PAROXETINE 20MG TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Paroxetine 20 mg film-coated 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 your 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 20 mg film-coated Tablets is and
what it is used for
2. Before you take Paroxetine 20 mg film-coated Tablets
3. How to take Paroxetine 20 mg film-coated Tablets
4. Possible side effects
5. How to store Paroxetine 20 mg film-coated Tablets
6. Further information
1. What Paroxetine 20 mg film-coated Tablets is and
what it is used for
Your medicine belongs to a group of medicines called
selective serotonin reuptake inhibitors (SSRIs). Everyone
as the substance called serotonin in their body. Low levels
of serotonin are thought to be a cause of depression and
other related conditions. Paroxetine works by bringing the
levels of serotonin back to normal.
Paroxetine is used to treat:
• Major Depressive Episode
• Obsessive Compulsive Disorder
• Panic Disorder with and without agoraphobia
• Social Anxiety Disorders/Social phobia
• Generalised Anxiety Disorder.
Paroxetine hydrochloride which is contained in your
medicine is also authorised to treat other illnesses,
which are not mentioned in this leaflet. Ask your doctor,
pharmacist or other healthcare professional if you have
further questions and always follow their instructions.
It is important that you continue to take your tablets, even
when you start to feel better. Do not stop taking these
tablets unless your doctor tells you to.
For information on the use of Paroxetine in children and
adolescents under 18 years of age, please see Section 2
“Before you take Paroxetine 20 mg film-coated Tablets”.
2. Before you take Paroxetine 20 mg film-coated
Tablets
Do not take Paroxetine 20 mg film-coated Tablets if:
• you are allergic (hypersensitive) to paroxetine
hydrochloride or any of the other ingredients of your
medicine.
• you are taking or have taken at any time within the
last two weeks, any medicines known as monoamine
oxidase inhibitors (also called MAOIs) normally
prescribed for the treatment of depression.
• You are taking thioridazine ( a major tranquilliser)
or pimozide (an antipsychotic) used to treat mental
illness.

Take special care with Paroxetine 20 mg film-coated
Tablets
If you answer YES to any of the following questions listed
below and you have not already discussed these with
your doctor, go back to your doctor and ask what to do:
• Are you breast-feeding or are you pregnant or









planning to get pregnant (see Pregnancy and breastfeeding in this leaflet)?
Do you have eye, kidney, liver or heart trouble?
Do you suffer from epilepsy or have a history of fits?
Do you suffer or have you ever suffered from episodes
of mania (overactive behaviour or thoughts)?
Are you having electro-convulsive therapy (ECT)?
Do you have a history of bleeding disorders?
Do you suffer from diabetes?
Are you on a low sodium diet?

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.
Certain groups of patients may be more likely to think
like this:
• If you are a young adult, for example aged 18 to 29
• If you have previously had thoughts about killing or
harming yourself
• If you get these thoughts at any time, contact your
doctor or go to a hospital immediately.
Paroxetine 20 mg film-coated Tablets 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 your medicine.
If your doctor has prescribed your medicine for you (or
your child) and you want to discuss this, please go back
to your doctor.
In studies of your medicine 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). These studies
also showed that the same symptoms affected children
and adolescents taking
sugar pills (placebo) instead of your medicine, although
these were seen less often.
Some patients in these studies of under 18s had
withdrawal effects when they stopped taking your
medicine.
These effects were mostly similar to those seen in adults
after stopping your medicine (see Section 3, “If you
stop taking Paroxetine 20 mg film-coated Tablets”). 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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. If you are
taking any of the following medicines 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.
• Aspirin, ibuprofen or other medicines called NSAIDs
(non-steroidal anti-inflammatory drugs) like celecoxib,
etodolac, meloxicam and refecoxib, used for pain and
inflammation
• Tramadol, a painkiller
• 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
• 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.
If you are taking any other medicines, not mentioned
above, check with your doctor or pharmacist before
taking paroxetine. They will know if it is safe for you to
do so.
Taking Paroxetine 20 mg film-coated Tablets with food
and drink
You should avoid alcohol while you are taking this
medicine.
You should take your medicine with food and swallow the
tablets with a drink of water.

