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SEROXAT 20 MG/10 ML ORAL SUSPENSION

Active substance(s): PAROXETINE HYDROCHLORIDE

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Other possible side effects during treatment



Very common side effects, likely to affect more than 1 in 10
people:



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

S059 LEAFLET Seroxat 20151123

Your medicine is called Seroxat 20mg/10 ml oral suspension but
will be referred to as Seroxat throughout the following patient
information leaflet.

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.

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



Sensitivity to sunlight

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

SEROXAT® 20 mg/10 ml ORAL SUSPENSION
(Paroxetine hydrochloride hemihydrate)

Read all of this leaflet carefully before you starts taking this
medicine because it contains important information for you.





Painful erection of the penis that won’t go away

Increases in the level of cholesterol in the blood





Low blood platelet count.

Lack of appetite



Not sleeping well (insomnia) or feeling sleepy



Abnormal dreams (including nightmares)

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



Feeling dizzy or shaky (tremors)



Headache



Difficulty in concentrating



Feeling agitated



Feeling unusually weak



Blurred vision



Yawning, dry mouth



Diarrhoea or constipation



Vomiting

5. How to store Seroxat



Weight gain

5. How to store Seroxat



Do not store above 25 °C.

6. Contents of the pack and other information



Your Seroxat oral suspension keeps for one month after it is
first opened. If you have any left after this time please give it
back to your pharmacist who will dispose of it safely. If you
need any more Seroxat oral suspension, please see your
doctor for a new prescription.

1. What Seroxat is and what it is used for

 Sweating.
Uncommon side effects, likely to affect up to 1 in every 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 Seroxat. Please speak to
your doctor about adjusting the dosage of your insulin or
diabetes medications.





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.

An increased risk of bone fractures has been observed in patients
taking this type of medicines.
Reporting of side effects



If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

1. What Seroxat is and what it is used for

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

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 :
2. What you need to know before you take Seroxat
3. How to take Seroxat
4. Possible side effects



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If your doctor tells you to stop using your medicine, please take
it back to the pharmacist for safe disposal. Only keep the
medicine if your 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.



This medicine is for YOUR use only. It can only be prescribed
by a doctor. Never give it to anyone else. It may harm them
even if their symptoms are the same as yours.



This leaflet does not contain the complete information about
your medicine. If you have any questions, or are not sure about
anything, ask your doctor or pharmacist, who has access to
additional information.

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.
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:

6. Contents of the pack and other information



Abnormal production of breast milk in men and women

What Seroxat contains



A slow heartbeat





Effects on the liver showing up in blood tests of your liver
function

Your medicine is called Seroxat. Each 5ml of the orange
suspension contains 10mg of the active ingredient paroxetine,
(as paroxetine hydrochloride).



Seroxat also contain the following: polacrilin potassium,
dispersible cellulose (E460), propylene glycol, glycerol (E422),
sorbitol (E420), methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), sodium citrate (E331), citric acid
(E330), sodium saccharin (E954), natural orange flavour,
natural lemon flavour, sunset yellow (E110), dimethicone
emulsion and purified water. Sodium content: 6.6 mg per 10 ml.

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).



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

What Seroxat looks like and contents of the pack

Talk to your doctor or pharmacist before taking Seroxat



Increase in a hormone called prolactin in the blood.

Seroxat is available as bottles containing 150ml.



Each 5 ml of the liquid contains 10 mg of paroxetine. The liquid is
an orange suspension with a smell of oranges and a sweet taste.

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?



