SEROXAT 10MG FILM-COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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2
Seroxat
K

P7816

2756

GSK-ROM-Brasov-ROBRA
Malta-MLT; United Kingdom-GBR

1

EPH_D_PVS1_630_170

Seroxat®
Paroxetine

Patient Information Leaflet

Eight important things you
need to know about Seroxat

Paroxetine

Seroxat ® 10 mg, 20 mg and 30 mg tablets

Front
Page 1 of 2

Please read all of the leaflet. It
includes a lot of additional important
information about this medicine.
• Seroxat treats depression and
anxiety disorders. Like all
medicines it can have unwanted
effects. It is therefore important
that you and your doctor weigh
up the benefits of treatment
against the possible unwanted
effects, before starting treatment.
• Seroxat is not for use in
children and adolescents
under 18. See section 6, Children
and adolescents under 18, inside
this leaflet.
• Seroxat won’t work straight
away. Some people taking
antidepressants feel worse before
feeling better. 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 feeling better. See
section 3, How to take your
tablets, inside this leaflet.
• Some people who are
depressed or anxious think of
harming or killing themselves.
If you start to feel worse, or think
of harming or killing yourself, see
your doctor or go to a hospital
straight away. See Thoughts of
harming yourself, inside this
leaflet.

• Don’t stop taking Seroxat
without talking to your
doctor. If you stop taking Seroxat
suddenly or miss a dose, you may
get withdrawal effects. See
section 5, Stopping Seroxat,
inside this leaflet.
• If you feel restless and feel
like you can’t sit or stand still,
tell your doctor. Increasing the
dose of Seroxat may make these
feelings worse. See section 4,
Possible side effects, inside this
leaflet.
• Taking some other medicines
with Seroxat can cause
problems. You may need to talk
to your doctor. See Other
medicines and Seroxat, inside this
leaflet.
• If you are pregnant or
planning to get pregnant, talk
to your doctor. See Pregnancy,
breast-feeding and Seroxat, inside
this leaflet.
Read this leaflet. It includes a lot of
important information about this
medicine.
Keep this leaflet. You may need to
read it again.
If you have more questions, ask your
doctor or pharmacist (chemist). You
may also find it helpful to contact a
self-help group, or patient
organisation, to find out more about
your condition. Your doctor will be
able to give you details.
Leaflet date: July 2012

1 What Seroxat is and
what it is used for

Seroxat is a treatment for adults
with depression and/or anxiety
disorders.
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.
Other medicines or psychotherapy can
also treat depression and anxiety.
Treating depression or anxiety
disorders properly is important to help
you get better. If it’s not treated, your
condition may not go away and may
become more serious and more
difficult to treat.
You may find it helpful to tell a
friend or relative that you are
depressed or suffering from 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.

2 Before you take Seroxat

Do not take Seroxat …

• 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 a
tranquilliser called thioridazine
• If you are taking an
anti-psychotic called pimozide
• If you have previously had an
allergic reaction to paroxetine or
any of the other tablet ingredients
listed. See section 8, What Seroxat
contains, inside this leaflet.
If any of these apply to you,
tell your doctor without taking
Seroxat

Check with your doctor …

• Are you taking any other
medicines (see 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 eye, kidney, liver or
heart trouble?
• Do you have epilepsy or have a
history of fits?

• Do you have episodes of mania
(overactive behaviour or
thoughts)?
• Are you having electro-convulsive
therapy (ECT)?
• Do you have a history of bleeding
disorders?
• 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 Seroxat, 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.

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.

Pregnancy, breast-feeding
and Seroxat

Talk to your doctor as soon as
possible if you’re pregnant, if you
might be pregnant, or if you’re
planning to become pregnant. 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 about 2 in 100 babies in
mothers who took Seroxat. You and
your doctor may decide that it is better
for you 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 blueish 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.
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.

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, ibuprofen or other
medicines called NSAIDs
(non-steroidal anti-inflammatory
drugs) like celecoxib, etodolac 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
• Medicines such as lithium,
risperidone, perphenazine (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 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
• 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 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.
If you are taking any other
medicines, including ones you have
bought yourself, check with your
doctor or pharmacist before taking
Seroxat. They will know if it is safe for
you to do so.

Seroxat and alcohol

Do not drink alcohol while you are
taking Seroxat. Alcohol may make
your symptoms or side effects worse.

Driving and using machinery

Possible side effects of Seroxat include
dizziness, confusion or changes in
eyesight. If you do get these side
effects, do not drive or use machinery.

3 How to take your tablets

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

Take your tablets in the morning
with food.

30 mg One blue tablet

Swallow them with a drink of
water.

40 mg Two white tablets

Do not chew.
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”
It is important to take your tablets
as instructed by your doctor. The
label will tell you how many tablets to
take and how often. If you are unsure,
ask your doctor or pharmacist.

