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PAROXETINE 20MG/10ML LIQUID

Active substance: PAROXETINE HYDROCHLORIDE

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Patient Information leaflet

Seroxat® 20mg/10ml Liquid
(Paroxetine)
The name of your medicine is Seroxat 20mg/10ml Liquid, but will be
referred to as Seroxat Liquid throughout the remainder of this
leaflet.

Eight important things you need to know about
Seroxat Liquid

Please read all of the leaflet. It includes a lot of additional important
information about this medicine.
Seroxat Liquid 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.
Seroxat Liquid is not for use in children and adolescents
under 18. See section 6, Children and adolescents under 18,
inside this leaflet.
Seroxat Liquid 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
medicine, inside this leaflet.
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.
Don’t stop taking Seroxat Liquid without talking to your
doctor. If you stop taking Seroxat Liquid suddenly or miss a
dose, you may get withdrawal effects. See section 5, Stopping
Seroxat Liquid, 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 Liquid
may make these feelings worse. See section 4, Possible sideeffects, inside this leaflet.
Taking some other medicines with Seroxat Liquid can
cause problems. You may need to talk to your doctor. See
Other medicines and Seroxat Liquid, inside this leaflet.
If you are pregnant or planning to get pregnant, talk to
your doctor. See Pregnancy, breast-feeding and Seroxat
Liquid, inside this leaflet.
Read this leaflet. It includes a lot of important information about
this medicine.
Keep this leaflet. You may need to read it again.
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.

1. What Seroxat Liquid is and what it is used
for
Your medicine is available in bottles of 150ml. Each 5ml of the liquid
contains 10mg of paroxetine. The liquid is an orange suspension
with a smell of oranges and a sweet taste.
Seroxat Liquid is a treatment for adults with depression
and/or anxiety disorders.
Seroxat Liquid 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 Liquid 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.

2. Before you take Seroxat Liquid
Do not take Seroxat Liquid…

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 Liquid once
you have stopped taking the MAOI
If you are taking a tranquilliser called thioridazine
If you are taking an anti-psychotic called pimozide
If you have previously had an allergic reaction to
paroxetine or any of the other liquid ingredients listed. See
section 8, What Seroxat Liquid contains, inside this leaflet.
If any of these apply to you, tell your doctor without taking
Seroxat Liquid.

Check with your doctor…

Are you taking any other medicines (see Other medicines and
Seroxat Liquid, inside this leaflet)?
Are you taking tamoxifen to treat breast cancer or fertility
problems? Seroxat Liquid 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)?
Are you having electro-convulsive therapy (ECT)?
Do you have a history of bleeding disorders?
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 Seroxat Liquid, inside this leaflet)?
Have you been told by your doctor that you have an
intolerance to some sugars, as this medicine contains the
sugar, sorbitol (E420)?
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
Liquid.

Certain non active ingredients of your medicine may
cause unwanted effects:
methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possibly delayed)
propylene glycol may cause skin irritation
Sunset yellow FCF (E110), may cause allergic reactions.

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 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.

Pregnancy, breast-feeding and Seroxat Liquid

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 Liquid 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 Liquid. You and your doctor may
decide that it is better for you to gradually stop taking Seroxat
Liquid while you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is better for you to
keep taking Seroxat Liquid.
Make sure your midwife or doctor knows you’re taking
Seroxat Liquid. When taken during pregnancy, particularly late
pregnancy, medicines like Seroxat Liquid 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 Liquid during the last 3 months of
pregnancy, your newborn baby might also have other conditions,
which usually begin during the first 24 hours after birth.
Symptoms include:
trouble with breathing
a blueish skin or being too hot or cold
blue lips
vomiting or not feeding properly
being very tired, not able to sleep or crying a lot
stiff or floppy muscles
tremors, jitters or fits.
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 Liquid may get into breast milk in very small
amounts. If you are taking Seroxat Liquid, 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 Liquid.
Medicines like Seroxat Liquid 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 Liquid.

