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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-ZE LEA PAROXETINE A/S TAB TUK

Version:

1

23 November 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

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

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Pharma code 449

REG0068008

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Paroxetine 20 mg and 30 mg
Film-Coated Tablets

TEVA UK Ref:

Version:

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

1

23 November 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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
Possible side effects
themselves, being hostile, aggressive or unfriendly, lack
of appetite, shaking, abnormal sweating, hyperactivity
Like all medicines, Paroxetine can cause side effects,
(having too much energy), agitation, changing emotions
although not everybody gets them.
(including crying and changes in mood). These studies
If you experience the following, stop taking Paroxetine
also showed that the same symptoms affected children
and tell your doctor immediately or go to the casualty and adolescents taking sugar pills (placebo) instead of
department at your nearest hospital:
Paroxetine, although these were seen less often.
• A severe allergic reaction (rash, itching, swelling of the Some patients in these studies of under 18s had
face, lips, mouth or throat which may cause difficulty
withdrawal effects when they stopped taking Paroxetine.
swallowing or breathing).
These effects were mostly similar to those seen in adults
This is a very serious but rare side effect. You may need
after stopping Paroxetine. In addition, patients under 18
urgent medical attention or hospitalisation.
also commonly (less than 1 in 10) experienced stomach
ache, feeling nervous and changing emotions (including
The following side effects have been reported at the
crying, changes in mood, trying to hurt themselves,
approximate frequencies shown:
thoughts of suicide and attempting suicide).
Very common (affecting more than one person in 10):
• Inability to concentrate
How to store Paroxetine
• Feeling sick
• Change in sex drive or sexual function, for example,
Keep Paroxetine out of the reach and sight of children.
lack of orgasm and, in men, abnormal erection and
Store in the original package. Do not use Paroxetine after
ejaculation.
the expiry date shown on the outer packaging.
Common (affecting fewer than one person in 10 but
Medicines should not be disposed of via wastewater or
more than one person in 100):
household waste. Ask your pharmacist how to dispose of
• Decreased appetite
medicines no longer required. These measures will help
• Not sleeping well (insomnia) or feeling sleepy
to protect the environment.
• Feeling dizzy or shaky
• Lack or loss of strength and energy, weakness
Further information
• Blurred vision
• Yawning, dry mouth, vomiting, increased appetite
What Paroxetine contains:
• Sweating
• The active ingredient is paroxetine (as hydrochloride
• Diarrhoea or constipation
hemihydrate), 20 mg or 30 mg
• Abnormal dreams including nightmares
• The other ingredients are calcium phosphate,
• High levels of cholesterol
povidone, sodium starch glycolate, magnesium
• Agitation
stearate, titanium dioxide (E171), methylcellulose,
• Headache
macrogol and polysorbate.
• Weight gain.
What Paroxetine looks like and contents of the pack:
Uncommon (affecting fewer than one person in 100 but
• Paroxetine 20 mg Film-Coated Tablets are white to
more than one person in 1,000people):
off-white, round biconvex film-coated tablets, 8.0 mm
• Unusual bruising or bleeding
in diameter, scored on one side and debossed with
• Feeling confused or having hallucinations
“2” on one side of the score and “0” on the other side
• Impairment of voluntary movement, tremors, tics,
of the score. The other side of the tablet debossed with
abnormal movements in the mouth and tongue
"PX”.The tablet can be divided into equal halves.
changes in muscle tone, slowness of movement
• Paroxetine 30 mg Film-Coated Tablets are white to
• Brief increase or decrease in blood pressure, a faster
off-white, round biconvex film-coated tablets,
than normal heartbeat
embossed with “30” and scored on one side and with
• Skin rashes, itching
“PX” on the other side
• Prolonged enlargement of the pupil (Mydriasis)
• The 20 mg tablets are available in pack sizes of 14, 20,
• Low blood pressure with dizziness when you stand
28, 30, 50, 56, 60, 84 and 100 tablets
rapidly (Postural hypertension)
• The 30 mg tablets are available in pack sizes of 28, 30,
• Involuntary leakage of urine
56 and 84 tablets.
Inability or difficulty in urinating (passing water)
Not all pack sizes may be marketed.
Rare (affecting fewer than one person in 1,000 but more
Marketing
Authorisation Holder and Manufacturer
than one person in 10,000):
• Low blood levels of sodium, which can cause tiredness TEVA UK Limited, Eastbourne, BN22 9AG.
and confusion, muscle twitching, fits or coma
This leaflet was last revised: November 2015
• Overactive behaviour or thoughts (mania), agitation,
PL 00289/0521
anxiety, a feeling of things being unreal, panic attacks, PL 00289/0522
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
83734-ZE
or lying down)
160x323
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.

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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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