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PAROXETINE 20MG FILM COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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PATIENT INFORMATION LEAFLET

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.

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:
(paroxetine)
 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
in this section
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, in this section
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
inflammation
 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
pharmacist.
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
anaesthesia)
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
Seroxat
 Fentanyl, used in anaesthesia or to treat chronic
demonstrated.
3. How to take Seroxat
pain
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
 Rifampicin, used to treat tuberculosis (TB) and
Seroxat is one of a group of medicines called SSRIs
take Seroxat, inside this leaflet). In addition, patients
leprosy
(selective serotonin reuptake inhibitors).
under 18 also commonly (affecting less than 1 in 10)
 Linezolid, an antibiotic
Everyone has a substance called serotonin in their
 Tamoxifen, which is used to treat breast cancer or
brain. People who are depressed or anxious have lower experienced stomach ache, feeling nervous and
fertility problems.
levels of serotonin than others. It is not fully understood changing emotions (including crying, changes in mood,
trying to hurt themselves, thoughts of suicide and
► If you are taking or have recently taken any of the
how Seroxat and other SSRIs work but they may help
attempting suicide).
medicines in this list, and you have not already
by increasing the level of serotonin in the brain.
discussed these with your doctor, go back to your
Treating depression or anxiety disorders properly is
Thoughts of suicide and worsening of your
doctor and ask what to do. The dose may need to be
important to help you get better.
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you changed or you may need to be given another
2. What you need to know before you take
medicine.
can sometimes have thoughts of harming or killing
Seroxat
Tell your doctor or pharmacist if you are taking,
yourself. These may be increased when first starting
Do not take Seroxat
antidepressants, since these medicines all take time to have recently taken or might take any other
 If you are taking medicines called monoamine
medicines, including medicines obtained without a
work, usually about two weeks but sometimes longer.
oxidase inhibitors (MAOIs, including moclobemide
prescription.
You may be more likely to think like this:
and methylthioninium chloride (methylene blue)) or
 If you have previously had thoughts about killing or
Seroxat with food, drink and alcohol
have taken them at any time within the last two
harming yourself.
Do not drink alcohol while you are taking Seroxat.
weeks. Your doctor will advise you how you should
 If you are a young adult. Information from clinical
Alcohol may make your symptoms or side effects
begin taking Seroxat once you have stopped taking
trials has shown an increased risk of suicidal
worse. Taking Seroxat in the morning with food will
the MAOI.
behaviour in adults aged less than 25 years with
reduce the likelihood of you feeling sick (nausea).
 If you are taking an anti-psychotic called
psychiatric conditions who were treated with an
thioridazine or an anti-psychotic called pimozide.
Pregnancy, breast-feeding and fertility
antidepressant.
 If you are allergic to paroxetine or any of the other
If you are pregnant or breast-feeding, think you may be
► If you have thoughts of harming or killing yourself at
ingredients of this medicine (listed in section 6).
pregnant or are planning to have a baby, ask your
any time, contact your doctor or go to a hospital
►If any of these apply to you, tell your doctor without straight away.
doctor or pharmacist for advice before taking this
taking Seroxat
medicine. In babies whose mothers took Seroxat during
You may find it helpful to tell a relative or close
the first few months of pregnancy, there have been
friend that you are depressed or have an anxiety
Warnings and precautions
some reports showing an increased risk of birth defects,
disorder, and ask them to read this leaflet. You might
Talk to your doctor or pharmacist before taking
in particular those affecting the heart. In the general
ask them to tell you if they think your depression or
Seroxat
population, about 1 in 100 babies are born with a heart
 Are you taking any other medicines (see Taking other anxiety is getting worse, or if they are worried about
defect. This increased to up to 2 in 100 babies in
changes in your behaviour.
medicines and Seroxat, inside this leaflet)?
mothers who took Seroxat. You and your doctor may
 Are you taking tamoxifen to treat breast cancer or
Important side effects seen with Seroxat
decide that it is better for you to change to another
fertility problems? Seroxat may make tamoxifen less
Some patients who take Seroxat develop something
treatment or to gradually stop taking Seroxat while you
effective, so your doctor may recommend you take
called akathisia, where they feel restless and feel like are pregnant. However, depending on your
another antidepressant.
they can’t sit or stand still. Other patients develop
circumstances, your doctor may suggest that it is better
 Do you have kidney, liver or heart trouble?
something called serotonin syndrome, where they
for you to keep taking Seroxat.
 Do you have epilepsy or have a history of fits or
have some or all of the following symptoms: feeling
seizures?
confused, feeling restless, sweating, shaking, shivering, Make sure your midwife or doctor knows you’re
 Have you ever had episodes of mania (overactive
hallucinations (strange visions or sounds), sudden jerks taking Seroxat. When taken during pregnancy,
behaviour or thoughts)?
particularly late pregnancy, medicines like Seroxat may
of the muscles or a fast heartbeat. If you notice any of
 Are you having electro-convulsive therapy (ECT)?
increase the risk of a serious condition in babies, called
these symptoms, contact your doctor. For more
 Do you have a history of bleeding disorders, or are
persistent pulmonary hypertension of the newborn
information on these or other side effects of Seroxat,
you taking other medicines that may increase the risk
(PPHN). In PPHN, the blood pressure in the blood
see section 4, Possible side effects, inside this leaflet.
of bleeding (these include medicines used to thin the
vessels between the baby’s heart and the lungs is too
blood, such as warfarin, anti-psychotics such as
high. If you take Seroxat during the last 3 months of
perphenazine or clozapine, tricyclic antidepressants,
pregnancy, your newborn baby might also have other
medicines used for pain and inflammation called nonconditions, which usually begin during the first 24
steroidal anti-inflammatory drugs or NSAIDs,
S0070-30-RM-PIL-27.01.2015
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
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.
Depression
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

