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SEROXAT 10MG FILM-COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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Seroxat®
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 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



what it is used for

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).
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.

paroxetine

Seroxat® 10 mg, 20 mg and 30 mg
film-coated tablets

Package leaflet: Information for the patient

paroxetine

1 What Seroxat is and

2 What you need to know

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
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 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
• 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

P8530

P8530

GSK-ROM-Brasov-ROBRA

Cyprus-CYP; Malta-MLT; United Kingdom-GBR

Seroxat

N/A

EPH_D_PVS1_630_170

N/A

N/A

K

2756

3

9pt
9pt
95%
9pt

1505

N

0

0

4

Brasov – Additional Artwork Information Panel
Leaflet / dimensions after folding

630 x 170 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

Replacement No.:

P8323

Page 1 of 2

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

40 mg

60 mg

Social Anxiety Disorder
(fear or avoidance of
social situations)

20 mg

20 mg

50 mg

Post-Traumatic Stress
Disorder

20 mg

20 mg

50 mg

Generalised Anxiety
Disorder

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

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.

P8530
Seroxat
N/A

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).

N/A

EPH_D_PVS1_630_170

Possible withdrawal effects
when stopping treatment

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.

N/A

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 or neuroleptic
malignant syndrome. The
symptoms include: 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 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 this medicine 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. The expiry
date refers to the last day of that
month.
• Do not store your tablets 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.
• 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

10 mg film-coated tablet
The active substance is paroxetine
(10 mg), as the hydrochloride
hemihydrate.
20 mg film-coated tablet
The active substance is paroxetine
(20 mg), as the hydrochloride
hemihydrate.
30 mg film-coated tablet
The active substance is paroxetine
(30 mg), as the hydrochloride
hemihydrate.
The other ingredients are
10 mg film-coated tablet
in the tablet core: dibasic calcium
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 iron oxide red (E172).
20 mg film-coated tablet
in the tablet core: dibasic calcium
phosphate dihydrate (E341), magnesium
stearate (E470b) and sodium starch
glycolate (Type A).
in the tablet coat: hypromellose
(E464), titanium dixoide (E171),
macrogol 400 and polysorbate
80 (E433).
30 mg film-coated tablet
in the tablet core: dibasic calcium
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 indigo carmine (E132).

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. Each pack of Seroxat
contains blisters of 28 tablets.
• Seroxat 20 mg film-coated tablets
are white, oval-shaped tablets,
marked ‘20’ on one side, and with a
break bar on the other side. Each
pack of Seroxat contains blisters of
30 tablets.
• Seroxat 30 mg film-coated tablets
are blue, oval-shaped tablets,
marked ‘30’ on one side, and with a
break bar on the other side. The
break bar is only to facilitate
breaking for ease of swallowing and
not to divide into equal doses. Each
pack of Seroxat contains blisters of
30 tablets.

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.
This leaflet was last revised in:
March 2015
Seroxat and the Seroxat tablet shape
and colours are registered trade marks
of the GSK group of companies
© 2015 GSK group of companies. All
rights reserved

Marketing Authorisation
Holder and Manufacturer

Marketing Authorisation Holder:
SmithKline Beecham Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: S.C. Europharm S.A.,
2 Panselelor St, Bra ov, County of
Bra ov, 500419, Romania
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.

GSK-ROM-Brasov-ROBRA

Cyprus-CYP; Malta-MLT; United Kingdom-GBR

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.

P8530

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

K

2756

3

9pt
9pt
95%
9pt

1505

N

0

0

4

Brasov – Additional Artwork Information Panel
Leaflet / dimensions after folding

630 x 170 mm

Carton dimensions

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

Replacement No.:

P8323

Page 2 of 2

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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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