Skip to Content


View full screen / Print PDF » Download PDF ⇩

Paroxetine 10 mg Tablets
Paroxetine 20 mg Tablets
Paroxetine 30 mg Tablets



Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Paroxetine is and what it is used for
2. Before you take Paroxetine
3. How to take Paroxetine
4. Possible side effects
5. How to store Paroxetine
6. Further information



Paroxetine belongs to a group of medicines
called selective serotonin reuptake inhibitors
(SSRIs), which are antidepressants.

Paroxetine is used in the treatment of:
• Depressive illness (major depressive
• Obsessive compulsive disorder
(compulsive thoughts and compulsive
actions) OCD
• Panic disorder with or without agoraphobia
(e.g. fear of leaving the house, entering
shops, or fear of public places)
• Social phobia
• Generalised anxiety disorder
• Post-traumatic stress disorder.



Do not take Paroxetine
• if you are allergic to paroxetine, or any of
the other ingredients of the product (see
section “What Paroxetine contains”).
• if you are taking medicines called
monoamine oxidase inhibitors (MAOIs,
e.g. for depression) or have taken MAOIs
within the last two weeks.
Exceptions are moclobemide and
methylthioninium chloride where
Paroxetine treatment can be initiated
after 24 hours, and linezolid, an
antibiotic, provided that there are
facilities for close observation.
At least one week should elapse between
discontinuation of Paroxetine and
initiation of therapy with any MAO inhibitor.
• if you are taking thioridazine
(antipsychotic agent).
• if you are taking pimozide (antipsychotic

Take special care with Paroxetine

• Use in children and adolescents
under 18 years of age
Paroxetine should normally not be used
for children and adolescents under 18.
You should know that 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 this class of
medicines. Despite this, your doctor may
prescribe Paroxetine for patients under
18 because he/she decides that this is in
their best interests. If your doctor has
prescribed Paroxetine for a patient under
18 and you want to discuss this, please
go back to your doctor. You should
inform your doctor if any of the listed
above develop or worsen when patients
under 18 are taking Paroxetine. Also, the
long-term safety effects concerning
growth, maturation and cognitive and
behavioural development of this age
group have not yet been demonstrated.

• Thoughts of suicide and worsening of
your depression or anxiety disorder
If you are depressed and/or have anxiety
disorders you can sometimes have
thoughts of harming or killing yourself.
These may be increased when first
starting antidepressants, since these
medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts
about killing or harming yourself.
- If you are a young adult. Information
from clinical trials has shown an
increased risk of suicidal behaviour in
adults aged less than 25 years with
psychiatric conditions who were
treated with an antidepressant.
If you have thoughts of harming or killing
yourself at any time, contact your doctor
or go to a hospital straight away.

You may find it helpful to tell a relative or
close friend that you are depressed or
have an anxiety disorder, and ask them to
read this leaflet. You might ask them to tell
you if they think your depression or anxiety
is getting worse, or if they are worried about
changes in your behaviour.

• Withdrawal symptoms seen on
discontinuation of a selective
serotonin reuptake inhibitor (SSRI)
When you stop taking Paroxetine,
especially if it is abruptly, you may feel
discontinuation symptoms (see “How to
take Paroxetine” and “Possible side
effects”). These are common when
treatment is stopped. The risk is higher,
when Paroxetine has been used for a
long time or in high doses or when the
dose is reduced too quickly. Most people

find that the symptoms are mild and go
away on their own within two weeks.
However, in some patients they may be
severe in intensity or they may be
prolonged (2-3 months or more).
If you get severe discontinuation symptoms
when you stop taking Paroxetine, please
contact your doctor. He or she may ask
you to start taking your tablets again and
come off them more slowly.

Check with your doctor if:
• you develop symptoms such as inner
sense of restlessness and psychomotor
agitation such as an inability to sit or stand
still usually associated with subjective
distress (akathisia). This is most likely to
occur within the first few weeks of
treatment. Increasing the dose of
Paroxetine may make these feelings worse
(see section “Possible side effects”).
• you develop symptoms such as a high
fever, muscle cramps, confusion and
anxiety since these symptoms could be a
sign of so called “serotonin syndrome“.
Therefore paroxetine should not be used in
combination with other medicines with
serotonergic effects such as sumatriptan or
other triptans (certain migraine medicines),
tramadol, linezolid, other SSRIs, lithium
and St. John's Wort (Hypericum
perforatum), oxitriptan and tryptophan.
• you have a history of mania (overactive
behaviour or thoughts). If you are entering
a manic phase, you should stop taking
Paroxetine. Ask your doctor for advice.
• you have heart, liver or kidney problems. In
patients with severe kidney disorder or
those with liver disorder a dose reduction is
• you have diabetes. Paroxetine can raise or
lower your blood sugar. The dose of your
insulin or anti-diabetes medicine taken
orally may need to be adjusted.
• you have epilepsy. If you develop seizures
during treatment with Paroxetine, you
should contact your doctor.
• your treatment for depression is electro
convulsive therapy, (ECT).
• you are taking tamoxifen to treat breast
cancer or fertility problems. Paroxetine
may make tamoxifen less effective so your
doctor may recommend you take another
• you have glaucoma (elevated pressure in
your eyes).
• you are at risk of a decreased sodium level
in the blood (hyponatraemia) e.g. from
concomitant medications and cirrhosis.
Hyponatraemia has been reported rarely
during treatment with Paroxetine,
predominantly in the elderly.
• you have a history of bleeding disorders
e.g. cutaneous bleeding abnormalities,
gynaecological or haemorrhage from the
stomach or if you use medicines which
possibly increase tendency to bleed (see
section “Taking other medicines”).

