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PAROXETINE 10 MG FILM-COATED TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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Your medicine is known as Seroxat®
10 mg Film-coated Tablets but will
be referred to as Seroxat throughout
this leaflet. Seroxat is also available
in strengths 20 mg and 30 mg and
reference to these strengths may
also be included in this leaflet.

What is in this leaflet:

(paroxetine hydrochloride)

Seroxat ® 10 mg
Film-coated Tablets

Package leaflet: Information for the patient

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

1 What Seroxat is and
what it is used for

2 What you need to know
before you take Seroxat

Seroxat is a treatment for adults
with depression and/or anxiety
disorders. The anxiety disorders
that Seroxat is used to treat are:
obsessive compulsive disorder
(repetitive, obsessive thoughts with
uncontrollable behaviour); panic
disorder (panic attacks, including
those caused by agoraphobia, which
is a fear of open spaces); social
anxiety disorder (fear or avoidance
of social situations); post-traumatic
stress disorder (anxiety caused by
a traumatic event); and generalised
anxiety disorder (generally feeling
very anxious or nervous).

Do not take Seroxat

Seroxat is one of a group of
medicines called SSRIs (selective
serotonin reuptake inhibitors).
Everyone has a substance called
serotonin in their brain. People who
are depressed or anxious have
lower levels of serotonin than
others. It is not fully understood how
Seroxat and other SSRIs work but
they may help by increasing the
level of serotonin in the brain.
Treating depression or anxiety
disorders properly is important to
help you get better.

• If you are taking medicines
called monoamine oxidase
inhibitors (MAOIs, including
moclobemide and
methylthioninium chloride
(methylene blue)) or have taken
them at any time within the last
two weeks. Your doctor will advise
you how you should begin taking
Seroxat once you have stopped
taking the MAOI
• If you are taking an
anti-psychotic called thioridazine
or an anti-psychotic called
pimozide
• If you are allergic to paroxetine or
any of the other ingredients of this
medicine (listed in section 6).
If any of these apply to you, tell
your doctor without taking Seroxat

Warnings and precautions

Talk to your doctor or pharmacist
before taking Seroxat
• Are you taking any other
medicines (see Taking other
medicines and Seroxat, inside this
leaflet)?
• Are you taking tamoxifen to treat
breast cancer or fertility problems?
Seroxat may make tamoxifen less
effective, so your doctor may
recommend you take another
antidepressant.
• Do you have kidney, liver or heart
trouble?
• Do you have epilepsy or have a
history of fits or seizures?
• Have you ever had episodes of
mania (overactive behaviour or
thoughts)?
• Are you having electro-convulsive
therapy (ECT)?

• Do you have a history of bleeding
disorders, or are you taking other
medicines that may increase the
risk of bleeding (these include
medicines used to thin the blood,
such as warfarin, anti-psychotics
such as perphenazine or clozapine,
tricyclic antidepressants,
medicines used for pain and
inflammation called non-steroidal
anti-inflammatory drugs or
NSAIDs, such as acetylsalicylic
acid, ibuprofen, celecoxib,
etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you on a low sodium diet?
• Do you have glaucoma (pressure
in the eye)?
• Are you pregnant or planning to
get pregnant (see Pregnancy,
breast-feeding and fertility, inside
this leaflet)?
• Are you under 18 years old (see
Children and adolescents under
18, inside this leaflet)?
If you answer YES to any of
these questions, and you have
not already discussed them with
your doctor, go back to your
doctor and ask what to do about
taking Seroxat.

Children and adolescents
under 18
Seroxat should not be used for
children and adolescents under
18 years. Also, 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 Seroxat. If your
doctor has prescribed Seroxat
for you (or your child) 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 you (or your child) are
taking Seroxat. Also, the long-term
safety effects, concerning growth,
maturation and cognitive and
behavioural development, of Seroxat
in this age group have not yet been
demonstrated.
In studies of Seroxat in under 18s,
common side effects that affected
less than 1 in 10 children/adolescents
were: an increase in suicidal
thoughts and suicide attempts;
deliberately harming themselves;
being hostile; aggressive or
unfriendly; lack of appetite; shaking;
abnormal sweating; hyperactivity
(having too much energy); agitation;
changing emotions (including crying
and changes in mood); and unusual
bruising or bleeding (such as nose
bleeds). These studies also showed
that the same symptoms affected
children and adolescents taking
sugar pills (placebo) instead of
Seroxat, although these were seen
less often.
Some patients in these studies of
under 18s had withdrawal effects
when they stopped taking Seroxat.
These effects were mostly similar to
those seen in adults after stopping
Seroxat (see section 3, How to take
Seroxat, inside this leaflet). In
addition, patients under 18 also
commonly (affecting less than 1 in
10) experienced stomach ache,
feeling nervous and changing
emotions (including crying, changes
in mood, trying to hurt themselves,
thoughts of suicide and attempting
suicide).

Thoughts of suicide and
worsening of your
depression or anxiety
disorder

If you are depressed and/or have
anxiety disorders you can sometimes
have thoughts of harming or killing
yourself. These may be increased
when first starting antidepressants,

since these medicines all take time
to work, usually about two weeks but
sometimes longer.
You may be more likely to think
like this:
• If you have previously had
thoughts about killing or harming
yourself.
• If you are a young adult.
Information from clinical trials has
shown an increased risk of suicidal
behaviour in adults aged less than
25 years with psychiatric
conditions who were treated with
an antidepressant.
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.