Other medicines and Seroxat Liquid

Some medicines can affect the way Seroxat Liquid works, or make it
more likely that you’ll have side effects. Seroxat Liquid 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 Liquid, inside
this leaflet
Thioridazine or pimozide, which are anti-psychotics – see Do
not take Seroxat Liquid, inside this leaflet
Aspirin, ibuprofen or other medicines called NSAIDs (nonsteroidal anti-inflammatory drugs) like celecoxib, etodolac 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
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
St John’s Wort, a herbal remedy for depression
Phenobarbital, phenytoin 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
Rifampicin, used to treat tuberculosis (TB) and leprosy
Linezolid, an antibiotic
Tamoxifen, which is used to treat breast cancer or
fertility problems
Medicines such as cimetidine or omeprazole, which are used
to reduce the amount of acid in your stomach.
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.
If you are taking any other medicines, including ones you have
bought yourself, check with your doctor or pharmacist before taking
Seroxat Liquid. They will know if it is safe for you to do so.

Page 1 of 4

Seroxat Liquid and alcohol

Do not drink alcohol while you are taking Seroxat Liquid. Alcohol
may make your symptoms or side-effects worse.

Driving and using machinery

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

Important information about some of the ingredients
of Seroxat Liquid

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 Liquid.
Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possible delayed).
Sunset yellow FCF (E110) is used as a colouring agent, and
may cause allergic reactions.

3. How to take your medicine
Take Seroxat Liquid in the morning with food.
Shake the bottle before use.
It is important to take your medicine as instructed by your
doctor. The label will tell you how much medicine to take and how
often. If you are unsure, ask your doctor or pharmacist.
Your doctor will advise you what dose to take when you first
start taking Seroxat Liquid. 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, 5ml (10mg of paroxetine) at a time, up
to a maximum daily dose.
The usual doses for different conditions are set out in the table
below.

Depression
Obsessive
Compulsive
Disorder
(obsessions and
compulsions)
Panic Disorder
(panic attacks)
Social Anxiety
Disorder (fear or
avoidance of social
situations)
Post Traumatic
Stress Disorder
Generalised
Anxiety Disorder

Starting
dose
10 ml

Recommended
daily dose
10 ml

Maximum
daily dose
25 ml

10 ml

20 ml

30 ml

5 ml

20 ml

30 ml

10 ml

10 ml

25 ml

10 ml

10 ml

25 ml

10 ml

10 ml

25 ml

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

Older people

The maximum dose for people over 65 is 20ml (40mg of
paroxetine) per day.

Patients with liver or kidney disease

If you have trouble with your liver or kidneys your doctor may
decide that you should have a lower dose of Seroxat Liquid than
usual. If you have severe liver or kidney disease the maximum dose
is 10ml (20mg of paroxetine) per day.

What if you miss a dose?

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.

What if you take too much Seroxat Liquid?

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

What to do if you’re feeling no better

Seroxat Liquid 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.

4. Possible side-effects
As with other medicines Seroxat Liquid can cause side-effects, but
not everybody gets them.

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.

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.

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 Liquid 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.

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

Allergic reactions to Seroxat Liquid.
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.

Frequency unknown

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

Other possible side effects during treatment
Likely to 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.

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)
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.

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
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:

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.

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
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
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).

Some patients have developed buzzing, hissing, whistling, ringing or
other persistent noise in the ears (tinnitus) when they take Seroxat
Liquid.
An increased risk of bone fractures has been observed in patients
taking this type of medicines.
If you have any concerns while you are taking Seroxat Liquid,
talk to your doctor or pharmacist who will be able to advise
you.

5. Stopping Seroxat Liquid
Do not stop taking Seroxat Liquid until your doctor tells you
to.
When stopping Seroxat Liquid, 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 Liquid you take
by 5ml (10mg of paroxetine) a week. Most people find that any
symptoms on stopping Seroxat Liquid 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.

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 Liquid.
Sleep disturbances (vivid dreams, nightmares, inability to
sleep)
Feeling anxious
Headaches.

Likely to affect up to 1 in every 100 people:
Feeling sick (nausea)
Sweating (including night sweats)
Feeling restless or agitated
Tremor (shakiness)
Feeling confused or disorientated
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 Seroxat Liquid.

