PAROXETINE 20MG FILM COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

2. Before you take Seroxat
Do not take Seroxat …

®

Seroxat 20 mg film-coated Tablets/
Paroxetine 20 mg film-coated Tablets
(paroxetine)
Your medicine is available using the above two
names, but will be referred to as Seroxat
throughout the remainder of this leaflet.
Your medicine is available in other strengths- 10mg
and 30mg.

Eight important things you need to know about
Seroxat
Please read all of the leaflet. It includes a lot of
additional important information about this medicine.
 Seroxat treats depression and anxiety disorders.
Like all medicines it can have unwanted effects. It is
therefore important that you and your doctor weigh
up the benefits of treatment against the possible
unwanted effects, before starting treatment.
 Seroxat is not for use in children and adolescents
under 18. See section 6, Children and adolescents
under 18, inside this leaflet.
 Seroxat 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 your tablets, inside this leaflet.
 Some 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 Thoughts of harming yourself, inside this leaflet.
 Don’t stop taking Seroxat without talking to your
doctor. If you stop taking Seroxat suddenly or miss a
dose, you may get withdrawal effects. See section 5,
Stopping Seroxat, inside this leaflet.
 If you feel restless and feel like you can’t sit or
stand still, tell your doctor. Increasing the dose of
Seroxat may make these feelings worse. See
section 4, Possible side-effects, inside this leaflet.
 Taking some other medicines with Seroxat can
cause problems. You may need to talk to your
doctor. See Other medicines and Seroxat, inside this
leaflet.
 If you are pregnant or planning to get pregnant,
talk to your doctor. See Pregnancy, breastfeeding
and Seroxat, inside this leaflet.



If you are taking medicines called monoamine
oxidase inhibitors (MAOIs, including moclobemide
and methylthioninium chloride (methylene blue)), or
have taken them at any time within the last two
weeks. Your doctor will advise you how you should
begin taking Seroxat once you have stopped taking
the MAOI.
 If you are taking a tranquilliser called thioridazine
 If you are taking a anti-psychotic called pimozide
 If you have previously had an allergic reaction to
paroxetine or any of the other tablet ingredients
listed. See section 8, What Seroxat contains, inside
this leaflet
►If any of these apply to you, tell your doctor without
taking Seroxat

Check with your doctor …
 Are you taking any other medicines (see Other

medicines and Seroxat, inside this leaflet)?
 Are you taking tamoxifen to treat breast cancer or








a blueish skin or being too hot or cold
blue lips
vomiting or not feeding properly,
being very tired, not able to sleep or crying a lot
stiff or floppy muscles
tremors, jitters or fits.
If your baby has any of these symptoms when it is born,
or you are concerned about your baby’s health,
contact your doctor or midwife who will be able to
advise you.
Seroxat may get into breast milk in very small
amounts. If you are taking Seroxat, go back and talk to
your doctor before you start breast-feeding. You and
your doctor may decide that you can breast-feed while
you are taking Seroxat.
Medicines like Seroxat may reduce the quality of your
sperm. Although the impact of this fertility is unknown,
fertility may be affected in some men whilst taking
Seroxat.