Starting Recommended Maximum
dose
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
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

4. Possible side effects



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
Seroxat.



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

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:





Itching
Feeling confused
Having hallucinations (strange visions or sounds)
An inability to urinate (urinary retention) or an
uncontrollable, involuntary passing of urine (urinary
incontinence).

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.

If you experience seizures (fits), contact your
Very rare side effects, likely to affect up to 1 in
doctor or go to a hospital straight away.
every 10,000 people:
 If you feel restless and feel like you can’t sit or
 Skin rash, which may blister, and looks like small
stand still, you may have something called
targets (central dark spots surrounded by a paler
akathisia. Increasing your dose of Seroxat may make
area, with a dark ring around the edge) called
these feelings worse. If you feel like this, contact
erythema multiforme
your doctor.
 A widespread rash with blisters and peeling skin,
 If you feel tired, weak or confused and have achy,
particularly around the mouth, nose, eyes and
stiff or uncoordinated muscles this may be
genitals (Stevens-Johnson syndrome)
because your blood is low in sodium. If you have
 A widespread rash with blisters and skin peeling on
these symptoms, contact your doctor.
much of the body surface (toxic epidermal necrolysis)
If you stop taking Seroxat
 Liver problems that make the skin or whites of the
Very rare side effects, likely to affect up to 1 in
Do not stop taking Seroxat until your doctor tells
eyes go yellow
every 10,000 people:
you to.
 Syndrome of inappropriate antidiuretic hormone
 Allergic reactions to Seroxat.
When stopping Seroxat, your doctor will help you to
production (SIADH) which is a condition in which the
If you develop a red and lumpy skin rash, swelling of
reduce your dose slowly over a number of weeks or
body develops an excess of water and a decrease in
the eyelids, face, lips, mouth or tongue, start to itch
months - this should help reduce the chance of
sodium (salt) concentration, as a result of improper
or have difficulty breathing or swallowing, contact
withdrawal effects. One way of doing this is to gradually
chemical signals. Patients with SIADH may become
your doctor or go to a hospital straight away.
reduce the dose of Seroxat you take by 10 mg a week.
severely ill or may have no symptoms at all
 If you have some or all of the following
Most people find that any symptoms on stopping
 Fluid or water retention (which may cause swelling of
symptoms you may have something called
Seroxat are mild and go away on their own within two
the arms or legs)
serotonin syndrome. The symptoms include: feeling
weeks. For some people, these symptoms may be
 Sensitivity to sunlight
confused, feeling restless, sweating, shaking,
more severe, or go on for longer.
 Painful erection of the penis that won’t go away
shivering, hallucinations (strange visions or sounds),
 Low blood platelet count.
If you get withdrawal effects when you are coming off
sudden jerks of the muscles or a fast heartbeat. If
your tablets your doctor may decide that you should
you feel like this contact your doctor.
Some patients have developed buzzing, hissing,
come off them more slowly. If you get severe
 Acute glaucoma.
whistling, ringing or other persistent noise in the ears
withdrawal effects when you stop taking Seroxat,
If your eyes become painful and you develop blurred (tinnitus) when they take Seroxat.
please see your doctor. He or she may ask you to start
vision, contact your doctor.
taking your tablets again and come off them more
An increased risk of bone fractures has been observed
slowly. It may be easier for you to take Seroxat oral
Frequency unknown
in patients taking this type of medicine.
suspension during the time that you are coming off your Some people have had thoughts of harming or killing
Reporting of side effects
medicine.
themselves while taking Seroxat or soon after stopping
If you get any side effects, talk to your doctor,
