorders
Uncommon: temporary increases or decreases in blood
pressure, especially when going from lying or sitting
position to standing up and usually in patients with pre−
existing high blood pressure (hypertension) or anxiety.
Respiratory, thoracic and mediastinal disorders
Common: yawning
Gastrointestinal disorders
Very common: feeling sick (nausea)
Common: constipation, diarrhoea, dry mouth, being sick
Very rare: bleeding in the stomach or intestine
Liver/bile (hepato−biliary disorders)
Rare: elevation of liver enzymes
Very rare: liver disorder (such as hepatitis, sometimes
associated with jaundice and/or liver failure)
Skin and subcutaneous tissue disorders
Common: sweating
Uncommon: skin rashes, itching
Very rare: hypersensitivity to sunlight
Renal and urinary disorders
Uncommon: inability to urinate (urinary retention) or an
uncontrollable, involuntary passing of urine (urinary
incontinence).
Reproductive system and breast disorders
Very common: sexual dysfunction
Rare: too much of prolactin, a lactation hormone, in the
blood (hyperprolactinaemia), breast discharge
Very rare: painful erection of the penis that won’t go away
Musculoskeletal and connective tissue disorders
Rare: joint pain, muscle pain
An increased risk of bone fractures has been observed in
patients taking this type of medicine.
General disorder and administration site conditions
Common: general disability, body weight gain
Very rare: swelling of the tissue caused by fluid retention
Withdrawal symptoms seen on discontinuation of
Paroxetine treatment
Withdrawal reactions commonly occur after discontinuation
of Paroxetine (see sections "Before you take Paroxetine"
and "How to take Paroxetine").
Dizziness, sensory disturbances (including tingling or
numbness in the hands or feet, electric shock sensations
and ringing in the ears), sleep disturbances (including
insomnia and intense dreams), agitation or anxiety, feeling
sick (nausea) and/or being sick (vomiting), trembling of the
body (tremor), confusion, sweating, emotional instability,
visual disturbances, fluttering or pounding heartbeat
(palpitations), diarrhoea, irritability and headache are the
most commonly reported reactions.
Generally these events are mild to moderate and are self−
limiting, however, in some patients they may be severe
and/or prolonged.
Children and adolescents under 18
In studies of Paroxetine in under 18s, the following side
effects were observed:
increased suicidal related behaviours (including suicide
attempts and suicidal thoughts), self−harm behaviours and
increased hostility.
Additional side effects that were seen were: decreased
appetite, trembling of the body, sweating, having too much
energy (hyperkinesias or hyperactivity), agitation, changing
emotions (including crying and mood fluctuations) and
unusual bruising or bleeding (such as nose bleeds).
In studies, some patients had withdrawal effects when they
stopped taking Paroxetine or gradually reduced the dose
before stopping, as follows: changing emotions (including
crying, mood fluctuations, self−harm, suicidal thoughts and
attempted suicide), nervousness, dizziness, feeling sick
and abdominal pain.

5

How to store Paroxetine

Do not use Paroxetine after the expiry date which is stated
on the carton or blister respectively.
The expiry date refers to the last day of that month.
Do not store above 30°C (for product available in blister
packs).
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.

6 Further information
What Paroxetine 20 mg and 40 mg contain
The active substance is paroxetine
Each tablet contains 20 mg or 40 mg paroxetine equivalent
to 22.2 mg or 44.4 mg of paroxetine hydrochloride anhydrate
The other ingredients are:
Tablet core
Mannitol
Cellulose, microcrystalline
Copovidone
Sodium starch glycollate (Type A)
Silica, colloidal anhydrous
Magnesium stearate
Tablet coating
Hypromellose
Talc (micronised)
Titanium dioxide (E171)
What Paroxetine looks like and contents of the pack
Paroxetine 20 mg is a white, round bisected film−coated
tablet with a pressure sensitive score notch, marked "PX
20"
The 20 mg tablet can be divided into equal halves, if
required.
Paroxetine 40 mg is a white, round, quadrisected film−
coated tablet with a pressure sensitive score notch, marked
"PX 40"
The 40 mg tablet can be divided into equal quarters, if
required.
The 20 mg and 40 mg tablets are available in blister packs
or containers with 7, 14, 15, 20, 28, 30, 40, 50, 50x1, 60,
100, 200 and 250 film−coated tablets.
The 20mg tablets are also available in blister packs or
containers with 10 film−coated tablets
Not all pack sizes may be marketed.

Nervous system disorders
Common: dizziness, trembling of the body (tremor), headache
Uncommon: slow or/and involuntary movements
(extrapyramidal disorders)
Rare: irresistible urge to move the legs (Restless Legs
Syndrome), convulsions
Very rare: serotonin syndrome (symptoms may include
restlessness, confusion, sweating, hallucinations,
exaggeration of reflexes, muscle cramps, shivering, rapid
heart rate and trembling of the body).

Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St. Neots,
Cambridgeshire,
PE19 8ET

Eye disorders
Common: blurred vision
Uncommon: enlarged pupils (mydriasis)
Very rare: increased pressure in the eye where your eyes
become painful and you get blurred vision (acute glaucoma)

Date of revision: June 2012

Product Licence Number:
Paroxetine 20mg tablets: PL 11311/0402
Paroxetine 40mg tablets: PL 11311/0403

Ear disorders
Frequency not known: Ringing in the ears (tinnitus)

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Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Paroxetine Combined PIL
Tablets
PIL
175 mm x 510 mm
Font SansSerif − Min.Text 8pt
Till−Ver.3s
05/07/2012
Pantone Black CVC

Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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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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