Other medicines and Seroxat

Some medicines can affect the way Seroxat works, or
make it more likely that you’ll have side effects. Seroxat
can also affect the way some other medicines work.
These include:
 Medicines called monoamine oxidase inhibitors
(MAOIs, including moclobemide and
methylthioninium chloride (methylene blue)) – see Do
not take Seroxat inside this leaflet
 Thioridazine or pimozide, which are anti-psychotics
- see Do not take Seroxat Inside this leaflet
 Aspirin, ibuprofen or other medicines called NSAIDs
(non-steroidal anti-inflammatory drugs) like celecoxib,
etodolac and meloxicam, used for pain and
inflammation
 Tramadol and pethidine, painkillers
 Medicines called triptans, such as sumatriptan, used
to treat migraine
 Other antidepressants including other SSRIs,
tryptophan and tricyclic antidepressants like
clomipramine, nortriptyline and desipramine
Thoughts of suicide and worsening of your
 Medicines such as lithium, risperidone, perphenazine
depression or anxiety disorder
(called anti-psychotics) used to treat some
If you are depressed and/or have anxiety disorders you
psychiatric conditions
can sometimes have thoughts of harming or killing
 Fentanyl, used in anaesthesia or to treat chronic
yourself. These may be increased when first starting
pain
antidepressants, since these medicines all take time to  A combination of fosamprenavir and ritonavir, which
work, usually about two weeks but sometimes longer.
is used to treat Human Immunodeficiency Virus
You may be more likely to think like this:
(HIV) infection.
 If you have previously had thoughts about killing or
 St John’s Wort, a herbal remedy for depression
harming yourself.
 Phenobarbital, phenytoin or carbamazepine, used to
Read this leaflet. It includes a lot of important
 If you are a young adult. Information from clinical
treat fits or epilepsy
information about this medicine.
trials has shown an increased risk of suicidal
 Atomoxetine which is used to treat attention deficit
 Keep this leaflet. You may need to read it again.
behaviour in adults aged less than 25 years with
hyperactivity disorder (ADHD)
 If you have more questions, ask your doctor or
psychiatric conditions who were treated with an
 Procyclidine, used to relieve tremor, especially in
pharmacist (chemist).
antidepressant.
Parkinson’s Disease
 You may also find it helpful to contact a self-help
► If you have thoughts of harming or killing yourself at
 Warfarin or other medicines (called anticoagulants)
group, or patient organisation, to find out more about any time, contact your doctor or go to a hospital
used to thin the blood
your condition. Your doctor will be able to give you
straight away.
 Propafenone, flecainide and medicines used to treat
details.
You may find it helpful to tell a relative or close
an irregular heartbeat
friend that you are depressed or have an anxiety
In this leaflet:
 Metoprolol, a beta-blocker used to treat high blood
disorder, and ask them to read this leaflet. You might
1. What Seroxat is and what it is used for
pressure and heart problems
ask them to tell you if they think your depression or
2. Before you take Seroxat
 Rifampicin, used to treat tuberculosis (TB) and
anxiety is getting worse, or if they are worried about
3. How to take your tablets
leprosy
changes in your behaviour.
4. Possible side effects
 Linezolid, an antibiotic.
5. Stopping Seroxat
 Tamoxifen, which is used to treat breast cancer or
Pregnancy, breast-feeding and Seroxat
6. Children and adolescents under 18
fertility problems.
Talk to your doctor as soon as possible if you’re
7. Looking after your tablets
► If you are taking any of the medicines in this list,
pregnant, if you might be pregnant, or if you’re
8. What Seroxat contains
planning to become pregnant. In babies whose mothers and you have not already discussed these with your
doctor, go back to your doctor and ask what to do.
took Seroxat during the first few months of pregnancy,
1. What Seroxat is and what it is used for
The dose may need to be changed or you may need to
there have been some reports showing an increased
Seroxat is a treatment for adults with depression
be given another medicine.
risk of birth defects, in particular those affecting the
and/or anxiety disorders.
heart. In the general population, about 1 in 100 babies
If you are taking any other medicines, including ones
Seroxat is one of a group of medicines called SSRIs
are born with a heart defect. This increased to about 2
you have bought yourself, check with your doctor or
(selective serotonin reuptake inhibitors).
in 100 babies in mothers who took Seroxat. You and
pharmacist before taking Seroxat. They will know if it is
Everyone has a substance called serotonin in their
safe for you to do so.
brain. People who are depressed or anxious have lower your doctor may decide that it is better for you to
levels of serotonin than others. It is not fully understood gradually stop taking Seroxat while you are pregnant.
Seroxat and alcohol
However, depending on your circumstances, your
how Seroxat and other SSRIs work but they may help
Do not drink alcohol while you are taking Seroxat.
doctor may suggest that it is better for you to keep
by increasing the level of serotonin in the brain.
Alcohol may make your symptoms or side-effects
taking Seroxat.
Other medicines or psychotherapy can also treat
worse.
depression and anxiety. Treating depression or anxiety Make sure your midwife and/or doctor know you are
disorders properly is important to help you get better. If on Seroxat. When taken during pregnancy, particularly Driving and using machinery
it’s not treated, your condition may not go away and
Possible side effects of Seroxat include dizziness,
late pregnancy, medicines like Seroxat may increase
may become more serious and more difficult to treat.
confusion or changes in eyesight.
the risk of a serious condition in babies, called
If you do get these side effects, do not drive or use
persistent pulmonary hypertension of the new born
You may find it helpful to tell a friend or relative that
machinery.
(PPHN). In PPHN, the blood pressure in the blood
you are depressed or suffering from an anxiety
vessels between the baby’s heart and the lungs is too
disorder, and ask them to read this leaflet. You might
3. How to take your tablets
high. If you take Seroxat during the last 3 months of
ask them to tell you if they think your depression or
Take your tablets in the morning with food.
pregnancy, your newborn baby might also have other
anxiety is getting worse, or if they are worried about
conditions, which usually begin during the first 24 hours Swallow them with a drink of water.
changes in your behaviour.
Do not chew.
after birth.
Symptoms include:
It is important to take your tablets as instructed by
 trouble with breathing
your doctor. The label will tell you how many tablets to
fertility problems? Seroxat may make tamoxifen less
effective so your doctor may recommend you take
another antidepressant.
 Do you have eye, kidney, liver or heart trouble?
 Do you have epilepsy or have a history of fits?
 Do you have episodes of mania (overactive
behaviour or thoughts)?
 Are you having electro-convulsive therapy (ECT)?
 Do you have a history of bleeding disorders?
 Do you have diabetes?
 Are you on a low sodium diet?
 Do you have glaucoma (pressure in the eye)?
 Are you pregnant or planning to get pregnant (see
Pregnancy, breastfeeding and Seroxat, inside this
leaflet)?
► If you answer YES to any of these questions and
you have not already discussed them with, your doctor,
go back to your doctor and ask what to do about
taking Seroxat.

