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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I taking PRILIGY?
PRILIGY contains the active ingredient dapoxetine hydrochloride. PRILIGY is a treatment
for premature ejaculation (PE) in men 18 to 64 years old. For more information, see
Section
1. Why am I taking PRILIGY? in the full CMI.
2. What should I know before I take PRILIGY?
Do not use if you have ever had an allergic reaction to dapoxetine hydrochloride or
any of the ingredients listed at the end of the CMI. There are a number of circumstances
in which a person should not take this medicine or may need to use caution. It is
important to understand if these apply to you before taking PRILIGY. Talk to your
doctor or pharmacist if you have any concerns about taking this medicine. See Section
2. What should I know before I use PRILIGY? in the full CMI.
3. What if I am taking other medicines?
4. How do I use PRILIGY?
The recommended dose is one tablet (30 mg) taken when you need it, about 1 to 3 hours
before sexual activity. Do not take more than one tablet in a 24 hour period. It is
not intended for continuous daily use.
Swallow the tablet whole with at least one full glass of water. PRILIGY can be taken
with or without food.
Avoid alcohol when taking PRILIGY. Do not drink grapefruit juice within 24 hour prior
to taking PRILIGY.
5. What should I know while taking PRILIGY?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking PRILIGY.
Keep all doctor appointments so your progress can be checked.
Talk to your doctor before you stop taking this medicine. You may have problems sleeping
and feel dizzy after you stop taking it, even if you have not taken it every day.
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Things you should not do
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Do not take PRILIGY to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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Be careful before you drive or use any machines or tools as PRILIGY may cause dizziness,
light-headedness, tiredness, drowsiness, fainting, having difficulty concentrating
and blurred vision.
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Drinking alcohol
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Avoid alcohol while taking PRILIGY as the effects of alcohol may be increased, such
as dizziness, drowsiness, slow reflexes or impaired judgement.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them. Store in a cool dry place
below 25°C and keep out of reach of children.
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6. Are there any side effects?
Common side effects include nausea; headache; dizziness; fainting or feeling dizzy
upon standing; increased blood pressure; flushing; trembling; tingling or numbness;
blurred vision, eye pain; ringing in ears; nasal congestion; dry mouth, vomiting,
diarrhoea, constipation, abdominal pain, indigestion, intestinal gas, bloating ; excessive
sweating; fatigue, sleepiness, yawning; difficulty paying attention, feeling irritable;
erectile dysfunction (difficulty getting or keeping an erection); difficulty sleeping;
anxiety, nervousness; decreased sexual desire; and abnormal dreams. Serious side effects
requiring medical attention include fits (seizures); changes in your mood, thoughts
of suicide or harming yourself; an allergic reaction; unusual bruising and bleeding.
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.
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WARNING:
PRILIGY can make you faint. You may experience warning symptoms such as nausea, dizziness
or light-headedness before you faint. Immediately lie down or sit down with your head
between your knees if you feel nauseous, dizzy or light-headed until the symptoms
pass. This will prevent falls and injury (see While you are taking PRILIGY and Side
Effects). Do not take more than one PRILIGY tablet once every 24 hours due to the
increased risk of fainting.
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Active ingredient(s):
dapoxetine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PRILIGY. 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 PRILIGY. Where to find information
in this leaflet:
1. Why am I taking PRILIGY?
PRILIGY contains the active ingredient dapoxetine hydrochloride. PRILIGY is a type of drug called a selective serotonin reuptake inhibitor (SSRI)
and it is also known as a urological medicine.
PRILIGY is a treatment for premature ejaculation (PE) in men 18 to 64 years old who
have all of the following:
ejaculation in less than 2 minutes following vaginal penetration, on most occasions,
with little stimulation and before the man wishes to; and
marked personal distress and interpersonal difficulty as a result of premature ejaculation
(premature ejaculation troubles the man and his partner); and
poor control over ejaculation.
PRILIGY increases your time to ejaculation and can improve your control over ejaculation
and reduce your distress over how fast you ejaculate. This may improve your satisfaction
with sexual intercourse.
2. What should I know before I take PRILIGY?
Warnings
Do not take PRILIGY if:
you are allergic to dapoxetine hydrochloride, or any of the ingredients listed at
the end of this leaflet. Always check the ingredients to make sure you can take this
medicine.
you are taking a monoamine oxidase inhibitor (MAOI ) medicine used to treat depression,
or have taken a MAOI within the last 14 days (see Section
3. What if I am taking other medicines?). Once you stop taking PRILIGY you will need to wait 7 days before taking a MAOI.
you are taking thioridazine used to treat schizophrenia, or have taken thioridazine
within the last 14 days. Once you stop taking PRILIGY you will need to wait 7 days
before taking thioridazine.
you are taking a serotonin reuptake inhibitor (such as a selective serotonin reuptake
inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant
(TCA)), and certain other medicines and herbal products to treat depression or have
taken these medicines within the last 14 days (see Section
3. What if I am taking other medicines? for examples of serotonin reuptake inhibitors and other medicines used to treat depression).
