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SEROXAT 20MG TABLETS

Active substance: PAROXETINE

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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.






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)



263 LEAFLET Seroxat 20150216

Information for other strength of Seroxat also may be present in this
leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



Low blood platelet count.

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 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.



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.

Children and adolescents under 18



Increases in the level of cholesterol in the blood

Reporting of side effects



Lack of appetite



Not sleeping well (insomnia) or feeling sleepy



Abnormal dreams (including nightmares)



Feeling dizzy or shaky (tremors)

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.



Headache

5



Difficulty in concentrating



What is in this leaflet:
1
2

What Seroxat is and what it is used for
What you need to know before you take Seroxat

3

How to take Seroxat

4

Possible side effects

5

How to store Seroxat

How to store Seroxat

6

Contents of the pack and other information



Keep your tablets in the pack with this leaflet.

Feeling agitated



1

What Seroxat is and what it is used for

Do not store your tablets above 30°C.



Feeling unusually weak



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Blurred vision



Do not take your tablets after the expiry date shown on the pack.



Yawning, dry mouth





Diarrhoea or constipation

If you are using half tablets, be careful to keep them safely in the
pack.



Vomiting





Weight gain

Never give these tablets to others, even if they have similar
symptoms to yours.



Finish all your tablets as the doctor tells you to.



If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

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.

Contents of the pack and other information



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

6



Dilated pupils

What Seroxat contains



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).

The active ingredient in Seroxat film-coated tablets is paroxetine (as
paroxetine hydrochloride hemihydrate). Each tablet contains 20mg
of the active ingredient, paroxetine (as the hydrochloride).
The inactive ingredients are calcium hydrogen phosphate,
magnesium stearate, sodium starch glycollate,
hydroxypropylmethylcellulose, titanium dioxide (E171), polyethylene
glycol and polysorbate 80.
What Seroxat looks like and contents of the pack



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

Seroxat 20mg tablets are white, oval shaped, marked with “20” on
one side and a break line on the other.
Seroxat is available as blister packs of 14 and 28 tablets.

Feeling anxious
Irresistible urge to move the legs (Restless Legs Syndrome)



Manufactured by:

Pain in the joints or muscles

 Increase in a hormone called prolactin in the blood.
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

2

What you need to know before you take Seroxat

Do not take Seroxat


Rare side effects, likely to affect up to 1 in every 1,000 people:



Are you under 18 years old (see Children and adolescents under
18, inside this leaflet)?

Painful erection of the penis that won’t go away

Common side effects, likely to affect up to 1 in 10 people:







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.

Feeling detached from yourself (depersonalisation)

Are you pregnant or planning to get pregnant (see Pregnancy,
breast-feeding and fertility, inside this leaflet)?



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



Do you have glaucoma (pressure in the eye)?



If you have any further questions, ask your doctor or pharmacist.



Overactive behaviour or thoughts (mania)

Are you on a low sodium diet?



Sensitivity to sunlight

Feeling sick (nausea). Taking your medicine in the morning with
food will reduce the chance of this happening.

Panic attacks



Keep this leaflet. You may need to read it again.





Do you have diabetes?

(paroxetine)
Your medicine is marketed using the above names but will be
referred to as Seroxat throughout the following patient information
leaflet.









SEROXAT 20mg TABLETS
PAROXETINE 20mg TABLETS



Other possible side effects during treatment
Very common side effects, likely to affect more than 1 in 10
people:

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

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, antipsychotics 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)?

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

A widespread rash with blisters and skin peeling on much of the
body surface (toxic epidermal necrolysis)

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).

A widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (Stevens-Johnson
syndrome)

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

POM

PL No. 08747/0263

Leaflet revision date: 16 February 2015
Seroxat is a trademark of GlaxoSmithKline group of companies.
263 LEAFLET Seroxat 20150216

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?



Procured from within the EU and repackaged by the PL holder:
Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0
1DX.





This product is manufactured by S.C Europharm S.A., 2 Panselelor
St. Brasov, Condado de Brasov 500419, Romania.
Product Licence holder

Have you ever had episodes of mania (overactive behaviour or
thoughts)?



Are you having electro-convulsive therapy (ECT)?

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

Pregnancy, breast-feeding and fertility

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,
where they have some or all of the following symptoms: feeling
confused, feeling restless, sweating, shaking, shivering,
hallucinations (strange visions or sounds), sudden jerks of the
muscles or a fast heartbeat. 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

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.

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, in this section
Thioridazine or pimozide, which are anti-psychotics – see Do
not take Seroxat, in this section
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

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

20 mg

50mg

Obsessive
Compulsive Disorder
(obsessions and
compulsions

20 mg

40mg

60mg

Panic Disorder (Panic
attack)

10mg

40mg

60mg

Social Anxiety
Disorder (fear or
avoidance of social
situations)

20 mg

20 mg

50mg

Post traumatic Stress
Disorder

20 mg

20 mg

50mg

Generalised Anxiety
Disorder

20 mg

20 mg

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.

50mg

If you do get withdrawal effects, you will still be able to stop
Seroxat.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on
stopping Seroxat. Some withdrawal effects on stopping occur more
frequently than others.
Common side effects, likely to affect up to 1 in 10 people:

being very tired, not able to sleep or crying a lot



stiff or floppy muscles

Swallow them with a drink of water.



tremors, jitters or fits

Do not chew.



Feeling dizzy, unsteady or off-balance



vomiting or not feeding properly

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

 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.

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.



Diarrhoea (loose stools)

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 breastfeed while you are taking Seroxat.

Patients with liver or kidney disease



Feeling emotional or irritable

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.



Visual disturbances



Fluttering or pounding heartbeat (palpitations).

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.

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

30 mg: Blue tablets, marked with “30”



Linezolid, an antibiotic



Tamoxifen, which is used to treat breast cancer or fertility
problems.

Sometimes you may need to take more than one tablet or half a
tablet. This table will show you how many tablets to take.

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).

20 mg





Seroxat with food, drink and alcohol

Depression



Warfarin or other medicines (called anticoagulants) used to thin
the blood

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.

Starting Recommended Maximum
dose
daily dose
daily dose

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.



 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.

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

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”

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

Dose

Number of tablets to take

10 mg

One white to pinkish-white tablet

20 mg

One white tablet

30 mg

One blue tablet

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.

40 mg

Two white tablets
One blue tablet +One white tablet

60 mg

Two blue tablets or Three white tablets

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4

or Two-and-a-half white tablets

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.

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.

If you stop taking Seroxat

50 mg

 Please see your doctor if you are worried about withdrawal
effects when stopping Seroxat.

Rare side effects, likely to affect up to 1 in every 1,000 people:


If you experience seizures (fits), contact your doctor or go to
a hospital straight away.



If you feel restless and feel like you can’t sit or stand still,
you may have something called akathisia. Increasing your dose
of Seroxat may make these feelings worse. If you feel like this,
contact your doctor.



If you feel tired, weak or confused and have achy, stiff or
uncoordinated muscles this may be because your blood is low
in sodium. If you have these symptoms, contact your doctor.

Very rare side effects, likely to affect up to 1 in every 10,000
people:


Allergic reactions 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.
263 LEAFLET Seroxat 20150216

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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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