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PAROXETINE 10MG TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE ANHYDROUS

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Package leaflet: Information for the user

PAROXETINE 10 mg TABLETS
(paroxetine hydrochloride)
The name of your medicine is Paroxetine 10mg Tablets but will be
referred to as Paroxetine throughout this leaflet. This product is
available in other strengths.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 signs of illness 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.
See section 4.
What is in this leaflet:
1. What Paroxetine is and what it is used for
2. What you need to know before you take Paroxetine
3. How to take Paroxetine
4. Possible side effects
5. How to store Paroxetine
6. Contents of the pack and other information

1. What Paroxetine is and what it is used
for
Paroxetine is a treatment for adults with depression and/or
anxiety disorders. The anxiety disorders that Paroxetine is used to
treat are: obsessive compulsive disorder (repetitive, obsessive
thoughts with uncontrollable behaviour), panic disorder (panic attacks,
including those caused by agoraphobia, which is a fear of open
spaces), social anxiety disorder (fear or avoidance of social
situations), post-traumatic stress disorder (anxiety caused by a
traumatic event); and generalised anxiety disorder (generally feeling
very anxious or nervous).
Paroxetine is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors). Everyone has a substance called
serotonin in their brain. People who are depressed or anxious have
lower levels of serotonin than others. It is not fully understood how
Paroxetine and other SSRIs work but they may help by increasing the
level of serotonin in the brain. Treating depression or anxiety
disorders properly is important to help you get better.

2. What you need to know before you take
Paroxetine
Do not take Paroxetine
• If you are taking medicines called monoamine oxidase
inhibitors (MAOIs, including moclobemide and methylthioninium
chloride (methylene blue)) or have taken them at any time within the
last two weeks. Your doctor will advise you how you should begin
taking Paroxetine once you have stopped taking the MAOI
• If you are taking an anti-psychotic called thioridazine or an antipsychotic called pimozide
• If you are allergic to paroxetine or any of the other ingredients of
this medicine (listed in section 6).
• If any of these apply to you, tell your doctor without taking
Paroxetine
Warnings and Precautions
Talk to your doctor or pharmacist before taking Paroxetine
• Are you taking any other medicines (see Taking other medicines
and Paroxetine,inside this leaflet)?
• Are you taking tamoxifen to treat breast cancer or fertility problems?
Paroxetine may make tamoxifen less effective, so your doctor may
recommend you take another antidepressant.
• Do you have kidney, liver or heart trouble?
• Do you have epilepsy or have a history of fits or seizures?
• have you ever had episodes of mania (overactive behaviour or
thoughts)?
• Are you having electro-convulsive therapy (ECT)?
• Do you have a history of bleeding disorders, or are you taking other
medicines that may increase the risk of bleeding (these include
medicines used to thin the blood, such as warfarin, anti- psychotics
such as perphenazine or clozapine, tricyclic antidepressants,
medicines used for pain and inflammation called non-steroidal antiinflammatory drugs or NSAIDs, such as acetylsalicylic acid,
ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Do you have diabetes
• Are you on a low sodium diet?
• Do you have glaucoma (pressure in the eye)?
• Are you pregnant, or planning to get pregnant (see Pregnancy,
breast-feeding and fertility, inside this leaflet)?
• Are you under 18 years old (see Children and adolescents under
18, inside this leaflet)?
 If you answer YES to any of these questions, and you have not
already discussed them with your doctor, go back to your doctor
and ask what to do about taking Paroxetine.
Children and adolescents under 18 Paroxetine should not be
used for children and adolescents under 18 years. Also, patients
under 18 have an increased risk of side effects such as suicide
attempt, suicidal thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take Paroxetine. If your
doctor has prescribed Paroxetine for you (or your child) and you want
to discuss this, please go back to your doctor. You should inform your
doctor if any of the symptoms listed above develop or worsen when
you (or your child) are taking Paroxetine. Also, the long-term safety
effects, concerning growth, maturation and cognitive and behavioural
development, of Paroxetine in this age group have not yet been
demonstrated.
In studies of Paroxetine in under 18s, common side effects that
affected less than 1 in 10 children/ adolescents were: an increase in
suicidal thoughts and suicide attempts, deliberately harming
themselves, being hostile, aggressive or unfriendly, lack of appetite,
shaking, abnormal sweating, hyperactivity (having too much energy),
agitation, changing emotions (including crying and changes in mood),
and unusual bruising or bleeding (such as nose bleeds). These
studies also showed that the same symptoms affected children and
adolescents taking sugar pills (placebo) instead of Paroxetine,
although these were seen less often