Once you stop taking PRILIGY you will need to wait 7 days before taking these medications/herbal
products.
you have a history of mania or severe depression.
you have heart problems, such as heart failure or problems with the heart rhythm.
you have moderate to severe liver problems.
you are prone to fainting or passing out caused by a temporary drop in blood pressure
(Syncope).
Before you start taking this medicine, your doctor should perform a test to make sure
that your blood pressure doesn’t drop too much when you stand up from sitting or lying
down.
Check with your doctor if:
you have not been diagnosed with premature ejaculation
you use recreational drugs such as ecstasy or LSD (lysergic acid diethylamide). Taking
PRILIGY with these drugs can cause serious reactions.
you take narcotics (strong pain medicines) or benzodiazepines such as Valium. These
medicines can increase the drowsiness and dizziness of PRILIGY.
you consume alcohol. Alcohol can increase the risk of fainting and should be avoided
while taking PRILIGY.
you are being treated for depression
you are currently using medications to treat fungal infections
you are currently taking medicine that thins your blood such as aspirin, anticoagulants
such as warfarin, non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen,
or medicine used to treat psychiatric conditions such as depression. Taking PRILIGY
together with these medications can increase the risk of bleeding abnormalities.
you have a history of dizziness from low blood pressure
you have or have had heart and blood vessel problems
you have a history of bleeding or blood clotting problems
you have or have had depression
you have or have had any thoughts of suicide or harming yourself.
All thoughts of suicide must be taken seriously.
Tell your doctor or a mental health professional immediately if you have any suicidal
thoughts or other mental/mood changes.
you have or have had psychiatric disorders, such as schizophrenia
you have history of mania (great excitement, hallucinations, difficulty in concentrating
or staying still) or bipolar disorder (extreme mood swings between mania and depression)
or develop these disorders
you have or have had seizures (fits) or have uncontrolled epilepsy
you have moderate or severe liver problems
you have severe kidney problems
you have or have had other forms of sexual problems such as erectile dysfunction.
It is not known whether PRILIGY can worsen these conditions.
you have eye problems such as glaucoma, (high pressure in the eye )
you have HIV.
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
Do not take PRILIGY if you are a woman. PRILIGY has been studied for use by men with
premature ejaculation. Its safety in women has not been established.
Children and adolescents
Do not take PRILIGY if you are under 18 years of age, or over 65 years of age. Safety
and effectiveness in patients under 18 years or over 65 years have not been established.
Lactose intolerance
This medicine contains lactose (a type of sugar). If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
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 and PRILIGY may interfere with each other. These include:
monoamine oxidase inhibitors (MAOIs) used to treat depression, such as moclobemide,
phenelzine and tranylcypromine
medicines used to treat depression such as amitriptyline, citalopram, escitalopram,
doxepin, fluoxetine, fluvoxamine, mianserin, mirtazapine, nortriptyline, paroxetine,
sertraline, nefazodone, venlafaxine or vortioxetine
triptans, medicines used to treat migraine (e.g. sumatriptan)
tramadol, used for pain
lithium, used for mood disorders
thioridazine, used to treat schizophrenia
linezolid, an antibiotic used to treat infection
tryptophan, used to help your mood and help you sleep
St John's wort (Hypericum perforatum), a herbal preparation.
PRILIGY should not be taken with the above listed medicines/ herbal preparations or
within 14 days of stopping these medicines.
Once you stop taking PRILIGY you will need to wait 7 days before taking these medicines/
herbal preparations.
Other medicines or food and PRILIGY may interfere with each other. These include:
medicines for mental health problems other than depression
medicines to thin your blood, such as warfarin
certain medicines for fungal infections, including ketoconazole, itraconazole and
fluconazole
certain medicines for HIV, including ritonavir, saquinavir and atazanavir
certain medicines used to treat high blood pressure and chest pain (angina), enlarged
prostate, or erectile dysfunction (impotence), as these medicines may lower your blood
pressure, possibly upon standing
anti-inflammatory medicines such as ibuprofen or aspirin
certain antibiotics for treating infection, such as erythromycin, telithromycin and
clarithromycin
aprepitant used to treat nausea
grapefruit. Do not drink grapefruit juice within 24 hours prior to taking PRILIGY
narcotics (strong pain medicines) or benzodiazepines such as valium. These medicines
can increase the drowsiness and dizziness of PRILIGY.
alcohol. Alcohol can increase the risk of fainting and should be avoided while taking
PRILIGY.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PRILIGY.
