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PAROXETINE 20 MG TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Paroxetine 20 mg Tablets
Paroxetine 30 mg Tablets

Paroxetine

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Paroxetine is and what it is
used for
2. What you need to know before you
take Paroxetine
3. How to take Paroxetine
4. Possible side effects
5. How to store Paroxetine
6. Contents of the pack and other
information

WHAT IT IS USED
1 AND
FOR

WHAT PAROXETINE IS

Paroxetine is a treatment for adults
with depression and/or anxiety
disorders. The anxiety disorders that
Paroxetine 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).
Paroxetine 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 Paroxetine
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.

YOU TAKE
2 BEFORE
PAROXETINE

WHAT YOU NEED TO KNOW

Do not take Paroxetine
• 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 Paroxetine once you have
stopped taking the MAOI
• if you are taking an
anti-psychotic called thioridazine
or an antipsychotic 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 Paroxetine

Warnings and precautions
Talk to your doctor or pharmacist
before taking Paroxetine.
• Are you taking any other medicines
(see Other medicines and
Paroxetine, inside this leaflet)?
• Are you taking tamoxifen to treat
breast cancer or fertility problems?
Paroxetine may make tamoxifen
less effective, so your doctor may
recommend you take another
antidepressant.
• Do you have kidney, liver or heart
trouble?
• Do you have epilepsy or have a
history of fits or seizures?
• Have you ever had episodes of
mania (overactive behaviour or
thoughts)?
• Are you having electro-convulsive
therapy (ECT)?
• Do you have a history of bleeding
disorders, or are you taking other
medicines that may increase the
risk of bleeding (these include
medicines used to thin the blood,
such as warfarin, anti-psychotics
such as perphenazine or clozapine,
tricyclic antidepressants, medicines
used for pain and inflammation
called non-steroidal anti-inflammatory
drugs or NSAIDs, such as
acetylsalicylic acid, ibuprofen,
celecoxib, etodolac, diclofenac,
meloxicam)?
• Do you have diabetes?
• Are you on a low sodium diet?
• Do you have glaucoma (pressure in
the eye)?
• Are you pregnant or planning to get
pregnant (see Pregnancy,
breast-feeding and fertility, inside
this leaflet)?
• Are you under 18 years old (see
Children and adolescents under 18,
inside this leaflet)?
• If you answer YES to any of
these questions, and you have not
already discussed them with your
doctor, go back to your doctor
and ask what to do about taking
Paroxetine

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Children and adolescents under 18
Paroxetine 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 Paroxetine.
If your doctor has prescribed Paroxetine
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 Paroxetine. Also, the
long-term safety effects concerning
growth, maturation and cognitive and
behavioural development, of Paroxetine
in this age group have not yet been
demonstrated. In studies of
Paroxetine 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
nosebleeds). These studies also
showed that the same symptoms
affected children and adolescents
taking sugar pills (placebo) instead of
Paroxetine, although these were
seen less often.

Some patients in these studies of
under 18s had withdrawal effects
when they stopped taking Paroxetine.
These effects were mostly similar to
those seen in adults after stopping
Paroxetine (see section 3, How to take
Paroxetine,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
Paroxetine
Some patients who take Paroxetine
develop something called akathisia,
where they feel restless and feel like
they can’t sit or stand still. Other
patients develop something called
serotonin syndrome, or neuroleptic
malignant syndrome, where they have
some or all of the following symptoms:
feeling very agitated or irritable, feeling
confused, feeling restless, feeling hot,
sweating, shaking, shivering,
hallucinations (strange visions or
sounds), muscle stiffness, sudden jerks
of the muscles or a fast heartbeat. The
severity can increase, leading to loss of
consciousness. If you notice any of
these symptoms, contact your doctor.
For more information on these or other
side effects of Paroxetine, see section
4, Possible side effects, inside this
leaflet.