Important side effects seen
with Seroxat

Some patients who take Seroxat
develop something called akathisia,
where they feel restless and feel
like they can’t sit or stand still.
Other patients develop something
called serotonin syndrome, or
neuroleptic malignant syndrome,
where they have some or all of the
following symptoms: feeling very
agitated or irritable, feeling confused,
feeling restless, feeling hot, sweating,
shaking, shivering, hallucinations
(strange visions or sounds), muscle
stiffness, sudden jerks of the muscles
or a fast heartbeat. The severity can
increase, leading to loss of
consciousness. If you notice any of
these symptoms, contact your
doctor. For more information on
these or other side effects of Seroxat,
see section 4, Possible side effects,
inside this leaflet.

Other medicines and
Seroxat

Some medicines can affect the way
Seroxat works, or make it more likely
that you’ll have side effects. Seroxat
can also affect the way some other
medicines work. These include:
• Medicines called monoamine
oxidase inhibitors (MAOIs,
including moclobemide and
methylthioninium chloride
(methylene blue)) - see Do not
take Seroxat, inside this leaflet
• Thioridazine or pimozide, which
are anti-psychotics - see Do not
take Seroxat, inside this leaflet
• Aspirin (acetylsalicylic acid),
ibuprofen or other medicines
called NSAIDs (non-steroidal
anti-inflammatory drugs) like
celecoxib, etodolac, diclofenac
and meloxicam, used for pain and
inflammation
• Tramadol and pethidine,
painkillers
• Medicines called triptans, such as
sumatriptan, used to treat
migraine
• Other antidepressants including
other SSRIs, tryptophan and
tricyclic antidepressants like
clomipramine, nortriptyline and
desipramine
• A dietary supplement called
tryptophan
• Mivacurium and suxamethonium
(used in anaesthesia)
• Medicines such as lithium,
risperidone, perphenazine,
clozapine (called anti-psychotics)
used to treat some psychiatric
conditions
• Fentanyl, used in anaesthesia or
to treat chronic pain
• A combination of fosamprenavir
and ritonavir, which is used to treat
Human Immunodeficiency Virus
(HIV) infection
• St John’s Wort, a herbal remedy
for depression

• Phenobarbital, phenytoin, sodium
valproate or carbamazepine, used
to treat fits or epilepsy
• Atomoxetine which is used to treat
attention deficit hyperactivity
disorder (ADHD)
• Procyclidine, used to relieve
tremor, especially in Parkinson’s
Disease
• Warfarin or other medicines (called
anticoagulants) used to thin the
blood
• Propafenone, flecainide and
medicines used to treat an
irregular heartbeat
• Metoprolol, a beta-blocker used to
treat high blood pressure and
heart problems
• Pravastatin, used to treat high
cholesterol
• Rifampicin, used to treat
tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen, which is used to treat
breast cancer or fertility
problems.
If you are taking or have
recently taken any of the
medicines in this list, and you
have not already discussed these
with your doctor, go back to your
doctor and ask what to do. The
dose may need to be changed or
you may need to be given another
medicine.
Tell your doctor or pharmacist if
you are taking, have recently
taken or might take any other
medicines, including medicines
obtained without a prescription.

Seroxat with food, drink
and alcohol

Do not drink alcohol while you are
taking Seroxat. Alcohol may make
your symptoms or side effects
worse. Taking Seroxat in the
morning with food will reduce the
likelihood of you feeling sick
(nausea).

Pregnancy, breast-feeding
and fertility

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. In
babies whose mothers took Seroxat
during the first few months of
pregnancy, there have been some
reports showing an increased risk of
birth defects, in particular those
affecting the heart. In the general
population, about 1 in 100 babies
are born with a heart defect. This
increased to up to 2 in 100 babies in
mothers who took Seroxat. You and
your doctor may decide that it is
better for you to change to another
treatment or to gradually stop taking
Seroxat while you are pregnant.
However, depending on your
circumstances, your doctor may
suggest that it is better for you to
keep taking Seroxat.
Make sure your midwife or doctor
knows you’re taking Seroxat.
When taken during pregnancy,
particularly late pregnancy,
medicines like Seroxat may increase
the risk of a serious condition in
babies, called persistent pulmonary
hypertension of the newborn
(PPHN). In PPHN, the blood
pressure in the blood vessels
between the baby’s heart and
the lungs is too high. If you take
Seroxat during 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:
• trouble with breathing
• a blue-ish skin or being too hot or
cold
• blue lips
• vomiting or not feeding properly
• being very tired, not able to sleep
or crying a lot
• stiff or floppy muscles

• tremors, jitters or fits
• exaggerated reflexes.
If your baby has any of these
symptoms when it is born, or you
are concerned about your baby’s
health, contact your doctor or
midwife who will be able to
advise you.
Seroxat may get into breast milk
in very small amounts. If you are
taking Seroxat, go back and talk to
your doctor before you start
breast-feeding. You and your doctor
may decide that you can breast-feed
while you are taking Seroxat.
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

Possible side effects of Seroxat
include dizziness, confusion, feeling
sleepy or blurred vision. If you do get
these side effects, do not drive or
use machinery.