These medicines may be affected by PRILIGY or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Other medicines not listed here may be affected by PRILIGY or may affect how well
it works. Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking this medicine.
4. How do I take PRILIGY?
How much to take
The recommended dose is one tablet (30mg), taken when you need it, about 1 to 3 hours
before sexual activity.
Do not take more than one tablet once every 24 hours due to increased risk of side
effects and lack of additional benefit.
Swallow the tablet whole to avoid a bitter taste, with at least one full glass of
water. PRILIGY may be taken with or without food.
Avoid alcohol when taking PRILIGY.
Do not drink grapefruit juice within 24 hours prior to taking PRILIGY. Grapefruit
juice can increase the level of this medicine in your body.
When to take PRILIGY
PRILIGY should be taken as needed, when sexual activity is anticipated. It is not
intended for continuous daily use.
If you forget to take PRILIGY
As PRILIGY is only taken when needed, it is not a problem if you forget to take it.
If you take too much PRILIGY
Tell your doctor or pharmacist if you have taken more PRILIGY tablets than you should.
You may feel sick or be sick. Symptoms of overdose in PRILIGY are drowsiness, nausea,
vomiting, rapid heartbeat, tremor, agitation and dizziness. If you think that you
have taken too much PRILIGY, you may need 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 taking PRILIGY?
WARNING: PRILIGY can make you faint or make you feel dizzy or light-headed.
To help lower the chance of this happening:
Take PRILIGY with at least one full glass of water.
Do not take PRILIGY if you are dehydrated (you do not have enough water in your body).
This can happen if:
You have not had water to drink in the past 4 to 6 hours
You have been sweating for a long time
You have an illness where you have a high temperature, diarrhoea or being sick
You have had alcohol
If you feel like you might faint (such as feeling sick, feeling dizzy, light-headed,
feeling weak, confused, sweaty or an abnormal heart beat), or feel light-headed when
you stand up, immediately lie down so your head is lower than the rest of your body
or sit down with your head between your knees until you feel better. This will stop
you from falling and hurting yourself if you do faint.
Do not stand up quickly after you have been sitting or lying down for a long time.
Do not drive or use any tools or machines if you feel faint when taking this medicine.
Tell your doctor if you faint when taking this medicine.
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking PRILIGY.
Keep all of your doctor's appointments so that your progress can be checked.
Talk to your doctor before you stop taking this medicine. You may have problems sleeping
and feel dizzy after you stop taking it, even if you have not taken it every day.
Things you should not do
Do not take PRILIGY to treat any other complaints unless your doctor tells you to.
Do not give your 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 PRILIGY
affects you.
This medicine may cause dizziness, light-headedness, tiredness, drowsiness, fainting,
having difficulty concentrating and blurred vision in some people. If you have any
of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Drinking alcohol
Avoid alcohol while you are taking this medicine.
The effects of alcohol, such as dizziness, drowsiness, slow reflexes or impaired judgement,
may be increased if taken with PRILIGY.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack they may not keep well.
Store it in a cool dry place below 25°C and 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 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.
Getting rid of any unwanted medicine
If you no longer need to take 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.
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.
Less serious side effects
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Less serious side effects
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What to do
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nausea
headache
dizziness
increased blood pressure
flushing
trembling
tingling or numbness
blurred vision
eye pain
ringing in the ears
nasal congestion
diarrhoea, abdominal pain, dry mouth, vomiting, indigestion, intestinal gas, constipation,
bloating
excessive sweating
fatigue, sleepiness and yawning
difficulty paying attention and feeling irritable
erectile dysfunction (difficulty getting or keeping an erection)
difficulty sleeping
anxiety, nervousness, decreased sexual desire
abnormal dreams
unusual bruising and bleeding
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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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fits (seizures)
fainted or feeling light-headed when you stand up
any changes in your mood
having any thoughts of suicide or harming yourself
Allergy reaction -related:
rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body
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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.
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 PRILIGY contains
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Active ingredient
(main ingredient)
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Dapoxetine (as hydrochloride)
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Other ingredients
(inactive ingredients)
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Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal
anhydrous silica, magnesium stearate, hypromellose, titanium dioxide, iron oxide black,
iron oxide yellow and triacetin
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This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What PRILIGY looks like
PRILIGY 30 mg film-coated tablets are light grey, round and marked "30" inside a triangle
on one side (AUST R 147946).
PRILIGY is supplied in blister packs containing 3 or 6 tablets.
Who distributes PRILIGY
A. Menarini Australia Pty Ltd
Sydney, Australia
Tel: 1800 644 542
This leaflet was prepared in March 2024.
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® PRILIGY is a registered trademark of Berlin-Chemie AG