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PAROXETINE 40 MG FILM-COATED TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE ANHYDROUS

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PATIENT INFORMATION LEAFLET

P0287T

Paroxetine 20mg Film−Coated Tablets
Paroxetine 40mg Film−Coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
• K
 eep 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
 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.

Eight important things you need to know about paroxetine
• Like all medicines, Paroxetine can have unwanted effects. It is therefore important that you and your

doctor weigh up the benefits against the possible unwanted effects before starting treatment.
• P
 aroxetine is not for use in children and adolescents under 18.
• Paroxetine

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.
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 Section 2, Thoughts of suicide.
Don’t

stop taking paroxetine without talking to your doctor. If you stop taking paroxetine suddenly or
miss a dose, you may get withdrawal effects. See section 3, If you stop taking the tablets.
I f you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of
paroxetine may make these feelings worse. See section 4, Possible side effects.
Taking

some other medicines with paroxetine can cause problems. See Taking other medicines.
If
 you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and
breastfeeding.

In this leaflet:
1

What Paroxetine is and what it is used for

2

Before you take Paroxetine



5 How to store Paroxetine

3

How to take Paroxetine



6

1 W hat Paroxetine is and what it
is used for
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 episodes)
• 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

2 Before you take Paroxetine
Do not take Paroxetine
• if you are allergic to paroxetine, or any of the other
ingredients of the product.
• if you are taking the medicines MAO−inhibitors (e.g.
against depression) concomitantly or have taken
MAO−inhibitors within the two last weeks.
An exception is moclobemide and linezolid where
Paroxetine treatment can be initiated after 24 hours. At
least one week should elapse between discontinuation of
Paroxetine and initiation of therapy with any MAO−inhibitor.
• if you take thioridazine (antipsychotic agent) concomitantly
• if you take pimozide (antipsychotic agent) concomitantly
Take special care with Paroxetine:
• Use in children and adolescents under 18 years
of age
Paroxetine should not normally be used for children and
adolescents under 18. Clinical trials have shown 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 interest. 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 a 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 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.

4

Possible side effects
Further information

• you have heart, liver or kidney problems. In patients with
severe kidney disorder or those with liver disorder a dose
reduction is recommended.
• 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 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 disorder 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 antidepressant (against depression) e.g.
clomipramine, nortriptyline and desipramine
• SSRI’s e.g. citalopram and fluoxetine
• L−tryptophan (against sleep disturbances)
• MAO−inhibitors (e.g. against depression or Parkinson)
• Lithium (antipsychotic)
• St. John’s Wort (Hypericum perforatum)
• Triptans (against migraine)
• Tramadol and pethidine (potent painkiller)
• Fentanyl (used in anaesthesia or to treat chronic pain)
• Linezolid (antibiotic)
Concomitant use of above mentioned medicinal products
may e.g. lead to “serotonin 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, thioridazine, pimozide and
clozapine (antipsychotics)
• Propafenone and flecainide (against irregular heart rhythm)
• Metoprolol (heart medicine)
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 (aspirin) (painkillers)
• Warfarin or other medicines used 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 Parkinson disease). Increased
side effects of procyclidine may occur by increasing the
concentration of procyclidine in the blood.
• Tamoxifen, (to treat breast cancer or fertility problems).
Concomitant use may reduce the effectiveness of
tamoxifen.
• Combination of fosamprenavir and ritonavir (to treat HIV
infection)
• Atomoxetine (to treat attention deficit hyperactivity
disorder (ADHD))
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.
Pregnancy:
Talk to your doctor as soon as possible if you are planning to
get pregnant or if you are already 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 Paroxetine. 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.
Make sure your midwife and/or doctor know you are on
Paroxetine. When taken during pregnancy, particularly in
the last 3 months of pregnancy, medicines like Paroxetine
may increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the new born (PPHN),
making the baby breathe faster and appear bluish. These
symptoms usually begin 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 are taking Paroxetine in the last 3 months of
pregnancy your newborn baby might also have other
Continued...

conditions which usually begin during the first 24 hours after
birth. Symptoms 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.
Breast−feeding:
Although small amounts of Paroxetine pass into breast milk,
studies did not show any effect on babies. You and your
doctor may decide that you can breast−feed while you are
taking Paroxetine.
Fertility:
Paroxetine has been shown to reduce the quality of sperm
in animal studies. Theoretically, this could affect fertility, but
impact on human fertility has not been observed as yet.
Driving and using machines
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.