treatment (see section 2, What you need to know
If you do get withdrawal effects, you will still be
pharmacist or nurse. This includes any possible side
before you take Seroxat).
able to stop Seroxat.
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
Other possible side effects during treatment
Possible withdrawal effects when stopping
www.mhra.gov.uk/yellowcard. By reporting side effects,
Very common side effects, likely to affect more
treatment
you can help provide more information on the safety of
than 1 in 10 people:
Studies show that 3 in 10 patients notice one or more
this medicine.
 Feeling sick (nausea). Taking your medicine in the
symptoms on stopping Seroxat. Some withdrawal
morning with food will reduce the chance of this
5. How to store Seroxat
effects on stopping occur more frequently than others.
happening.
 Do not store your tablets above 30°C. Store in the
 Change in sex drive or sexual function. For example,
Common side effects, likely to affect up to 1 in
original package.
lack of orgasm and, in men, abnormal erection and
10 people:
 Keep your tablets out of the sight and reach of
ejaculation.
 Feeling dizzy, unsteady or off-balance
children.
 Feelings like pins and needles, burning sensations
 Do not take your tablets after the expiry date shown
Common side effects, likely to affect up to 1 in
and (less commonly) electric shock sensations,
on the pack.
10 people:
including in the head
 If you are using half tablets, be careful to keep them
 Increases in the level of cholesterol in the blood
 Some patients have developed buzzing, hissing,
safely in the pack.
 Lack of appetite
whistling, ringing or other persistent noise in the ears
 If your doctor tells you to stop taking this medicine,
 Not sleeping well (insomnia) or feeling sleepy
(tinnitus) when they take Seroxat
take any unused tablets back to your pharmacist for
 Abnormal dreams (including nightmares)
 Sleep disturbances (vivid dreams, nightmares,
safe disposal. Only keep them if your doctor tells you
 Feeling dizzy or shaky (tremors)
inability to sleep)
to.
 Headache
 Feeling anxious
 If the tablets become discoloured or show any signs
 Difficulty in concentrating
 Headaches.
of deterioration, you should seek the advice of your
 Feeling agitated
pharmacist.
Uncommon side effects, likely to affect up to 1 in  Feeling unusually weak
 Never give these tablets to others, even if they have
 Blurred vision
every 100 people:
similar symptoms to yours.
 Yawning, dry mouth
 Feeling sick (nausea)
 Finish all your tablets as the doctor tells you to.
 Diarrhoea or constipation
 Sweating (including night sweats)
 Keep this leaflet. You may need to read it again.
 Vomiting
 Feeling restless or agitated
 Weight gain
 Tremor (shakiness)
 Sweating.
 Feeling confused or disorientated
 Diarrhoea (loose stools)
Uncommon side effects, likely to affect up to 1 in
 Feeling emotional or irritable
every 100 people:
 Visual disturbances
 A brief increase in blood pressure, or a brief
 Fluttering or pounding heartbeat (palpitations).
decrease that may make you feel dizzy or faint when
you stand up suddenly
►Please see your doctor if you are worried about
 A faster than normal heartbeat
withdrawal effects when stopping Seroxat.
 Lack of movement, stiffness, shaking or abnormal
If you have any further questions on the use of this
movements in the mouth and tongue
medicine, ask your doctor or pharmacist.
 Dilated pupils
 Skin rashes
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.

6.

Contents of the pack and other
information

Each film-coated tablet contains 22.80mg paroxetine
hydrochloride hemihydrate equivalent to 20mg of
paroxetine.
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
Or
Glaxo Wellcome Production, Terras 1, Zone Industrialle
du Terras, 53 100 Mayenne, France.
Or
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,
NW9 6AQ
POM

PL No: 33902/0070

Leaflet revised: 27/01/2015
Seroxat® and the Seroxat tablet shape and colours are
registered trademarks of the GlaxoSmithKline Group of
Companies
S0070-30-RM-PIL-27.01.2015

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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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