50 mg One blue tablet + One
white tablet
or Two-and-a-half white
tablets
60 mg Two blue tablets
or Three white tablets
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.

2
Seroxat
K

P7816

2756

GSK-ROM-Brasov-ROBRA
Malta-MLT; United Kingdom-GBR

1

EPH_D_PVS1_630_170

Back
Page 2 of 2

The usual doses for different conditions are set out in the table below.
Starting
dose

Recommended
daily dose

Maximum
daily
dose

Depression

20 mg

20 mg

50 mg

Obsessive Compulsive
Disorder (obsessions and
compulsions)

20 mg

40 mg

60 mg

Panic Disorder (panic
attacks)

10 mg

Social Anxiety Disorder
(fear or avoidance of
social situations)

20 mg

Post Traumatic Stress
Disorder

20 mg

Generalised Anxiety
Disorder

20 mg

What if you take too many
tablets?

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.

What to do if you’re feeling
no better

Remember, your doctor will advise
you on the daily dose you should
take.
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

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.

40 mg
20 mg

20 mg
20 mg

60 mg
50 mg

50 mg
50 mg

What if you miss a dose?

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.

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.

4 Possible side effects
As with other medicines Seroxat can
cause side effects, but not everybody
gets them.

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.
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.
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.
Likely to affect up to 1 in every
10,000 people:
• Allergic reactions 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
or swallowing, 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,
Before you take Seroxat).

Other possible side effects
during treatment

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.
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
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Feeling weak
• Sweating.

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
• Feeling confused
• Having hallucinations (strange
visions or sounds)
• An inability to urinate (urinary
retention) or an uncontrollable,
involuntary passing of urine
(urinary incontinence).
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.
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 dark ring around the
edge) called erythema mutiforme

• 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
• 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
• 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)
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 medicines.
If you have any concerns while
you are taking Seroxat, talk to
your doctor or pharmacist who
will be able to advise you.

5 Stopping 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.
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.

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.

6 Children and adolescents
under 18

Seroxat should not be used for
children and adolescents under
18 years because it has not been
proven to be an effective medicine for
this age group. Also, patients under
18 have an increased risk of side
effects such as suicidal thoughts and
harming themselves 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.
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.

8 What Seroxat contains

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 5, Stopping
Seroxat, above). 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).

Seroxat tablets come in three strengths.
10 mg tablets are oval, white to
pinkish white tablets and marked with
“FC1” and break line on one side and
“GS” and break line on the other side.
20 mg tablets are white ovals marked
“20” on one side, and with a break-line
on the other side. 30 mg tablets are
blue ovals marked “30” on one side,
and with a break-line on the other
side. Each pack of Seroxat 10 mg
tablets contains 2 strips of 14 tablets
(28 tablets in total). Each pack of
Seroxat 20 mg and 30 mg tablets
contains three strips of 10 tablets
(30 tablets in total).

7 Looking after your tablets
• Keep your tablets in the pack with
this leaflet.
• Do not store your tablets above
30°C.
• Keep your tablets out of the
reach and sight of children.
• Do not take your tablets after the
expiry date shown on the pack.
• If you are using half tablets, be
careful to keep them safely in the
pack.
• Never give these tablets to others,
even if they have similar
symptoms to yours.
• Finish all your tablets as the
doctor tells you to.
• Keep this leaflet. You may need to
read it again.

The active ingredient in Seroxat
film-coated tablets is paroxetine
(as paroxetine hydrochloride
hemihydrate).
The inactive ingredients are dibasic
calcium phosphate dihydrate (E341),
sodium starch glycolate (Type A),
magnesium stearate (E470b),
hypromellose (E464), macrogol 400,
polysorbate 80 (E433), titanium
dioxide (E171). The 30 mg tablet also
contains indigo carmine (E132) and
the 10 mg tablet also contains iron
oxide red (E172). Sodium content of
the 10 mg tablet is 0.1 mg, of the
20 mg tablet is 0.3 mg and of the
30 mg tablet, 0.4 mg.
Seroxat film-coated tablets are
made by S.C. Europharm S.A.,
2 Panselelor St, Bra ov, County of
Bra ov, 500419, Romania
The Product Licence holder is
SmithKline Beecham Limited, trading
as GlaxoSmithKline UK, Stockley Park
West, Uxbridge, Middlesex UB11 1BT

Other formats:
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name

Seroxat 10 mg tablets
Seroxat 20 mg tablets
Seroxat 30 mg tablets
Reference number
10592/0218
This is a service provided by the Royal
National Institute of Blind People.
Seroxat and the Seroxat tablet shape
and colours are registered trademarks
of the GlaxoSmithKline group of
companies
© 2012 GlaxoSmithKline group of
companies. All rights reserved

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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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