6. Children and adolescents under 18
Seroxat Liquid 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 Liquid. If your doctor
has prescribed Seroxat Liquid for you (or your child) and you want
to discuss this, please go back to your doctor.
In studies of Seroxat Liquid 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 Liquid, although these were seen less often.
Some patients in these studies of under 18s had withdrawal effects
when they stopped taking Seroxat Liquid. These effects were mostly
similar to those seen in adults after stopping Seroxat Liquid (see
section 5, Stopping Seroxat Liquid, 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).

7. Looking after your medicine
Keep your medicine in the original bottle. Do not store above
25°C.
Keep your medicine out of the sight and reach of children.
Do not take your medicine after the expiry date shown on the
label.
Your Seroxat Liquid keeps for one month after it is first
opened. If you have any left this time please give it back to
your pharmacist who will dispose of it safely. If you need any
more Seroxat Liquid, please see your doctor for a new
prescription.
Never give this medicine to others, even if they have similar
symptoms to yours.
Finish all your medicine as the doctor tells you to.
Keep this leaflet. You may need to read it again.
If your medicine appears discoloured, or shows any other
signs of deterioration, take it back to the pharmacist who will
advise you.

8. What Seroxat Liquid contains
The active ingredient in Seroxat liquid is paroxetine (as
Paroxetine hydrochloride hemihydrate).
The inactive ingredients are polacrilin potassium, dispersible
cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420),
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), sodium citrate (E331), citric acid (E330), sodium saccharin
(E954), natural orange flavour, natural lemon flavour, sunset yellow
(E110), simethicone emulsion and purified water. Sodium content is
6.6mg per 10ml.
Manufactured by: Farmaclair, Herouville Saint Clair, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0089

POM

Other formats:

To listen to or request a copy of this leaflet in Braille, large print
or audio please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name: Seroxat 20mg/10ml Liquid
Reference number: 08929/0089
Leaflet revision and issue date (Ref): 04.09.12
Seroxat® is a registered trademark of the GlaxoSmithKline group of
companies.

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 Liquid, 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 Liquid.

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

Page 2 of 4

Patient Information leaflet

Paroxetine 20mg/10ml Liquid
(Paroxetine)

The name of your medicine is Paroxetine 20mg/10ml Liquid, but will
be referred to as Paroxetine Liquid throughout the remainder of this
leaflet.

Eight important things you need to know about
Paroxetine Liquid

Please read all of the leaflet. It includes a lot of additional important
information about this medicine.
Paroxetine Liquid 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.
Paroxetine Liquid is not for use in children and
adolescents under 18. See section 6, Children and
adolescents under 18, inside this leaflet.
Paroxetine Liquid 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
medicine, inside this leaflet.
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.
Don’t stop taking Paroxetine Liquid without talking to
your doctor. If you stop taking Paroxetine Liquid suddenly or
miss a dose, you may get withdrawal effects. See section 5,
Stopping Paroxetine Liquid, inside this leaflet.
If you feel restless and feel like you can’t sit or stand
still, tell your doctor. Increasing the dose of Paroxetine
Liquid may make these feelings worse. See section 4, Possible
side-effects, inside this leaflet.
Taking some other medicines with Paroxetine Liquid
can cause problems. You may need to talk to your doctor.
See Other medicines and Paroxetine Liquid, inside this leaflet.
If you are pregnant or planning to get pregnant, talk to
your doctor. See Pregnancy, breast-feeding and Paroxetine
Liquid, inside this leaflet.
Read this leaflet. It includes a lot of important information about
this medicine.
Keep this leaflet. You may need to read it again.
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.

5. What Paroxetine Liquid is and what it is
used for
Your medicine is available in bottles of 150ml. Each 5ml of the liquid
contains 10mg of paroxetine. The liquid is an orange suspension
with a smell of oranges and a sweet taste.
Paroxetine Liquid is a treatment for adults with depression
and/or anxiety disorders.
Paroxetine Liquid 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 Liquid 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.

6. Before you take Paroxetine Liquid
Do not take Paroxetine Liquid…

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 Liquid
once you have stopped taking the MAOI
If you are taking a tranquilliser called thioridazine
If you are taking an anti-psychotic called pimozide
If you have previously had an allergic reaction to
paroxetine or any of the other liquid ingredients listed. See
section 8, What Paroxetine Liquid contains, inside this leaflet.
If any of these apply to you, tell your doctor without taking
Paroxetine Liquid.

