Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking PAXTINE?
PAXTINE contains the active ingredient paroxetine (as hydrochloride hemihydrate).
PAXTINE is used to treat depression, panic attack prevention, anxiety and other illnesses
by helping to control mood.
2. What should I know before I take PAXTINE?
Do not use if you have ever had an allergic reaction to PAXTINE or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with PAXTINE and affect how it works.
4. How do I take PAXTINE?
The usual dose of PAXTINE for depression and social anxiety disorder/social phobia
is one 20 mg tablet per day.
To treat obsessions and compulsions or panic attacks, the usual dose of PAXTINE is
two 20 mg tablets per day.
PAXTINE tablets can be broken in half but should not be chewed or crushed.
PAXTINE should be taken in the morning, preferably with food.
5. What should I know while taking PAXTINE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PAXTINE.
Take PAXTINE with a full glass of water or another liquid.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
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Driving or using machines
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Be careful driving or operating machinery until you know how PAXTINE affects you.
PAXTINE may cause drowsiness, dizziness or lightheadedness in some people.
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Drinking alcohol
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Although drinking moderate amounts of alcohol is unlikely to affect your response
to PAXTINE, it is best to avoid alcohol while you are taking this medicine.
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Looking after your medicine
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Keep your tablets in the blister pack until it is time to take them.
Store it in a cool dry place below 25°C.
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6. Are there any side effects?
Like other medicines, PAXTINE can cause some side effects. If they occur, they are
most likely to be minor and temporary.
Less serious side effects can include feeling sick, dry mouth, constipation, decreased appetite, diarrhoea,
vomiting, drowsiness, dizziness, difficulty in getting to sleep, impaired sexual function,
weakness, feeling sweaty or shaky, bruising, abnormal dreams (including nightmares),
weight gain. Serious side effects can include allergic reaction including swelling of limbs, mouth or throat which
may cause wheezing, skin rashes that may blister, sudden onset of prolonged muscular
spasms.
Active ingredient(s):
paroxetine (as hydrochloride hemihydrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PAXTINE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PAXTINE.
Where to find information in this leaflet:
1. Why am I taking PAXTINE?
PAXTINE contains the active ingredient paroxetine (as hydrochloride hemihydrate).
PAXTINE belongs to a group of medicines called selective serotonin reuptake inhibitors
(SSRI) antidepressants. They are thought to work by their action on brain chemicals
called amines which are involved in controlling mood.
PAXTINE is used to treat:
depression which is longer lasting or more severe than the ‘low moods’ that everyone
has from time to time. It is thought to be caused by a chemical imbalance in part
of the brain that affects your whole body and can cause emotional and physical symptoms.
You may feel low in spirit, lose interest in usual activities, have poor appetite
or over eat, have disturbed sleep, wake up early, have low energy and feel guilty
over nothing.
irrational fears or obsessional behaviour. These can also be due to chemical imbalance
in parts of the brain.
panic attacks. PAXTINE may be used to help prevent panic attacks.
patients who may avoid and/or are fearful of social situations.
Your doctor may decide that you should continue to use PAXTINE for some time, even
when you have overcome your problem. This should prevent the problem from returning.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I take PAXTINE?
Warnings
In some children and adolescents, treatment with an antidepressant increases suicidal
thinking or actions.
Suicidal thoughts and actions can also be caused by depression, a serious medical
condition that is commonly treated with antidepressants. Thinking about killing yourself
or trying to kill yourself is called suicidality or being suicidal.
It is more important to discuss all the risks of treating depression and also all
the risks of not treating it. You should discuss all treatment choices with your doctor
not just antidepressants.
Patients (and caregivers of patients) need to monitor for any worsening of their condition
and/or the emergence of thoughts of suicide or suicidal behaviour or thoughts of harming
themselves and to seek medical advice immediately if these symptoms present (see section
2.
What should I know before I take PAXTINE?- Children and Adolescents).
There is an increased risk of breaking a bone in people taking medicines like PAXTINE.
This risk is greatest during the early stages of treatment.