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, antipsychotics such as perphenazine or clozapine, tricyclic
antidepressants, medicines used for pain and inflammation



Menstrual period disorders (including heavy or irregular periods,
bleeding between periods and absence or delay of periods.
Very rare side effects, likely to affect up to 1 in every 10,000
people:







Product Licence holder

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

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

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

Manufacturer

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

This product is manufactured by Farmaclair, Herouville, France.
POM

PL. 19488/0059

Leaflet revision date: 23 November 2015
Seroxat is a registered trade mark of Beecham Group plc, UK.
S059 LEAFLET Seroxat 20151123

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 Seroxat.
Children and adolescents under 18
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 any of these apply to you, tell your doctor without taking
Seroxat

 If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

Warnings and precautions

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
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, 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 Seroxat, see section 4,
Possible side effects, inside this leaflet.

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:


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



Thioridazine or pimozide, which are anti-psychotics - see Do
not take Seroxat, 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 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

However, depending on your circumstances, your doctor may
suggest that it is better for you to keep taking Seroxat.
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:

Older people

Visual disturbances

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

The maximum dose for people over 65 is 20 ml (40 mg of
paroxetine) per day.
Patients with liver or kidney disease

If you take more Seroxat than you should



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.

Never take more medicine than your doctor recommends. If
you take too much Seroxat (or someone else does), tell your doctor
or a hospital straight away. Show them the bottle of medicine.
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.



exaggerated reflexes.

If you forget to take Seroxat

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.

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.

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.

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.

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

Do not take a double dose to make up for a forgotten dose.

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.
Seroxat contains




This medicine contains the sugar, sorbitol (E420). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking Seroxat.
Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possible delayed).



Pravastatin, used to treat high cholesterol

3. How to take Seroxat



Rifampicin, used to treat tuberculosis (TB) and leprosy



Linezolid, an antibiotic



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

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



Medicines such as cimetidine or omeprazole, which are used to
reduce the amount of acid in your stomach.

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.

Feeling emotional or irritable



a blue-ish skin or being too hot or cold



Pregnancy, breast-feeding and fertility





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

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).

Diarrhoea (loose stools)

Your doctor will talk to you about how long you will need to keep
taking your medicine. This may be for many months or even longer.

trouble with breathing



Seroxat with food, drink and alcohol

Feeling confused or disorientated





Propafenone, flecainide and medicines used to treat an
irregular heartbeat

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



Take Seroxat oral suspension in the morning with food.

If you have trouble with your liver or severe kidney disease, your
doctor may decide that you should have a lower dose of Seroxat
than usual.



 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.

Shake the bottle before use.

Sunset yellow FCF (E110) is used as a colouring agent, and
may cause allergic reactions.

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

Depression

Starting
dose

Recommended Maximum
daily dose
daily dose

10 ml

10 ml

Obsessive
Compulsive
Disorder
(obsessions and
compulsions)

10 ml

Panic Disorder
(Panic attacks)

5ml

25ml

What to do if you’re feeling no better
Seroxat will not relieve your symptoms straight away – all
antidepressants take time to work. Some people will start to feel
better within a couple of weeks, but for others it may take a little
longer. Some people taking antidepressants feel worse before
feeling better. If you don’t start to feel better after a couple of
weeks, go back to your doctor who will advise you. Your doctor
should ask to see you again a couple of weeks after you first start
treatment. Tell your doctor if you haven’t started to feel better.
If you stop taking Seroxat
Do not stop taking Seroxat until your doctor tells you to.

20ml

30ml

30ml

Social Anxiety
Disorder (fear or
avoidance of
social situations)

10 ml

10 ml

25ml

Post Traumatic
Stress Disorders

10 ml

10 ml

25ml

Generalised
Anxiety Disorders

10 ml

10 ml

25ml

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, 5 ml (10 mg of paroxetine) at a time, up to a
maximum daily dose.

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 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.
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:

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 5 ml (10 mg of
paroxetine) a week. Most people find that any symptoms on
stopping Seroxat are mild and go away on their own within two
weeks.



For some people, these symptoms may be more severe, or go on
for longer.
If you get withdrawal effects when you are coming off your
medicine your doctor may decide that you should come off it 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 medicine again and come off it more slowly.