3 How to take Paroxetine
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 your breakfast.
Drink a glass of water with your medicine. The tablet or tablet
halves should be swallowed rather than chewed.
The usual dose is:
Adults
Depression
The recommended dose is 20 mg daily. Depending on your
response, the dose may be increased gradually up to a
maximum dose of 50 mg daily in 10 mg steps. In general,
improvement in patients starts after one week but may only
become evident from the second week of therapy. The
treatment should be continued for several months.
Obsessive thoughts and obsessive actions (OCD)
The initial dose is 20 mg daily. Depending on your response,
the dose may be increased gradually to 40 mg daily in
10 mg steps. The recommended dose is 40 mg daily.
The maximum dose is 60 mg daily. The treatment should
be continued for several months.
Panic disorder
The initial dose is 10 mg daily. Depending on your response,
the dose may be gradually increased to 40 mg daily in
10 mg steps. The recommended dose is 40 mg daily.
The maximum dose is 60 mg daily. The treatment should be
continued for several months.
Social phobia, generalised anxiety disorder and post−
traumatic stress disorder
The recommended dose is 20 mg daily. Depending on your
response, the dose may be increased gradually to 50 mg in
10 mg steps. The maximum dose is 50 mg daily.
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.
Severe decreased kidney function
Your doctor prescribes a suitable dose for you.
Decreased liver function
Your doctor prescribes a suitable dose for you.
If you take more Paroxetine than you should
If you have taken more Paroxetine than you should, talk to
your doctor or pharmacist, or contact with the nearest
hospital. Symptoms of overdose are e.g. being sick, fever,
headache and involuntary muscle contractions.
If you forget to take Paroxetine
If you forget to take 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 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 several weeks or 2 − 3
months or more 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.
What to do if you feel 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 do not 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 have not started to feel better.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
You should see your doctor immediately if you experience
any of the following effects:
• allergic reactions such as swollen face, tongue and/or
throat, difficulty swallowing, hives, itchy rash or difficulty
breathing
• feeling confused or agitated, sweating, hallucinations,
sudden jerks of the muscles, shivering, fast heart beat or
shaking as these may be signs of serotonin syndrome
• you develop thoughts of harming or killing yourself while
taking paroxetine, especially in the first 2-4 weeks, or
soon after stopping treatment
• unusual bruising or bleeding, including vomiting blood or
passing blood in your stools
• inability to urinate.
• convulsions (fits)
• feeling restless and unable to sit or stand still (akathisia)
• low blood levels of sodium which can cause tiredness and
confusion, muscle twitching, fits and coma.
Tell your doctor or pharmacist if you suffer from any of the
following effects:
Very common (may affect more than 1 in 10 people)
• feeling sick
• change in sex drive or sexual function e.g. lack of orgasm,
abnormal erection and ejaculation in men.
Common (may affect up to 1 in 10 people)
• decreased appetite, increase in cholesterol levels
• sleepiness, difficulty in sleeping, agitation, abnormal
dreams (including nightmares)
• dizziness, shakes (tremors), headache
• blurred vision
• yawning
• constipation, diarrhoea, dry mouth, being sick
• sweating
• feeling of weakness, weight gain.
Uncommon (may affect up to 1 in 100 people)
• temporary increase or decrease in blood pressure that
may make you feel dizzy or faint when you stand up
suddenly

