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PAROXETINE 20 MG FILM-COATED TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE ANHYDROUS / PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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TEVA UK Ref:

231-30-83734-ZC LEA PAROXETINE A/S TAB TUK

Version:

4

21 July 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

• Medicines used to thin the blood (anticoagulants),
such as warfarin
• Medicines used to treat an irregular heartbeat, such as
propafenone and flecainide
PACKAGE LEAFLET: INFORMATION
• Metoprolol, a beta-blocker used to treat high blood
FOR THE USER
pressure and heart problems
Read all of this leaflet carefully before you start taking
• Rifampicin (used to treat tuberculosis (TB) and
this medicine.
leprosy)
• Keep this leaflet. You may need to read it again.
• Fosamprenavir, ritonavir, used in treating HIV infection
• If you have any further questions, ask your doctor or
• Tamoxifen, used for breast cancer or fertility
pharmacist.
• Linezolid (an antibiotic)
• This medicine has been prescribed for you. Do not
• Pimozide (a medicine for mental disorders such as
pass it on to others. It may harm them, even if their
psychosis)
symptoms are the same as yours.
• Methylene blue (a pre-operative visualising agent).
• If any of the side effects get serious, or if you notice
Please tell your doctor or pharmacist if you are taking or
any side effects not listed in this leaflet, please tell
have recently taken any other medicines, including
your doctor or pharmacist.
medicines obtained without a prescription.
Taking Paroxetine with food and drink
What is in this leaflet:
You are advised not to drink alcohol whilst taking these
1. What Paroxetine is and what it is used for
tablets.
2. Before you take Paroxetine
Pregnancy and breast-feeding
3. How to take Paroxetine
If you are already taking Paroxetine and have just found
4. Possible side effects
out that you are pregnant, you should talk to your doctor
5. How to store Paroxetine
immediately. Also if you are planning to get pregnant,
6. Further information
talk to your doctor. This is because some studies have
suggested an increase in the risk of heart defects in
What Paroxetine is and what it is used for
babies whose mothers received Paroxetine in the first
few months of pregnancy. These studies found that less
• Paroxetine belongs to a group of drugs called selective than 2 in 100 babies (2%) whose mothers received
serotonin re-uptake inhibitors (SSRIs). Serotonin is a
Paroxetine in early pregnancy had a heart defect,
chemical that, in the brain, passes messages between compared with the normal rate of 1 in 100 babies (1%)
nerve cells and may help to control mood. Paroxetine seen in the general population. You and your doctor may
brings the level of serotonin back to normal.
decide that it is better for you to gradually stop taking
• Paroxetine is used to treat the symptoms, and prevent Paroxetine while you are pregnant. However, depending
on your circumstances, your doctor may suggest that it
a recurrence of, depression and any accompanied
is better for you to keep taking Paroxetine.
anxiety, obsessive compulsive disorder (OCD), panic
If you are taking Paroxetine in the last 3 months of
attacks (with or without agoraphobia - fear of going
into public places) and generalised anxiety disorder. It pregnancy, let your midwife know as your baby might
have some symptoms when it is born. These symptoms
is also used to treat social anxiety disorder (social
usually begin during the first 24 hours after the baby is
phobia).
born. They include not being able to sleep or feed
Before you take Paroxetine
properly, trouble with breathing, a bluish 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
Do NOT take Paroxetine:
• If you are allergic (hypersensitive) to paroxetine or any any of these symptoms when it is born and you are
concerned, contact your doctor or midwife who will be
of the other ingredients of this medicine
• If you are taking thioridazine, used in the treatment of able to advise you.
schizophrenia
Make sure your midwife and/or doctor know you are on
• If you are taking pimozide, used to treat schizophrenia Paroxetine. When taken during pregnancy, particularly in
and other mental illnesses
the last 3 months of pregnancy, medicines like Paroxetine
• If you are taking, or have taken in the past 2 weeks, a
may increase the risk of a serious condition in babies,
monoamine oxidase inhibitor (MAOI) also used to
called persistent pulmonary hypertension of the new born
treat depression, e.g. selegiline
(PPHN), making the baby breathe faster and appear
• At least 24 hours after discontinuing a reversible MAOI bluish. These symptoms usually begin during the first 24
e.g. methylene blue or linezolid or moclobemide.
hours after the baby is born. If this happens to your baby
