PAROXETINE 10MG FILM-COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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Paroxetine 10mg Film-coated Tablets
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.
•   f you have any further questions, ask your doctor,
I
pharmacist or nurse.
•   his medicine has been prescribed for you only. Do not
T
pass it on to others. It may harm them, even if their signs of
illness 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.
•   aroxetine is not for use in children and adolescents
P
under 18.
•   aroxetine won’t work straight away. Some people taking
P
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.
•   ome people who are depressed or anxious think of
S
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.
•  on’t stop taking paroxetine without talking to your
D
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.
•   f you feel restless and feel like you can’t sit or stand
I
still, tell your doctor. Increasing the dose of paroxetine
may make these feelings worse. See section 4, Possible side
effects.
•   aking some other medicines with paroxetine can cause
T
problems. See Taking other medicines.
•   f you are pregnant or planning to get pregnant, talk to
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your doctor. See section 2, Pregnancy, breastfeeding and
fertility.

Index
W
1   hat Paroxetine tablets are and what they are
used for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
W
1  hat 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
•   anic disorder with or without agoraphobia (fear of open
p
spaces or new situations)
• social anxiety disorders/social phobias
• post traumatic stress disorder
• anxiety disorders.


2 What you need to know 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 of this medicine (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.

Paroxetine tablets contains soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

Talk to your doctor, pharmacist or nurse before taking
Paroxetine tablets if you:









suffer from eye, kidney, liver or heart problems
suffer from epilepsy or have a history of fits
h
 ave 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 (excess 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”.

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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:
•  ave previously had thoughts about killing or harming
h
yourself
•   re a young adult. Information from clinical trials has shown
a
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.

Other medicines and Paroxetine tablets

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
• thioridazine (a tranquilliser)
• fentanyl or pethidine (for severe pain)
• tramadol (a painkiller)
•  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
• St John’s Wort, (a herbal remedy for depression)
• linezolid (an antibiotic)
m
•  ethylene blue (used to treat high levels of
methaemoglobin 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)
o
•  ther antidepressants including, tryptophan and tricyclic
antidepressants like clomipramine, nortriptyline and
desipramine
•  rugs to treat some psychiatric conditions such as clozapine,
d
risperidone, pimozide
•  odium valproate, phenobarbital, phenytoin or
s
carbamazepine (to treat epilepsy)
•  tomoxetine (to treat attention deficit hyperactivity disorder
a
(ADHD))
•  rocyclidine (to relieve tremor, especially in Parkinson’s
p
Disease)
• warfarin or other anticoagulants (to thin the blood)
• propafenone, flecainide (to treat an irregular heartbeat)
• tamoxifen (used in breast cancer)
• fosamprenavir/ritonavir (used in HIV)
• metoprolol (for high blood pressure and heart problems)
• rifampicin (to treat tuberculosis (TB) and leprosy).
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Pregnancy, breast-feeding and fertility

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 others
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 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.
Medicines like Paroxetine may reduce the quality of your sperm.
Although the impact of this on fertility is unknown, fertility may
be affected in some men whilst taking Paroxetine.

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 with alcohol

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

Paroxetine tablets contains sunset yellow

These tablets also contain the colouring agent sunset yellow FCF
lake (E110) which may cause allergic reactions.

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 tablets can be broken into halves.
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
-  bsessive compulsive disorder: 20mg a day to a maximum
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of 60mg
- Panic disorder: 10mg a day to a maximum of 60mg
-  ocial anxiety disorder: 20mg a day to a maximum of 50mg
S
-  ost traumatic stress disorder: 20mg a day to a maximum
P
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
I
 f 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

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.

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, 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)
•   kathisia (restlessness, and feeling like you can’t sit or
a
stand still), low blood sodium (causing tiredness, weakness,
confusion and achy, stiff or uncoordinated muscles)
•   erotonin syndrome (confusion, restlessness, sweating,
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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):
- changes in sex drive or function (lack of orgasm, abnormal
erection and ejaculation in men).
• Common (occurs in less than 1 in 10 users):
- dry mouth, diarrhoea, constipation, being sick
 lack of appetite, weight gain, increase in blood
cholesterol levels
d
-  ifficulty sleeping, abnormal dreams/nightmares, feeling
sleepy, dizziness, headache
- shakes (tremors), feeling agitated
- blurred vision, yawning.
• Uncommon (occurs in less than 1 in 100 users):
- 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
- increase in the need to pass urine.
• Rare (occurs in less than 1 in 1,000 users):
- 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 (occurs in less than 1 in 10,000 users):
- yellowing of the skin or whites of the eyes
-  uid or water retention which may cause swelling of the
fl
arms or legs
- sensitivity to sunlight
- acute glaucoma (eye pain and blurred vision)
- painful erection of the penis that won’t go away.
• Other possible side effects (frequency cannot be estimated
from the data):
- bone fractures, ringing in the ears.

5 How to store
Keep out of the sight and reach 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.

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.

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

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.



T
 he active substance (the ingredient that makes the tablet
work) is paroxetine hydrochloride anhydrous. Each tablet
contains 11.11mg of the active ingredient (equivalent to
10mg of paroxetine).
T
 he other ingredients are tablet core: Magnesium stearate,
sodium starch glycollate, mannitol, cellulose microcrystalline.
Film-coating: Opadry AMB blue (polyvinyl alcohol-part
hydrolysed, titanium dioxide (E171), talc, indigo carmine
lake (E132), lecithin soya (E322), xanthan gum (E415), sunset
yellow FCF lake (E110) and quinoline yellow lake (E104) and
basic butylated methacrylate copolymer.

What Paroxetine tablets look like and contents of the
pack

Paroxetine 10mg tablets are blue, round biconvex film-coated
tablets, scored on one face. The tablet can be divided into equal
halves.
Pack sizes are 28 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Balkanpharma - Dupnitsa AD,
3 Samokovsko, Shosse Str. Dupnitsa 2600,
Bulgaria
Date of revision: May 2012

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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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