Some patients in these studies of under 18s had withdrawal effects
when they stopped taking Paroxetine. These effects were mostly
similar to those seen in adults after stopping Paroxetine (see section
3, How to take Paroxetine, inside this leaflet). In addition, patients
under 18 also commonly (affecting less than 1 in 10) experienced
stomach ache, feeling nervous and changing emotions (including
crying, changes in mood, trying to hurt themselves, thoughts of
suicide and attempting suicide).
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines
all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
 If you have previously had thoughts about killing or harming
yourself.
 If you are a young adult. Information from clinical trials has shown
an increased risk of suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were treated with an
antidepressant.
 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.
Important side effects seen with Paroxetine
Some patients who take Paroxetine develop something called
akathisia, where they feel restless and feel like they can’t sit or
stand still. Other patients develop something called serotonin
syndrome, or neuroleptic malignant syndrome, where they have
some or all of the following symptoms: feeling very agitated or
irritable, feeling confused, feeling restless, feeling hot, sweating,
shaking, shivering, hallucinations (strange visions or sounds), muscle
stiffness, sudden jerks of the muscles or a fast heartbeat. The severity
can increase, leading to loss of consciousness. If you notice any of
these symptoms, contact your doctor.
For more information on these or other side effects of Paroxetine, see
section 4, Possible side effects, inside this leaflet.
Other medicines and Paroxetine
Some medicines can affect the way Paroxetine works, or make it
more likely that you’ll have side effects. Paroxetine can also affect the
way some other medicines work. These include:
• Medicines called monoamine oxidase inhibitors (MAOIs,
including moclobemide and methylthioninium chloride (methylene
blue)) - see Do not take Paroxetine, inside this leaflet
• Thioridazine or pimozide, which are anti-psychotics - see Do not
take Paroxetine, inside this leaflet
• Aspirin (acetylsalicylic acid), ibuprofen or other medicines called
NSAIDs (non-steroidal anti- inflammatory drugs) like celecoxib,
etodolac, diclofenac and meloxicam, used for pain and
inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as sumatriptan, used to treat
migraine
• Other antidepressants including other SSRIs tryptophan and
tricyclic antidepressants like clomipramine, nortriptyline and
desipramine
• A dietary supplement called tryptophan
• Mivacurium and suxamethonium (used in anaesthesia)
• Medicines such as lithium, risperidone, perphenazine, clozapine
(called anti-psychotics) used to treat some psychiatric conditions
• Fentanyl, used in anaesthesia or to treat chronic pain
• A combination of fosamprenavir and ritonavir, which is used to treat
Human Immunodeficiency Virus (HIV) infection
• St John’s Wort, a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate or carbamazepine,
used to treat fits or epilepsy
• Atomoxetine which is used to treat attention deficit hyperactivity
disorder (ADHD)
• Procyclidine, used to relieve tremor, especially in Parkinson’s
Disease
• Warfarin or other medicines (called anticoagulants) used to thin the
blood
• Propafenone, flecainide and medicines used to treat an irregular
heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and
heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen, which is used to treat breast cancer or fertility
problems.
 If you are taking or have recently taken any of the medicines in
this list, and you have not already discussed these with your
doctor, go back to your doctor and ask what to do. The dose
may need to be changed or you may need to be given another
medicine.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
Paroxetine with food, drink and alcohol
Do not drink alcohol while you are taking Paroxetine. Alcohol may
make your symptoms or side effects worse. Taking Paroxetine in the
morning with food will reduce the likelihood of you feeling sick
(nausea).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. In babies whose mothers took Paroxetine
during the first few months of pregnancy, there have been some
reports showing an increased risk of birth defects, in particular those
affecting the heart. In the general population, about 1 in 100 babies
are born with a heart defect. This increased to up to 2 in 100 babies in
mothers who took Paroxetine. You and your doctor may decide that it
is better for you to change to another treatment or to gradually stop
taking Paroxetine while you are pregnant. However, depending on
your circumstances, your doctor may suggest that it is better for you
to keep taking Paroxetine.
Make sure your midwife or doctor knows you’re taking
Paroxetine. When taken during pregnancy, particularly late
pregnancy, medicines like Paroxetine may increase the risk of a

serious condition in babies, called persistent pulmonary hypertension
of the newborn (PPHN). In PPHN, the blood pressure in the blood
vessels between the baby’s heart and the lungs is too high. If you
take Paroxetine during the last 3 months of pregnancy, your newborn
baby might also have other conditions, which usually begin during the
first 24 hours after birth. Symptoms include:
• trouble with breathing
• a blue-ish skin or being too hot or cold
• blue lips
• vomiting or not feeding properly
• being very tired, not able to sleep or crying a lot
• stiff or floppy muscles
• tremors, jitters or fits
• exaggerated reflexes.
 If your baby has any of these symptoms when it is born, or you are
concerned about your baby’s health, contact your doctor or
midwife who will be able to advise you.
Paroxetine may get into breast milk in very small amounts. If you
are taking Paroxetine, go back and talk to your doctor before you start
breast-feeding. You and your doctor may decide that you can
breastfeed while you are taking Paroxetine.
Paroxetine has been shown to reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human
fertility has not been observed as yet.
Driving and using machines
Possible side effects of Paroxetine include dizziness, confusion,
feeling sleepy or blurred vision. If you do get these side effects, do not
drive or use machinery.

