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PAROXETINE 30MG TABLETS

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

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Package leaflet: Information for the patient

Paroxetine 20mg and 30mg tablets
(paroxetine)
Eight important things you need to know about paroxetine
• Like all medicines, Paroxetine can have unwanted effects. It is
therefore important that you and your doctor weigh up the benefits
against the possible unwanted effects before starting treatment.
•P
 aroxetine is not for use in children and adolescents under 18.
•P
 aroxetine won’t work straight away. Some people taking
antidepressants feel worse before feeling better. 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 feeling better. See section 3,
How to take.
•S
 ome people who are depressed or anxious think of harming or
killing themselves. If you start to feel worse, or think of harming or
killing yourself, see your doctor or go to a hospital straight away.
See section 2, Thoughts of suicide.
•D
 on’t stop taking paroxetine without talking to your doctor. If
you stop taking paroxetine suddenly or miss a dose, you may get
withdrawal effects. See section 3, If you stop taking the tablets.
• I f you feel restless and feel like you can’t sit or stand still, tell
your doctor. Increasing the dose of paroxetine may make these
feelings worse. See section 4, Possible side effects.
•T
 aking some other medicines with paroxetine can cause
problems. See Taking other medicines.
• I f you are pregnant or planning to get pregnant, talk to your
doctor. See section 2, Pregnancy and breastfeeding.

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.
•  T his 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.
•  I f you get any 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:
 hat Paroxetine tablets are and what they are
1W
used for
2  What you need to know before you take
Paroxetine tablets
3  How to take Paroxetine tablets
4  Possible side effects
5  How to store Paroxetine tablets
6  Contents of the pack and other information
1  What Paroxetine tablets are and what they are

used for

Paroxetine is one of a type of antidepressants known as Selective
Serotonin Re-uptake Inhibitors (SSRIs). Low levels of the hormone
serotonin are thought to be a cause of depression and other
related conditions. Paroxtine works by bringing the levels of
serotonin back to normal. Paroxetine is used in adults to treat:
• major depression
• obsessive compulsive disorder
• panic disorder with or without agoraphobia (fear of open spaces
or new situations)
• social anxiety disorders/social phobias
• anxiety after traumatic experience (post-traumatic stress
disorder)
• anxiety disorders.

2  What you need to know before you take

Paroxetine tablets

Do not take Paroxetine tablets if you are:

•a
 llergic to paroxetine, peanut, soya or any of the other
ingredients of this medicine (listed in section 6)
• taking medicines called pimozide or monoamine oxidase
inhibitors (MAOls, including moclobemide), or have taken them
at any time within the last two weeks
• taking a tranquilliser called thioridazine or pimozide.
• using medicines containing linezolid, which is used for the
treatment of infections.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paroxetine tablets
if you:
• suffer from eye, kidney, liver or heart problems
• suffer from epilepsy or have a history of fits
• have episodes of mania (overactive behaviour or thoughts)
• are having electro-convulsive therapy (ECT)
• have a history of bleeding disorders
• suffer from diabetes
• are on a low sodium diet
• have glaucoma (pressure in the eye)
During treatment, talk to your doctor or pharmacist if you:
• develop symptoms such as confusion, restlessness, sweating,
shaking, shivering, hallucinations (strange visions or sounds),
sudden jerks of the muscles or a fast heartbeat, since these
symptoms could be a sign of “serotonin syndrome”

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 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.
• 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.

Children and adolescents

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,).
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).

