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PRILIGY 60MG FILM-COATED TABLETS

Active substance(s): DAPOXETINE HYDROCHLORIDE

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UK/40037031/C368

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Package Leaflet: Information for the user

Priligy 30 mg film−coated tablets
Priligy 60 mg film−coated tablets
®
®

dapoxetine

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Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their symptoms are the
same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet:
1. What Priligy is and what it is used for ������������������������������������������������������������������   1
2. What you need to know before you take Priligy ���������������������������������������   3
3. How to take Priligy ����������������������������������������������������������������������������������������������������������������������  20
4. Possible side effects ����������������������������������������������������������������������������������������������������������������  24
5. How to store Priligy �������������������������������������������������������������������������������������������������������������������  34
6. Contents of the pack and other information �������������������������������������������������  35

1.  What Priligy is and what it is used for
Priligy contains an active substance called ‘dapoxetine’. This
belongs to a group of medicines called ‘selective serotonin
reuptake inhibitors’ (SSRIs). Priligy may also be known as a
‘urological’ medicine.
Priligy increases the time it takes to ejaculate and can improve the
control over the ejaculation. This may reduce the frustration or
worry about fast ejaculation.
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Priligy is used to treat premature ejaculation in adult men aged 18
to 64 years.
Premature ejaculation is when a man ejaculates with little sexual
stimulation and before the man wants. This can cause problems for
the man and may cause problems in sexual relationships.

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2.  What you need to know before you take Priligy
Do not take Priligy if:
• you are allergic to dapoxetine or any of the other ingredients of this
medicine (listed in section 6)
• you have heart problems, such as heart failure or problems with
the heart rhythm
• you have a history of fainting
• you have ever had mania (symptoms include feeling over−excited,
irritable or not being able to think clearly) or severe depression

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• you have moderate or severe liver problems.
• you are taking:
- Medicines for depression called ‘monoamine oxidase inhibitors’
(MAOIs)
- Thioridazine used for schizophrenia
- Other medicines for depression
- Lithium − a medicine for bipolar disorder
- Linezolid − an antibiotic used to treat infections
- Tryptophan − a medicine to help you sleep
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- St John’s wort − a herbal medicine
- Tramadol − used to treat serious pain
- Medicines used to treat migraines.
Do not take Priligy at the same time as any of the medicines listed
above. If you have taken any of these medicines, you will need to wait
14 days after you stop taking it before you can start taking Priligy. Once
you have stopped taking Priligy, you will need to wait 7 days before
taking any of the medicines listed above. If you are not sure about what
to do, talk to your doctor or pharmacist before taking this medicine.
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- Certain medicines for fungal infection, including ketoconazole
and itraconazole
- Certain medicines for HIV, including ritonavir, saquinavir,
nelfinavir and atazanavir
- Certain antibiotics for treating infection, including telithromycin
- Nefazodone − an antidepressant
Also see section “Other medicines and Priligy”.
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Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking this
medicine.
Children and adolescents
This medicine should not be used in children or adolescents under
age 18 years.
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Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Priligy if:
• You have not been diagnosed with premature ejaculation
• You also have another sexual problem, such as erectile
dysfunction
• You have a history of dizziness from low blood pressure
• You use recreational drugs such as ecstasy, LSD, narcotics or
benzodiazepines
• You drink alcohol (see section “Priligy with food, drink and alcohol”)
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• You have ever had a mental health problem such as depression,
mania (symptoms include feeling over−excited, irritable or not
being able to think clearly), bipolar disorder (symptoms include
serious mood swings between mania and depression) or
schizophrenia (a psychiatric disease)
• You have epilepsy
• You have a history of bleeding or blood clotting problems
• You have kidney problems
• You have, or are at risk of, high pressure in the eye (glaucoma).
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If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking this medicine.
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 lying down.