If you do get withdrawal effects, you will still be able to stop
Seroxat.
Possible withdrawal effects when stopping treatment

20ml

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

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


Feeling dizzy, unsteady or off-balance



Feelings like pins and needles, burning sensations and (less
commonly) electric shock sensations, including in the head and
buzzing, hissing, whistling, ringing or other persistent noise in
the ears (tinnitus)



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)



Allergic reactions, which may be severe 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 (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 agitated
or irritable, feeling confused, feeling restless, feeing hot,
sweating, shaking, shivering, hallucinations (strange visions or
sounds), and 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.

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).
 Some people have experienced aggression while taking
SEROXAT
If you experience these side effects, contact your doctor.
S059 LEAFLET Seroxat 20151123

Other possible side effects during treatment



Very common side effects, likely to affect more than 1 in 10
people:





S059 LEAFLET Paroxetine 20151123

PAROXETINE 20 mg/10 ml ORAL SUSPENSION
(paroxetine hydrochloride hemihydrate)



Do you have diabetes?

Your medicine is called Paroxetine 20 mg/10 ml Oral Suspension
but will be referred to as Paroxetine throughout the following patient
information leaflet.



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)?

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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



Read all of this leaflet carefully before you starts taking this
medicine because it contains important information for you.

Low blood platelet count.



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.

Common side effects, likely to 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)

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 medicines.



Feeling dizzy or shaky (tremors)



Headache



Difficulty in concentrating



Feeling agitated



Feeling unusually weak



Blurred vision



Yawning, dry mouth



Diarrhoea or constipation



Vomiting

5. How to store Paroxetine



5. How to store Paroxetine

Weight gain



Do not store above 25 °C.

6. Contents of the pack and other information



Your Paroxetine oral suspension keeps for one month after it is
first opened. If you have any left after this time please give it
back to your pharmacist who will dispose of it safely. If you
need any more Paroxetine oral suspension, please see your
doctor for a new prescription.

1. What Paroxetine is and what it is used for

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



Reporting of side effects



If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

1. What Paroxetine is and what it is used for

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If your doctor tells you to stop using your medicine, please take
it back to the pharmacist for safe disposal. Only keep the
medicine if your 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.



This medicine is for YOUR use only. It can only be prescribed
by a doctor. Never give it to anyone else. It may harm them
even if their symptoms are the same as yours.



This leaflet does not contain the complete information about
your medicine. If you have any questions, or are not sure about
anything, ask your doctor or pharmacist, who has access to
additional information.

6. Contents of the pack and other information

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

What Paroxetine contains



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)

What Paroxetine looks like and contents of the pack



Pain in the joints or muscles

Paroxetine is available as bottles containing 150ml.



Increase in a hormone called prolactin in the blood.

Each 5 ml of the liquid contains 10 mg of paroxetine. The liquid is
an orange suspension with a smell of oranges and a sweet taste.



Menstrual period disorders (including heavy or irregular periods,
bleeding between periods and absence or delay of periods.
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
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

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 :
2. What you need to know before you take Paroxetine
3. How to take Paroxetine
4. Possible side effects



called non-steroidal anti-inflammatory drugs or NSAIDs,
such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac,
diclofenac, meloxicam)?

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

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.
2. What you need to know before you take Paroxetine
Do not take Paroxetine


Your medicine is called Paroxetine. Each 5ml of the orange
suspension contains 10mg of the active ingredient paroxetine,
(as paroxetine hydrochloride).
Paroxetine also contain the following: polacrilin potassium,
dispersible cellulose (E460), propylene glycol, glycerol (E422),
sorbitol (E420), methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), sodium citrate (E331), citric acid
(E330), sodium saccharin (E954), natural orange flavour,
natural lemon flavour, sunset yellow (E110), dimethicone
emulsion and purified water. Sodium content: 6.6 mg per 10 ml.

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
anti-psychotic called pimozide



If you are allergic to paroxetine or any of the other ingredients
of’ this medicine’ (listed in section 6).