Other medicines and Paroxetine tablets

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines Especially:
• monoamine oxidase inhibitors (MAOls, including moclobemide),
or have taken them at any time within the last two weeks
• thioridazine (a tranquilliser)
• fentanyl or pethidine (for severe pain)
• tramadol (a painkiller)
• medicines called triptans, such as sumatriptan (to treat migraine)
• other antidepressants including other Selective Serotonin
Reuptake Inhibitors (SSRls)
• drugs to treat some psychiatric conditions such as lithium,
perphenazine
• St John’s Wort, (a herbal remedy for depression)
• linezolid (an antibiotic)
• methylene blue (used to treat high levels of methaemoglobin in
the blood)
Concomitant use of above-mentioned medicinal products may
lead to ‘serotonin syndrome’ (see “Warnings and precautions”).
Some medicines can affect the way Paroxetine tablets works,
or make it more likely that you’ll have side effects. Paroxetine
tablets can also affect the way some other medicines work.
These include:
• aspirin, ibuprofen or other medicines called NSAIDs (nonsteroidal anti-inflammatory drugs) such as celecoxib, etodolac,
meloxicam and refecoxib (for pain and inflammation)
• other antidepressants including, tryptophan and tricyclic
antidepressants like clomipramine, nortriptyline and desipramine
• drugs to treat some psychiatric conditions such as clozapine,
risperidone, pimozide
• sodium valproate, phenobarbital, phenytoin or carbamazepine
(to treat epilepsy)
• atomoxetine (to treat attention deficit hyperactivity disorder
(ADHD))
• procyclidine (to relieve tremor, especially in Parkinson’s Disease)
• warfarin or other anticoagulants (to thin the blood)
• propafenone, flecainide (to treat an irregular heartbeat)
• tamoxifen (used in breast cancer)
• fosamprenivir/ritonavir (used in HIV)
• metoprolol, a beta blocker used to treat high blood pressure and
heart problems
• rifampicin (to treat tuberculosis (TB) and leprosy)
• pravastatin, used to treat high cholesterol

Paroxetine tablets with alcohol:

Do not drink alcohol while you are taking Paroxetine tablets.
Alcohol may make your symptoms or side effects worse

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.
Pregnancy
If you are already taking Paroxetine and have just found out that
you are pregnant you should talk to your doctor immediately.
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.
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Date sent:
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Date received: 10.02.17

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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 newborn (PPHN). PPHN increases
blood pressure in the blood vessels in the lungs. This may result in
abnormal blood flow to the lungs and heart and the baby cannot
get enough oxygen into their bloodstream. These symptoms
usually begin during the first 24 hours after birth and include not
being able to sleep or feed properly, breathing faster, 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.
Fertility
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

Paroxetine may cause dizziness, confusion or changes in eyesight.
If you are affected by these side effects, do not drive or use
machinery.

Paroxetine tablets contains soya lecithin

Paroxetine tablets contain soya lecithin. If you are allergic to
peanut or soya, do not use this medicine.

3  How to take Paroxetine tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor, pharmacist or nurse if you are not sure.
Take your tablets in the morning with food. Swallow them with a
drink of water. The white tablets can be cut in half. Do not chew.
Doses:
Your doctor will advise you what dose to take when you first start
taking paroxetine.
Use in adults
• Depression: 20mg a day to a maximum of 50mg
• Obsessive compulsive disorder: 20mg a day to a maximum of
60mg
• Panic disorder: 10mg a day to a maximum of 60mg
• Social anxiety disorder: 20mg a day to a maximum of 50mg
• Post traumatic stress disorder: 20mg a day to a maximum of
50mg
• Anxiety disorder: 20mg a day to a maximum of 50mg
Use in elderly
• The maximum dose for people over 65 is 40mg per day.
Use in children and adolescents
Not recommended for use in children aged under 18 years.
Use in 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. If you have severe liver
or kidney disease, the maximum dose is 20mg per day.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time,
or you think a child may have swallowed any, contact your nearest
hospital casualty department or tell your doctor immediately.
Signs of overdose include being sick, dilated pupils, fever, blood
pressure changes, headache, involuntary muscle contractions,
agitation, anxiety and rapid heart beat.

If you forget to Paroxetine tablets

Do not take a double dose to make up for a forgotten dose. If you
do forget a dose, and you remember before you go to bed,
take it straight away. then take the next dose at the right time. If
you only remember during the night, or the next day, leave out
the missed dose.

If you stop taking Paroxetine tablets

Do not stop treatment early because 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 such
as dizziness or a feeling of unsteadiness, tingling, electric shock
sensations, burning sensations, sleep disturbances, intense
dreams, restlessness, anxiety, feeling sick, shaking, confusion,
sweating, headache, diarrhoea, irregular heartbeat, emotional
instability, irritability or changes in vision. Talk to your doctor
before you stop taking the tablets and follow their advice.

What to do if you are 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 start
treatment. Tell your doctor then if you haven’t started to feel
better.