3 How to take Seroxat
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.
Seroxat tablets come in three
strengths:
10 mg: White to pinkish-white
tablets, marked with “FC1”
on one side and “GS” on
the other
20 mg: White tablets, marked with
“20”
30 mg: Blue tablets, marked with
“30”
Sometimes you may need to take
more than one tablet or half a tablet.
This table will show you how many
tablets to take.
Dose Number of tablets to take
10 mg One white to pinkish-white
tablet
20 mg One white tablet
30 mg One blue tablet
40 mg Two white tablets
50 mg One blue tablet + One white
tablet or
Two-and-a-half white tablets
60 mg Two blue tablets or Three
white tablets

Ref: 801

The usual doses for different conditions are set out in the table below.
Starting dose Recommended Maximum
daily dose
daily dose
Depression
20 mg
20 mg
50 mg
Obsessive Compulsive
Disorder (obsessions
and compulsions)
Panic Disorder
(panic attacks)
Social Anxiety Disorder
(fear or avoidance
of social situations)
Post-Traumatic Stress
Disorder
Generalised Anxiety
Disorder

20 mg

60 mg

10 mg

40 mg

60 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

Your doctor will advise you what
dose to take when you first start
taking Seroxat. Most people start to
feel better after a couple of weeks. If
you don’t start to feel better after
this time, talk to your doctor, who will
advise you. He or she may decide to
increase the dose gradually, 10 mg
at a time, up to a maximum daily
dose.
Take your tablets in the morning
with food.
Swallow them with a drink of
water.
Do not chew.
Your doctor will talk to you about
how long you will need to keep
taking your tablets. This may be for
many months or even longer.

Older people

40 mg

The maximum dose for people over
65 is 40 mg per day.

Patients with liver or
kidney disease

If you have trouble with your liver or
kidneys your doctor may decide that
you should have a lower dose of
Seroxat than usual. If you
have severe liver or kidney disease
the maximum dose is 20 mg per day.

If you take more Seroxat
than you should

Never take more tablets than your
doctor recommends. If you take
too many Seroxat tablets (or
someone else does), tell your doctor
or a hospital straight away. Show
them the pack of tablets. Someone
who has taken an overdose of
Seroxat may have any one of the
symptoms listed in section 4,
Possible side effects, or the following
symptoms: fever; uncontrollable
tightening of the muscles.

If you forget to take
Seroxat

Take your medicine at the same time
every day. If you do forget 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.
Do not take a double dose to make
up for a forgotten dose.

What to do if you’re feeling
no better

Seroxat 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 don’t 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
haven’t started to feel better.

If you stop taking Seroxat

Do not stop taking Seroxat until
your doctor tells you to.
When stopping Seroxat, your
doctor will help you to reduce your
dose slowly over a number of weeks
or months - this should help reduce
the chance of withdrawal effects.
One way of doing this is to gradually
reduce the dose of Seroxat you take
by 10 mg a week. Most people find
that any symptoms on stopping
Seroxat are mild and go away on
their own within two weeks. For
some people, these symptoms may
be more severe, or go on for longer.
If you get withdrawal effects
when you are coming off your
tablets your doctor may decide
that you should come off them
more slowly. If you get severe
withdrawal effects when you stop
taking Seroxat, please see your

doctor. He or she may ask you to
start taking your tablets again and
come off them more slowly. It may
be easier for you to take Seroxat
oral suspension during the time that
you are coming off your medicine.
If you do get withdrawal effects,
you will still be able to stop
Seroxat.

Possible withdrawal effects
when stopping treatment
Studies show that 3 in 10 patients
notice one or more symptoms on
stopping Seroxat. Some withdrawal
effects on stopping occur more
frequently than others.

Common side effects, likely to
affect up to 1 in 10 people:
• Feeling dizzy, unsteady or
off-balance
• Feelings like pins and needles,
burning sensations and (less
commonly) electric shock
sensations, including in the head
• Some patients have developed
buzzing, hissing, whistling, ringing
or other persistent noise in the
ears (tinnitus) when they take
Seroxat
• Sleep disturbances (vivid dreams,
nightmares, inability to sleep)
• Feeling anxious
• Headaches.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• Feeling sick (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor (shakiness)
• Feeling confused or disorientated
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Fluttering or pounding heartbeat
(palpitations).

Please see your doctor if you
are worried about withdrawal
effects when stopping Seroxat.
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. Side effects
are more likely to happen in the first
few weeks of taking Seroxat.

See the doctor if you get
any of the following side
effects during treatment

You may need to contact your doctor
or go to a hospital straight away.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• If you have unusual bruising or
bleeding, including vomiting blood
or passing blood in your stools,
contact your doctor or go to a
hospital straight away.
• If you find that you are not able
to pass water, contact your
doctor or go to a hospital
straight away.
Rare side effects, likely to affect
up to 1 in every 1,000 people:
• If you experience seizures (fits),
contact your doctor or go to a
hospital straight away.
• If you feel restless and feel like
you can’t sit or stand still, you
may have something called
akathisia. Increasing your dose of
Seroxat may make these feelings
worse. If you feel like this, contact
your doctor.

• If you feel tired, weak or
confused and have achy, stiff or
uncoordinated muscles this may
be because your blood is low in
sodium. If you have these
symptoms, contact your doctor.
Very rare side effects, likely to
affect up to 1 in every 10,000
people:
• Allergic reactions, which may
be severe to Seroxat.
If you develop a red and lumpy
skin rash, swelling of the eyelids,
face, lips, mouth or tongue, start to
itch or have difficulty breathing
(shortness of breath) or swallowing
and feel weak or lightheaded
resulting in collapse or loss of
consciousness contact your
doctor or go to a hospital
straight away.
• If you have some or all of the
following symptoms you may
have something called serotonin
syndrome. The symptoms
include: feeling confused, feeling
restless, sweating, shaking,
shivering, hallucinations (strange
visions or sounds), sudden jerks of
the muscles or a fast heartbeat. If
you feel like this contact your
doctor.
• Acute glaucoma.
If your eyes become painful and
you develop blurred vision,
contact your doctor.
Frequency unknown
• Some people have had thoughts
of harming or killing themselves
while taking Seroxat or soon after
stopping treatment (see Section 2,
What you need to know before you
take Seroxat)
• Some people have experienced
aggression while taking Seroxat
If you experience these side
effects, contact your doctor.