Check with your doctor…

Are you taking any other medicines (see Other medicines and
Paroxetine Liquid, inside this leaflet)?
Are you taking tamoxifen to treat breast cancer or fertility
problems? Paroxetine Liquid 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)?
Are you having electro-convulsive therapy (ECT)?
Do you have a history of bleeding disorders?
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 Paroxetine Liquid, inside this leaflet)?
Have you been told by your doctor that you have an
intolerance to some sugars, as this medicine contains the
sugar, sorbitol (E420)?
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 Liquid.

Certain non active ingredients of your medicine may
cause unwanted effects:
methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possibly delayed)
propylene glycol may cause skin irritation
Sunset yellow FCF (E110), may cause allergic reactions.

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 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.

Pregnancy, breast-feeding and Paroxetine Liquid

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 Paroxetine Liquid 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 Liquid. You and your doctor may
decide that it is better for you to gradually stop taking Paroxetine
Liquid while you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is better for you to
keep taking Paroxetine Liquid.
Make sure your midwife or doctor knows you’re taking
Paroxetine Liquid. When taken during pregnancy, particularly
late pregnancy, medicines like Paroxetine Liquid 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 Liquid during the last 3 months of
pregnancy, your newborn baby might also have other conditions,
which usually begin during the first 24 hours after birth.
Symptoms include:
trouble with breathing
a blueish skin or being too hot or cold
blue lips
vomiting or not feeding properly
being very tired, not able to sleep or crying a lot
stiff or floppy muscles
tremors, jitters or fits.
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 Liquid may get into breast milk in very small
amounts. If you are taking Paroxetine Liquid, 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 Liquid.
Medicines like Paroxetine Liquid 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 Paroxetine Liquid.

Other medicines and Paroxetine Liquid

Some medicines can affect the way Paroxetine Liquid works, or
make it more likely that you’ll have side effects. Paroxetine Liquid
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 Liquid, inside
this leaflet
Thioridazine or pimozide, which are anti-psychotics – see Do
not take Paroxetine Liquid, inside this leaflet
Aspirin, ibuprofen or other medicines called NSAIDs (nonsteroidal anti-inflammatory drugs) like celecoxib, etodolac 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
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
St John’s Wort, a herbal remedy for depression
Phenobarbital, phenytoin 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
Rifampicin, used to treat tuberculosis (TB) and leprosy
Linezolid, an antibiotic
Tamoxifen, which is used to treat breast cancer or
fertility problems
Medicines such as cimetidine or omeprazole, which are used
to reduce the amount of acid in your stomach.
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.
If you are taking any other medicines, including ones you have
bought yourself, check with your doctor or pharmacist before taking
Paroxetine Liquid. They will know if it is safe for you to do so.
Page 3 of 4

Paroxetine Liquid and alcohol

Do not drink alcohol while you are taking Paroxetine Liquid. Alcohol
may make your symptoms or side-effects worse.

Driving and using machinery

Possible side-effects with Paroxetine Liquid include dizziness,
confusion or changes in eyesight. If you do get these side-effects,
do not drive or use machinery.

Important information about some of the ingredients
of Paroxetine Liquid

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 Liquid.
Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) may cause allergic reactions
(possible delayed).
Sunset yellow FCF (E110) is used as a colouring agent, and
may cause allergic reactions.

7. How to take your medicine
Take Paroxetine Liquid in the morning with food.
Shake the bottle before use.
It is important to take your medicine as instructed by your
doctor. The label will tell you how much medicine to take and how
often. If you are unsure, ask your doctor or pharmacist.
Your doctor will advise you what dose to take when you first
start taking Paroxetine Liquid. 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, 5ml (10mg of paroxetine) at a time,
up to a maximum daily dose.
The usual doses for different conditions are set out in the table
below.

