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 using PRISTIQ?
PRISTIQ contains the active ingredient desvenlafaxine succinate. PRISTIQ is used in
the treatment and prevention of relapse of depression. For more information, see Section
1. Why am I using PRISTIQ? in the full CMI.
2. What should I know before I use PRISTIQ?
Do not use if you have ever had an allergic reaction to desvenlafaxine, venlafaxine
or any of the ingredients listed at the end of the CMI. Do not take PRISTIQ if you
are taking other medications for depression known as monoamine oxidase inhibitors,
even if you have stopped taking them, but have taken them within the last 14 days.
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. PRISTIQ is not recommended
for use during pregnancy or breastfeeding.
For more information, see Section
2. What should I know before I use PRISTIQ? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with PRISTIQ and affect how it works. These include medications
for depression known as monoamine oxidase inhibitors, any other medications for bipolar
disorder, depression, anxiety, obsessive-compulsive disorder or pre-menstrual dysphoric
disorder, ADHD, drugs that affect serotonin levels, medicines for weight loss, triptans,
aspirin or NSAIDs and warfarin. A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How do I take PRISTIQ?
Usual dose is 50 mg taken once daily with or without food.
Swallow the tablets whole with a glass of water or other non-alcoholic liquid. Do
not divide, crush, chew or place the tablets in water.
5. What should I know while using PRISTIQ?
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Things you should do
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Remind any doctor or dentist you visit that you are using PRISTIQ.
Watch carefully for signs that your depression is getting worse, especially in the
first few weeks of treatment or if your dose has changed.
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Things you should not do
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Do not stop using this medicine or change the dose without the advice of your doctor.
Avoid drinking alcohol while you are taking PRISTIQ
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Driving or using machines
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Be careful driving or operating dangerous machinery until you know how PRISTIQ affects
you.
PRISTIQ tablets may make you feel drowsy.
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Looking after your medicine
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Keep your PRISTIQ tablets in their blister pack until it is time to take them.
Keep PRISTIQ tablets in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Common side effects of PRISTIQ include stomach, bowel or urinary tract problems (e.g.
nausea, diarrhoea, constipation, difficulty passing urine), change in behaviour (e.g.
difficulty/abnormal sleeping, anxiety, irritable), difficulty in thinking or working
(due to yawning, disturbed concentration, fainting/dizziness, fatigue), excessive
sweating, hot flushes, rash, weight gain/loss or changes to sensory (vision, hearing,
taste). Seek emergency treatment if you experience symptoms of neuroleptic malignant
syndrome or serotonin syndrome.
Tell your doctor immediately if you experience negative changes to mood or behaviour,
worsening depression including thoughts of suicide
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Desvenlafaxine Succinate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PRISTIQ. 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 PRISTIQ.
Where to find information in this leaflet:
1. Why am I using PRISTIQ?
PRISTIQ contains the active ingredient desvenlafaxine succinate. It belongs to a class of medications called Serotonin-Noradrenaline Reuptake Inhibitors
(SNRIs).
Serotonin and noradrenaline are chemical messengers that allow certain nerves in the
brain to work. PRISTIQ tablets increase the level of these two messengers. Experts
think this is how it helps to restore your feeling of wellness.
PRISTIQ is used in the treatment and prevention of relapse of depression.
Depression can affect your whole body and may cause emotional and physical symptoms
such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating,
disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing.
Ask your doctor if you have any questions about why PRISTIQ has been prescribed for
you.
Your doctor may have prescribed it for another reason.
2. What should I know before I use PRISTIQ?
Warnings
Do not use PRISTIQ if:
1. You are allergic to desvenlafaxine, venlafaxine, or any of the ingredients listed
at the end of this leaflet.
2. Always check the ingredients to make sure you can use this medicine.
3. You are taking other medications for depression known as monoamine oxidase inhibitors,
even if you have stopped taking them, but have taken them within the last 14 days.