3.

How to take Paroxetine

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
Paroxetine tablets come in four strengths:
10mg tablets: Biconvex, off-white, round tablet, diameter 6.6mm,
inscribed 10 on one side.
20mg tablets: Flat-faced, bevel-edged, off-white, round tablet,
diameter 9.1mm, inscribed 20 on one side with a score line.
30mg tablets: Flat-faced, bevel-edged, off-white, round tablet,
diameter 10.1mm, with a score line.
40mg tablets: Off-white, capsule-shaped, biconvex tablets scored on
one side with dimensions, Length: 15.5 – 15.8 mm, Width: 7.0 – 7.3
mm, Thickness: 4.4 – 4.7 mm.
Sometimes you may need to take more than one tablet or half a
tablet. This table will show you how many tablets to take.
Dose
10 mg
20 mg
30 mg
40 mg
50 mg

60 mg

Number of Tablets to take
One tablet of 10 mg
One tablet of 20 mg
One tablet of 30 mg
One tablet of 40 mg
One tablet of 40 mg and One tablet of 10
mg or One tablet of 30 mg and One tablet
of 20 mg
Two tablets of 30 mg One tablet of 40 mg
and one tablet of 20 mg Three tablets of
20 mg

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)
PostTraumatic
Stress
Disorder
Generalised
Anxiety
Disorder

Starting
dose
20 mg
20 mg

Recommended
daily dose
20 mg
40 mg

Maximum
daily dose
50 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

Your doctor will advise you what dose to take when you first
start taking Paroxetine. Most people start to feel better after a
couple of weeks. If you don’t start to feel better after this time, talk to
your doctor, who will advise you. He or she may decide to increase
the dose gradually, 10 mg at a time, up to a maximum daily dose.
Take your tablets in the morning with food.
Swallow them with a drink of water.
Do not chew.
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 Paroxetine than usual. If you
have severe liver or kidney disease the maximum dose is 20 mg per
day.
If you take more Paroxetine than you should
Never take more tablets than your doctor recommends.
If you take too many Paroxetine tablets (or someone else does), tell
your doctor or a hospital straight away. Show them the pack of

tablets. Someone who has taken an overdose of Paroxetine may
have any one of the symptoms listed in section 4, Possible side
effects, or the following symptoms: fever, uncontrollable tightening of
the muscles.

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.

If you forget to take Paroxetine
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 take a double dose to make up for a forgotten dose.

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

What to do if you’re feeling no better Paroxetine will not relieve
your symptoms straight away - all antidepressants take time to
work. Some people will start to feel better within a couple of weeks,
but for others it may take a little longer. Some people taking
antidepressants feel worse before feeling better. If you don’t start to
feel better after a couple of weeks, go back to your doctor who will
advise you. Your doctor should ask to see you again a couple of
weeks after you first start treatment. Tell your doctor if you haven’t
started to feel better.
If you stop taking Paroxetine
Do not stop taking Paroxetine until your doctor tells you to.
When stopping Paroxetine, your doctor will help you to reduce your
dose slowly over a number of weeks or months - this should help
reduce the chance of withdrawal effects. One way of doing this is to
gradually reduce the dose of Paroxetine you take by 10 mg a week.
Most people find that any symptoms on stopping Paroxetine are mild
and go away on their own within two weeks. For some people, these
symptoms may be more severe, or go on for longer.
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 Paroxetine,
please see your doctor. He or she may ask you to start taking your
tablets again and come off them more slowly. It may be easier for you
to take Paroxetine oral suspension during the time that you are
coming off your medicine.
If you do get withdrawal effects, you will still be able to stop
Paroxetine.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on
stopping Paroxetine. Some withdrawal effects on stopping occur more
frequently than others.
Common side effects, likely to affect up to 1 in
10 people:
• Feeling dizzy, unsteady or off-balance
• Feelings like pins and needles, burning sensations and (less
commonly) electric shock sensations, including in the head
• Some patients have developed buzzing, hissing, whistling, ringing
or other persistent noise in the ears (tinnitus) when they take
Paroxetine
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headaches.
Uncommon side effects, likely to affect up to 1 in
every 100 people:
• Feeling sick (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor (shakiness)
• 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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4.