Do not take PAXTINE if:
you are allergic to paroxetine, or any of the ingredients listed at the end of this
leaflet. Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
you are pregnant or intend to become pregnant.
you have taken PAXTINE before and became unwell, tell your doctor or pharmacist before
taking the first dose.
you are taking any other medications for the treatment of depression or have done
so in the last 2 weeks.
Taking PAXTINE with another antidepressant can cause a serious reaction.
you must not take PAXTINE until 2 weeks after stopping monoamine oxidase inhibitor
drugs (MAOIs).
Examples of MAOIs are phenelzine and tranylcypromine. Another MAOI includes the antibiotic
linezolid. There may be others so please check with your doctor. Taking PAXTINE with
a MAOI may cause a serious reaction.
you are taking or have recently taken (within the last two weeks) a medicine called
methylthioninium chloride (methylene blue).
you are taking thioridazine for the treatment of schizophrenia.
you are taking pimozide
the expiry date (EXP) printed on the pack has passed.
the packaging is torn or shows signs of tampering.
Check with your doctor if you:
are allergic to foods, dyes preservatives or any other medicines.
have any other medical conditions such as:
liver problems
heart problems
kidney problems
epilepsy
mania
raised pressure in the eye (glaucoma)
problems with blood clotting
other psychiatric conditions (bipolar disorder)
diabetes
history of bleeding disorders, such as after childbirth
you are pregnant or intend to become pregnant.
you are breastfeeding or wish to breastfeed. Your doctor will discuss with you the
possible risks and benefits of using PAXTINE during breastfeeding.
If you have not told your doctor about any of the above, tell them before you start
taking PAXTINE.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
If you take PAXTINE near the end of your pregnancy, there may be an increased risk
of heavy vaginal bleeding shortly after birth, especially if you have a history of
bleeding disorders.
Your doctor or midwife should be aware that you are taking PAXTINE so they can advise
you.
Studies show that use of paroxetine in early pregnancy (first 13 weeks) may be associated
with an increased risk of some birth defects in babies.
If you become pregnant or intend to become pregnant while taking paroxetine, you should
make an appointment to see your doctor and have your treatment reviewed.
It is important that you do not stop taking paroxetine suddenly.
Paroxetine is a medicine that can have withdrawal side effects if stopped suddenly.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
Fertility
Medicines like PAXTINE may affect your sperm. Fertility in some men may be reduced
while taking PAXTINE.
Elderly
Take special care with PAXTINE if you are over 65 years of age as PAXTINE may cause
a reduction in the amount of sodium within your blood which can lead to sleepiness
and muscle weakness.
If you experience these symptoms, please consult your doctor as soon as possible.
Children and adolescents
PAXTINE is not recommended for use in children and adolescents under 18 years.
The use of PAXTINE is not recommended to treat depression in children and adolescents
under 18, as the drug has not been shown to be effective in this age group and there
are possible unwanted effects.
Information from clinical trials has suggested that young adults, particularly those
with depression, may be at an increased risk of suicidal behaviour (including suicide
attempts) when treated with PAXTINE, especially during initial treatment (generally
the first one to two months).
The majority of attempted suicides in clinical trials in depression involved patients
aged 18 to 30 years.
Family and caregivers of children and adolescents being treated with antidepressants
for major depressive disorder or for any other condition (psychiatric or non-psychiatric)
need to monitor them for the emergence of agitation, irritability, unusual changes
in behaviour, as well as the emergence of thoughts of suicide, and to report such
symptoms immediately to their doctor.
It is particularly important that monitoring be undertaken during the initial few
months of antidepressant treatment or at times of dose increase or decrease.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with PAXTINE and affect how it works. In particular, tell your doctor if you are taking any of the following medicines
which:
treat depression, anxiety, schizophrenia or attention-deficit hyperactivity disorder
(ADHD) such as tryptophan, hypericum perforatum (St John's Wort), perphenazine, risperidone,
lithium or atomoxetine
are used in anaesthesia to treat pain or chronic pain, specifically tramadol or fentanyl
lower blood pressure or treat heart conditions, such as metoprolol or flecainide
control epilepsy (anti-convulsants), such as phenytoin, carbamazepine, phenobarbital
(phenobarbitone)
thin blood (anti-coagulants), such as warfarin, aspirin, non-steroidal anti-inflammatory
drugs (NSAIDs)
treat Parkinson's disease, such as selegiline and procyclidine
treat stomach ulcers, such as cimetidine
treat migraine attacks such as sumatriptan
treat or prevent breast cancer, specifically tamoxifen
treat HIV infection such as a combination of fosamprenavir and ritonavir
used in anaesthesia, such as mivacurium and suxamethonium.