Other possible side effects
during treatment
Very common side effects, likely
to affect more than 1 in 10 people:
• Feeling sick (nausea). Taking your
medicine in the morning with food
will reduce the chance of this
happening.
• Change in sex drive or sexual
function. For example, lack of
orgasm and, in men, abnormal
erection and ejaculation.
Common side effects, likely to
affect up to 1 in 10 people:
• Increases in the level of
cholesterol in the blood
• Lack of appetite
• Not sleeping well (insomnia) or
feeling sleepy
• Abnormal dreams (including
nightmares)
• Feeling dizzy or shaky (tremors)
• Headache
• Difficulty in concentrating
• Feeling agitated
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• A brief increase in blood pressure,
or a brief decrease that may make
you feel dizzy or faint when you
stand up suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness,
shaking or abnormal movements
in the mouth and tongue
• Dilated pupils
• Skin rashes
• Itching

• Feeling confused
• Having hallucinations (strange
visions or sounds)
• An inability to urinate (urinary
retention) or an uncontrollable,
involuntary passing of urine
(urinary incontinence)
• If you are a diabetic patient you
may notice a loss of control of your
blood sugar levels whilst taking
Seroxat. Please speak to your
doctor about adjusting the dosage
of your insulin or diabetes
medications.
Rare side effects, likely to affect
up to 1 in every 1,000 people:
• Abnormal production of breast milk
in men and women
• A slow heartbeat
• Effects on the liver showing up in
blood tests of your liver function
• Panic attacks
• Overactive behaviour or thoughts
(mania)
• Feeling detached from yourself
(depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs
(Restless Legs Syndrome)
• Pain in the joints or muscles
• Increase in a hormone called
prolactin in the blood
• Menstrual period disorders
(including heavy or irregular
periods, bleeding between periods
and absence or delay of periods.
Very rare side effects, likely to
affect up to 1 in every 10,000
people:
• Skin rash, which may blister, and
looks like small targets (central
dark spots surrounded by a paler
area, with a dark ring around the
edge) called erythema multiforme
• A widespread rash with
blisters and peeling skin,
particularly around the











mouth, nose, eyes and genitals
(Stevens-Johnson syndrome)
A widespread rash with blisters
and skin peeling on much of the
body surface (toxic epidermal
necrolysis)
Liver problems that make the skin
or whites of the eyes go yellow
Syndrome of inappropriate
antidiuretic hormone production
(SIADH) which is a condition in
which the body develops an
excess of water and a decrease in
sodium (salt) concentration, as a
result of improper chemical
signals. Patients with SIADH may
become severely ill or may have
no symptoms at all
Fluid or water retention (which
may cause swelling of the arms or
legs)
Sensitivity to sunlight
Painful erection of the penis that
won’t go away
Low blood platelet count.

Some patients have developed
buzzing, hissing, whistling, ringing or
other persistent noise in the ears
(tinnitus) when they take Seroxat.
An increased risk of bone fractures
has been observed in patients taking
this type of medicine.

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 Seroxat
• Keep out of the sight and reach of
children.

• Do not use this medicine after the
expiry date which is stated on the
blister and the carton, after EXP.
The expiry date refers to the last
day of that month.
• Do not store above 30˚C.
• Store in the original package in
order to protect from light.
• If you are using half tablets, be
careful to keep them safely in the
pack.
• If your tablets become discoloured
or show any other signs of
deterioration, talk to your
pharmacist who will advise you
what to do.
• 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 Seroxat contains

Each film-coated tablet contains 10
mg paroxetine (as paroxetine
hydrochloride hemihydrate).

The other ingredients are

In the tablet core: calcium
hydrogen phosphate dihydrate
(E341), magnesium stearate
(E470b) and sodium starch glycolate
(Type A).
In the tablet coat: hypromellose
(E464), titanium dioxide (E171),
macrogol 400, polysorbate 80
(E433) and red iron oxide
(E172).

What Seroxat looks like
and contents of the pack

• Seroxat 10 mg Film-coated Tablets
are white to pinkish-white,
oval-shaped tablets, marked ‘FC1’
on one side and ‘GS’ on the other
side.

The tablets have a break bar on
both sides.
The tablets are available in blister
packs of 28 tablets.
Manufactured by:
SmithKline Beecham plc (trading as
SmithKline Beecham
Pharmaceuticals), Manor Royal,
Crawley, West Sussex, RH10 9QJ,
UK.
or,
Glaxo Wellcome Production, Terras
1, Zone Industrielle du Terras, 53100
Mayenne, France.
or,
S.C. Europharm S.A., 2 Panselelor
St, Braşov, County of Braşov,
500419, Romania.
Procured from within the EU by
the Product Licence Holder:
Expono Ltd, Smethwick,
Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0154 - Seroxat® 10
Film-coated Tablets
POM
Revision Date: 21.06.2016
Ref: 801
Seroxat® and the Seroxat tablet
shape and colours are registered
trademarks of the GlaxoSmithKline
group of companies.

Your medicine is known as
Paroxetine 10 mg Film-coated
Tablets but will be referred to as
Paroxetine throughout this leaflet.
Paroxetine is also available in
strengths 20 mg and 30 mg and
reference to these strengths may
also be included in this leaflet.

