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PAROXETINE 20 MG FILM-COATED TABLETS

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

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Paroxetine

Package leaflet: Information
for the user
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 only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Paroxetine is and what it is used for
What you need to know before you take Paroxetine
How to take Paroxetine
Possible side effects
How to store Paroxetine
Contents of the pack and other information

1

What Paroxetine is and what it is used for

Pharma code 650

• Paroxetine belongs to a group of drugs called selective
serotonin re-uptake inhibitors (SSRIs). Serotonin is a chemical
that, in the brain, passes messages between nerve cells and
may help to control mood. Paroxetine brings the level of
serotonin back to normal.
• Paroxetine is used to treat the symptoms, and prevent a
recurrence of, depression and any accompanied anxiety,
obsessive compulsive disorder (OCD), panic attacks (with or
without agoraphobia – fear of going into public places) and
generalised anxiety disorder. It is also used to treat social
anxiety disorder (social phobia).

2

What you need to know before you take
Paroxetine

Do not take Paroxetine:
• If you are allergic to paroxetine or any of the other ingredients of
this medicine (listed in section 6).
• If you are taking thioridazine, used in the treatment of
schizophrenia
• If you are taking pimozide, used to treat schizophrenia and other
mental illnesses
• If you are taking, or have taken in the past 2 weeks, a
monoamine oxidase inhibitor (MAOI) also used to treat
depression, e.g. selegiline
• At least 24 hours after discontinuing a reversible MAOI e.g.
methylene blue or linezolid or moclobemide.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Paroxetine.
• If you have a history of mania (periods of unusually elevated high
mood and activity)
• If you have kidney, liver or heart problems
• If you have a history of bleeding disorders or a tendency to bleed
• If you have epilepsy or a history of fits
• If you have diabetes
• If you have glaucoma (increased pressure in the eye)
• If you have been told that you have low levels of sodium
• If you are due to receive electro-convulsive therapy (ECT).
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 young adults
(less than 25 years old) 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.
Other medicines and Paroxetine
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Check with your doctor if you are taking any of the following:
• Other antidepressants including other SSRIs, tryptophans and
tricyclic antidepressants such as clomipramine, nortriptyline and
desipramine
• The herbal remedy St John's Wort (Hypericum perforatum), used
to treat depression
• Medicines such as lithium, risperidone, perphenazine,
phenothiazine and clozapine (known as anti-psychotics),
atomoxetine used to treat some psychiatric conditions
• Phenobarbital, phenytoin or carbamazepine, sodium valproate
used to treat fits or epilepsy
• Procyclidine (used to relieve tremor, especially in Parkinson’s
Disease)
• Aspirin, ibuprofen, or other medicines known as 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 to treat
migraine)

REG0216703

Version 1.0

Approved

• Medicines used to thin the blood (anticoagulants), such as
warfarin
• Medicines used to treat an irregular heartbeat, such as
propafenone and flecainide
• 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)
• Fosamprenavir, ritonavir, used in treating HIV infection
• Tamoxifen, used for breast cancer or fertility
• Linezolid (an antibiotic)
• Pimozide (a medicine for mental disorders such as psychosis)
• Methylene blue (a pre-operative visualising agent).
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Paroxetine with food and drink and alcohol
You are advised not to drink alcohol whilst taking these tablets.
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.
This is because some studies have suggested an increase in the
risk of heart defects in babies whose mothers received Paroxetine
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
Paroxetine while you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is better for you to
keep taking Paroxetine.
If you are taking Paroxetine 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.
Make sure your midwife and/or doctor know you are on
Paroxetine. When taken during pregnancy, particularly in the last 3
months of pregnancy, medicines like Paroxetine may increase the
risk of a serious condition in babies, called persistent pulmonary
hypertension of the new born (PPHN), making the baby breathe
faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby you
should contact your midwife and/or doctor immediately.
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 breastfeeding.
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
Your tablets may make you feel sleepy or dizzy. Do not drive or
operate machinery if you are affected.