Please consult your doctor, even if these
statements were applicable to you at any time
in the past.

Using other medicines
Certain other medicines may influence the
effect of Paroxetine, or Paroxetine may
influence their effects. Some of the medicines
in question are listed below:
• Tricyclic antidepressants (against
depression) e.g. clomipramine, nortriptyline
and desipramine
• SSRIs e.g. citalopram and fluoxetine
• L-tryptophan (against sleep disturbances)
• MAO-inhibitors (e.g. against depression or
Parkinsonʼs disease)
• Lithium (antipsychotic)
• St. Johnʼs Wort (Hypericum perforatum)
• Triptans (against migraine)
• Tramadol, pethidine (potent painkillers)
• Fentanyl (anaesthetic, potent painkiller)
• Linezolid (antibiotic).
Concomitant use of above mentioned
medicinal products may e.g. lead to
“serotonine syndrome” by potentiating
serotonergic effects of Paroxetine (see “Do
not take Paroxetine” and “Take special care
with Paroxetine”). Your doctor will want to
monitor you more closely.

• Perphenazine, risperidone, atomoxetine,
thioridazine, pimozide and clozapine
• A combination of fosamprenavir and
ritonavir, which is used to treat Human
Immunodeficiency Virus (HIV) infection
• Propafenone and flecainide (against
irregular heart rhythm)
• Metoprolol (heart medicines).
Concomitant use of above mentioned
medicinal products may lead to an increased
rate of side effects of these such as cardiac
effects, which in some cases may be severe
(see “Do not take Paroxetine”).

• Phenobarbital, carbamazepine and
phenytoin (against epilepsy)
• rifampicin (antibiotic).
Concomitant use of above mentioned medicinal
products may weaken the effect of Paroxetine
by increasing the metabolism of paroxetine.
• NSAIDs (e.g. ibuprofen, diclofenac),
COX-2 inhibitors and acetylsalicylic acid
(pain killers)

• Warfarin (to prevent blood clotting)
• Clozapine, phenothiazines
(antipsychotics) and most tricyclic
antidepressants (against depression).
Concomitant use of above mentioned
medicinal products may lead to
increased/prolonged bleeding (see “Take
special care with Paroxetine“).

• Procyclidine (against Parkinsonʼs
disease). Increased side effects of
procyclidine may occur by increasing the
concentration of Procyclidine in the blood
• Tamoxifen, which is used to treat breast
cancer or fertility problems.

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

Taking Paroxetine with food and drink
Alcohol: The combination of Paroxetine and
alcohol is not recommended.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
Talk to your doctor as soon as possible if
youʼre pregnant, if you might be pregnant,
or if youʼre planning to become pregnant.
In babies whose mothers took paroxetine
during the first few months of pregnancy,
there have been some reports showing an
increased risk of birth defects, in particular
those affecting the heart. In the general
population, about 1 in 100 babies are born
with a heart defect. This increased to about
2 in 100 babies in mothers who took

You and your doctor may decide that it is
better for you 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.

If you are taking Paroxetine in the last 3
months of pregnancy, let your doctor
know as your baby might have some
symptoms when it is born. These symptoms
usually begin during the first 24 hours after
the baby is born. They include not being
able to sleep or feed properly, trouble with
breathing, a blue-ish skin or being too hot or
cold, being sick, crying a lot, stiff or floppy
muscles, tiredness, lack of energy,
trembling of the body, jitters or fits. If your
baby has any of these symptoms when it is
born, contact your doctor who will be
able to advise you.

Make sure your midwife and/or doctor
knows you are taking Paroxetine. When
taken during pregnancy, particularly in the
last 3 month of pregnancy, medicines like
Paroxetine may increase the risk of a
serious condition in babies, called persistent
pulmonary hypertension of the newborn
(PPHN), making the baby breath faster and
appear bluish. These symptoms begin
usually during the first 24 hours after the
baby is born. If this happens to your baby
you should contact your midwife and/or
doctor immediately.
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.
If your baby has any of these symptoms
when it is born, or you are concerned about
your babyʼs health, contact your doctor or
midwife immediately who will be able to
advise you.