take and how often. If you are unsure, ask your doctor
or pharmacist.
Sometimes you may need to take more than one tablet
or half a tablet. This table will show you how many
tablets to take.
Dose

Number of tablets to
take
Half a white tablet
One white tablet
One-and-a half white
tablets
Two white tablets
Two-and-a half white
tablets
Three white tablets

10 mg
20 mg
30 mg
40 mg
50 mg
60 mg

Your doctor will advise you what dose to take when
you first start taking Seroxat. Most people start to feel
better after a couple of weeks. If you don’t start to feel
better after this time, talk to your doctor, who will advise
you. He or she may decide to increase the dose
gradually, 10 mg at a time, up to a maximum daily dose.
The usual doses for different conditions are set out in
the table below.
Starting Recommended Maximum
dose
daily dose
daily dose
20 mg 20 mg
50 mg

Depression
Obsessive Compulsive
Disorder
(obsessions and
compulsions)
20 mg
Panic Disorder (panic
attacks)
10 mg
Social Anxiety
Disorder
(fear or avoidance of
social situations)
20 mg
Post Traumatic Stress
Disorder
20 mg
Generalised Anxiety
Disorder
20 mg

40 mg

60 mg

40 mg

60 mg

20 mg

50 mg

20 mg

50 mg

20 mg

50 mg

Remember, your doctor will advise you on the daily
dose you should take.
Your doctor will talk to you about how long you will need
to keep taking your tablets. This may be for many
months or even longer.

Older people
The maximum dose for people over 65 is 40 mg per
day.

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 of
Seroxat than usual. If you have severe liver or kidney
disease the maximum dose is 20 mg per day.

What if you miss a dose?
Take your medicine at the same time every day.
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.

What if you take too many tablets?
Never take more tablets than your doctor
recommends. If you take too many Seroxat tablets (or
someone else does), tell your doctor or a hospital
straight away. Show them the pack of tablets.

What to do if you’re feeling no better
Seroxat 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 first start treatment. Tell your doctor if you haven’t
started to feel better.

4. Possible side effects
As with other medicines Seroxat can cause side effects,
but not everybody gets them.

See the doctor if you get any of the following
side effects during treatment
You may need to contact your doctor or go to a hospital
straight away.

Likely to affect up to 1 in every 100 people:
 If you have unusual bruising or bleeding,

including vomiting blood or passing blood in your
stools, contact your doctor or go to a hospital
straight away.