• faster heart beat
• slow and/or involuntary movements, abnormal
movements in the mouth or tongue
• enlarged pupils
• skin rashes, itching
• confusion, hallucinations
• uncontrollable involuntary passing of urine.
Rare (may affect up to 1 in 1,000 people)
• overactive behaviour or thoughts (manic reactions),
anxiety, feeling detached from yourself (depersonalisation),
panic attacks
• slow heart beat
• irresistible urge to move the legs (Restless Legs Syndrome)
• elevation of liver enzymes (showing up in blood tests for
liver function)
• too much prolactin (a lactation hormone) in the blood,
abnormal production of breast milk in men and women
• joint pain, muscle pain.
Very rare (may affect up to 1 in 10,000 people)
• Stevens-Johnson syndrome (serious illness with blistering
of the skin, mouth, eyes and genitals), toxic epidermal
necrolysis (serious illness with blistering of the skin),
erythema multiforme (skin rash which may blister and
looks like small targets)
• yellowing of the skin or whites of the eyes caused by liver
or blood problems
• syndrome of inappropriate anti-diuretic hormone secretion
(SIADH)
• restlessness, confusion, sweating, hallucinations,
exaggeration of reflexes, muscle cramps, shivering, rapid
heart rate and trembling (these may be symptoms of
serotonin syndrome)
• fluid or water retention which may cause swelling in the
arms or legs
• sensitivity to sunlight
• eye pain and blurred vision (acute glaucoma)
• reduction in blood platelets which increases risk of
bleeding or bruising
• painful erection of the penis that won’t go away.
Not known (frequency cannot be estimated from the
available data)
• aggression
• ringing in the ears
• an increased risk of bone fractures has been observed in
patients taking this type of medicine.
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 tingling or
numbness in the hands or feet, electric shock sensations
and ringing in the 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 prolonged.
Children and adolescents under 18
In studies of Paroxetine in under 18s, the following side
effects were observed:
increased suicidal related behaviours (including suicide
attempts and suicidal thoughts), self−harm behaviours and
increased hostility.
Additional side effects that were seen were: decreased
appetite, trembling of the body, sweating, having too much
energy (hyperkinesias or hyperactivity), agitation, changing
emotions (including crying and mood fluctuations) and
unusual bruising or bleeding (such as nose bleeds).
In studies, some patients had withdrawal effects when they
stopped taking Paroxetine or gradually reduced the dose
before stopping, as follows: changing emotions (including
crying, mood fluctuations, self−harm, suicidal thoughts and
attempted suicide), nervousness, dizziness, feeling sick and
abdominal pain.
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. By
reporting side effects you can help provide more information
on the safety of this medicine.

5 How to store Paroxetine
Keep out of the sight and reach of children
Do not use Paroxetine after the expiry date which is stated
on the carton or blister respectively.
The expiry date refers to the last day of that month.
Do not store above 30°C (for product available in blister
packs).
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.

6 Further information
What Paroxetine 20 mg and 40 mg contain
The active substance is paroxetine
Each tablet contains 20 mg or 40 mg paroxetine equivalent to
22.2 mg or 44.4 mg of paroxetine hydrochloride anhydrous
The other ingredients are:
Tablet core
Mannitol
Cellulose, microcrystalline
Copovidone
Sodium starch glycollate (Type A)
Silica, colloidal anhydrous
Magnesium stearate
Tablet coating
Hypromellose
Talc (micronised)
Titanium dioxide (E171)
What Paroxetine looks like and contents of the pack
Paroxetine 20 mg is a white, round bisected film−coated
tablet with a pressure sensitive score notch, marked “PX 20”
The 20 mg tablet can be divided into equal halves, if required.
Paroxetine 40 mg is a white, round, quadrisected film−
coated tablet with a pressure sensitive score notch, marked
“PX 40”
The 40 mg tablet can be divided into equal quarters, if required.
The 20 mg and 40 mg tablets are available in blister packs or
containers with 7, 14, 15, 20, 28, 30, 40, 50, 50x1, 60, 100,
200 and 250 film−coated tablets.
The 20mg tablets are also available in blister packs or
containers with 10 film−coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Crescent Pharma Limited, Units 3-4 Quidhampton Business
Units, Polhampton Lane Overton, Hampshire, RG25 3ED, UK
Manufacturer
Tillomed Laboratories Ltd, 3 Howard Road, Eaton Socon,
St Neots, Cambridgeshire, PE19 8ET, UK
Product Licence Number:
Paroxetine 20mg Film-Coated Tablets: PL 20416/0355
Paroxetine 40mg Film-Coated Tablets: PL 20416/0363
Date of last revision: December 2015

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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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