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, antipsychotics such as perphenazine or clozapine, tricyclic
antidepressants, medicines used for pain and inflammation

Leaflet revision date: 23 November 2015
S059 LEAFLET Paroxetine 20151123

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 nose
bleeds). 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.

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.

Talk to your doctor or pharmacist before taking Paroxetine

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

PL. 19488/0059

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
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 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.

Warnings and precautions

Product Licence holder

POM

Children and adolescents under 18

 If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

Are you taking any other medicines (see Taking other
medicines and Paroxetine, inside this leaflet)?

This product is manufactured by Farmaclair, Herouville, France.

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.

 If any of these apply to you, tell your doctor without taking
Paroxetine



Manufacturer



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 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 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



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’re 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.
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 breast-feeding. You and your doctor may decide that you
can breast-feed while you are taking Paroxetine.
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.
Paroxetine contains


This medicine contains the sugar, sorbitol (E420). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking Paroxetine.



Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possible delayed).

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



Sunset yellow FCF (E110) is used as a colouring agent, and
may cause allergic reactions.



Pravastatin, used to treat high cholesterol

3. How to take Paroxetine



Rifampicin, used to treat tuberculosis (TB) and leprosy



Linezolid, an antibiotic



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

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



Medicines such as cimetidine or omeprazole, which are used to
reduce the amount of acid in your stomach.

 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, including medicines
obtained without a prescription.
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
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 up to
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

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

Depression

Starting
dose

Recommended Maximum
daily dose
daily dose

10 ml

10 ml

25ml



Feeling restless or agitated

Shake the bottle before use.



Tremor (shakiness)

Take Paroxetine oral suspension in the morning with food.



Feeling confused or disorientated

Your doctor will talk to you about how long you will need to keep
taking your medicine. This may be for many months or even longer.



Diarrhoea (loose stools)



Feeling emotional or irritable



Visual disturbances

Older people
The maximum dose for people over 65 is 20 ml (40 mg of
paroxetine) per day.
Patients with liver or kidney disease
If you have trouble with your liver or severe kidney disease, 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 medicine than your doctor recommends. If
you take too much Paroxetine (or someone else does), tell your
doctor or a hospital straight away. Show them the bottle of
medicine. 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

10 ml

Panic Disorder
(Panic attacks)

5ml

20ml

30ml

Social Anxiety
Disorder (fear or
avoidance of
social situations)

10 ml

10 ml

25ml

Post Traumatic
Stress Disorders

10 ml

10 ml

25ml

Generalised
Anxiety Disorders

10 ml

10 ml

25ml

20ml

30ml

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, 5 ml (10 mg of paroxetine) at a time,
up to a maximum daily dose.

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.

Take your medicine at the same time every day.

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

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.

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.

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 5 ml (10
mg of paroxetine) 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.

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 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.

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




If you get withdrawal effects when you are coming off your
medicine your doctor may decide that you should come off it 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 medicine again and come off it more slowly.
If you do get withdrawal effects, you will still be able to stop
Paroxetine.

Obsessive
Compulsive
Disorder
(obsessions and
compulsions)

 Fluttering or pounding heartbeat (palpitations).
 Please see your doctor if you are worried about withdrawal
effects when stopping 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, 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 and
buzzing, hissing, whistling, ringing or other persistent noise in
the ears (tinnitus)



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)



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 (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 agitated
or irritable, feeling confused, feeling restless, feeing hot,
sweating, shaking, shivering, hallucinations (strange visions or
sounds), and 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.

Frequency unknown
 Some people have had thoughts of harming or killing
themselves while taking Paroxetine or soon after stopping
treatment (see section 2, What you need to know before you
take Paroxetine).
 Some people have experienced aggression while taking
PAROXETINE
If you experience these side effects, contact your doctor.
S059 LEAFLET Paroxetine 20151123

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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