S0070-30-RM-PIL-30.04.2012

 If you find that you are not able to pass water,



A widespread rash with blisters and peeling skin,
particularly around the mouth, nose, eyes and
genitals (Stevens-Johnson syndrome)
 A widespread rash with blisters and skin peeling on
Likely to affect up to 1 in every 1,000 people:
much of the body surface (toxic epidermal necrolysis)
 If you experience seizures (fits), contact your
 Liver problems that make the skin or whites of the
doctor or go to a hospital straight away.
eyes go yellow
 If you feel restless and feel like you can’t sit or
 Fluid or water retention which may cause swelling of
stand still, you may have something called
the arms or legs
akathisia. Increasing your dose of Seroxat may make  Sensitivity to sunlight
these feelings worse. If you feel like this, contact
 Painful erection of the penis that won’t go away
your doctor.
 Unexpected bleeding, e.g. bleeding gums, blood in
 If you feel tired, weak or confused and have achy,
the urine or in vomit, or the appearance of
stiff or uncoordinated muscles this may be
unexpected bruises or broken blood vessels (broken
because your blood is low in sodium. If you have
veins).
these symptoms, contact your doctor.
Some patients have developed buzzing, hissing,
whistling, ringing or other persistent noise in the ears
Likely to affect up to 1 in every 10,000 people:
(tinnitus) when they take Seroxat.
 Allergic reactions to Seroxat.
If you develop a red and lumpy skin rash, swelling of An increased risk of bone fractures has been observed
in patients taking this type of medicine.
the eyelids, face, lips, mouth or tongue, start to itch
►If you have any concerns while you are taking
or have difficulty breathing or swallowing, contact
Seroxat, talk to your doctor or pharmacist who will be
your doctor or go to a hospital straight away.
able to advise you.
 If you have some or all of the following
symptoms you may have something called
5. Stopping Seroxat
serotonin syndrome. The symptoms include: feeling
Do not stop taking Seroxat until your doctor tells
confused, feeling restless, sweating, shaking,
you to.
shivering, hallucinations (strange visions or sounds),
When stopping Seroxat, your doctor will help you to
sudden jerks of the muscles or a fast heartbeat. If
reduce your dose slowly over a number of weeks or
you feel like this contact your doctor.
months - this should help reduce the chance of
 Acute glaucoma.
If your eyes become painful and you develop blurred withdrawal effects. One way of doing this is to gradually
reduce the dose of Seroxat you take by 10 mg a week.
vision, contact your doctor.
Most people find that any symptoms on stopping
Seroxat are mild and go away on their own within two
Frequency unknown
weeks. For some people, these symptoms may be
Some people have had thoughts of harming or killing
themselves while taking Seroxat or soon after stopping more severe, or go on for longer.
treatment (see section 2, Before you take Seroxat).
If you get withdrawal effects when you are coming off
your tablets your doctor may decide that you should
Other possible side effects during treatment
come off them more slowly. If you get severe
Likely to affect more than 1 in 10 people:
withdrawal effects when you stop taking Seroxat,
 Feeling sick (nausea). Taking your medicine in the
please see your doctor. He or she may ask you to start
morning with food will reduce the chance of this
taking your tablets again and come off them more
happening.
slowly. It may be easier for you to take Seroxat oral
 Change in sex drive or sexual function. For example,
suspension during the time that you are coming off your
lack of orgasm and, in men, abnormal erection and
medicine.
ejaculation.
contact your doctor or go to a hospital straight
away.

Likely to affect up to 1 in 10 people:
















Increases in the level of cholesterol in the blood
Lack of appetite
Not sleeping well (insomnia) or feeling sleepy
Abnormal dreams (including nightmares)
Feeling dizzy or shaky (tremors)
Headache
Difficulty in concentrating
Feeling agitated
Blurred vision
Yawning, dry mouth
Diarrhoea or constipation
Vomiting
Weight gain
Feeling weak
Sweating.

Likely to affect up to 1 in every 100 people:










A brief increase in blood pressure, or a brief
decrease that may make you feel dizzy or faint when
you stand up suddenly
A faster than normal heartbeat
Lack of movement, stiffness, shaking or abnormal
movements in the mouth and tongue
Dilated pupils
Skin rashes
Feeling confused
Having hallucinations (strange visions or sounds)
An inability to urinate (urinary retention) or an
uncontrollable, involuntary passing of urine (urinary
incontinence).