you should contact your midwife and/or doctor
Take special care with Paroxetine:
immediately.
• If you have a history of mania (periods of unusually
elevated high mood and activity)
Paroxetine may get into breast milk in very small
• If you have kidney, liver or heart problems
amounts. If you are taking Paroxetine, go back and talk
• If you have a history of bleeding disorders or a
to your doctor before you start breast-feeding.
tendency to bleed
Paroxetine has been shown to reduce the quality of
• If you have epilepsy or a history of fits
sperm in animal studies. Theoretically, this could affect
• If you have diabetes
fertility, but impact on human fertility has not been
• If you have glaucoma (increased pressure in the eye)
observed as yet.
• If you have been told that you have low levels of
Driving and using machines
sodium
Your tablets may make you feel sleepy or dizzy. Do not
• If you are due to receive electro-convulsive therapy
drive or operate machinery if you are affected.
(ECT).
Thoughts of suicide and worsening of your depression
How to take Paroxetine
or anxiety disorder
If you are depressed and/or have anxiety disorders you
Always take Paroxetine exactly as your doctor has told
can sometimes have thoughts of harming or killing
you. You should check with your doctor or pharmacist if
yourself. These may be increased when first starting
you are not sure.
antidepressants, since these medicines all take time to
Take the tablets each morning with food. The tablets
work, usually about two weeks but sometimes longer.
should be swallowed whole with a drink of water and not
You may be more likely to think like this:
chewed.
• If you have previously had thoughts about killing or
The usual dose is:
harming yourself
Adults
• If you are a young adult. Information from clinical
Depression and social anxiety disorder (social phobia):
trials has shown an increased risk of suicidal
One 20 mg tablet daily. Where necessary your doctor may
behaviour in young adults (less than 25 years old)
increase this to a maximum of 50 mg daily.
with psychiatric conditions who were treated with an
antidepressant.
Obsessive compulsive disorder (OCD):
If you have thoughts of harming or killing yourself at any 40 mg daily. Your doctor will start you on a lower dose
time, contact your doctor or go to a hospital straight away. and increase this gradually. The maximum dose is 60 mg
a day.
You may find it helpful to tell a relative or close friend
Panic disorder:
that you are depressed or have an anxiety disorder, and
40 mg daily. Your doctor will start you on a dose of 10 mg
ask them to read this leaflet. You might ask them to tell
a day and increase this gradually. The maximum dose is
you if they think your depression or anxiety is getting
60 mg daily.
worse, or if they are worried about changes in your
behaviour.
Generalised anxiety disorder:
One 20 mg tablet daily. Your doctor may increase your
Taking other medicines
doses gradually up to a maximum dose of 50 mg a day.
Check with your doctor if you are taking any of the
Elderly
following:
Your doctor will start you on the normal adult dose which
• Other antidepressants including other SSRIs,
he may increase up to a maximum of 40 mg a day.
tryptophans and tricyclic antidepressants such as
clomipramine, nortriptyline and desipramine
Patients with severe liver or kidney problems
• The herbal remedy St John’s Wort (Hypericum
The recommended dose is 20 mg per day.
perforatum), used to treat depression
Children and adolescents under 18
• Medicines such as lithium, risperidone, perphenazine, Not recommended.
phenothiazine and clozapine (known as
Paroxetine will not relieve your symptoms straight away.
anti-psychotics), atomoxetine used to treat some
You should start to feel better after a week or two,
psychiatric conditions
although it may take longer.
• Phenobarbital, phenytoin or carbamazepine, sodium
If you take more Paroxetine than you should
valproate used to treat fits or epilepsy
If you (or someone else) swallow a lot of the tablets all
• Procyclidine (used to relieve tremor, especially in
together, or if you think a child has swallowed any of the
Parkinson’s Disease)
tablets, contact your nearest hospital casualty
• Aspirin, ibuprofen, or other medicines known as
department or your doctor immediately. An overdose is
non-steroidal anti-inflammatory drugs (NSAIDs) such
likely to cause nausea, vomiting, shaking, dilated pupils,
as celecoxib, etodolac, meloxicam and refecoxib that
dry mouth, irritability, sweating and insomnia. Please
are used to treat pain and inflammation
take this leaflet, any remaining tablets and the container
• Tramadol, fentanyl, pethidine (painkillers)
with you to the hospital or doctor so that they know
• Medicines called triptans, such as sumatriptan (used
which tablets were consumed.
to treat migraine)