Paroxetine may pass into breast milk in
small amounts. If you are taking Paroxetine,
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.

Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Paroxetine may cause side effects (such as
feeling dizzy, sleepy, or confused) that affect
how well you concentrate and how quickly
you can react. If you get these side effects,
do not drive or operate machines, or
anything else where you need to be alert
and concentrate.

Continued on the next page >>



Always take Paroxetine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

The tablets should be taken in the morning
with breakfast.
Drink a glass of water with your medicine.
The tablet or tablet halves should be
swallowed rather than chewed.

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 donʼt start to
feel better after this time, talk to your doctor,
who will advise you.
He or she may decide to increase the dose
gradually, 10 mg at a time, up to a
maximum daily dose.

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





Starting Recomdose mended


20 mg

20 mg

50 mg

20 mg

40 mg

60 mg

10 mg

40 mg

60 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

20 mg

20 mg

50 mg

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 tablets.
This may be for many months or even longer.

Elderly (more than 65 years)
Depending on your response the dose may
be increased to 40 mg daily. The maximum
dose is 40 mg daily.

Patients with liver or kidney disease
If you have trouble with your liver or kidneys
your doctor may decide that you should
have a lower dose of Paroxetine than usual.

If you take more Paroxetine than you
If you have taken more Paroxetine than you
should, talk to your doctor or pharmacist, or
contact with the nearest hospital straight away.
Symptoms of overdose are e.g. being sick,
dilated pupils, fever, blood pressure changes,
headache, involuntary muscle contractions,
agitation, anxiety and rapid heart rate.

If you forget to take Paroxetine
• and you remember before you go to
bed, take it straight away. Carry on as
usual the next day.
• and 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 to do if youʼre 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 donʼt 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 havenʼt started to feel better.
If you stop taking Paroxetine
Do not stop taking Paroxetine until your
doctor tells you to, even if you feel better.

If you stop suddenly after taking this
medicine for a long time you can experience
withdrawal effects.

When stopping treatment with Paroxetine
the dose should be gradually reduced over
a period of at least one to two weeks in
order to reduce the risk of withdrawal
reactions (for withdrawal symptoms see
section “Possible side effects”). One way of
doing this is to gradually reduce the dose of
Paroxetine you take by 10 mg a week. If
intolerable symptoms occur following a
decrease in the dose or upon
discontinuation of treatment, your doctor
may ask you to start taking your tablets
again and come off them more slowly.

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



Like all medicines, Paroxetine can cause side
effects, although not everybody gets them.

You should see your doctor immediately if
you experience symptoms such as:
• swollen face, tongue and/or throat and/or
difficulty to swallow or hives together with
difficulties to breathe (angioedema)

• high fever, muscle cramps, confusion
and anxiety since these symptoms could
be a sign of so called “serotonin syndrome”

If you develop suicidal thoughts or suicidal
ideation during treatment with Paroxetine,
especially in the first 2-4 weeks, you should
contact your doctor immediately.

Other side effects
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Frequencies are defined as:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated
from the available data
Blood and lymphatic system disorders
Uncommon: abnormal bleeding,
predominantly of the skin and mucous
membranes (mostly ecchymosis)
Very rare: deficiency of blood platelets

Immune system disorders
Very rare: allergic reactions including nettle
rash (urticaria) and swelling of the face, lips,
tongue or throat with difficulty to breathe or
swallow (angioedema)

Hormone (endocrine) disorders
Very rare: syndrome of inappropriate
anti-diuretic hormone secretion (SIADH)

Metabolism and nutrition disorders
Common: Increases in the level of cholesterol
in the blood, decreased appetite
Rare: reduced sodium level in the blood
Hyponatraemia has been reported
predominantly in elderly patients and is
sometimes due to syndrome of inappropriate
anti-diuretic hormone secretion (SIADH)

Psychiatric disorders
Common: somnolence, insomnia, agitation,
abnormal dreams (including nightmares)
Uncommon: confusion, hallucinations
Rare: overactive behaviour or thoughts
(manic reactions), anxiety, feeling detached
from yourself (depersonalisation), panic
Frequency not known: Cases of suicidal
ideation and suicidal behaviour have been
reported during paroxetine therapy or early
after treatment discontinuation (see section
ʻTake special care with Paroxetineʼ)

These symptoms may also be due to the
underlying disease.

