NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CHEMMART PAROXETINE TABLETS
Paroxetine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about paroxetine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What this medicine is used for
Paroxetine is used to treat:
depression
Obsessive Compulsive Disorder (OCD)
panic disorder
social anxiety disorder or social phobia
generalised anxiety disorder
post-traumatic stress disorder.
It is also used to prevent the symptoms of depression, Obsessive Compulsive Disorder and panic disorder from coming back.
Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).
How it works
Paroxetine is thought to work by acting on brain chemicals called amines which are involved in controlling mood. Paroxetine corrects the chemical imbalance and helps to relieve the symptoms of depression and stop them coming back.
Depression is longer lasting and/or more severe than the ‘low moods’ everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms. You may feel low in spirit, not interested in usual activities, being unable to enjoy life, poor appetite or overeat, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.
Paroxetine is thought to have a similar action when it used to for irrational fears, obsessional behaviour or panic attacks, and when it is used to treat patients who may avoid or are fearful of social situations, have excessive anxiety and worry, who feel irritable, restless and/or tense in the muscles, or who experience repeated and distressing recollections of a past traumatic event.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive
Paroxetine is not recommended for use in children under 18 years of age. It has been shown that the risk of serious side effects such as suicidal thoughts and actions is higher in this age group.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
paroxetine
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, throat or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you are taking other medicines called Monoamine Oxidase Inhibitors (MAOIs).
MAOIs may be used for the treatment of depression (e.g. phenelzine, tranylcypromine, moclobemide), Parkinson’s disease (e.g. selegiline), infections (e.g. linezolid), or diagnosis of certain conditions or treatment of certain blood disorders (e.g. methylene blue). Check with your doctor or pharmacist if you are taking any MAOIs.
Do not take paroxetine until 14 days after stopping any MAOI, and do not take MAOIs until 14 days after stopping paroxetine.
Taking paroxetine with or within 14 days of taking MAOIs may cause a serious reaction with a sudden increase in body temperature, very high blood pressure and convulsions. Your doctor will know when it is safe to start paroxetine after the MAOI has been stopped.
Do not take this medicine if you are taking thioridazine or pimozide for the treatment of schizophrenia or other psychoses (disturbances in thinking, feelings and behaviours).
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
mania, hypomania, bipolar disorder, previous episodes of depression or other psychiatric conditions
epilepsy, fits or seizures
heart, liver or kidney problems
narrow-angle glaucoma (raised pressure in the eye)
problems with blood clotting or abnormal bleeding
diabetes
thoughts or actions relating to self-harm or suicide
intolerance to lactose. These tablets contain lactose.
Tell your doctor if you are pregnant or plan to become pregnant.
Studies show that use of paroxetine in early pregnancy (first 13 weeks) may be associated with an increased risk of heart defects in babies. If you become pregnant or intend to become pregnant while taking this medicine, see your doctor for a review of your treatment immediately. It is important that you do not stop taking this medicine suddenly. Paroxetine can have withdrawal side effects if stopped suddenly.
If you are male, your chances of fathering a child may be reduced.
Tell your doctor if you are breastfeeding.
Paroxetine passes into breast milk and it is not known if it affects babies. Your doctor will discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
When taken with paroxetine, some medicines may increase the risk of having serious side effects. These serious side effects may be life-threatening. These include:
MAOIs (e.g. phenelzine, tranylcypromine, moclobemide, linezolid, selegiline, methylene blue)
thioridazine and pimozide.
Other medicines may interfere with paroxetine. These include:
tricyclic antidepressants (e.g. nortriptyline, amitriptyline, imipramine, desipramine)
other SSRIs (e.g. fluoxetine, citalopram, sertraline, fluvoxamine)
medicines used for treating disorders which affect the way you think, feel or act (e.g. perphenazine, risperidone, atomoxetine, lithium)
procyclidine, used to treat Parkinson’s disease
some medicines used to control epilepsy or fits (e.g. phenytoin, carbamazepine, phenobarbital, sodium valproate)
metoprolol and flecainide, used to lower blood pressure or treat heart conditions
aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) and anti-coagulants (such as warfarin), which can thin the blood
cimetidine, used to treat stomach ulcers or reflux
some medicines used to treat migraines (e.g. sumatriptan, naratriptan, zolmitriptan)
St John’s Wort (Hypericum perforatum) or L-tryptophan, contained in some multivitamin and herbal preparations
medicines used to relieve severe pain (e.g. fentanyl, tramadol)
tamoxifen, used to treat breast cancer
fosamprenavir and ritonavir, used to treat HIV infection
anaesthetic medicines (e.g. mivacurium, suxamethonium).
These medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
Other medicines not listed above may also interact with paroxetine.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
If you have kidney or liver problems, then the doses may be lower.
For depression, social anxiety disorder/social phobia, generalised anxiety disorder or post-traumatic stress disorder:
The usual dose is one 20 mg tablet taken once a day. This dose may be increased slowly by your doctor if needed. This may require you to break the tablet in half. The dose should not go above 50 mg per day in adults, or 40 mg per day in elderly people.
For obsessions and compulsions or panic attacks:
The usual dose is two 20 mg tablets taken once a day. Your doctor should start you on a lower dose and increase the dose slowly over several weeks. This may require you to break the tablet in half. The dose should not go above 60 mg per day in adults, or 40 mg per day in elderly people.
How to take it
Swallow the tablets with a glass of water.
The tablets should not be chewed.
When to take it
Take this medicine in the morning at about the same time each day.
Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It should preferably be taken with food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
Like other drugs of this type, this medicine 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 or increase until your medicine starts to work.
Make sure that you or anyone close to you or caring for you watch for these symptoms in the first few months or treatment or when changing the dose. 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.
Contact your doctor if you experience any worsening of your depression or other symptoms at any time during your treatment.
Stopping Treatment
Do not stop taking this medicine even if you begin to feel better.
Your doctor may decide that you should continue to take it for some time, even when you have overcome your problem. For best effect, this medicine must be taken regularly.
Your doctor will tell you when and how this medicine 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 this medicine, especially if this is done suddenly, you may experience unwanted side effects such as feeling dizzy, sick or anxious; sweating; pins and needles or electric shock feelings, or disturbed sleep.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it 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 that you missed.
This may increase the chance of unwanted side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include nausea, vomiting, tremor, dilated pupils, dry mouth, sedation, sweating, dizziness, confusion, headache, fast heartbeat and irritability.
While you are taking this medicine
Things you must do
People taking paroxetine may be more likely to think about killing themselves or actually try to do so, especially when paroxetine is first started or the dose is changed.
Tell your doctor immediately if you have thoughts about killing yourself, or if you are close to or care for someone using paroxetine who talks about or shows signs of killing him or herself.
All mentions of suicide or violence must be taken seriously.
Occasionally, the symptoms of depression may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur if you are a young adult, i.e. 18 to 24 years of age, and you have not used antidepressant medicines before.
If you or someone you know or care for demonstrates any of the following warning signs of suicide-related behaviour while taking paroxetine, contact a doctor immediately, or even to go to the nearest hospital for treatment:
thoughts or talk of death or suicide
thoughts of talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or agitation.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are a male and you and your partner have been unsuccessful whilst trying for a baby, tell your doctor.
Some studies have shown that medicines such as paroxetine may affect sperm quality. However, the effect goes away if the medicine is stopped.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
If you have an accident, and/or break a bone, tell your doctor that you are taking paroxetine.
Some antidepressant medicines have been associated with an increased risk of bone fracture.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
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, thoughts of suicide, bursts of unusual energy, anger or aggression, or if you become particularly agitated or restless.
This will help your doctor to determine the best treatment for you.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how this medicine affects you.
This medicine may cause dizziness, drowsiness, light-headedness or problems concentrating in some people. If you have any of these symptoms, do not drive a car; operate machinery, or anything else that could be dangerous.
Be careful when drinking alcohol while you are taking paroxetine.
If you drink alcohol, dizziness, drowsiness or impaired concentration may be worse, or your symptoms of depression or anxiety may become worse. Your doctor may suggest avoiding alcohol while you are being treated with this medicine.
You should wait at least 14 days after stopping paroxetine before starting any medicines known as monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide.
When your doctor decides that you should stop taking this medicine, the dose may be reduced slowly or the time between the doses increased over 1 to 2 weeks (see ‘Stopping Treatment’).
Side effects
Tell your doctor as soon as possible if you do not feel well while you are taking paroxetine.
