SEROXAT 20MG TABLETS

Active substance: PAROXETINE

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263 LEAFLET Seroxat 20120420

Some patients in these studies of under 18s had withdrawal effects
when they stopped taking Seroxat. These effects were mostly
similar to those seen in adults after stopping Seroxat (see section 5,
Stopping Seroxat, above). In addition, patients under 18 also
commonly (affecting less than 1 in 10) experienced stomach ache,
feeling nervous and changing emotions (including crying, changes
in mood, trying to hurt themselves, thoughts of suicide and
attempting suicide).

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

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.

7. Looking after your tablets


Some patients have developed buzzing, hissing, whistling, ringing
or other persistent noise in the ears (tinnitus) when they take
Seroxat. An increased risk of bone fractures has been observed in
patients taking this type of medicines.

PATIENT INFORMATION LEAFLET
SEROXAT 20mg TABLETS
PAROXETINE 20mg TABLETS

2. Before you take Seroxat
Do not take Seroxat …


Information for other strength of Seroxat also may be present in this
leaflet.

If you are taking medicines called monoamine oxidase
inhibitors (MAOIs, including moclobemide and
methylthioninium chloride (methylene blue)) or have taken them
at any time within the last two weeks. Your doctor will advise
you how you should begin taking Seroxat once you have
stopped taking the MAOI



If you are taking a tranquilliser called thioridazine

Keep your tablets in the pack with this leaflet.

Eight important things you need to know about Seroxat



If you are taking an anti-psychotic called pimozide



Do not store your tablets above 30°C.





Please read all of the leaflet. It includes a lot of additional important
information about this medicine.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





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.

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



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



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



Finish all your tablets as the doctor tells you to.



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.

Possible withdrawal effects when stopping treatment



 If you have any concerns while you are taking Seroxat, talk to
your doctor or pharmacist who will be able to advise you.
5. Stopping Seroxat
Do not stop taking Seroxat until your doctor tells you to.

Studies show that 3 in 10 patients notice one or more symptoms on
stopping Seroxat. Some withdrawal effects on stopping occur more
frequently than others.
Likely to affect up to 1 in 10 people:


Feeling dizzy, unsteady or off-balance



Feelings like pins and needles, burning sensations and (less
commonly) electric shock sensations, including in the head



Some patients have developed buzzing, hissing, whistling,
ringing or other persistent noise in the ears (tinnitus) when they
take Seroxat



Sleep disturbances (vivid dreams, nightmares, inability to sleep)



Feeling anxious

 Headaches.
Likely to affect up to 1 in every 100 people:

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.

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.
Seroxat 20mg tablets are white, oval shaped, marked with “20” on
one side and a break line on the other.

Sweating (including night sweats)



Manufacturer

Feeling restless or agitated



Tremor (shakiness)

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



Feeling confused or disorientated

Product Licence holder



Diarrhoea (loose stools)



Feeling emotional or irritable



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

Visual disturbances

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.







Are you taking tamoxifen to treat breast cancer or fertility
problems? Seroxat may make tamoxifen less effective so your
doctor may recommend you take another antidepressant.



Do you have eye, kidney, liver or heart trouble?



Do you have epilepsy or have a history of fits?



Do you have episodes of mania (overactive behaviour or
thoughts)?

Some people who are depressed or anxious think of
harming or killing themselves. If you start to feel worse, or
think of harming or killing yourself, see your doctor or go to a
hospital straight away. See Thoughts of harming yourself,
inside this leaflet.



Are you having electro-convulsive therapy (ECT)?



Do you have a history of bleeding disorders?



Do you have diabetes?

Don’t stop taking Seroxat without talking to your doctor. If
you stop taking Seroxat suddenly or miss a dose, you may get
withdrawal effects. See section 5, Stopping Seroxat inside this
leaflet.



Are you on a low sodium diet?



Do you have glaucoma (pressure in the eye)?

Seroxat won’t work straight away. Some people taking
antidepressants feel worse before feeling better. Your doctor
should ask to see you again a couple of weeks after you first
start treatment. Tell your doctor if you haven’t started feeling
better. See section 3, How to take your tablets, inside this
leaflet.



Taking some other medicines with Seroxat can cause
problems. You may need to talk to your doctor. See Other
medicines and Seroxat, inside this leaflet.

If you are pregnant or planning to get pregnant, talk to your
doctor. See Pregnancy, breast-feeding and Seroxat, inside this
leaflet.
Read this leaflet. It includes a lot of important information about
this medicine.
If you have more questions, ask your doctor or pharmacist
(chemist). You may also find it helpful to contact a self-help group,
or patient organisation, to find out more about your condition. Your
doctor will be able to give you details
Seroxat is a treatment for adults with depression and/or
anxiety disorders.

Seroxat is a trademark of GlaxoSmithKline group of companies.
263 LEAFLET Seroxat 20120912



Are you pregnant or planning to get pregnant (see Pregnancy,
breast-feeding and Seroxat, inside this leaflet)?
 If you answer YES to any of these questions, and you have
not already discussed them with your doctor, go back to your
doctor and ask what to do about taking Seroxat.
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these
medicines all take time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:


If you have previously had thoughts about killing or harming
yourself.