Other medicines and Paroxetine
Some medicines can affect the way
Paroxetine works, or make it more
Paroxetine likely that you’ll have side
effects. Paroxetine 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 Paroxetine,
inside this leaflet
• Thioridazine or pimozide, which are
anti-psychotics - see Do not take
Paroxetine, inside this leaflet
• Aspirin (acetylsalicylic acid),
ibuprofen or other medicines called
NSAIDs (non-steroidal
anti- inflammatory drugs)
like celecoxib, etodolac, diclofenac
and meloxicam, used for pain and
inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as
sumatriptan, used to treat migraine
• Other antidepressants including
other SSRIs, tryptophan and tricyclic
antidepressants like clomipramine,
nortriptyline and desipramine
• A dietary supplement called
tryptophan
• Mivacurium and suxamethonium
(used in anaesthesia)
• Medicines such as lithium,
risperidone, perphenazine, clozapine
(called anti-psychotics) used to treat
some psychiatric conditions
• Fentanyl used in anaesthesia, or to
treat chronic pain
• A combination of fosamprenavir and
ritonavir, which is used to treat
Human Immunodeficiency Virus
(HIV) infection
• St John’s Wort, a herbal remedy for
depression
• Phenobarbital, phenytoin, sodium
valproate or carbamazepine, used to
treat fits or epilepsy
• Atomoxetine which is used to treat
attention deficit hyperactivity
disorder (ADHD)
• Procyclidine, used to relieve tremor,
especially in Parkinson’s Disease
• Warfarin or other medicines (called
anticoagulants) used to thin the
blood
• Propafenone, flecainide and
medicines used to treat an irregular
heartbeat
• Metoprolol, a beta-blocker used to
treat high blood pressure and heart
problems
• Pravastatin, used to treat high
cholesterol
• Rifampicin, used to treat
tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen, which is used to treat
breast cancer or fertility problems
▶ If you are taking or have
recently taken any of the
medicines in this list, and you
have not already discussed these
with your doctor, go back to your
doctor and ask what to do. The
dose may need to be changed or
you may need to be given another
medicine.
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Paroxetine with food, drink and
alcohol
Do not drink alcohol while you are
taking Paroxetine. Alcohol may make
your symptoms or side effects worse.
Taking Paroxetine in the morning with
food will reduce the likelihood of you
feeling sick (nausea).

Pregnancy, breast-feeding and
fertility Pregnancy:
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
paroxetine 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 paroxetine.

You and your doctor may decide that
it is better for you to change to
another treatment or to gradually stop
taking Paroxetine while you are
pregnant. However, depending on
your circumstances, your doctor may
suggest that it is better for you to keep
taking Paroxetine.

Make sure your midwife or doctor
knows you are taking Paroxetine.
When taken during pregnancy,
particularly late pregnancy, medicines
like Paroxetine 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 Paroxetine 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 blue-ish 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.

Breast-feeding:
Paroxetine may get into breast milk
in very small amounts. If you are
taking Paroxetine, go back and talk to
your doctor before you start breastfeeding. You and your doctor may
decide that you can breast-feed while
you are taking Paroxetine.

Fertility:
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 Paroxetine
include dizziness, confusion, feeling
sleepy or blurred vision. If you do get
these side-effects, do not drive or use
machinery.

TO TAKE
3 HOW
PAROXETINE

Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure.

Sometimes you may need to take
more than one tablet or half a tablet.

The recommended doses for
different conditions are set out in
the table below.
Starting Recomdose mended
daily
dose

Depression

Panic
Disorder
(panic
attacks)

PostTraumatic
Stress
Disorder

Generalised
Anxiety
Disorder

Dimensions: 165 x 620 mm

40 mg

60 mg

40 mg

60 mg

20 mg

50 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

10 mg

Your doctor will advise you what
dose to take when you first start
taking Paroxetine. 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.

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

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Colours:
Black

50 mg

Social
20 mg
Anxiety
Disorder
(fear or
avoidance
of social
situations)

00000000

Date prepared:
07/04/2016

20 mg

Obsessive
20 mg
Compulsive
Disorder
(obsessions
and coompulsions)

Artwork Proof Box
Proof no.
013.0

20 mg

Maximum
daily
dose

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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
Paroxetine than usual.