1

Pharma code 449

2

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Top of page cut-off to middle of registration mark: 44 mm.

PAROXETINE 20 mg and 30 mg
FILM-COATED TABLETS

TEVA UK Ref:

231-30-83734-ZC LEA PAROXETINE A/S TAB TUK

Version:

4

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you forget to take Paroxetine
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.
If you stop taking Paroxetine
Do not stop taking your tablets suddenly. When your
doctor decides to stop your tablets, your dose will be
reduced gradually over a number of weeks or months to
help reduce the chance of withdrawal effects.
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, who 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 Paroxetine.
Possible withdrawal effects when stopping treatment:
Common (affecting fewer than one person in 10 but more
than one person in 100):
• Feeling dizzy, unsteady or off-balance
• Pins and needles, electric shock sensations, ringing in
the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability
to sleep)
• Feeling anxious
• Headaches.
Uncommon (affecting fewer than one person in 100 but
more than one person in 1,000):
• Feeling sick, diarrhoea
• Sweating
• Feeling restless or agitated
• Tremor (shakiness)
• Feeling confused
• Feeling emotional or irritable
• Visual disturbances
• Fluttering or pounding heartbeat (palpitations).
Generally these side effects are mild and do not last for a
very long time but in some people they may be more
serious or last longer.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Paroxetine can cause side effects,
although not everybody gets them.
If you experience the following, stop taking Paroxetine
and tell your doctor immediately or go to the casualty
department at your nearest hospital:
• A severe allergic reaction (rash, itching, swelling of the
face, lips, mouth or throat which may cause difficulty
swallowing or breathing).
This is a very serious but rare side effect. You may need
urgent medical attention or hospitalisation.
The following side effects have been reported at the
approximate frequencies shown:
Very common (affecting more than one person in 10):
• Inability to concentrate
• Feeling sick
• Change in sex drive or sexual function, for example,
lack of orgasm and, in men, abnormal erection and
ejaculation.
Common (affecting fewer than one person in 10 but more
than one person in 100):
• Decreased appetite
• Not sleeping well (insomnia) or feeling sleepy
• Feeling dizzy or shaky
• Lack or loss of strength and energy, weakness
• Blurred vision
• Yawning, dry mouth, vomiting, increased appetite
• Sweating
• Diarrhoea or constipation
• Abnormal dreams including nightmares
• High levels of cholesterol
• Agitation
• Headache
• Weight gain.
Uncommon (affecting fewer than one person in 100 but
more than one person in 1,000):
• Unusual bruising or bleeding
• Feeling confused or having hallucinations
• Impairment of voluntary movement, tremors, tics,
abnormal movements in the mouth and tongue,
changes in muscle tone, slowness of movement
• Brief increase or decrease in blood pressure, a faster
than normal heartbeat
• Skin rashes, itching
• Prolonged enlargement of the pupil (Mydriasis)
• Low blood pressure with dizziness when you stand
rapidly (Postural hypertension)
• Involuntary leakage of urine
• Inability or difficulty in urinating (passing water)
Rare (affecting fewer than one person in 1,000 but more
than one person in 10,000):
• Low blood levels of sodium, which can cause tiredness
and confusion, muscle twitching, fits or coma
• Overactive behaviour or thoughts (mania), agitation,
anxiety, a feeling of things being unreal, panic attacks,
feeling restless and like you can’t sit or stand still
• Fits (convulsions)
• A slow heartbeat
• Effects on the liver that show up in blood tests of your
liver function
• Production of breast milk in both men and women
• Pain in the joints or muscles
• Restless legs syndrome (a condition where your legs
feel extremely uncomfortable when resting i.e. sitting
or lying down).
Very rare (affecting fewer than one person in 10,000):
• Increased bleeding, reduction in blood platelets, which
increases risk of bleeding or bruising

• Allergic reaction including nettle rash and swelling of
the face, lips, mouth or throat
• A condition known as syndrome of inappropriate
anti-diuretic hormone secretion (SIADH), the
symptoms of which include weight gain, feeling or
being sick, muscle cramps, confusion and fits
• A condition known as serotonin syndrome, the
symptoms of which include agitation, confusion,
sweating, hallucinations, sudden jerks of the muscles,
shivering, a fast heartbeat and shaking
• Acute glaucoma - the symptoms are painful eyes and
blurred vision
• Inflammatory skin eruption
• Serious illness with blistering of the skin, mouth, eyes
and genitals
• Skin reactions caused by exposure to sunlight
• Painful erection of the penis that won’t go away
• Fluid or water retention which may cause swelling of
the arms or legs
• Liver problems that make the skin or whites of the
eyes go yellow.
Not known (frequency cannot be estimated from the
available data):
• Aggression.
The following side effects have also been reported.
• Suicidal behaviour and ideas
• Ringing in the ears.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Children and adolescents under 18
Paroxetine should not be used for children and
adolescents under 18 years because it has not been
proven to be an effective medicine for this age group.
Also, patients under 18 have an increased risk of
side-effects such as suicidal thoughts and harming
themselves when they take Paroxetine. If your doctor has
prescribed Paroxetine for you (or your child) and you
want to discuss this, please go back to your doctor.
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). 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. In addition, patients under 18
also commonly (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).

5

How to store Paroxetine

Keep Paroxetine out of the reach and sight of children.
Store in the original package. Do not use Paroxetine after
the expiry date shown on the outer packaging.
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 contains:
• The active ingredient is paroxetine (as hydrochloride
hemihydrate), 20 mg or 30 mg
• The other ingredients are calcium phosphate,
povidone, sodium starch glycolate, magnesium
stearate, titanium dioxide (E171), methylcellulose,
macrogol and polysorbate.
What Paroxetine looks like and contents of the pack:
• Paroxetine 20 mg Film-Coated Tablets are white to
off-white, round biconvex film-coated tablets, 8.5 mm
in diameter, scored on one side and debossed with
“2” on one side of the score and “0” on the other side
of the score. The other side of the tablet debossed with
"PX”The tablet can be divided into equal halves.
.
• Paroxetine 30 mg Film-Coated Tablets are white to
off-white, round biconvex film-coated tablets,
embossed with “30” and scored on one side and with
“PX” on the other side
• The 20 mg tablets are available in pack sizes of 14, 20,
28, 30, 50, 56, 60, 84 and 100 tablets
• The 30 mg tablets are available in pack sizes of 28, 30,
56 and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/0521
PL 00289/0522

83734-ZC
160x323

21 July 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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