Check with your doctor if you have:
Other medications that you are taking
A history of fits (seizures or convulsions)
A personal history or family history of bipolar disorder
Blood pressure problems
Glaucoma (increased pressure in the eye)
A tendency to bleed more than normal or you are taking a blood thinning medication
Raised cholesterol or lipid levels
Problems with your kidneys or liver
Problems with your heart
Low sodium levels in your blood
Any other medical conditions.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
PRISTIQ is not recommended for use during pregnancy. Your doctor will discuss the
risks and benefits of taking PRISTIQ if you are pregnant. One of these risks is that
newborn babies whose mothers have been taking PRISTIQ may have several problems including
breathing difficulties, rapid breathing, seizures, lack of oxygen in their blood,
physical and / or behavioural problems, vomiting and diarrhoea.
If you take PRISTIQ or similar anti-depressants mid to late in your pregnancy, you
may develop a condition known as "pre-eclampsia", which is characterised by persistent
high-blood pressure during or after pregnancy. Symptoms of pre-eclampsia can include
headaches, abdominal pain, shortness of breath or burning behind the sternum, nausea
and vomiting, confusion, heightened state of anxiety, and/or visual disturbances such
as oversensitivity to light, blurred vision, or seeing flashing spots or auras.
If you take PRISTIQ or similar antidepressants in the last month of your pregnancy,
you may experience heavy bleeding during and/or after delivery.
Continuing treatment with PRISTIQ or similar antidepressants during pregnancy should
be strictly as directed by your doctor. Symptoms of a relapse may occur if treatment
is discontinued, even if major depression was previously under control.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.
PRISTIQ passes into breast milk and there is a possibility that the breast-fed baby
may be affected. For this reason, the use of PRISTIQ is not recommended in breast-feeding
women.
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 such as St John's wort or tryptophan supplements.
Do not start to take any other medicine while you are taking PRISTIQ, unless it is
prescribed or approved by your doctor.
Some medicines may interfere with PRISTIQ and affect how it works. These include:
Medications for depression known as monoamine oxidase inhibitors (such as moclobemide,
phenelzine and tranylcypromine). Tell your doctor if you are taking or have stopped
taking them within the last 14 days. Ask your doctor or pharmacist if you are unsure
if you are taking any of these medicines. It is important that you do not take PRISTIQ
or medicines similar to PRISTIQ with monoamine oxidase inhibitors or within 14 days
of taking a monoamine oxidase inhibitor as this may result in a serious life-threatening
condition. Your doctor or pharmacist can tell you what to do if you are taking any
of these medicines.
Any other medications for bipolar disorder, depression, anxiety, obsessive-compulsive
disorder or pre-menstrual dysphoric disorder, including St John's wort
Drugs that affect serotonin levels e.g. tramadol, dextromethorphan, fentanyl, methadone
and pentazocine
Medicines used to treat Attention Deficit Hyperactivity Disorder (ADHD) such as dexamphetamine
and lisdexamphetamine
Medicines for weight loss, including sibutramine
Triptans (used to treat migraine)
Linezolid (used to treat infections)
Drugs that affect your tendency to bleed (e.g. Aspirin, NSAIDS, Warfarin)
Opioids (used to manage pain)
You may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking PRISTIQ.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PRISTIQ.
4. How do I take PRISTIQ?
How much to take
The usual dose is 50 mg taken once daily with or without food.
Swallow tablets whole with a glass of water or other non-alcoholic liquid.
Do not divide, crush, chew or place the tablets in water.
Do not change your dose unless your doctor tells you to. Your doctor will gradually increase your dose if needed.
If you have kidney problems, you may need a lower dose of PRISTIQ.
Follow the instructions provided and use PRISTIQ until your doctor tells you to stop.
Do not be concerned if you see a tablet 'shell' in your faeces after taking PRISTIQ.
