PAROXETINE 30MG TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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Paroxetine 20mg and 30mg tablets
(paroxetine hydrochloride anhydrous)




Please read all of the leaflet and keep it. You
may need to read it again.
It contains a lot of important information
about this medicine.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

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.
• Paroxetine is not for use in children and adolescents
under 18.
• Paroxetine 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.
• 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 section
2, Thoughts of suicide.
• Don’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.
• If 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.
• Taking some other medicines with paroxetine can
cause problems. See Taking other medicines.
• If you are pregnant or planning to get pregnant,
talk to your doctor. See section 2, Pregnancy and
breastfeeding.

Index
1 What Paroxetine tablets are and what they are
used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further 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. Paroxetine works by bringing the levels of serotonin
back to normal. Paroxetine is used in adults to treat:
• depression
• obsessive compulsive disorder
• panic disorder with or without agoraphobia (fear of open
spaces or new situations)
• social anxiety disorders/social phobias
• post traumatic stress disorder
• anxiety disorders.


2 Before you take
Do not take Paroxetine tablets and tell your doctor if
you are:




allergic (hypersensitive) to paroxetine or any of the other
ingredients (see 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.

Check with 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).

Take special care with Paroxetine


Contact your doctor 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”,

Continued top of next column
AAAE0185

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.
Children and adolescents under 18
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,
How to take, inside this leaflet). 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).
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription. Especially:
•  onoamine oxidase inhibitors (MAOls, including
m
moclobemide), or have taken them at any time within the last
two weeks
•  hioridazine (a tranquilliser)
t
•  entanyl or pethidine (for severe pain)
f
•  ramadol (a painkiller)
t
•  edicines called triptans, such as sumatriptan (to treat
m
migraine)
•  ther antidepressants including other Selective Serotonin
o
Reuptake Inhibitors (SSRls)
•  rugs to treat some psychiatric conditions such as lithium,
d
perphenazine
•  t John’s Wort, (a herbal remedy for depression)
S
• inezolid (an antibiotic)
l
•  ethylene blue (used to treat high levels of methaemoglobin
m
in the blood)

Concomitant use of above-mentioned medicinal products
may lead to ‘serotonin syndrome’ (see “Take special care with
paroxetine”).
Other drugs taken with Paroxetine that may cause unwanted
effects include:
•  spirin, ibuprofen or other medicines called NSAIDs (nona
steroidal anti-inflammatory drugs) such as celecoxib, etodolac,
meloxicam and refecoxib (for pain and inflammation)
•  ther antidepressants including, tryptophan and tricyclic
o
antidepressants like clomipramine, nortriptyline and
desipramine
•  rugs to treat some psychiatric conditions such as clozapine,
d
risperidone, pimozide
•  odium valproate, phenobarbital, phenytoin or carbamazepine
s
(to treat epilepsy)
•  tomoxetine (to treat attention deficit hyperactivity disorder
a
(ADHD))
•  rocyclidine (to relieve tremor, especially in Parkinson’s
p
Disease)
•  arfarin or other anticoagulants (to thin the blood)
w
•  ropafenone, flecainide (to treat an irregular heartbeat)
p
•  amoxifen (used in breast cancer)
t
•  osamprenivir/ritonavir (used in HIV)
f
•  etoprolol (for high blood pressure and heart problems)
m
•  ifampicin (to treat tuberculosis (TB)
r
and leprosy)
Continued over page

Pregnancy and breast-feeding

If you are planning to become pregnant or are breast-feeding
ask your doctor, midwife or pharmacist for advice before taking
this medicine. 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.
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 blood stream. 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.
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.

Alcohol

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

Important information about some of the ingredients of
Paroxetine

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

3 How to take
Always take paroxetine exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
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.
• 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
• Elderly
 
The maximum dose for people over 65 is 40mg per day.
• Children and adolescents

N
 ot recommended for use in children aged under 18 years.
• Patients with liver or kidney disease
 you have trouble with your liver or kidneys, your doctor may
If
decide that you should have a lower dose. If you have severe
liver or kidney disease, the maximum dose is 20mg per day.

4 Possible side effects
As with other medicines paroxetine can cause side effects, but not
everybody gets them.
Contact your doctor at once if you experience any of the
following:
• an allergic reaction: red and lumpy skin rash, severe skin rash
with flushing, fever, blisters or ulcers, swelling of the eyelids,
face, lips, mouth or tongue, itching or difficulty breathing or
swallowing
• unusual bruising or bleeding, including vomiting blood or
passing blood in your stools
• not being able to pass water
• 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.
Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
• Very common (occurs in more than 1 in 10 users):
-c
  hanges in sex drive or function (lack of orgasm, abnormal
erection and ejaculation in men), impaired concentration.
• Common (occurs in less than 1 in 10 users):
  ry mouth, diarrhoea, constipation, being sick
-d
 ack of appetite, weight gain, increase in blood cholesterol
-l
levels
  ifficulty sleeping, abnormal dreams/nightmares, feeling
-d
sleepy, dizziness, headache
 shakes (tremors), feeling agitated
  lurred vision, yawning
-b
• Uncommon (occurs in less than 1 in 100 users):
 ncrease or decrease in blood pressure
-i
 rregular or fast heartbeat
-i
 ack of movement, stiffness, shaking
-l
-a
  bnormal movements of the mouth and tongue
  bnormal dilated pupils
-a
 ncrease in the need to pass urine
-i
• Rare (occurs in less than 1 in 1,000 users):
-a
  bnormal production of breast milk in men and women
  low heartbeat
-s
  ffects on the liver showing up in liver function tests
-e
  anic attacks, overactive behaviour or thoughts (mania),
-p
feeling detached from yourself (depersonalisation), feeling
anxious, restless leg syndrome (RLS)
  oint or muscle pain.
-j
• Very rare (occurs in less than 1 in 10,000 users):
-y
  ellowing of the skin or whites of the eyes
  luid or water retention which may cause swelling of the arms
-f
or legs
  ensitivity to sunlight
-s
-a
  cute glaucoma (eye pain and blurred vision)
  ainful erection of the penis that won’t go away
-p
•  ther possible side effects (frequency cannot be estimated
O
from the data):
-b
  one fractures, ringing in the ears, suicidal ideation and
suicidal behaviour (see section 2).

5 How to store
Keep out of the reach and sight of children. No special precautions
for storage.
Do not use Paroxetine after the expiry date stated on the label. The
expiry date refers to the last day of that month.
Ask your pharmacist how to dispose of medicines no longer
required.

6  urther information
F
What Paroxetine tablets contain


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 take the 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 the 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’re 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.

Continued top of next column
AAAE0185



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: July 2012

Actavis, Barnstaple, EX32 8NS, UK

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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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