Likely to affect up to 1 in every 1,000 people:










Abnormal production of breast milk in men and
women
A slow heartbeat
Effects on the liver showing up in blood tests of your
liver function
Panic attacks
Overactive behaviour or thoughts (mania)
Feeling detached from yourself (depersonalisation)
Feeling anxious
Irresistible urge to move the legs (Restless Legs
Syndrome)
Pain in the joints or muscles.

Likely to affect up to 1 in every 10,000 people:


Skin rash, which may blister, and looks like small
targets (central dark spots surrounded by a paler
area, with dark ring around the edge) called
erythema mutiforme

If you do get withdrawal effects, you will still be
able to stop Seroxat.

Possible withdrawal effects when stopping
treatment
Studies show that 3 in 10 patients notice one or more
symptoms on stopping Seroxat. Some withdrawal
effects on stopping occur more frequently than others.

Likely to affect up to 1 in 10 people:









Feeling dizzy, unsteady or off-balance
Feelings like pins and needles, burning sensation
and (less commonly) electric shock sensations,
including in the head
Some patients have developed buzzing, hissing,
whistling, ringing or other persistent noise in the ears
(tinnitus) when they take Seroxat
Sleep disturbances (vivid dreams, nightmares,
inability to sleep)
Feeling anxious
Headaches.

Likely to affect up to 1 in every 100 people:










Feeling sick (nausea)
Sweating (including night sweats)
Feeling restless or agitated
Tremor (shakiness)
Feeling confused or disorientated
Diarrhoea (loose stools)
Feeling emotional or irritable
Visual disturbances
Fluttering or pounding heartbeat (palpitations).

►Please see your doctor if you are worried about
withdrawal effects when stopping Seroxat.

6.

Children and adolescents under 18

Seroxat 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 Seroxat. If your doctor has
prescribed Seroxat for you (or your child) and you want
to discuss this, please go back to your doctor.
In studies of Seroxat 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
Seroxat, although these were seen less often.
Some patients in these studies of under 18s had
withdrawal effects when they stopped taking Seroxat.
These effects were mostly similar to those seen in
adults after stopping Seroxat (see section 5, Stopping
Seroxat, above). 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).

7. Looking after your tablets


Do not store your tablets above 30°C. Store in the
original package.
Keep your tablets out of the reach and sight of
children.
Do not take your tablets after the expiry date shown
on the pack.
If you are using half tablets, be careful to keep them
safely in the pack.
If your doctor tells you to stop taking this medicine,
take any unused tablets back to your pharmacist for
safe disposal. Only keep them if your doctor tells
you to.
If the tablets become discoloured or show any signs
of deterioration, you should seek the advice of your
pharmacist.
Never give these tablets to others, even if they have
similar symptoms to yours.
Finish all your tablets as the doctor tells you to.
Keep this leaflet. You may need to read it again.












8.

What Seroxat contains

Each film-coated tablet contains 22.80mg paroxetine
hydrochloride hemihydrate equivalent to 20mg of
paroxetine.
The inactive ingredients are: calcium dihydrogen
phosphate, sodium starch glycolate (Type A),
magnesium stearate; Opadry White YS-1R-7003
containing: hypromellose, macrogol 400, polysorbate 80
and titanium dioxide (E171).
Sodium content of the 20 mg tablet is 0.3 mg
Seroxat are white, film-coated, oval shaped biconvex
tablets debossed with “20” on one side and having a
break bar on the other.
Each pack of Seroxat contains 30 tablets.
Manufactured by: SmithKline Beecham Plc, Manor
Royal, Crawley, West Sussex RH10 9QJ, UK
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon, London,
NW9 6AQ
POM

PL No: 33902/0070

Leaflet revised: 30/04/2012
Seroxat® and the Seroxat tablet shape and colours are
registered trademarks of the GlaxoSmithKline Group of
Companies
S0070-30-RM-PIL-30.04.2012

Expand view ⇕

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.

Hide
(web3)