Possible side effects

Like all medicines, these tablets can cause side effects, although not
everybody gets them. Side effects are more likely to happen in the
first few weeks of taking Paroxetine.
See the doctor if you get any of the following side effects during
treatment
You may need to contact your doctor or go to a hospital straight away.
Uncommon side effects, likely to affect up to 1 in
every 100 people:
• If you have unusual bruising or bleeding, including vomiting
blood or passing blood in your stools, contact your doctor or go
to a hospital straight away
• If you find that you are not able to pass water, contact your doctor
or go to a hospital straight away.
Rare side effects, likely to affect up to 1 in every
1,000 people:
• If you experience seizures (fits), contact your doctor or go to a
hospital straight away
• If you feel restless and feel like you can’t sit or stand still, you
may have something called akathisia. Increasing your dose of
Paroxetine may make these feelings worse. If you feel like this,
contact your doctor
• If you feel tired, weak or confused and have achy, stiff or
uncoordinated muscles this may be because your blood is low in
sodium. If you have these symptoms, contact your doctor.
Very rare side effects, likely to affect up to 1 in
every 10,000 people:
• Allergic reactions, which may be severe to Paroxetine
If you develop a red and lumpy skin rash, swelling of
the eyelids, face, lips, mouth or tongue, start to itch
or have difficulty breathing (shortness of breath) or
swallowing and feel weak or lightheaded resulting
in collapse or loss of consciousness contact your
doctor or go to a hospital straight away
• If you have some or all of the following symptoms you may
have something called serotonin syndrome. The symptoms
include: feeling confused, feeling restless, sweating, shaking,
shivering, hallucinations (strange visions or sounds), sudden jerks

Other possible side effects during treatment
Very common side effects, 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.
Common side effects, likely to affect up to 1 in
10 people:
• Increases in the level of cholesterol in the blood
• Lack of appetite
• Not sleeping well (insomnia) or feeling sleepy
• Abnormal dreams (including nightmares)
• Feeling dizzy or shaky (tremors)
• Headache
• Difficulty in concentrating
• Feeling agitated
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating.
Uncommon side effects, likely to affect up to 1 in
every 100 people:
• A brief increase in blood pressure, or a brief decrease that may
make you feel dizzy or faint when you stand up suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal movements in
the mouth and tongue
• Dilated pupils
• Skin rashes
• Itching
• Feeling confused
• Having hallucinations (strange visions or sounds)
• An inability to urinate (urinary retention) or an uncontrollable,
involuntary passing of urine (urinary incontinence)
• If you are a diabetic patient you may notice a loss of control of your
blood sugar levels whilst taking Paroxetine. Please speak to your
doctor about adjusting the dosage of your insulin or diabetes
medications.
Rare side effects, likely to affect up to 1 in every
1,000 people:
• Abnormal production of breastmilk 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
• Increase in a hormone called prolactin in the blood
• Menstrual period disorders (including heavy or irregular periods,
bleeding between periods and absence or delay of periods.
Very rare side effects, likely to affect up to 1 in
every 10,000 people:
• Skin rash, which may blister, and looks like small targets (central
dark spots surrounded by a paler area, with a dark ring around the
edge) called erythema multiforme
• A widespread rash with blisters and peeling skin, particularly around
the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• A widespread rash with blisters and skin peeling on much of the
body surface (toxic epidermal necrolysis)
• Liver problems that make the skin or whites of the eyes go yellow
• Syndrome of inappropriate antidiuretic hormone production (SIADH)
which is a condition in which the body develops an excess of water
and a decrease in sodium (salt) concentration, as a result of
improper chemical signals. Patients with SIADH may become
severely ill or may have no symptoms at all
• 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
• Low blood platelet count.
Some patients have developed buzzing, hissing,
whistling, ringing or other persistent noise in the ears
(tinnitus) when they take Paroxetine.
An increased risk of bone fractures has been observed
in patients taking this type of medicine.
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 this medicine out of the sight and reach of children.
Do not use any tablets after the expiry date which is stated on the
carton and blister, after ‘EXP…’ The expiry date refers to the last day
of the month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

If this medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

6. Contents of the pack and other
information
What Paroxetine contains
The active ingredient is paroxetine 10 mg as paroxetine
hydrochloride.
The other ingredients are:
Microcrystalline cellulose (E460), calcium hydrogen phosphate
dihydrate (E341), croscarmellose sodium (E468), colloidal anhydrous
silica (E551) and magnesium stearate (E470b).
What Paroxetine looks like and the contents of the pack
Round, white to off-white tablets inscribed with 10 on one side and
plain on the reverse.
In each box there are blister packs containing 30 tablets.
Paroxetine is manufactured by Farmaceutisch Analytisch
Laboratorium Duiven BV, Dijkgraaf 30 te Duiven, The Netherlands.
Procured from within the EU and repackaged in the UK by the Parallel
Import Product Licence holder, CD Pharma Limited, Unit 3, Manor
Point, Manor Way, Borehamwood, Herts. WD6 1EE.

Paroxetine 10 mg Tablets

PL No. 20492/0593

POM

Date of preparation: 01st August 2017

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