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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
 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.

Other medicines and Seroxat

Some medicines can affect the way Seroxat works, or
make it more likely that you’ll have side effects. Seroxat
Seroxat® 20 mg film-coated Tablets/
can also affect the way some other medicines work.
Paroxetine 20 mg film-coated Tablets
These include:
 Medicines called monoamine oxidase inhibitors
(MAOIs, including moclobemide and methylthioninium
Your medicine is available using the above two
chloride (methylene blue)) - see Do not take Seroxat,
names, but will be referred to as Seroxat
inside this leaflet
throughout the remainder of this leaflet.
 Thioridazine or pimozide, which are anti-psychotics
Your medicine is available in other strengths- 10mg
- see Do not take Seroxat, inside this leaflet
and 30mg.
 Aspirin (acetylsalicylic acid), ibuprofen or other
medicines called NSAIDs (non-steroidal antiRead all of this leaflet carefully before you start
inflammatory drugs) like celecoxib, etodolac,
taking this medicine because it contains important
diclofenac and meloxicam, used for pain and
information for you.
Children and adolescents under 18
 Keep this leaflet. You may need to read it again.
Seroxat should not be used for children and
 Tramadol and pethidine, painkillers
 If you have any further questions, ask your doctor or
adolescents under 18 years. Also, patients under 18
 Medicines called triptans, such as sumatriptan, used
have an increased risk of side effects such as suicide
to treat migraine
 This medicine has been prescribed for you only. Do
attempt, suicidal thoughts and hostility (predominantly
 Other antidepressants including other SSRIs,
not pass it on to others. It may harm them, even if
aggression, oppositional behaviour and anger) when
tryptophan and tricyclic antidepressants like
their signs of illness are the same as yours.
they take Seroxat. If your doctor has prescribed Seroxat
clomipramine, nortriptyline and desipramine
 If you get any side effects, talk to your doctor or
for you (or your child) and you want to discuss this,
 A dietary supplement called tryptophan
pharmacist. This includes any possible side effects
please go back to your doctor. You should inform your
 Mivacurium and suxamethonium (used in
not listed in this leaflet. See section 4.
doctor if any of the symptoms listed above develop or
worsen when you (or your child) are taking Seroxat.
What is in this leaflet:
 Medicines such as lithium, risperidone,
Also, the long-term safety effects, concerning growth,
1. What Seroxat is and what it is used for
perphenazine, clozapine (called anti-psychotics) used
maturation and cognitive and behavioural development,
2. What you need to know before you take
to treat some psychiatric conditions
of Seroxat in this age group have not yet been
 Fentanyl, used in anaesthesia or to treat chronic
3. How to take Seroxat
4. Possible side effects
In studies of Seroxat in under 18s, common side effects  A combination of fosamprenavir and ritonavir, which
5. How to store Seroxat
is used to treat Human Immunodeficiency Virus
that affected less than 1 in 10 children/adolescents
6. Contents of the pack and other information
(HIV) infection
were: an increase in suicidal thoughts and suicide
 St John’s Wort, a herbal remedy for depression
attempts; deliberately harming themselves; being
1. What Seroxat is and what it is used for
 Phenobarbital, phenytoin, sodium valproate or
hostile; aggressive or unfriendly; lack of appetite;
Seroxat is a treatment for adults with depression
carbamazepine, used to treat fits or epilepsy
shaking; abnormal sweating; hyperactivity (having too
and/or anxiety disorders. The anxiety disorders that
 Atomoxetine which is used to treat attention deficit
much energy); agitation; changing emotions (including
Seroxat is used to treat are: obsessive compulsive
hyperactivity disorder (ADHD)
crying and changes in mood); and unusual bruising or
disorder (repetitive, obsessive thoughts with
 Procyclidine, used to relieve tremor, especially in
bleeding (such as nose bleeds). These studies also
uncontrollable behaviour); panic disorder (panic attacks,
Parkinson’s Disease
including those caused by agoraphobia, which is a fear showed that the same symptoms affected children and
 Warfarin or other medicines (called anticoagulants)
adolescents taking sugar pills (placebo) instead of
of open spaces); social anxiety disorder (fear or
used to thin the blood
Seroxat, although these were seen less often.
avoidance of social situations); post-traumatic stress
 Propafenone, flecainide and medicines used to treat
disorder (anxiety caused by a traumatic event); and
Some patients in these studies of under 18s had
an irregular heartbeat
generalised anxiety disorder (generally feeling very
withdrawal effects when they stopped taking Seroxat.
 Metoprolol, a beta-blocker used to treat high blood
anxious or nervous).
These effects were mostly similar to those seen in
pressure and heart problems
adults after stopping Seroxat (see section 3, How to
 Pravastatin, used to treat high cholesterol
Seroxat is one of a group of medicines called SSRIs
take Seroxat, inside this leaflet). In addition, patients
 Rifampicin, used to treat tuberculosis (TB) and
(selective serotonin reuptake inhibitors).
under 18 also commonly (affecting less than 1 in 10)
Everyone has a substance called serotonin in their
 Linezolid, an antibiotic
brain. People who are depressed or anxious have lower experienced stomach ache, feeling nervous and
levels of serotonin than others. It is not fully understood changing emotions (including crying, changes in mood,  Tamoxifen, which is used to treat breast cancer or
trying to hurt themselves, thoughts of suicide and
fertility problems.
how Seroxat and other SSRIs work but they may help
attempting suicide).
► If you are taking or have recently taken any of the
by increasing the level of serotonin in the brain.
medicines in this list, and you have not already
Treating depression or anxiety disorders properly is
Thoughts of suicide and worsening of your
discussed these with your doctor, go back to your
important to help you get better.
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you doctor and ask what to do. The dose may need to be
2. What you need to know before you take
changed or you may need to be given another
can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
Do not take Seroxat
antidepressants, since these medicines all take time to Tell your doctor or pharmacist if you are taking,
 If you are taking medicines called monoamine
have recently taken or might take any other
work, usually about two weeks but sometimes longer.
oxidase inhibitors (MAOIs, including moclobemide
medicines, including medicines obtained without a
You may be more likely to think like this:
and methylthioninium chloride (methylene blue)) or
 If you have previously had thoughts about killing or
have taken them at any time within the last two
harming yourself.
Seroxat with food, drink and alcohol
weeks. Your doctor will advise you how you should
 If you are a young adult. Information from clinical
Do not drink alcohol while you are taking Seroxat.
begin taking Seroxat once you have stopped taking
trials has shown an increased risk of suicidal
Alcohol may make your symptoms or side effects
the MAOI.
behaviour in adults aged less than 25 years with
worse. Taking Seroxat in the morning with food will
 If you are taking an anti-psychotic called
psychiatric conditions who were treated with an
reduce the likelihood of you feeling sick (nausea).
thioridazine or an anti-psychotic called pimozide.
 If you are allergic to paroxetine or any of the other
Pregnancy, breast-feeding and fertility
► If you have thoughts of harming or killing yourself at
ingredients of this medicine (listed in section 6).
If you are pregnant or breast-feeding, think you may be
any time, contact your doctor or go to a hospital
►If any of these apply to you, tell your doctor without straight away.
pregnant or are planning to have a baby, ask your
taking Seroxat
doctor or pharmacist for advice before taking this
You may find it helpful to tell a relative or close