Pregnancy and breast-feeding
• If you are already taking your medicine and have just
found out that you are pregnant, you should talk to
your doctor immediately. Also if you are planning
to get pregnant, talk to your doctor. This is because
some studies have suggested an increase in the risk of
heart defects in babies whose mothers received your
medicine in the first few months of pregnancy. These
studies found that less than 2 in 100 babies (2%)
whose mothers received paroxetine in early pregnancy
had a heart defect, compared with the normal rate of 1
in 100 babies (1%) seen in the general population. You
and your doctor may decide that it is better for you
to gradually stop taking your medicine while you are
pregnant. However, depending on your circumstances,
your doctor may suggest that it is better for you to
keep taking your medicine.
• If you are taking your medicine in the last
3 months of pregnancy, let your midwife 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, lethargy, tremors,
jitters or fits. If your baby has any of these symptoms
when it is born and you are concerned, contact your
doctor or midwife who will be able to advise you.
• your medicine may get into breast milk in very small
amounts. If you are taking your medicine, go back and
talk to your doctor before you start breast-feeding.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Possible side effects with paroxetine are dizziness,
confusion or changes in eyesight. If you do get these side
effects, it may mean that your co-­ rdination, judgement
o
or concentration is affected so that it is not possible to do
certain things. If you are affected in this way, do not drive
or use machinery.
Important information about some of the ingredients of
Paroxetine 20 mg film-coated Tablets
This product contains the sugar lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this product.
3. How to take Paroxetine 20 mg film-coated Tablets
Always take your medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure. Sometimes you may need to take
more than one tablet or half a tablet to make up the dose
required. The table below will help you decide how many
tablets to take:
Dose per Day Number of Tablets to Take
10 mg

Half a 20 mg tablet

20 mg

One 20 mg tablet

30 mg

One 20 mg tablet + Half a 20 mg tablet

40 mg

Two 20 mg tablets

50 mg

Two 20 mg tablets + Half a 20 mg tablet

60 mg

Three 20 mg tablets


Take your tablets in the morning with food. Swallow the
tablets with a drink of water. Do not chew.

Your doctor will advise you what dose to take when you
first start taking your medicine. Most people start to feel
better after a couple of weeks. If you don’t start to feel
better after this time, talk to your doctor, who will advise
you. He or she may decide to increase the dose gradually,
10 mg at a time, up to a maximum daily dose.
The usual doses for different conditions are set out in the
table below.
Starting
dose
20 mg
20 mg

Depression
Obsessive
Compulsive
Disorder
(obsessions and
compulsions)
Panic Disorder
10 mg
(panic attacks)
20 mg
Social Anxiety
Disorder (fear or
avoidance of
social situations)
Generalised
20 mg
Anxiety Disorder

Recommended
daily dose
20 mg
40 mg

Maximum
daily dose
50 mg
60 mg

40 mg

60 mg

20 mg

50 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.
Older people
The maximum dose for people over 65 is 40 mg 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 your
medicine than usual. If you have severe liver or kidney
disease the maximum dose is 20 mg per day.
Never take more tablets than your doctor recommends.
If you take too much of your medicine (or someone else
does), tell your doctor or a hospital immediately. Show
them the pack of tablets.
If you forget to take your medicine
Take your medicine at the same time every day.
• If you do forget a dose, and you remember before
you go to bed, take it straight away. Carry on as usual
the next day.
• If you only remember during the night, or the next
day, leave out the missed dose. You may possibly get
withdrawal effects, but these should go away after you
take your next dose at the usual time.
Do not stop taking your medicine until your doctor tells
you to.
When stopping your medicine, 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 your medicine you take by 10 mg a
week. Most people find that any symptoms on stopping
your medicine are mild and go away on their own within
two weeks. For some people, these symptoms may be
more severe, or go on for longer.
If you get withdrawal effects when you are coming off

your tablets your doctor may decide that you should
come off them more slowly. If you get severe withdrawal
effects when you stop taking your medicine, please see
your doctor. He or she may ask you to start taking your
tablets again and come off them more slowly.
If you do get withdrawal effects, you will still be able to
stop your medicine.

Increasing your dose of your medicine 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.