3

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

Paroxetine 20 mg and 30 mg
Film-Coated Tablets

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.
Take the tablets each morning with food. The tablets should be
swallowed whole with a drink of water and not chewed.
The usual dose is:
Adults
Depression and social anxiety disorder (social phobia):
One 20 mg tablet daily. Where necessary your doctor may increase
this to a maximum of 50 mg daily.
Obsessive compulsive disorder (OCD):
40 mg daily. Your doctor will start you on a lower dose and increase
this gradually. The maximum dose is 60 mg a day.
Panic disorder:
40 mg daily. Your doctor will start you on a dose of 10 mg a day and
increase this gradually. The maximum dose is 60 mg daily.
Generalised anxiety disorder:
One 20 mg tablet daily. Your doctor may increase your doses
gradually up to a maximum dose of 50 mg a day.
Older people
Your doctor will start you on the normal adult dose which he may
increase up to a maximum of 40 mg a day.
Patients with severe liver or kidney problems
The recommended dose is 20 mg per day.
Use in children and adolescents
Not recommended.
Paroxetine will not relieve your symptoms straight away. You should
start to feel better after a week or two, although it may take longer.
If you take more Paroxetine than you should
If you (or someone else) swallow a lot of the tablets all together, or
if you think a child has swallowed any of the tablets, contact your
nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause nausea, vomiting, shaking, dilated
pupils, dry mouth, irritability, sweating and insomnia. Please take
this leaflet, any remaining tablets and the container 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.

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

• 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
Possible side effects
discuss this, please go back to your doctor.
In studies of Paroxetine in under 18s, common side-effects that
Like all medicines, Paroxetine can cause side effects, although not affected less than 1 in 10 children/adolescents were: an increase in
everybody gets them.
suicidal thoughts and suicide attempts, deliberately harming
If you experience the following, stop taking Paroxetine and tell your themselves, being hostile, aggressive or unfriendly, lack of appetite,
shaking, abnormal sweating, hyperactivity (having too much
doctor immediately or go to the casualty department at your
energy), agitation, changing emotions (including crying and
nearest hospital:
changes in mood). These studies also showed that the same
• A severe allergic reaction (red and lumpy skin rash, itching,
symptoms affected children and adolescents taking sugar pills
swelling of the eyelids, face, lips, mouth or tongue, throat or
have difficulty breathing (shortness of breath) or swallowing and (placebo) instead of Paroxetine, although these were seen less
often.
feel week or lightheaded resulting in collapse or loss of
Some patients in these studies of under 18s had withdrawal effects
consciousness.
when they stopped taking Paroxetine. These effects were mostly
This is a very serious but rare side effect. You may need urgent
similar to those seen in adults after stopping Paroxetine. In addition,
medical attention or hospitalisation.
patients under 18 also commonly (less than 1 in 10) experienced
The following side effects have been reported at the approximate
stomach ache, feeling nervous and changing emotions (including
frequencies shown:
crying, changes in mood, trying to hurt themselves, thoughts of
suicide and attempting suicide).
Very common (may affect more than 1in 10 people):
• Inability to concentrate
Reporting of side effects:
• Feeling sick
If you get any side effects, talk to your doctor or pharmacist. This
• Change in sex drive or sexual function, for example, lack of
includes any possible side effects not listed in this leaflet. You can
orgasm and, in men, abnormal erection and ejaculation.
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Common (may affect up to 1 in 10 people):
By reporting side effects you can help provide more information on
• Decreased appetite
the safety of this medicine.
• Not sleeping well (insomnia) or feeling sleepy
• Feeling dizzy or shaky
• Lack or loss of strength and energy, weakness
How to store Paroxetine
• Blurred vision
• Yawning, dry mouth, vomiting, increased appetite
Keep this medicine out of the sight and reach of children. Store in
• Sweating
the original package. Do not use Paroxetine after the expiry date
• Diarrhoea or constipation
shown on the outer packaging.
• Abnormal dreams including nightmares
Do not throw away any medicines via wastewater or household
• High levels of cholesterol
waste. Ask your pharmacist how to throw away medicines you no
• Agitation
longer use. These measures will help protect the environment.
• Headache
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

5

• 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 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

REG0216703

Version 1.0

Approved

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, 8.0 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: July 2017
PL 00289/0521
PL 00289/0522

EAS1330a
83734-ZF
160x323

Page 2 of 2

Expand Transcript

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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