Depression
Obsessive
Compulsive
Disorder
(obsessions and
compulsions)
Panic Disorder
(panic attacks)
Social Anxiety
Disorder (fear or
avoidance of social
situations)
Post Traumatic
Stress Disorder
Generalised
Anxiety Disorder

Starting
dose
10 ml

Recommended
daily dose
10 ml

Maximum
daily dose
25 ml

10 ml

20 ml

30 ml

5 ml

20 ml

30 ml

10 ml

10 ml

25 ml

10 ml

10 ml

25 ml

10 ml

10 ml

25 ml

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

Older people

The maximum dose for people over 65 is 20ml (40mg of
paroxetine) per day.

Patients with liver or kidney disease

If you have trouble with your liver or kidneys your doctor may
decide that you should have a lower dose of Paroxetine Liquid than
usual. If you have severe liver or kidney disease the maximum dose
is 10ml (20mg of paroxetine) per day.

What if you miss a dose?

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.

What if you take too much Paroxetine Liquid?

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

What to do if you’re feeling no better

Paroxetine Liquid 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.

8. Possible side-effects
As with other medicines Paroxetine Liquid can cause side-effects,
but not everybody gets them.

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.

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.

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 Liquid 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.

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

Allergic reactions to Paroxetine Liquid.
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.

Frequency unknown

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

Other possible side effects during treatment
Likely to 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.

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)
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.

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
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:

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.

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
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
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).

Some patients have developed buzzing, hissing, whistling, ringing or
other persistent noise in the ears (tinnitus) when they take
Paroxetine Liquid.
An increased risk of bone fractures has been observed in patients
taking this type of medicines.
If you have any concerns while you are taking Paroxetine
Liquid, talk to your doctor or pharmacist who will be able to
advise you.

8. Stopping Paroxetine Liquid
Do not stop taking Paroxetine Liquid until your doctor tells
you to.
When stopping Paroxetine Liquid, 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 Liquid you
take by 5ml (10mg of paroxetine) a week. Most people find that any
symptoms on stopping Paroxetine Liquid 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.

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 Paroxetine Liquid.
Sleep disturbances (vivid dreams, nightmares, inability to
sleep)
Feeling anxious
Headaches.

Likely to affect up to 1 in every 100 people:
Feeling sick (nausea)
Sweating (including night sweats)
Feeling restless or agitated
Tremor (shakiness)
Feeling confused or disorientated
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 Liquid.

9. Children and adolescents under 18
Paroxetine Liquid 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 Paroxetine Liquid. If your
doctor has prescribed Paroxetine Liquid for you (or your child) and
you want to discuss this, please go back to your doctor.
In studies of Paroxetine Liquid 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 Liquid, although these were seen less often.
Some patients in these studies of under 18s had withdrawal effects
when they stopped taking Paroxetine Liquid. These effects were
mostly similar to those seen in adults after stopping Paroxetine
Liquid (see section 5, Stopping Paroxetine Liquid, 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).

7. Looking after your medicine
Keep your medicine in the original bottle. Do not store above
25°C.
Keep your medicine out of the sight and reach of children.
Do not take your medicine after the expiry date shown on the
label.
Your Paroxetine Liquid keeps for one month after it is first
opened. If you have any left this time please give it back to
your pharmacist who will dispose of it safely. If you need any
more Paroxetine Liquid, please see your doctor for a new
prescription.
Never give this medicine to others, even if they have similar
symptoms to yours.
Finish all your medicine as the doctor tells you to.
Keep this leaflet. You may need to read it again.
If your medicine appears discoloured, or shows any other
signs of deterioration, take it back to the pharmacist who will
advise you.

8. What Paroxetine Liquid contains
The active ingredient in Paroxetine Liquid is paroxetine (as
Paroxetine hydrochloride hemihydrate).
The inactive ingredients are polacrilin potassium, dispersible
cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420),
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), sodium citrate (E331), citric acid (E330), sodium saccharin
(E954), natural orange flavour, natural lemon flavour, sunset yellow
(E110), simethicone emulsion and purified water. Sodium content is
6.6mg per 10ml.
Manufactured by: Farmaclair, Herouville Saint Clair, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0089

POM

Other formats:

To listen to or request a copy of this leaflet in Braille, large print
or audio please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name: Paroxetine 20mg/10ml Liquid
Reference number: 08929/0089
Leaflet revision and issue date (Ref): 04.09.12

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 Liquid, 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 Liquid.

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

Page 4 of 4

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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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