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Other medicines and Priligy
Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other medicines. This includes medicines you get
without a prescription, such as herbal medicines. This is because
Priligy can affect the way some other medicines work. Also some
other medicines can affect the way Priligy works. Therefore, use of
other medicines may affect the maximum dose of Priligy you’re
allowed to take.
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Do not take Priligy at the same time as any of the following
medicines:
• Medicines for depression called ‘monoamine oxidase inhibitors’
(MAOIs)
• Thioridazine used for schizophrenia
• Other medicines for depression
• Lithium − a medicine for bipolar disorder
• Linezolid − an antibiotic used to treat infections
• Tryptophan − a medicine to help you sleep
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• St John’s wort − a herbal medicine
• Tramadol − used to treat serious pain
• Medicines used to treat migraines.
Do not take Priligy at the same time as any of the medicines listed
above. If you have taken any of these medicines, you will need to wait
14 days after you stop taking it before you can start taking Priligy.
Once you have stopped taking Priligy, you will need to wait 7 days
before taking any of the medicines listed above. If you are not sure
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about what to do, talk to your doctor or pharmacist before taking this
medicine.
• Certain medicines for fungal infection, including ketoconazole
and itraconazole
• Certain medicines for HIV, including ritonavir, saquinavir,
nelfinavir and atazanavir
• Certain antibiotics for treating infection, including telithromycin
• Nefazodone − an antidepressant.
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Tell your doctor or pharmacist if you are taking any of the
following medicines:
• Medicines for mental health problems other than depression
• Non−steroidal anti−inflammatory medicines such as ibuprofen or
acetylsalicyclic acid
• Medicines to thin your blood, such as warfarin
• Certain medicines used to treat erectile dysfunction, such as
sildenafil, tadalafil or vardenafil, as these medicines may lower
your blood pressure, possibly upon standing
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• Certain medicines used to treat high blood pressure and chest
pain (angina) (such as verapamil and diltiazem), or enlarged
prostate, as these medicines may also lower your blood pressure,
possibly upon standing
• Certain other medicines for fungal infection, such as fluconazole
• Certain other medicines for HIV, such as amprenavir and
fosamprenavir
• Certain other antibiotics for treating infection, such as
erythromycin and clarithromycin
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• Aprepitant − used to treat nausea.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking this medicine.
Priligy with food, drink and alcohol
• This medicine can be taken with or without food.
• You should take this medicine with at least one full glass of
water.
• Avoid alcohol when taking this medicine.
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• The effects of alcohol such as feeling dizzy, sleepy and having
slow reactions, may be increased if taken with this medicine.
• Drinking alcohol while taking this medicine may increase your
risk of injury from fainting or from other side effects.
Pregnancy, breast−feeding and fertility
This medicine should not be taken by women.
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Driving and using machines
You may feel sleepy, dizzy, faint, have difficulty concentrating and
blurred vision while taking this medicine. If you experience any of
these or similar effects, you should avoid driving or operating
hazardous machinery. The effects of alcohol may be increased if
taken with this medicine and you may be more at risk of injury from
fainting or from other side effects if you take this medicine with
alcohol.
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Priligy contains lactose
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.  How to take Priligy
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
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• The recommended dose is 30 mg. Your doctor may increase the
dose to 60 mg.
• Only take the medicine 1 to 3 hours before sexual activity is
anticipated.
• Do not take this medicine more than once every 24 hours
or every day.
• Swallow the tablets whole to avoid a bitter taste, with at least one
full glass of water. This may help lower your chance of fainting
(see ‘Fainting and low blood pressure’ in section 4).
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• This medicine can be taken with or without food.
• This medicine should not be used by men under 18 or over 65
years of age.
• Discuss your Priligy treatment with your doctor after the first 4
weeks or after 6 doses to see whether you should continue
treatment. If treatment is continued, you should see your doctor
again to discuss this at least every six months.
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If you take more Priligy than you should
Tell your doctor or pharmacist if you have taken more tablets than
you should. You may feel sick or be sick.
If you stop taking Priligy
Talk to your doctor before you stop taking this medicine. You may
have problems sleeping and feel dizzy after you stop taking this
medicine, even if you have not taken it every day.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

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4.  Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking Priligy and see your doctor straight away if:
• You have fits (seizures)
• You faint or feel light headed when you stand up
• You notice any changes in your mood
• You have any thoughts of suicide or harming yourself.