4  Possible side effects
Like all medicines, this medicine can cause side effects, but not
everybody gets them.

Contact your doctor at once if you experience any of
the following:

•A
 llergic reactions which may be severe to Paroxetine tablets:
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.
•S
 erious skin rashes: Serious skin rashes are potentially lifethreatening and require immediate medical attention. These
appear initially as circular patches often with central blisters
usually on arms and hands or legs and feet, more severe
rashes may include blistering of the chest and back. Additional
symptoms such as infection of the eye (conjunctivitis) or ulcers
of the mouth, throat or nose may occur. Severe forms of rash
may progress to widespread peeling of the skin which can be
life threatening. These serious skin rashes are often preceded by
headache, fever, body aches (flu-like symptoms).
• unusual bruising or bleeding, including vomiting blood, passing
blood in your stools or urine, bleeding from your gums or nose
and prolonged bleeding from cuts.

• not being able to pass water(urinary retention)
• seizures (fits)
• akathisia (restlessness, and feeling like you can’t sit or stand still),
low blood sodium (causing tiredness, weakness, confusion and
achy, stiff or uncoordinated muscles)
• serotonin syndrome (confusion, restlessness, sweating, shaking,
shivering, hallucinations (strange visions or sounds), sudden jerks
of the muscles or a fast heartbeat.
• acute glaucoma (eye pain and blurred vision)
• if you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
Very common: may affect more than 1 in 10 people
• changes in sex drive or function (lack of orgasm, abnormal
erection and ejaculation in men), impaired concentration.
• Feeling sick (nausea). Taking your medicine in the morning with
food will reduce the chance of this happening.
Common: may affect up to 1 in 10 people
• dry mouth, diarrhoea, constipation, being sick
• lack of appetite, weight gain, increase in blood cholesterol levels
• difficulty sleeping, abnormal dreams/nightmares, feeling sleepy,
dizziness, headache
• sweating, shakes (tremors), feeling agitated
• blurred vision, yawning
Uncommon: may affect up to 1 in 100 people
• increase or decrease in blood pressure
• irregular or fast heartbeat
• lack of movement, stiffness, shaking
• abnormal movements of the mouth and tongue
• abnormal dilated pupils
• 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 tablets. Please
speak to your doctor about adjusting the dosage of your insulin
or diabetes medications.
• confusion, hallucinations, involontary body or face movements
Rare: may affect up to 1 in 1,000 people
• abnormal production of breast milk in men and women
• slow heartbeat
• effects on the liver showing up in liver function tests
• panic attacks, overactive behaviour or thoughts (mania), feeling
detached from yourself (depersonalisation), feeling anxious,
restless leg syndrome (RLS)
• joint or muscle pain.
Very rare: may affect up to 1 in 10,000 people
• yellowing of the skin or whites of the eyes due to liver disorders
• 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.
Not known: frequency cannot be estimated from the available
data
• bone fractures, ringing in the ears (tinnitus), aggression.

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 Parotxetine tablets
Keep this medicine out of the sight and reach of children. This
medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label
or carton after “EXP”. The expiry date refers to the last day of that
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 protect the enviroment.

6  Contents of the pack and other information
What Paroxetine tablets contain

• The active substance (the ingredient that makes the tablet work)
is paroxetine hydrochloride anhydrous. Each tablet contains
either 22.22mg or 33.33mg of the active ingredient (equivalent to
20mg or 30mg of paroxetine).
• The other ingredients are magnesium stearate, sodium starch
glycollate (Type A), mannitol DC (E421), cellulose microcrystalline,
and polymethacrylate. 20mg tablets also contain opadry AMB
white (polyvinyl alcohol-part hydrolysed, titanium dioxide (E171),
talc, lecithin soya (E322), and xanthan gum (E415)). 30mg tablets
also contain opadry AMB blue (polyvinyl alcohol-part hydrolysed,
titanium dioxide (E171), talc, FD&C blue #2 / indigo carmine lake
(E132), lecithin soya (E322), xanthan gum (E415), FD&C yellow #6
/ sunset yellow (E110) and quinoline yellow lake (E104)).

What Paroxetine tablets look like and contents of the
pack
Paroxetine 20mg tablets are white and Paroxetine 30mg tablets
are blue, circular film-coated tablets.
Pack sizes are 30 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Wasdell Packaging Ltd, Units 6, 7, 8 Euro Way, Blagrove, Swindon,
Wiltshire, SN5 8YW
Date of revision: February 2017

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Paroxetine 20mg & 30mg 30 Tablets PIL - UK
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Item no:

BBBA0520

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
10.02.17
23.02.17
S.Anson

Date sent:
10.02.17
Date received: 10.02.17

Dimensions:
190 x 380
Min Body Text Size: 8pts
Supplier:
Actavis Zdravlje Serbia

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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