If you are a young adult. Information from clinical trials has
shown an increased risk of suicidal behaviour in adults aged
less than 25 years with psychiatric conditions who were treated
with an antidepressant.

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

1. What Seroxat is and what it is used for
Leaflet revision date: 12 September 2012

Check with your doctor …
Are you taking any other medicines (see Other medicines and
Seroxat, inside this leaflet)?



PL No. 08747/0263

If you have previously had an allergic reaction to paroxetine
or any of the other tablet ingredients listed. See section 8, What
Seroxat contains, inside this leaflet.
 If any of these apply to you, tell your doctor without taking
Seroxat


Seroxat is not for use in children and adolescents under
18. See section 6, Children and adolescents under 18, inside
this leaflet.

If you feel restless and feel like you can’t sit or stand still,
tell your doctor. Increasing the dose of Seroxat may make
these feelings worse. See section 4, Possible side effects,
inside this leaflet.

Seroxat is available as blister packs of 14 and 28 tablets.

POM

Seroxat treats depression and anxiety disorders. Like all
medicines it can have unwanted effects. It is therefore important
that you and your doctor weigh up the benefits of treatment
against the possible unwanted effects, before starting
treatment.



What Seroxat looks like and contents of the pack



Seroxat should not be used for children and adolescents under
18 years because it has not been proven to be an effective
medicine for this age group. Also, patients under 18 have an
increased risk of side effects such as suicidal thoughts and harming
themselves when they take Seroxat. If your doctor has prescribed
Seroxat for you (or your child) and you want to discuss this, please
go back to your doctor.



What Seroxat contains

Feeling sick (nausea)

6. Children and adolescents under 18



8. What Seroxat contains



 Fluttering or pounding heartbeat (palpitations).
 Please see your doctor if you are worried about withdrawal
effects when stopping Seroxat.

(paroxetine)

Seroxat is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors). Everyone has a substance called
serotonin in their brain. People who are depressed or anxious have
lower levels of serotonin than others. It is not fully understood how
Seroxat and other SSRIs work but they may help by increasing the
level of serotonin in the brain.
Other medicines or psychotherapy can also treat depression and
anxiety. Treating depression or anxiety disorders properly is
important to help you get better. If it’s not treated, your condition
may not go away and may become more serious and more difficult
to treat.
You may find it helpful to tell a friend or relative that you are
depressed or suffering from an anxiety disorder, and ask them to
read this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.

 If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.
Pregnancy, breast-feeding and Seroxat
Talk to your doctor as soon as possible if you’re pregnant, if
you might be pregnant, or if you’re planning to become pregnant. In
babies whose mothers took Seroxat during the first few months of
pregnancy, there have been some reports showing an increased
risk of birth defects, in particular those affecting the heart. In the
general population, about 1 in 100 babies are born with a heart
defect. This increased to about 2 in 100 babies in mothers who took
Seroxat. You and your doctor may decide that it is better for you to
gradually stop taking Seroxat while you are pregnant. However,
depending on your circumstances, your doctor may suggest that it
is better for you to keep taking Seroxat.

263 LEAFLET Seroxat 20120420

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.

If you are taking any other medicines, including ones you have
bought yourself, check with your doctor or pharmacist before taking
Seroxat. They will know if it is safe for you to do so.
Seroxat and alcohol
Do not drink alcohol while you are taking Seroxat. Alcohol may
make your symptoms or side effects worse.
Driving and using machinery

Older people

Other possible side effects during treatment

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

Likely to affect more than 1 in 10 people:

Patients with liver or kidney disease



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.

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.
What if you miss a dose?

trouble with breathing

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



a blueish skin or being too hot or cold

3. How to take your tablets



blue lips

Take your tablets in the morning with food.



vomiting or not feeding properly

Swallow them with a drink of water.



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

Do not chew.

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.



stiff or floppy muscles

Seroxat tablets come in three strengths:

What if you take too many tablets?

tremors, jitters or fits.

10 mg:

Symptoms include:




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.
Medicines like Seroxat may reduce the quality of your sperm.
Although the impact of this on fertility is unknown, fertility may be
affected in some men whilst 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 can also affect the way
some other medicines work. These include:




10 mg

One white to pinkish white tablet

20 mg

One white tablet

30 mg

One blue tablet

As with other medicines Seroxat can cause side effects, but not
everybody gets them.
See the doctor if you get any of the following side effects
during treatment

60 mg

Other antidepressants including other SSRIs, tryptophan and
tricyclic antidepressants like clomipramine, nortriptyline and
desipramine
Medicines such as lithium, risperidone, perphenazine (called
anti-psychotics) used to treat some psychiatric conditions
Fentanyl, used in anaesthesia or to treat chronic pain
A combination of fosamprenavir and ritonavir, which is used to
treat Human Immunodeficiency Virus (HIV) infection

or Two-and-a-half white tablets

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

20 mg

Obsessive
Compulsive
Disorder
(obsessions
and
compulsions)

20 mg

10mg

Phenobarbital, phenytoin or carbamazepine, used to treat fits
or epilepsy



Atomoxetine which is used to treat attention deficit
hyperactivity disorder (ADHD)

Panic Disorder
(Panic attacks)



Procyclidine, used to relieve tremor, especially in Parkinson’s
Disease



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

Social Anxiety
Disorder (fear
or avoidance of
social
situations)

20 mg

Post traumatic
Stress Disorder

20 mg

Metoprolol, a beta-blocker used to treat high blood pressure
and heart problems



Rifampicin, used to treat tuberculosis (TB) and leprosy



Linezolid, an antibiotic



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

 If you are taking any of the medicines in this list, and you
have not already discussed these with your doctor, go back to
your doctor and ask what to do. The dose may need to be
changed or you may need to be given another medicine.