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If you notice any of the above, stop taking this medicine and see
your doctor straight away.
Fainting and low blood pressure
This medicine can make you faint or make your blood pressure
drop when you stand up. To help lower the chance of this
happening:
• Take this medicine with at least one full glass of water.
• Do not take this medicine if you are dehydrated (you do not have
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enough water in your body). This can happen if:
- You have not had anything 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.
• If you feel like you might faint (such as feeling sick, feeling dizzy,
light headed, 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
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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.
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Very common side effects (may affect more than 1 in 10
men):
• Feeling dizzy
• Headache
• Feeling sick.
Common side effects (may affect up to 1 in 10 men):
• Feeling irritable, anxious, agitated or restless
• Feeling numb or having ‘pins and needles’
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• Difficulty getting or keeping an erection
• Sweating more than normal or flushing
• Diarrhoea, constipation or having wind
• Stomach pain, bloating or being sick
• Problems sleeping or strange dreams
• Feeling tired or sleepy, yawning
• Blocked nose (nasal congestion)
• A rise in blood pressure
• Difficulty concentrating
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• Shaking or trembling
• Lower interest in sex
• Ringing in the ears
• Blurred vision
• Indigestion
• Dry mouth.

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Uncommon side effects (may affect up to 1 in 100 men):
• Fainting or feeling dizzy upon standing (see advice above)
• Change in mood, feeling overly excited or feelings of paranoia
• Feeling confused, disoriented or unable to think clearly
• Slow or irregular heartbeat or increase in heart rate
• Loss of sex drive, problems reaching orgasm
• Feeling weak, sedated, lethargic or fatigued
• Feeling depressed, nervous or indifferent
• Feeling hot, jittery, abnormal or drunk
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• Vision problems, eye pain or dilated pupils
• Low or high blood pressure
• Feeling itchy or cold sweat
• Spinning sensation
• Abnormal taste
• Teeth grinding.

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Rare side effects (may affect up to 1 in 1,000 men):
• Feeling dizzy following exertion
• Sudden onset of sleep
• Urgency of bowel action.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
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By reporting side effects you can help provide more information on
the safety of this medicine.
5.  How to store Priligy
• This medicinal product does not require any special storage
conditions.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that month.

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• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6.  Contents of the pack and other information
What Priligy contains
The active substance is dapoxetine. Each tablet contains 30 mg or
60 mg dapoxetine as a hydrochloride salt.
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The other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose,
croscarmellose sodium, colloidal anhydrous silica, magnesium
stearate.
• Tablet coating: lactose monohydrate, hypromellose, titanium
dioxide (E171), triacetin, Iron Oxide Black (E172), Iron Oxide
Yellow (E172).
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What Priligy looks like and contents of the pack
• Priligy 30 mg film−coated tablets are light grey, round, convex,
approximately 6.5 mm in diameter and debossed with “30” inside
a triangle on one side.
• Priligy 60 mg film−coated tablets are grey, round, convex,
approximately 8 mm in diameter and debossed with “60” inside a
triangle on one side.
The tablets are provided in compliance multi-fold blister packs
containing 1, 2, 3 and 6 film−coated tablets.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
A. Menarini Farmaceutica Internazionale SRL
Menarini House - Mercury Park
Wycombe Lane - Wooburn Green
Buckinghamshire HP10 0HH
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Manufacturer
Janssen−Cilag S.p.A., Via C. Janssen, 04010 Borgo S. Michele, Italy
Or
Menarini - Von Heyden GmbH, Leipziger Strasse 7-13, 01097
Dresden, Germany

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This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Priligy
This leaflet was last revised in May 2015.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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