If you take more Paroxetine than
you should
Never take more tablets than your
doctor recommends. If you take too
many Paroxetine (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 Paroxetine 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 Paroxetine
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
Paroxetine 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 Paroxetine
Do not stop taking Paroxetine until
your doctor tells you to.

When stopping Paroxetine, 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 Paroxetine you
take by 10 mg a week. Most people
find that any symptoms on stopping
Paroxetine 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 Paroxetine, please see
your doctor. He or she may ask you to
start taking your tablets again and
come off them more slowly.
If you do get withdrawal effects,
you will still be able to stop
Paroxetine.

Possible withdrawal effects when
stopping treatment
Studies show that 3 in 10 patients
notice one or more symptoms on
stopping Paroxetine. Some
withdrawal effects on stopping occur
more frequently than others.

Common side effects (may effect 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
Paroxetine
• Sleep disturbances (vivid dreams,
nightmares, inability to sleep)
• Feeling anxious
• Headaches.

Uncommon side effects (may effect
up to 1 in 100 people):
• Feeling sick (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor (shakiness)
• Feeling confused or disorientated
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Fluttering or pounding heartbeat
(palpitations).
▶ Please see your doctor if you are
worried about withdrawal effects
when stopping Paroxetine.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can
cause side effects, although not
everybody gets them. Side effects are
more likely to happen in the first few
weeks of taking Paroxetine.
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 (may affect
up to 1 in 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 (may affect up to
1 in 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
Paroxetine 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.

Not known (frequency cannot be
estimated from the available data)
• Some people have had thoughts of
harming or killing themselves while
taking Paroxetine or soon after
stopping treatment (see section 2).
• Some people have experienced
aggression while taking Paroxetine
If you experience these side effects,
contact your doctor.
Other possible side effects during
treatment

Very common side effects (may affect
more than 1 in 10 people):
• Feeling sick (nausea). Taking your
medicine in the morning with food will
reduce the chance of this happening.
• Change in sex drive or sexual
function. For example, lack of
orgasm and, in men, abnormal
erection and ejaculation.
Common side effects (may affect up
to 1 in 10 people):
• Increases in the level of cholesterol
in the blood
• Lack of appetite
• Not sleeping well (insomnia) or
feeling sleepy
• Abnormal dreams (including
nightmares)
• Feeling dizzy or shaky (tremors)
• Headache
• Difficulty in concentrating
• Feeling agitated
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating.

Blister (Al/PVC):
For 30 mg: Do not store above 30ºC.

For 20 mg: This medicinal product
does not require any special storage
conditions.

Polyethylene tablet container:
For 20 mg and 30 mg: Do not store
above 30°C.

Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6

CONTENTS OF THE PACK
AND OTHER
INFORMATION

What Paroxetine 20 mg & 30 mg
contains
The active substance is paroxetine
Paroxetine 20 mg film-coated tablets
One film-coated tablet contains 20 mg
paroxetine.

Paroxetine 30 mg film-coated tablets
One film-coated tablet contains 30 mg
paroxetine.

The other ingredients are:
Tablet core
Mannitol, cellulose microcrystalline,
copovidone K28, sodium starch
glycollate (Type A), silica colloidal
anhydrous,
magnesium stearate.

Tablet-coating
Hypromellose 5 cps, talc (micronised),
titanium dioxide (E171).
30 mg tablets additionally:
Ferric oxide (E172), indigotine (E132).

What Paroxetine looks like and
contents of the pack
Paroxetine 20 mg is a white, round
bisected film-coated tablet with a
score notch, marked “PX 20” and
available in blister packs or containers
with 7, 10, 14, 15, 20, 28, 30, 40, 50,
50x1, 60, 100, 200 and 250 filmcoated tablets. The tablet can be
divided into equal doses.