(paroxetine hydrochloride)

Paroxetine 10 mg
Film-coated Tablets

Package leaflet: Information for the patient

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 Paroxetine is and what it is
used for
2 What you need to know before
you take Paroxetine
3 How to take Paroxetine
4 Possible side effects
5 How to store Paroxetine
6 Contents of the pack and other
information

1 What Paroxetine is and
what it is used for

2 What you need to know
before you take Paroxetine

Paroxetine is a treatment for
adults with depression and/or
anxiety disorders. The anxiety
disorders that Paroxetine is used to
treat are: obsessive compulsive
disorder (repetitive, obsessive
thoughts with uncontrollable
behaviour); panic disorder (panic
attacks, including those caused by
agoraphobia, which is a fear of open
spaces); social anxiety disorder (fear
or avoidance of social situations);
post-traumatic stress disorder
(anxiety caused by
a traumatic event); and generalised
anxiety disorder (generally feeling
very anxious or nervous).

Do not take Paroxetine

Paroxetine is one of a group of
medicines called SSRIs (selective
serotonin reuptake inhibitors).
Everyone has a substance called
serotonin in their brain. People who
are depressed or anxious have
lower levels of serotonin than
others. It is not fully understood how
Paroxetine and other SSRIs work
but they may help by increasing the
level of serotonin in the brain.
Treating depression or anxiety
disorders properly is important to
help you get better.

• If you are taking medicines
called monoamine oxidase
inhibitors (MAOIs, including
moclobemide and
methylthioninium chloride
(methylene blue)) or have taken
them at any time within the last
two weeks. Your doctor will advise
you how you should begin taking
Paroxetine once you have stopped
taking the MAOI
• If you are taking an
anti-psychotic called thioridazine
or an anti-psychotic called
pimozide
• If you are allergic to paroxetine or
any of the other ingredients of this
medicine (listed in section 6).
If any of these apply to you, tell
your doctor without taking Paroxetine

Warnings and precautions

Talk to your doctor or pharmacist
before taking Paroxetine
• Are you taking any other
medicines (see Taking other
medicines and Paroxetine, inside
this leaflet)?
• Are you taking tamoxifen to treat
breast cancer or fertility problems?
Paroxetine may make tamoxifen
less effective, so your doctor may
recommend you take another
antidepressant.
• Do you have kidney, liver or heart
trouble?
• Do you have epilepsy or have a
history of fits or seizures?
• Have you ever had episodes of
mania (overactive behaviour or
thoughts)?
• Are you having electro-convulsive
therapy (ECT)?

• Do you have a history of bleeding
disorders, or are you taking other
medicines that may increase the
risk of bleeding (these include
medicines used to thin the blood,
such as warfarin, anti-psychotics
such as perphenazine or clozapine,
tricyclic antidepressants,
medicines used for pain and
inflammation called non-steroidal
anti-inflammatory drugs or
NSAIDs, such as acetylsalicylic
acid, ibuprofen, celecoxib,
etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you on a low sodium diet?
• Do you have glaucoma (pressure
in the eye)?
• Are you pregnant or planning to
get pregnant (see Pregnancy,
breast-feeding and fertility, inside
this leaflet)?
• Are you under 18 years old (see
Children and adolescents under
18, inside this leaflet)?
If you answer YES to any of
these questions, and you have
not already discussed them with
your doctor, go back to your
doctor and ask what to do about
taking Paroxetine.

Children and adolescents
under 18

Paroxetine should not be used for
children and adolescents under
18 years. Also, 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 Paroxetine. If your
doctor has prescribed Paroxetine
for you (or your child) 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 you (or your child) are
taking Paroxetine. Also, the
long-term safety effects, concerning
growth, maturation and cognitive
and behavioural development, of
Paroxetine in this age group have
not yet been demonstrated.
In studies of Paroxetine in under 18s,
common side effects that affected
less than 1 in 10 children/adolescents
were: an increase in suicidal
thoughts and suicide attempts;
deliberately harming themselves;
being hostile; aggressive or
unfriendly; lack of appetite; shaking;
abnormal sweating; hyperactivity
(having too much energy); agitation;
changing emotions (including crying
and changes in mood); and unusual
bruising or bleeding (such as nose
bleeds). These studies also showed
that the same symptoms affected
children and adolescents taking
sugar pills (placebo) instead of
Paroxetine, although these were
seen less often.
Some patients in these studies of
under 18s had withdrawal effects
when they stopped taking Paroxetine.
These effects were mostly similar to
those seen in adults after stopping
Paroxetine (see section 3, How to
take Paroxetine, inside this leaflet).
In addition, patients under 18 also
commonly (affecting less than 1 in
10) experienced stomach ache,
feeling nervous and changing
emotions (including crying, changes
in mood, trying to hurt themselves,
thoughts of suicide and attempting
suicide).

Thoughts of suicide and
worsening of your
depression or anxiety
disorder

If you are depressed and/or have
anxiety disorders you can sometimes
have thoughts of harming or killing
yourself. These may be increased
when first starting antidepressants,

since these medicines all take time
to work, usually about two weeks but
sometimes longer.
You may be more likely to think
like this:
• If you have previously had
thoughts about killing or harming
yourself.
• If you are a young adult.
Information from clinical trials has
shown an increased risk of suicidal
behaviour in adults aged less than
25 years with psychiatric
conditions who were treated with
an antidepressant.
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.