As the tablet travels the length of your gastrointestinal tract, the active ingredient
desvenlafaxine is slowly released. The tablet 'shell' remains undissolved and is eliminated
in your faeces. Therefore, even though, you may see a tablet 'shell' in your faeces,
your dose of desvenlafaxine has been absorbed.
How long to take PRISTIQ
Continue taking your medicine for as long as your doctor tells you.
Although you may begin to feel better after two weeks, it may take several weeks before
you feel much better. It is important to give PRISTIQ time to work.
This medicine helps to control your condition, so it is important to keep taking your
medicine even if you feel well.
When to take PRISTIQ
Take PRISTIQ at approximately the same time each day.
This could be either in the morning or in the evening.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
If you forget to use PRISTIQ
PRISTIQ should be used regularly at the same time each day.
If you miss your dose and if it is less than 12 hours until 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 as you would normally.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much PRISTIQ
If you think that you have used too much PRISTIQ, you must seek urgent medical attention.
You should immediately:
Phone the Poisons Information Centre
(by calling
13 11 26), 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.
5. What should I know while using PRISTIQ?
Things you should do
Visit your doctor regularly for a checkup so that your progress can be checked. Always
discuss any questions you have about PRISTIQ with your doctor.
Take PRISTIQ tablets as your doctor has prescribed.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
Keep enough PRISTIQ tablets to last weekends and holidays.
This medicine helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
Watch carefully for signs that your depression is getting worse, especially in the
first few weeks of treatment or if your dose has changed.
Sometimes people with depression can experience a worsening of their depressive symptoms.
This can happen even when taking an antidepressant.
Tell your doctor there is the potential for a false positive urinary drug screen while
on PRISTIQ.
Call your doctor immediately if you experience any of the following symptoms, especially
if they are severe, you have not had these symptoms before or they happen very suddenly:
Anxiety or agitation
Panic attacks
Difficulty sleeping
Irritability
Confusion
Hallucination (seeing or hearing things)
Aggressiveness
Hostility or impulsiveness
Restlessness
Unusual/involuntary muscle movements (e.g., hyper-reflex or blurred vision)
Irregular/high blood pressure, irregular/increased heart rate and/or fever
Overactivity or uninhibited behaviour
Other unusual changes in behaviour
Worsening depression
Thoughts of suicide.
High fever, stiffness of the muscles, altered mental status (paranoid behaviour) and
autonomic dysfunction (wide swings of blood pressure, excessive sweating and excessive
saliva) may be signs of something called neuroleptic malignant syndrome.
Headache, shivering, diarrhoea, muscle stiffness, high fever and seizures may be signs
of something called serotonin syndrome.
Neuroleptic malignant syndrome and serotonin syndrome are serious and may be life-threatening.
Symptoms of neuroleptic malignant syndrome or serotonin syndrome can vary, if you
think you might have either of these syndromes while taking PRISTIQ, call your doctor
immediately or go to the emergency department of nearest hospital. If you have severe
or rapidly worsening symptoms, seek emergency treatment immediately.
Tell your doctor immediately if you have any thoughts about suicide or doing harm
to yourself.
Warning signs of suicide:
If you, or someone you know who is taking PRISTIQ, shows the following warning signs,
contact your doctor or a mental health advisor right away or go to the nearest hospital
for treatment.
All thoughts or talk about suicide or violence are serious.
Thoughts or talk about death or suicide
Thoughts or talk about self-harm or doing harm to others
Any recent attempts of self-harm
An increase in aggressive behaviour, irritability or agitation.
Things you should not do
Do not stop using this medicine or change the dose without the advice of your doctor,
even if you feel better.
Your doctor may want to slowly decrease your dose of PRISTIQ to help avoid side effects.
Side effects are known to occur when people stop taking PRISTIQ, especially when they
suddenly stop therapy.
