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PAROXETINE 30 MG FILM COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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TEVA UK Ref:

Version:

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

1

26 March 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

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

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Pharma code 449

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PAROXETINE 20 mg and 30 mg
FILM-COATED TABLETS
Paroxetine

TEVA UK Ref:

Version:

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

1

26 March 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

with you to the hospital or doctor so that they know
which tablets were consumed.
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.
Do not take a double dose to make up for a forgotten dose.
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
medicine, 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 (red and lumpy skin rash,
itching, swelling of the eyelids, face, lips, mouth or
tongue, throat or have difficulty breathing (shortness
of breath) or swallowing and feel weak or lightheaded
resulting in collapse or loss of consciousness.
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 (may affect more than 1 in 10 people):
• 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 (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 100 people):
• 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)
• 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 (may affect up to 1 in 1,000 people):
• 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

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feel extremely uncomfortable when resting i.e. sitting
or lying down).
Very rare (may affect up to 1 in 10,000 people):
• 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.
Additional side effects in children and adolescents
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).
Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist. 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.
Store in the original package. Do not use Paroxetine after
the expiry date shown on the outer packaging.
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 protect the environment.

6

Contents of the pack and other information

What Paroxetine contains:
• The active substance 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: March 2015
PL 00289/0521
PL 00289/0522
83734-ZC
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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
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Teva Pharmaceuticals Europe B.V
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APPROVALS
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Server Date
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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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