Important side effects seen
with Paroxetine

Some patients who take Paroxetine
develop something called akathisia,
where they feel restless and feel
like they can’t sit or stand still.
Other patients develop something
called serotonin syndrome, or
neuroleptic malignant syndrome,
where they have some or all of the
following symptoms: feeling very
agitated or irritable, feeling confused,
feeling restless, feeling hot, sweating,
shaking, shivering, hallucinations
(strange visions or sounds), muscle
stiffness, sudden jerks of the muscles
or a fast heartbeat. The severity can
increase, leading to loss of
consciousness. If you notice any of
these symptoms, contact your
doctor. For more information on
these or other side effects of
Paroxetine, see section 4, Possible
side effects, inside this leaflet.

Other medicines and
Paroxetine

Some medicines can affect the way
Paroxetine works, or make it more likely
that you’ll have side effects. Paroxetine
can also affect the way some other
medicines work. These include:
• Medicines called monoamine
oxidase inhibitors (MAOIs,
including moclobemide and
methylthioninium chloride
(methylene blue)) - see Do not
take Paroxetine, inside this leaflet
• Thioridazine or pimozide, which
are anti-psychotics - see Do not
take Paroxetine, inside this leaflet
• Aspirin (acetylsalicylic acid),
ibuprofen or other medicines
called NSAIDs (non-steroidal
anti-inflammatory drugs) like
celecoxib, etodolac, diclofenac
and meloxicam, used for pain and
inflammation
• Tramadol and pethidine,
painkillers
• Medicines called triptans, such as
sumatriptan, used to treat
migraine
• Other antidepressants including
other SSRIs, tryptophan and
tricyclic antidepressants like
clomipramine, nortriptyline and
desipramine
• A dietary supplement called
tryptophan
• Mivacurium and suxamethonium
(used in anaesthesia)
• Medicines such as lithium,
risperidone, perphenazine,
clozapine (called anti-psychotics)
used to treat some psychiatric
conditions
• Fentanyl, used in anaesthesia or
to treat chronic pain
• A combination of fosamprenavir
and ritonavir, which is used to treat
Human Immunodeficiency Virus
(HIV) infection
• St John’s Wort, a herbal remedy
for depression

• Phenobarbital, phenytoin, sodium
valproate or carbamazepine, used
to treat fits or epilepsy
• Atomoxetine which is used to treat
attention deficit hyperactivity
disorder (ADHD)
• Procyclidine, used to relieve
tremor, especially in Parkinson’s
Disease
• Warfarin or other medicines (called
anticoagulants) used to thin the
blood
• Propafenone, flecainide and
medicines used to treat an
irregular heartbeat
• Metoprolol, a beta-blocker used to
treat high blood pressure and
heart problems
• Pravastatin, used to treat high
cholesterol
• Rifampicin, used to treat
tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen, which is used to treat
breast cancer or fertility
problems.
If you are taking or have
recently taken any of the
medicines in this list, and you
have not already discussed these
with your doctor, go back to your
doctor and ask what to do. The
dose may need to be changed or
you may need to be given another
medicine.
Tell your doctor or pharmacist if
you are taking, have recently
taken or might take any other
medicines, including medicines
obtained without a prescription.

Paroxetine with food, drink
and alcohol
Do not drink alcohol while you are
taking Paroxetine. Alcohol may
make your symptoms or side effects
worse. Taking Paroxetine in the
morning with food will reduce the
likelihood of you feeling sick
(nausea).

Pregnancy, breast-feeding
and fertility

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. In babies
whose mothers took Paroxetine
during the first few months of
pregnancy, there have been some
reports showing an increased risk of
birth defects, in particular those
affecting the heart. In the general
population, about 1 in 100 babies
are born with a heart defect. This
increased to up to 2 in 100 babies in
mothers who took Paroxetine. You
and your doctor may decide that it is
better for you to change to another
treatment or to gradually stop taking
Paroxetine while you are pregnant.
However, depending on your
circumstances, your doctor may
suggest that it is better for you to
keep taking Paroxetine.
Make sure your midwife or doctor
knows you’re taking Paroxetine.
When taken during pregnancy,
particularly late pregnancy,
medicines like Paroxetine may
increase the risk of a serious
condition in babies, called persistent
pulmonary hypertension of the
newborn (PPHN). In PPHN, the
blood pressure in the blood vessels
between the baby’s heart and
the lungs is too high. If you take
Paroxetine during 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:
• trouble with breathing
• a blue-ish skin or being too hot or
cold
• blue lips
• vomiting or not feeding properly
• being very tired, not able to sleep
or crying a lot
• stiff or floppy muscles

• tremors, jitters or fits
• exaggerated reflexes.
If your baby has any of these
symptoms when it is born, or you
are concerned about your baby’s
health, contact your doctor or
midwife who will be able to
advise you.
Paroxetine may get into breast
milk in very small amounts. If you
are taking Paroxetine, go back and
talk to your doctor before you start
breast-feeding. You and your doctor
may decide that you can breast-feed
while you are taking Paroxetine.
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

Possible side effects of Paroxetine
include dizziness, confusion, feeling
sleepy or blurred vision. If you do
get these side effects, do not drive
or use machinery.