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

Very rare (affecting less than 1 person in 10000):
• Allergic reactions to your medicine. 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 immediately.
• 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.

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
• 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 your medicine.
Your medicine 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
Like all medicines, your medicine can cause side effects,
although 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
immediately.
Uncommon (affecting less than 1 person in 100):
• If you have unusual bruising or bleeding, including
vomiting blood or passing blood in your stools,
contact your doctor or go to a hospital immediately.
• If you find that you are not able to pass water,
contact your doctor or go to a hospital immediately.
Rare (affecting less than 1 person in 1000):
• If you experience seizures (fits), contact your doctor
or go to a hospital immediately.
• If you feel restless and feel like you can’t sit or
stand still, you may have something called akathisia.

Other possible side effects during treatment
Very common (affecting more than 1 person in 10):
• Feeling sick (nausea). Taking your medicine in the
morning with food will reduce the chance of this
happening.
• Change in sex drive or sexual function. For example,
lack of orgasm and, in men, abnormal erection and
ejaculation.
Common (affecting less than 1 person in 10):
• Lack of appetite
• Not sleeping well (insomnia) or feeling sleepy
• Feeling dizzy or shaky (tremors)
• Feeling agitated
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Weight gain.
• Sweating
Uncommon (affecting less than 1 person in 100):
• Brief increase or decrease in blood pressure, a faster
than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal
movements in the mouth and tongue
• Skin rashes
• Feeling confused
• Having hallucinations (strange visions or sounds).
• Itching
Rare (affecting less than 1 person in 1000):
• 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
• Pain in the joints or muscles.
Very rare (affecting less than 1 person in 10000):
• 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.
If you have any concerns while you are taking your
medicine, talk to your doctor or pharmacist who will be
able to advise you.
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.
5. How to store Paroxetine 20 mg film-coated Tablets
• Keep out of the reach and sight of children.
• Store in the original package.
• If you are using half tablets, be careful to keep them
safely in the pack.
Do not use your medicine after the expiry date which is
stated on the carton and blister after “EXP”. The expiry
date refers to the last day of that month.
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 film-coated Tablets contains
The active substance is paroxetine hydrochloride.
Each tablet contains 22.2 mg paroxetine hydrochloride
anhydrous equivalent to 20 mg paroxetine.
The other ingredients are magnesium stearate, sodium
starch glycolic, anhydrous lactose; the tablet filmcoating contains hyprolose, hypromellose, macrogol and
colourant titanium dioxide (E171).
What Paroxetine 20 mg film-coated Tablets look like
and contents of the pack
Paroxetine 20 mg film-coated Tablets are oval and white,
with the markings “20” and a breakline on one side. The
tablets are available in pack sizes of
30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apotex Europe Limited, 41 London Street, Reading,
Berkshire RG1 4PS, United Kingdom.
Manufacturer responsible for release:
Katwijk B.V., Bio Science Park, Archimedesweg 2-2333;
CN Leiden, The Netherlands.
Distributed by:
Apotex UK Limited, 6 Ridgeway Court, Grovebury Road,
Leighton Buzzard, LU7 4SF, United Kingdom.

Paroxetine 20 mg (film-coated tablets: PL 15922/0026)
This leaflet was last approved in April 2008

PARO20UK02

Artikelinformatie
INTERGRAFIPAK B.V.
Grafische industrie
Postbus 245
2150 AE Nieuw-Vennep
Boekweitstraat 45
2153 GK Nieuw-Vennep
Telefoon (0252) 62 24 22*
Fax (0252) 62 23 37
e-mail: info@intergrafipak.nl

STANDPROEF
Klantnaam

: 320 mm x 280 mm

Vouwmaat

: 160 x 140 mm

Farmacode : 13016

Deze standproef is niet maatgevend voor
drukkleur, papierkwaliteit en afmetingen.
De productie start pas na ontvangst van
uw akkoord.





Kleuren:
▲ 1 PMS BLACK C

Proef
Akkoord

: 013016 mock up

Ordernr. Katwijk : P50246

Gebruikt corps:

8,5 pt

Versie drukproef : 2

Regelafstand:

3,5 mm

Paraaf klant:



Revisie
proef


Datum:

: Katwijk B.V.

Artikelnummer

Formaat



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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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