Nervous system disorders
Very common: concentration impaired
Common: dizziness, trembling of the body
(tremor), headache
Uncommon: slow or/and involuntary
movements (extrapyramidal disorders)
Rare: akathisia (inability to sit still) (see
section ʻTake special care with Paroxetineʼ),
convulsions, irresistible urge to move the legs
(Restless Legs Syndrome)
Very rare: serotonin syndrome (symptoms
may include restlessness, confusion,
sweating, hallucinations, exaggeration of
reflexes, muscle cramps, shivering, rapid
heart rate and trembling of the body)

Eye disorders
Common: blurred vision
Uncommon: dilated pupils
Very rare: increased pressure in the eye
where your eyes become painful and you get
blurred vision (acute glaucoma)

Ear and labyrinth disorders
Frequency not known: Some patients have
developed buzzing, hissing, whistling, ringing
or other persistent noise in the ears (tinnitus)
when they take paroxetine

Cardiac disorders
Uncommon: rapid heart rate
Rare: slow heart rate

Vascular disorders
Uncommon: temporary increases in blood
pressure or temporary decreases in blood
pressure that may make you feel dizzy or faint
when you stand up suddenly

Respiratory, thoracic and mediastinal
Common: yawning

Gastrointestinal disorders
Very common: feeling sick (nausea)
Common: constipation, diarrhoea, vomiting,
dry mouth
Very rare: bleeding in the stomach or intestine

Liver/bile (hepato-biliary disorders)
Rare: elevation of liver enzymes
Very rare: liver disorders (such as hepatitis,
sometimes associated with jaundice and/or
liver failure)

Skin and subcutaneous tissue disorders
Common: sweating
Uncommon: skin rashes, itching
Very rare: severe skin disorders (including
erythema multiforme, Stevens-Johnson
syndrome and toxic epidermal necrolysis),
hypersensitivity to sunlight

Renal and urinary disorders
Uncommon: urination disturbances such as
an inability to urinate or an uncontrollable,
involuntary passing of urine

Reproductive system and breast disorders
Very common: sexual dysfunction
Rare: too much Prolactin, a lactation
hormone, in the blood
(hyperprolactinaemia)/breast discharge
Very rare: painful erection of the penis that
wonʼt go away

Musculoskeletal and connective tissue
Rare: joint pain, muscle pain
An increased risk of bone fractures has been
observed in patients taking this type of
General disorder and administration site
Common: general debility, body weight gain
Very rare: swelling of the tissue caused by
fluid retention

Withdrawal symptoms seen on
discontinuation of Paroxetine treatment
Withdrawal reactions commonly occur after
discontinuation of Paroxetine (see sections
“Before you take Paroxetine” and “How to
take Paroxetine”).

Dizziness, sensory disturbances (including
paraesthesia and noises in ears), sleep
disturbances (including insomnia and
intense dreams), agitation or anxiety, feeling
sick (nausea) and/or being sick (vomiting),
trembling of the body (tremor), confusion,
sweating, emotional instability, visual
disturbances, fluttering or pounding
heartbeat (palpitations), diarrhoea, irritability
and headache are the most commonly
reported reactions.
Generally these events are mild to
moderate and are self-limiting, however, in
some patients they may be severe and/or

Further side effects from paediatric
clinical trials
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 below and
“Possible side effects”). 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).



Keep out of the reach and sight of

Do not use Paroxetine after the expiry date
which is stated on the carton and blister or
container respectively.

The expiry date refers to the last day of that
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.



What Paroxetine 10, 20 & 30 mg contains
The active substance is paroxetine
Paroxetine 10 mg film-coated tablets
One film-coated tablet contains 10 mg
paroxetine (as paroxetine hydrochloride
anhydrous 11.1 mg).

Paroxetine 20 mg film-coated tablets
One film-coated tablet contains 20 mg
paroxetine (as paroxetine hydrochloride
anhydrous 22.2 mg).

Paroxetine 30 mg film-coated tablets
One film-coated tablet contains 30 mg
paroxetine (as paroxetine hydrochloride
anhydrous 33.3 mg).

The other ingredients are:
Tablet core
Mannitol, cellulose, microcrystalline,
copovidone K28, sodium starch glycollate
(Type A), silica, colloidal anhydrous,
magnesium stearate.
Hypromellose 5 cps, talc (micronised),
titanium dioxide (E171)
30 mg tablets additionally:
Ferric oxide (E 172), indigotine (E 132).

What Paroxetine looks like and contents
of the pack
Paroxetine 10 mg is a white, round
film-coated tablet, marked “PX 10” and
available in blister packs or containers with
7, 10, 14, 20, 28, 30, 50, 60, 100 and 250
film-coated tablets.

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

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

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

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
D-39179 Barleben, Germany or
Podlipie 16, Stryków, Poland or
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana, Slovenia or
Bantry, Co. Cork, Ireland.
This leaflet was last approved in 07/2012
(to be amended after approval).



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.