Warnings and precautions
Talk to your doctor or pharmacist before taking
 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
 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 nonsteroidal anti-inflammatory drugs or NSAIDs,

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
Important side effects seen with Seroxat
mothers who took Seroxat. You and your doctor may
Some patients who take Seroxat develop something
decide that it is better for you to change to another
called akathisia, where they feel restless and feel like treatment or to gradually stop taking Seroxat while you
they can’t sit or stand still. Other patients develop
are pregnant. However, depending on your
something called serotonin syndrome, or neuroleptic circumstances, your doctor may suggest that it is better
malignant syndrome, where they have some or all
for you to keep taking Seroxat.
of the following symptoms: feeling very agitated or
Make sure your midwife or doctor knows you’re
irritable, feeling confused, feeling restless, feeling hot,
taking Seroxat. When taken during pregnancy,
sweating, shaking, shivering, hallucinations (strange
visions or sounds), muscle stiffness, sudden jerks of the particularly late pregnancy, medicines like Seroxat may
muscles or a fast heartbeat. The severity can increase, increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn
leading to loss of consciousness. If you notice any of
(PPHN). In PPHN, the blood pressure in the blood
these symptoms, contact your doctor. For more
vessels between the baby’s heart and the lungs is too
information on these or other side effects of Seroxat,
high. If you take Seroxat during the last 3 months of
see section 4, Possible side effects, inside this leaflet.
pregnancy, your newborn baby might also have other
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.

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.

Number of tablets to
One white to pinkishwhite tablet
One white tablet
One blue tablet
Two white tablets
One blue tablet + One
white tablet or Twoand-a-half white tablets
Two blue tablets or
Three white tablets

10 mg
20 mg
30 mg
40 mg
50 mg

60 mg

The usual doses for different conditions are set out in
the table below.
Obsessive Compulsive
(obsessions and
Panic Disorder (panic
Social Anxiety
(fear or avoidance of
social situations)
Post-Traumatic Stress
Generalised Anxiety

Starting Recommended Maximum
daily dose
daily dose
20 mg 20 mg
50 mg

20 mg

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


►Please see your doctor if you are worried about
If you have trouble with your liver or kidneys your doctor withdrawal effects when stopping Seroxat.
may decide that you should have a lower dose of
If you have any further questions on the use of this
Seroxat than usual. If you have severe liver or kidney
medicine, ask your doctor or pharmacist.
disease the maximum dose is 20 mg per day.