Uncommon side effects (may affect
up to 1 in 100 people):
• A brief increase in blood pressure, or
a brief decrease that may make you
feel dizzy or faint when you stand up
suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness, shaking
or abnormal movements in the mouth
and tongue
• Dilated pupils
• Skin rashes
• Itching
• Feeling confused
• Having hallucinations (strange
visions or sounds)
• An inability to urinate (urinary
retention) or an uncontrollable,
involuntary passing of urine (urinary
incontinence).
• If you are a diabetic patient you may
notice a loss of control of your blood
sugar levels whilst taking Paroxetine.
Please speak to your doctor about
adjusting the dosage of your insulin
or diabetes medications.
Rare side effects (may affect up to 1 in
1,000 people):
• Abnormal production of breast milk in
men and women
• A slow heartbeat
• Effects on the liver showing up in
blood tests of your liver function
• Panic attacks
• Overactive behaviour or thoughts
(mania)
• Feeling detached from yourself
(depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs
(Restless Legs Syndrome)
• Pain in the joints or muscles
• Increase in a hormone called
prolactin in the blood.
• Menstrual period disorders (including
heavy or irregular periods, bleeding
between periods and absence or
delay of periods

Paroxetine 30 mg is a blue, oval,
convex film-coated tablet with a
pressure sensitive score, marked “PX
30” and available in blister packs or
containers with 7, 10, 14, 20, 28, 30,
50, 60, 100 and 250 film-coated
tablets. The tablet can be divided into
equal doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR
UK.

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee,
D-39179 Barleben
Germany

or

Lek S.A.,
Podlipie 16,
95-010 Stryków,
Poland

or

Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
or

ROWA PHARMACEUTICALS LTD.,
Bantry, Co. Cork,
Ireland

This leaflet was last revised in
04/2016

Very rare side effects (may affect up
to 1 in 10,000 people):
• Skin rash, which may blister, and
looks like small targets (central dark
spots surrounded by a paler area,
with a dark ring around the edge)
called erythema multiforme
• A widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals
(Stevens-Johnson syndrome)
• A widespread rash with blisters and
skin peeling on much of the body
surface (toxic epidermal necrolysis)
• Liver problems that make the skin or
whites of the eyes go yellow
• Syndrome of inappropriate
antidiuretic hormone production
(SIADH) which is a condition in which
the body develops an excess of
water and a decrease in sodium
(salt) concentration, as a result of
improper chemical signals. Patients
with SIADH may become severely ill
or may have no symptoms at all
• Fluid or water retention (which may
cause swelling of the arms or legs)
• Sensitivity to sunlight
• Painful erection of the penis that
won’t go away
• Low blood platelet count.

Some patients have developed buzzing,
hissing, whistling, ringing or other
persistent noise in the ears (tinnitus)
when they take Paroxetine.
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 (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help
provide more information on the safety
of this medicine.

TO STORE
5 HOW
PAROXETINE

Very rare side effects (may affect
up to 1 in 10,000 people):
• Allergic reactions, which may be
severe to Paroxetine
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

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mat.no.: 00000000

(shortness of breath) or swallowing
and feel weak or lightheaded
resulting in collapse or loss of
consciousness, contact your doctor
or go to a hospital straight away.
• If you have some or all of the
following symptoms you may have
something called serotonin
syndrome or neuroleptic
malignant syndrome. The
symptoms include: feeling very
agitated or irritable, feeling confused,
feeling restless, feeling hot, sweating,
shaking, shivering, hallucinations
(strange visions or sounds), muscle
stiffness, sudden jerks of the muscles
or a fast heartbeat. The severity can
increase, leading to loss of
consciousness. If you feel like this
contact your doctor.
• Acute glaucoma.
If your eyes become painful and you
develop blurred vision, contact your
doctor.

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the
carton and blister or container
respectively.

The expiry date refers to the last day of
that month.

Artwork Proof Box
Ref: N004 - Corrections to align with common text
Proof no.
013.0

Date prepared:
07/04/2016

Colours:
Black
Dimensions: 165 x 620 mm

Font size:
7.5pt
Fonts:
Helvetica

00000000
SZ00000LT000

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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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