Some of these side effects include:
Headache
Nausea
Dizziness
Tiredness
Irritability
Anxiety
Abnormal dreams
Diarrhoea
Excessive sweating
Visual impairment
High blood pressure
Slowly reducing the amount of PRISTIQ being taken reduces the possibility of these
effects occurring. In some people this may need to occur over periods of months or
longer.
Some of these symptoms may impair driving, or the operation of dangerous machinery.
Avoid these activities if you experience any of these symptoms.
Do not give this medicine to anyone else even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PRISTIQ
affects you.
PRISTIQ may cause dizziness in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Avoid drinking alcohol while you are taking PRISTIQ.
Looking after your medicine
Keep your PRISTIQ tablets in their blister pack until it is time to take them.
The tablets may not last as well if you take them out of the blister pack.
Store it in a cool (below 25°C) 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 and dampness can destroy some medicines.
Keep PRISTIQ tablets and all medication 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.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
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.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
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Stomach, bowel or urinary tract problems:
Nausea or vomiting
Loss of appetite
Diarrhoea
Constipation
Difficulty passing urine
Changes in your behaviour:
Difficulty sleeping, abnormal sleepiness or abnormal dreams
Sexual function problems such as decreased sex drive, delayed ejaculation, problems
achieving erection or difficulties achieving orgasm
Nervousness or anxiety
Feeling jittery or irritable
Difficulty thinking or working because of:
Yawning
Disturbances in concentration
Fainting or dizziness after standing up
Fatigue
Rapid heartbeat
Chills
Headache
Excessive sweating
Hot flushes
Rash
Weight loss
Weight gain
Blurred vision
Ringing in the ears
Altered taste, dry mouth.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Muscle spasms, stiffness, weakness or movement disorders
Abnormal facial movements such as tongue thrusting, repetitive chewing, jaw swinging,
or grimacing
A feeling of apathy or not caring about things
Feeling detached from yourself
Hallucinations
Confusion
Agitation
Unusually overactive
Problems with breathing, shortness of breath
Bleeding or bruising more easily than normal
Numbness or pins and needles
Sensitivity to sunlight.
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Call your doctor as soon as possible.
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Palpitations, shortness of breath, intense chest pain, or irregular heartbeats
Severe upper abdominal pain
Swollen and tender abdomen
Fever
Rise or decrease in blood pressure. You may experience headache, blurred vision, palpitations,
confusion or loss of consciousness. Sometimes you may not experience any of these
symptoms. It is important to keep your routine doctor's appointments so that your
blood pressure can be checked
Swelling of the face, lips, tongue, throat or other parts of the body
Seizures or fits
Symptoms of sudden fever with sweating, rapid heartbeat and muscle stiffness, which
may lead to loss of consciousness.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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.
Some of these side effects (for example, increase in blood pressure, increase in blood
cholesterol, changes to liver function, protein in the urine) can only be found when
your doctor does tests from time to time to check your progress.
This is not a complete list of all possible side effects. Others may occur in some
people and there may be some side effects not yet known.
Tell your doctor if you notice anything that is making you feel unwell.
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 PRISTIQ contains
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Active ingredient
(main ingredient)
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50 mg or 100 mg desvenlafaxine succinate
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Hypromellose
Purified talc
Magnesium stearate
Polyvinyl alcohol
Titanium dioxide
Macrogol
Iron oxide red
Iron oxide yellow (50 mg tablet only)
Sunset yellow FCF CI15985 (100 mg tablet only).
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Do not take this medicine if you are allergic to any of these ingredients.
PRISTIQ does not contain gluten
What PRISTIQ looks like
There are two strengths of PRISTIQ tablets:
The 50 mg tablet is light pink, square (pyramid, one sided) film coated tablet debossed
with "W" over "50" on the flat side. (Aust R 170674)
The 100 mg tablet is a reddish-orange, square (pyramid, one sided) film coated tablet
debossed with "W" over "100" on the flat side. (Aust R 170696)
Each blister pack contains 28 tablets.
Who distributes PRISTIQ
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in October 2023.