Patients with liver or kidney disease

If you take more Seroxat than you should

4. Possible side effects

Uncommon side effects, likely to affect up to 1 in
every 100 people:

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.

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

You may need to contact your doctor or go to a hospital
straight away.

If you forget to take Seroxat

Uncommon side effects, likely to affect up to 1 in
every 100 people:

 If you have unusual bruising or bleeding,

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

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
If you do get withdrawal effects, you will still be
able to stop Seroxat.

Possible withdrawal effects when stopping
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

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

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

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).

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
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:

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:

Abnormal production of breast milk in men and
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
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.

Allergic reactions, which may be severe to
If you develop a red and lumpy skin rash, swelling of
the eyelids, face, lips, mouth or tongue, start to itch or Very rare side effects, likely to affect up to 1 in
have difficulty breathing (shortness of breath) or
every 10,000 people:
swallowing and feel weak or lightheaded resulting in
 Skin rash, which may blister, and looks like small
collapse or loss of consciousness, contact your
targets (central dark spots surrounded by a paler
doctor or go to a hospital straight away.
area, with a dark ring around the edge) called
 If you have some or all of the following symptoms
erythema multiforme
you may have something called serotonin syndrome  A widespread rash with blisters and peeling skin,
or neuroleptic malignant syndrome. The symptoms
particularly around the mouth, nose, eyes and
include: feeling very agitated or irritable, feeling
genitals (Stevens-Johnson syndrome)
confused, feeling restless, feeling hot, sweating,
 A widespread rash with blisters and skin peeling on
shaking, shivering, hallucinations (strange visions or
much of the body surface (toxic epidermal necrolysis)
sounds), muscle stiffness, sudden jerks of the
 Liver problems that make the skin or whites of the
muscles or a fast heartbeat. The severity can
eyes go yellow
increase, leading to loss of consciousness. If you feel  Syndrome of inappropriate antidiuretic hormone
like this contact your doctor.
production (SIADH) which is a condition in which the
 Acute glaucoma.
body develops an excess of water and a decrease in
If your eyes become painful and you develop blurred
sodium (salt) concentration, as a result of improper
vision, contact your doctor.
chemical signals. Patients with SIADH may become
severely ill or may have no symptoms at all
Frequency unknown
 Fluid or water retention (which may cause swelling of
 Some people have had thoughts of harming or killing
the arms or legs)
themselves while taking Seroxat or soon after
 Sensitivity to sunlight
stopping treatment (see section 2, What you need to
 Painful erection of the penis that won’t go away
know before you take Seroxat)
 Low blood platelet count.
 Some people have experienced aggression while
taking Seroxat
Some patients have developed buzzing, hissing,
If you experience these side effects, contact your
whistling, ringing or other persistent noise in the ears
(tinnitus) when they take Seroxat.

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
Change in sex drive or sexual function. For example,
lack of orgasm and, in men, abnormal erection and

Common side effects, likely to affect up to 1 in
Uncommon side effects, likely to affect up to 1 in 10 people:
every 100 people:
 Increases in the level of cholesterol in the blood

Diarrhoea or constipation
Weight gain

Lack of appetite
Not sleeping well (insomnia) or feeling sleepy
Abnormal dreams (including nightmares)
Feeling dizzy or shaky (tremors)
Difficulty in concentrating
Feeling agitated
Feeling unusually weak
Blurred vision
Yawning, dry mouth

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: By reporting side effects
you can help provide more information on the safety of
this medicine.

5. How to store Seroxat

Do not store your tablets above 30°C. Store in the
original package.
Keep your tablets out of the sight and reach of
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.
If your doctor tells you to stop taking this medicine,
take any unused tablets back to your pharmacist for
safe disposal. Only keep them if your doctor tells you
If the tablets become discoloured or show any signs
of deterioration, you should seek the advice of your
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.


Contents of the pack and other

Each film-coated tablet contains 22.80mg paroxetine
hydrochloride hemihydrate equivalent to 20mg of
The inactive ingredients are: calcium dihydrogen
phosphate, sodium starch glycolate (Type A),
magnesium stearate; Opadry White YS-1R-7003
containing: hypromellose, macrogol 400, polysorbate 80
and titanium dioxide (E171).
Sodium content of the 20 mg tablet is 0.3 mg
Seroxat are white, film-coated, oval shaped biconvex
tablets debossed with “20” on one side and having a
break bar on the other.
Each pack of Seroxat contains 30 tablets.
Manufactured by: SmithKline Beecham Plc, Manor
Royal, Crawley, West Sussex RH10 9QJ, UK
Glaxo Wellcome Production, Terras 1, Zone Industrialle
du Terras, 53 100 Mayenne, France.
S.C. EUROPHARM S.A., Str. Panselelor nr.2, Brașov,
500419, Romania.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon, London,

PL No: 33902/0070

Leaflet revised: 26/08/2015
Seroxat® and the Seroxat tablet shape and colours are
registered trademarks of the GlaxoSmithKline Group of

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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.