Generalised
Anxiety
Disorder

Recommended
Daily Dose
20 mg

Maximum
Daily
Dose



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.

Increases in the level of cholesterol in the blood



Lack of appetite



Not sleeping well (insomnia) or feeling sleepy



Abnormal dreams (including nightmares)



Feeling dizzy or shaky (tremors)



Headache



Difficulty in concentrating



Feeling agitated



Blurred vision



Yawning, dry mouth



Diarrhoea or constipation



Vomiting



Weight gain



Feeling weak



Sweating.

40mg

20 mg

Dilated pupils



Skin rashes



Feeling confused



Having hallucinations (strange visions or sounds)



An inability to urinate (urinary retention) or an uncontrollable,
involuntary passing of urine (urinary incontinence).
Likely to affect up to 1 in every 1,000 people:
A slow heartbeat
Effects on the liver showing up in blood tests of your liver
function



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.



Panic attacks



Overactive behaviour or thoughts (mania)



Feeling detached from yourself (depersonalisation)

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.



Feeling anxious



Irresistible urge to move the legs (Restless Legs Syndrome)

 Pain in the joints or muscles.
Likely to affect up to 1 in every 10,000 people:


Skin rash, which may blister, and looks like small targets
(central dark spots surrounded by a paler area, with dark ring
around the edge) called erythema mutiforme



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



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



Liver problems that make the skin or whites of the eyes go
yellow



Fluid or water retention which may cause swelling of the arms
or legs

Frequency unknown



Sensitivity to sunlight

Some people have had thoughts of harming or killing themselves
while taking Seroxat or soon after stopping treatment (see section
2, Before you take Seroxat).



Painful erection of the penis that won’t go away



Unexpected bleeding, e.g. bleeding gums, blood in the urine or
in vomit, or the appearance of unexpected bruises or broken
blood vessels (broken veins)

60mg

50mg

50mg

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.





60mg

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

Lack of movement, stiffness, shaking or abnormal movements
in the mouth and tongue

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

50mg

50mg

A faster than normal heartbeat






20 mg



Abnormal production of breast milk in men and women



20 mg

A brief increase in blood pressure, or a brief decrease that may
make you feel dizzy or faint when you stand up suddenly





20 mg





Likely to affect up to 1 in every 10,000 people:
40mg

Likely to affect up to 1 in every 100 people:

Likely to affect up to 1 in every 1,000 people:



St John’s Wort, a herbal remedy for depression



Likely to affect up to 1 in every 100 people:

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.



Propafenone, flecainide and medicines used to treat an
irregular heartbeat

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

Two blue tablets
or Three white tablets







4. Possible side effects

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

Medicines called triptans, such as sumatriptan, used to treat
migraine



Number of tablets to take

One blue tablet +One white tablet

Tramadol and pethidine, painkillers

Never take more tablets than your doctor recommends. If you
take too many Seroxat tablets (or someone else does), tell your
doctor or a hospital straight away. Show them the pack of tablets.
What to do if you’re feeling no better

Dose

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

50 mg



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.

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.

Two white tablets





30 mg: Blue tablets, marked with “30”
It is important to take your tablets as instructed by your doctor.
The label will tell you how many tablets to take and how often. If
you are unsure, ask your doctor or pharmacist.

40 mg

Aspirin, ibuprofen or other medicines called NSAIDs (nonsteroidal anti-inflammatory drugs) like celecoxib, etodolac and
meloxicam, used for pain and inflammation



White tablets, marked with “20”

Medicines called monoamine oxidase inhibitors (MAOIs,
including moclobemide and methylthioninium chloride
(methylene blue)) – see Do not take Seroxat, inside this leaflet





20 mg:

White to pinkish white tablets, marked with “FC1” on one
side and “GS” on the other

Take your medicine at the same time every day.

Likely to affect up to 1 in 10 people:

Allergic reactions to Seroxat. If you develop a red and lumpy
skin rash, swelling of the eyelids, face, lips, mouth or tongue,
start to itch or have difficulty breathing or swallowing, contact
your doctor or go to a hospital straight away.
If you have some or all of the following symptoms you may
have something called serotonin syndrome. The symptoms
include: feeling confused, feeling restless, sweating, shaking,
shivering, hallucinations (strange visions or sounds), sudden
jerks of the muscles or a fast heartbeat. If you feel like this
contact your doctor.
Acute glaucoma. If your eyes become painful and you develop
blurred vision, contact your doctor.

Expand view ⇕

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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