3 How to take Paroxetine
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.
Paroxetine tablets come in three
strengths:
10 mg: White to pinkish-white
tablets, marked with “FC1”
on one side and “GS” on
the other
20 mg: White tablets, marked with
“20”
30 mg: Blue tablets, marked with
“30”
Sometimes you may need to take
more than one tablet or half a tablet.
This table will show you how many
tablets to take.
Dose Number of tablets to take
10 mg One white to pinkish-white
tablet
20 mg One white tablet
30 mg One blue tablet
40 mg Two white tablets
50 mg One blue tablet + One white
tablet or
Two-and-a-half white tablets
60 mg Two blue tablets or Three
white tablets

Ref: 800

The usual doses for different conditions are set out in the table below.
Starting dose Recommended Maximum
daily dose
daily dose
Depression
20 mg
20 mg
50 mg
Obsessive Compulsive
Disorder (obsessions
and compulsions)
Panic Disorder
(panic attacks)
Social Anxiety Disorder
(fear or avoidance
of social situations)
Post-Traumatic Stress
Disorder
Generalised Anxiety
Disorder

20 mg

60 mg

10 mg

40 mg

60 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

Your doctor will advise you what
dose to take when you first start
taking Paroxetine. Most people
start to feel better after a couple of
weeks. If you don’t start to feel better
after this time, talk to your doctor,
who will advise you. He or she may
decide to increase the dose
gradually, 10 mg at a time, up to a
maximum daily dose.
Take your tablets in the morning
with food.
Swallow them with a drink of
water.
Do not chew.
Your doctor will talk to you about
how long you will need to keep
taking your tablets. This may be for
many months or even longer.

Older people

40 mg

The maximum dose for people over
65 is 40 mg per day.

Patients with liver or
kidney disease

If you have trouble with your liver or
kidneys your doctor may decide that
you should have a lower dose of
Paroxetine than usual. If you
have severe liver or kidney disease
the maximum dose is 20 mg per day.

If you take more Paroxetine
than you should
Never take more tablets than your
doctor recommends. If you take
too many Paroxetine tablets (or
someone else does), tell your doctor
or a hospital straight away. Show
them the pack of tablets. Someone
who has taken an overdose of
Paroxetine may have any one of the
symptoms listed in section 4,
Possible side effects, or the following
symptoms: fever; uncontrollable
tightening of the muscles.

If you forget to take
Paroxetine

Take your medicine at the same time
every day. If you do forget 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.
Do not take a double dose to make
up for a forgotten dose.

What to do if you’re feeling
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 don’t 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
haven’t started to feel better.

If you stop taking Paroxetine
Do not stop taking Paroxetine
until your doctor tells you to.
When stopping Paroxetine, your
doctor will help you to reduce your
dose slowly over a number of weeks
or months - this should help reduce
the chance of withdrawal effects.
One way of doing this is to gradually
reduce the dose of Paroxetine you
take by 10 mg a week. Most people
find that any symptoms on stopping
Paroxetine are mild and go away on
their own within two weeks. For
some people, these symptoms may
be more severe, or go on for longer.
If you get withdrawal effects
when you are coming off your
tablets your doctor may decide
that you should come off them
more slowly. If you get severe
withdrawal effects when you stop
taking Paroxetine, please see your

doctor. He or she may ask you to
start taking your tablets again and
come off them more slowly. It may
be easier for you to take Paroxetine
oral suspension during the time that
you are coming off your medicine.
If you do get withdrawal effects,
you will still be able to stop
Paroxetine.

Possible withdrawal effects
when stopping treatment
Studies show that 3 in 10 patients
notice one or more symptoms on
stopping Paroxetine. Some
withdrawal effects on stopping occur
more frequently than others.
Common side effects, likely to
affect up to 1 in 10 people:
• Feeling dizzy, unsteady or
off-balance
• Feelings like pins and needles,
burning sensations and (less
commonly) electric shock
sensations, including in the head
• Some patients have developed
buzzing, hissing, whistling, ringing
or other persistent noise in the
ears (tinnitus) when they take
Paroxetine
• Sleep disturbances (vivid dreams,
nightmares, inability to sleep)
• Feeling anxious
• Headaches.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• Feeling sick (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor (shakiness)
• Feeling confused or disorientated
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Fluttering or pounding heartbeat
(palpitations).

Please see your doctor if you
are worried about withdrawal
effects when stopping Paroxetine.
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. Side effects
are more likely to happen in the first
few weeks of taking Paroxetine.

See the doctor if you get
any of the following side
effects during treatment

You may need to contact your doctor
or go to a hospital straight away.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• If you have unusual bruising or
bleeding, including vomiting blood
or passing blood in your stools,
contact your doctor or go to a
hospital straight away.
• If you find that you are not able
to pass water, contact your
doctor or go to a hospital
straight away.
Rare side effects, likely to affect
up to 1 in every 1,000 people:
• If you experience seizures (fits),
contact your doctor or go to a
hospital straight away.
• If you feel restless and feel like
you can’t sit or stand still, you
may have something called
akathisia. Increasing your dose of
Paroxetine may make these
feelings worse. If you feel like this,
contact your doctor.

• If you feel tired, weak or
confused and have achy, stiff or
uncoordinated muscles this may
be because your blood is low in
sodium. If you have these
symptoms, contact your doctor.
Very rare side effects, likely to
affect up to 1 in every 10,000
people:
• Allergic reactions, which may
be severe to Paroxetine.
If you develop a red and lumpy
skin rash, swelling of the eyelids,
face, lips, mouth or tongue, start to
itch or have difficulty breathing
(shortness of breath) or swallowing
and feel weak or lightheaded
resulting in collapse or loss of
consciousness contact your
doctor or go to a hospital
straight away.
• If you have some or all of the
following symptoms you may
have something called serotonin
syndrome. The symptoms
include: feeling confused, feeling
restless, sweating, shaking,
shivering, hallucinations (strange
visions or sounds), sudden jerks of
the muscles or a fast heartbeat. If
you feel like this contact your
doctor.
• Acute glaucoma.
If your eyes become painful and
you develop blurred vision,
contact your doctor.
Frequency unknown
• Some people have had thoughts
of harming or killing themselves
while taking Paroxetine or soon
after stopping treatment (see
Section 2, What you need to know
before you take Paroxetine)
• Some people have experienced
aggression while taking Paroxetine
If you experience these side
effects, contact your doctor.