These medicines may be affected by PAXTINE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PAXTINE.
4. How do I take PAXTINE?
How much to take
The usual dose of PAXTINE for depression, social anxiety disorder/social phobia is
one 20 mg tablet per day. Your doctor may increase the dose slowly over several weeks.
This may require you to break the tablet in half.
To treat obsessions and compulsions or panic attacks, the usual dose of PAXTINE is
two 20 mg tablets per day. Your doctor may start you on a lower dose (half a tablet)
and increase the dose slowly over several weeks. This may require you to break the
tablet in half.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
When to take PAXTINE
PAXTINE should be taken in the morning, preferable with food.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take PAXTINE
Take PAXTINE with a full glass of water or another liquid.
PAXTINE tablets can be broken in half along the break line if required but should
not be chewed or crushed.
How long to take PAXTINE
Keep taking you PAXTINE for as long as your doctor tells you.
Your doctor may decide that you should continue to use PAXTINE for some time, even
when you have overcome your problem. For best effect PAXTINE must be taken regularly.
Your doctor will tell you when and how PAXTINE should be discontinued.
Your doctor will usually recommend that you stop treatment by slowly reducing the
dosage over a period of several weeks. When you stop treatment with PAXTINE, especially
if this is done suddenly, you may experience unwanted symptoms. Please see Section
6.
Are there any side effects?
If you forget to take PAXTINE
If you miss your dose at the usual time and it is almost time for your next dose,
skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much PAXTINE
If you think that you or anyone else has taken too much PAXTINE, urgent medical attention
may be needed.
If you take too much PAXTINE, symptoms include sedation, blood pressure changes, involuntary
muscle contractions and facial flush. It rarely can lead to seizures, heart rhythm
changes and unconsciousness. For more information see Section 6.
Are there any side effects?
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
5. What should I know while taking PAXTINE?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using PAXTINE.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may want to do some blood tests and check your heart and blood pressure
from time to time. This helps to prevent unwanted side effects.
Call your doctor straight away if you:
For any reason, have not taken your medicine exactly as directed. Otherwise, your
doctor may think that it was not working as it should and change your treatment unnecessarily.
Like other drugs of this type PAXTINE will not relieve your symptoms straight away.
People generally start feeling better in a few weeks or so. Occasionally, the symptoms
of depression or other psychiatric conditions may include thoughts of harming yourself
or committing suicide. It is possible that these symptoms may continue to increase
until the full antidepressant effect of your medicine becomes apparent, especially
when PAXTINE is first started or when the dose is changed. People who are close to
individuals taking PAXTINE can help by paying attention to changes in their moods
or actions.
Tell your doctor if you feel the tablets are not helping your condition.
If you are being treated for depression, discuss with your doctor any problems you
may have and how you feel, especially any feelings of severe sadness or bursts of
unusual energy or anger.
This will help your doctor determine the best treatment for you.
All thoughts of suicide must be taken seriously. Contact your doctor right away if
someone taking PAXTINE talks about or shows signs of killing him or herself. Tell
your doctor immediately or go to the nearest hospital if you have any distressing
thoughts or experiences during this initial period or at any other time.
Also contact your doctor if you experience any worsening of your depression/other
symptoms at any time during your treatment.
Tell your doctor or go to the nearest hospital immediately if you experience symptoms
of
serotonin syndrome or neuroleptic malignant syndrome
, which are rare life-threatening conditions. These symptoms include high body temperature,
stiffness, involuntary muscle jerks, confusion, extreme agitation, delirium and coma.
Things you should not do
Do not stop using this medicine suddenly.