This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
gastrointestinal problems e.g. feeling or being sick, dry mouth, increased or decreased appetite, wind, indigestion, constipation or diarrhoea
weight gain or loss
teeth grinding
yeast infection of the mouth
drowsiness, dizziness, difficulty in getting to sleep; strange dreams
feeling nervous, anxious or agitated
sexual problems
headache, pain, weakness or apathy, back pain
feeling sweaty or shaky
bruising
mild rash, itching, excess sweating
sunburn-type rash following a short time in the sun
red bumps on the shins, rash following contact with certain materials
impaired concentration, confusion
changes in taste sensation
muscle weakness or muscle or joint or cartilage pain or inflammation
stiff or painful neck
burping or problems swallowing
sore throat, yawning, cough, stuffy nose
excess saliva
breast pain, missed or painful periods
acne, hair loss or excess growth, dry skin, unusual bruising, eczema, boils, cold sores
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following.
muscle spasms or twitches, facial twitching, feeling restless and needing to move often
Restless Legs Syndrome (leg discomfort in the calves, twitching, burning, tingling, feeling of insects crawling)
menstrual period disorder (including heavy periods, bleeding between periods and absence of periods
confusion, changing emotions or mood
low levels of sodium in the blood, especially if you are over 65 years of age. This may be felt as sleepiness and muscle weakness.
chills or fever
feeling dizzy or faint when standing up (due to low blood pressure)
high or low blood pressure
flushing
pain in the upper or lower abdomen
varicose veins, swollen veins
migraine or severe headache
shingles (painful skin rash with blisters), discoloured or ulcerated skin
abnormal breast milk production, infected breasts
problems with your eyesight or hearing
hormone disturbances
mood of excitement, over-activity and uninhibited behaviour
problems with urinating (frequent or painful urination or large amounts of urine produced, night time urination)
vaginal irritation or infection
diabetes or thyroid problems
changes in your blood which you may notice as feeling tired, weak, thirsty, easily bruised, or prone to infections
The above list includes serious side effects that may require medical attention.
If any of the following happen, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital:
sudden increase in body temperature, severe convulsions (fits)
yellowing of your skin or eyes. unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems)
sudden fever, hallucinations, loss of coordination, confusion and overactive reflexes
fast heartbeat, sweating, muscle spasm, racing thoughts, restlessness
seizures
thumping, fluttering, slow or irregular heartbeat, chest pain or left arm/neck pain, unconsciousness
thinking or acting strangely
thoughts of suicide and attempting suicide or self-harm
sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech
suddenly getting long-lasting muscle spasms, affecting the eyes, head, neck and body.
feeling out of sorts, with fever, headache and cough, then suddenly getting spots or blisters which quickly develop into large amounts of blistering or peeling skin
abnormal bleeding (including vaginal and gastrointestinal bleeding, nosebleed) or bruising, bloody diarrhoea, black tarry stools, vomiting blood
blood clots, swollen veins due to blood clots, coughing up blood
severe skin rash, which may blister and looks like small targets (central dark spots surround by a paler area, with a dark ring around the edge) (erythema multiforme)
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 much of the body surface (toxic epidermal necrolysis)
kidney stones and/or kidney pain, blood in the urine
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin (symptoms of an allergic reaction).
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Withdrawal Symptoms
Unwanted effects that may occur after paroxetine has been stopped suddenly include:
headache, dizziness, confusion
sensory disturbances such as pins and needles, burning sensations and electric shock-like sensations
feeling sick, diarrhoea
agitation or anxiety
sweating, shaking or tremors
disturbed sleep (including nightmares)
tinnitus (ringing or buzzing in the ears)
These are likely to occur within 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 paroxetine too quickly. Therefore, always consult your doctor before stopping your medicine.
For most people, the above side effects will disappear within a few weeks. However, if you feel that these effects are too severe, see your doctor who can suggest how to stop your medicine more gradually.
Although paroxetine is not recommended for children under 18 years of age, the most common unwanted effects in this age group are as follows:
decreased appetite
uncontrollable trembling or shaking
sweating
hyperactivity
abdominal (e.g. stomach) pain
hostile or unfriendly behaviour
trying to harm themselves
thinking about or trying to commit suicide
changing emotions or moods e.g. feeling tearful
feeling nervous or agitated.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Storage and Disposal
Storage
Keep the tablets in the pack until it is time to take them.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool, dry place where the temperature stays below 25°C. Protect from moisture.
Do not store your medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
20 mg tablets:
White, oval, biconvex and film-coated, with a partial bisect and engraved “20” on one side. The other side is plain.
Blister pack of 30 tablets.
AUST R 83104
Ingredients
Each tablet contains 20 mg of paroxetine hydrochloride as the active ingredient.
It also contains the following:
magnesium stearate
sodium starch glycollate
lactose
hydroxypropylcellulose
hypromellose
macrogol 8000
titanium dioxide.
This medicine does not contain gluten, sucrose, tartrazine and other azo dyes.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in September 2018.
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