Other possible side effects
during treatment
Very common side effects, likely
to affect more than 1 in 10 people:
• Feeling sick (nausea). Taking your
medicine in the morning with food
will reduce the chance of this
happening.
• Change in sex drive or sexual
function. For example, lack of
orgasm and, in men, abnormal
erection and ejaculation.
Common side effects, likely to
affect up to 1 in 10 people:
• Increases in the level of
cholesterol in the blood
• Lack of appetite
• Not sleeping well (insomnia) or
feeling sleepy
• Abnormal dreams (including
nightmares)
• Feeling dizzy or shaky (tremors)
• Headache
• Difficulty in concentrating
• Feeling agitated
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating.
Uncommon side effects, likely to
affect up to 1 in every 100 people:
• A brief increase in blood pressure,
or a brief decrease that may make
you feel dizzy or faint when you
stand up suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness,
shaking or abnormal movements
in the mouth and tongue
• Dilated pupils
• Skin rashes
• Itching

• Feeling confused
• Having hallucinations (strange
visions or sounds)
• An inability to urinate (urinary
retention) or an uncontrollable,
involuntary passing of urine
(urinary incontinence)
• If you are a diabetic patient you
may notice a loss of control of your
blood sugar levels whilst taking
Paroxetine. Please speak to your
doctor about adjusting the dosage
of your insulin or diabetes
medications.
Rare side effects, likely to affect
up to 1 in every 1,000 people:
• Abnormal production of breast milk
in men and women
• A slow heartbeat
• Effects on the liver showing up in
blood tests of your liver function
• Panic attacks
• Overactive behaviour or thoughts
(mania)
• Feeling detached from yourself
(depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs
(Restless Legs Syndrome)
• Pain in the joints or muscles
• Increase in a hormone called
prolactin in the blood
• Menstrual period disorders
(including heavy or irregular
periods, bleeding between periods
and absence or delay of periods.
Very rare side effects, likely to
affect up to 1 in every 10,000
people:
• Skin rash, which may blister, and
looks like small targets (central
dark spots surrounded by a paler
area, with a dark ring around the
edge) called erythema multiforme
• A widespread rash with
blisters and peeling skin,
particularly around the











mouth, nose, eyes and genitals
(Stevens-Johnson syndrome)
A widespread rash with blisters
and skin peeling on much of the
body surface (toxic epidermal
necrolysis)
Liver problems that make the skin
or whites of the eyes go yellow
Syndrome of inappropriate
antidiuretic hormone production
(SIADH) which is a condition in
which the body develops an
excess of water and a decrease in
sodium (salt) concentration, as a
result of improper chemical
signals. Patients with SIADH may
become severely ill or may have
no symptoms at all
Fluid or water retention (which
may cause swelling of the arms or
legs)
Sensitivity to sunlight
Painful erection of the penis that
won’t go away
Low blood platelet count.

Some patients have developed
buzzing, hissing, whistling, ringing or
other persistent noise in the ears
(tinnitus) when they take Paroxetine.
An increased risk of bone fractures
has been observed in patients taking
this type of medicine.

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 Paroxetine
• Keep out of the sight and reach of
children.

• Do not use this medicine after the
expiry date which is stated on the
blister and the carton, after EXP.
The expiry date refers to the last
day of that month.
• Do not store above 30˚C.
• Store in the original package in
order to protect from light.
• If you are using half tablets, be
careful to keep them safely in the
pack.
• If your tablets become discoloured
or show any other signs of
deterioration, talk to your
pharmacist who will advise you
what to do.
• 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 Paroxetine contains

Each film-coated tablet contains 10
mg paroxetine (as paroxetine
hydrochloride hemihydrate).

The other ingredients are

In the tablet core: calcium
hydrogen phosphate dihydrate
(E341), magnesium stearate
(E470b) and sodium starch glycolate
(Type A).
In the tablet coat: hypromellose
(E464), titanium dioxide (E171),
macrogol 400, polysorbate 80
(E433) and red iron oxide
(E172).

What Paroxetine looks like
and contents of the pack

• Paroxetine 10 mg Film-coated
Tablets are white to pinkish-white,
oval-shaped tablets, marked ‘FC1’
on one side and ‘GS’ on the other
side.

The tablets have a break bar on
both sides.
The tablets are available in blister
packs of 28 tablets.
Manufactured by:
SmithKline Beecham plc (trading as
SmithKline Beecham
Pharmaceuticals), Manor Royal,
Crawley, West Sussex, RH10 9QJ,
UK.
or,
Glaxo Wellcome Production, Terras
1, Zone Industrielle du Terras, 53100
Mayenne, France.
or,
S.C. Europharm S.A., 2 Panselelor
St, Braşov, County of Braşov,
500419, Romania.
Procured from within the EU by
the Product Licence Holder:
Expono Ltd, Smethwick,
Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0154 - Paroxetine 10
Film-coated Tablets
POM
Revision Date: 21.06.2016
Ref: 800

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Source: Medicines and Healthcare Products Regulatory Agency

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