Suddenly stopping PAXTINE may cause symptoms like dizziness, trouble sleeping, shaking,
feeling anxious, nausea, sweating or tinnitus.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use PAXTINE to treat any other complaints unless your doctor says to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PAXTINE
affects you.
Tests have shown that PAXTINE does not have a marked effect on driving ability. However,
PAXTINE may cause drowsiness, dizziness or lightheadedness in some people. If you
have any of these symptoms, do not drive, operate machinery or do anything else that
could be dangerous. Make sure you know how to react to PAXTINE before you drive a
car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Although drinking moderate amounts of alcohol is unlikely to affect your response
to PAXTINE, it is best to avoid alcohol while you take this medicine.
Looking after your medicine
Store below 25°C.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place, away from moisture, heat or sunlight, for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat or dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Stopping treatment
Do not stop taking PAXTINE even if you begin to feel better.
Your doctor may decide that you should continue to use PAXTINE for some time, even
when you have overcome your problem. For best effect PAXTINE must be taken regularly.
Your doctor will tell you when and how PAXTINE should be discontinued.
When your doctor decides that you should stop taking PAXTINE the dose may be reduced
slowly or the time between doses increased over 1 or 2 weeks. Some people may have
symptoms such as dizziness, anxiety, sleep disturbances, pins and needles, electric
shock sensations or feeling sick and sweating if PAXTINE is stopped, particularly
if stopped suddenly.
Although PAXTINE is not recommended for children under 18 years of age, additional
symptoms that have been experienced by children whilst stopping treatment are abdominal
pain, nervousness and mood changes.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date or the packaging is torn or shows signs
of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking PAXTINE.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Other rare events that have been reported with PAXTINE include:
blurred vision
abnormal liver function
low levels of sodium un the blood, especially in older people
bleeding disorders, including nose bleeds and gastrointestinal bleeding which occurs
vary rarely
hormone disturbances
mood of excitement, over-activity and uninhibited behaviour
confusion
seizures
rash caused by light
itchy rash, hives, swelling of the face, lips, mouth, tongue or throat
akathisia (restlessness or difficulty keeping still, caused by medicines to treat
mental disorders).
irresistible urge to move legs (Restless Legs Syndrome)
menstrual period disorder (including heavy periods, bleeding between periods and absence
of periods).
heavy vaginal bleeding shortly after birth
severe allergic reactions
Unwanted effects that may occur on stopping treatment:
Symptoms may include
dizziness
sensory disturbances such as, pins and needles, burning sensations and electric shock-like
sensations
sleep disturbances, including intense dreams
agitation or anxiety
feeling sick
shaking or tremors
confusion
sweating
headache
diarrhoea
These are likely to occur in the first few days of stopping treatment or very rarely
if you miss a dose. However, they are more likely to occur if you stop taking PAXTINE
too quickly.
Therefore, always consult your doctor before stopping your medicine. For the majority
of patients, symptoms go away on their own within a few weeks.
However, if you feel that unwanted symptoms are too severe, see your doctor who will
suggest how to manage stopping treatment more slowly.
Although PAXTINE Is not recommended for children under 18 years of age, the most common
unwanted effects in children under 18 are:
decreased appetite
tremor (uncontrollable trembling)
sweating
hyperactivity
hostile/unfriendly behaviour
agitation
changing emotions, including crying, changes in mood, trying to harm themselves, thoughts
of suicide and attempting suicide
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PAXTINE contains
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Active ingredient
(main ingredient)
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Paroxetine (as hydrochloride hemihydrate)
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Other ingredients
(inactive ingredients)
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Calcium hydrogen phosphate
Sodium starch glycollate
Magnesium stearate
Colloidal anhydrous silica
Methacrylic acid copolymer
Purified talc
Titanium dioxide
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Allergens
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Sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What PAXTINE looks like
PAXTINE tablets are white, round film-coated tablets marked P/2 and G. (AUST R 227120)
Available in blister packs of 30 tablets.
Who distributes PAXTINE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2024.
PAXTINE® is a Viatris company trade mark
PAXTINE_cmi\Jul24/00