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 SPEDRA?
SPEDRA contains the active ingredient avanafil. SPEDRA is used to treat erectile dysfunction
(when you cannot get or keep a hard erect penis suitable for sexual activity) in adult
men. See Section
1. Why am I taking SPEDRA? in the full CMI for more details.
2. What should I know before I take SPEDRA?
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 SPEDRA. For more information, see Section
2. What should I know before I take SPEDRA? in the full CMI.
3. What if I am taking other medicines?
4. How do I take SPEDRA?
Your doctor will decide the correct dose for you depending on your condition and response.
SPEDRA will only help you to get an erection if you are sexually stimulated.
The recommended dose is a 100 mg tablet, as needed, approximately 15 to 30 minutes
before anticipated sexual activity. Do not take more than one dose of SPEDRA in a
24-hour period.
Swallow the tablet whole with water. SPEDRA can be taken with or without food.
5. What should I know while taking SPEDRA?
There are many important things to consider while you are taking SPEDRA. The most
common and serious considerations are summarised below.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking SPEDRA.
If you have emergency treatment for any suspected heart condition, tell the emergency
staff that you are taking SPEDRA.
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Things you should not do
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Do not take nitrate medicines for chest pain (angina) including the recreational drug
amyl nitrite.
Do not take certain oral medicines used to treat HIV, fungal or bacterial infections,
or grapefruit juice
Do not give your tablets 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 SPEDRA can make you feel
dizzy or affect your vision. Dizziness or faintness may be worse if you are also taking
alpha-blockers.
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Drinking alcohol
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Avoid substantial consumption of alcohol as this can increase the potential for symptoms
such as increase in heart rate, decrease in standing blood pressure, dizziness and
headache.
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Looking after your medicine
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Keep your tablets in the blister 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 but usually mild potential side effects include headache; flushing; dizziness
or light-headedness; symptoms related to cold and influenza; back pain; indigestion,
nausea, constipation, diarrhoea; rash; and joint pain. Serious potential side effects
requiring medical attention include an allergic reaction; chest pain, irregular heartbeats
or palpitations; an erection that will not go away or lasts more than 4 hours; changes
to vision; and changes to hearing (possibly with dizziness or ringing in ears). 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):
avanafil
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SPEDRA. 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 SPEDRA.
Where to find information in this leaflet:
1. Why am I taking SPEDRA?
SPEDRA contains the active ingredient avanafil. SPEDRA belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
SPEDRA is used to treat erectile dysfunction, more commonly known as impotence, in
adult men. This is when a man cannot get, or keep, a hard erect penis suitable for
sexual activity.
SPEDRA works by relaxing the blood vessels in your penis. This increases the blood
flow into your penis, helping it stay hard and erect when you get sexually aroused.
SPEDRA does not cure your condition.
It is important to note that SPEDRA only works if you are sexually aroused. SPEDRA
will not increase your sex drive.
SPEDRA will not help you if you do not have erectile dysfunction. SPEDRA is not for
women.
2. What should I know before I take SPEDRA?
Warnings
Do not take SPEDRA if:
you are allergic to avanafil, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can take this medicine.
Do not take SPEDRA if you are taking nitrate medicines which include:
glyceryl trinitrate (also called nitroglycerin)
nicorandil
sodium nitroprusside
isosorbide mononitrate
isosorbide dinitrate
amyl nitrite (also known as poppers, amyl or rush).
SPEDRA has been shown to increase the effects of these medicines and severely lower
your blood pressure.
Do not take SPEDRA if you are taking:
riociguat, a medicine used to treat high blood pressure in the lungs
nefazodone, a medicine used to treat depression
medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or
atazanavir
medicines for fungal infections such as ketoconazole, itraconazole or voriconazole
clarithromycin and telithromycin, antibiotics used for bacterial infections.
Because sexual activity may place a strain on your heart, your doctor will need to
check whether you are fit enough to take SPEDRA.
Do not take SPEDRA if you have:
chest pain (unstable angina) or you get chest pain during sexual intercourse
congestive heart failure
hypotension (low blood pressure)
uncontrolled hypertension (high blood pressure)
ever had loss of vision in one eye due to not enough blood getting to your eyes (non-arteritic
ischaemic optic neuropathy-NAION)
eye disorders that run in your family (such as retinitis pigmentosa)
severe liver or kidney problems.
Do not take SPEDRA if you have a serious cardiac problem or you have had any of the
following conditions within the previous 6 months:
myocardial infarction (heart attack)
stroke
serious arrhythmia (irregular heart beat)
heart surgery.
Check with your doctor if you have or have had any of the following medical conditions:
any heart trouble or blood vessel problems
a physical condition that affects the shape of your penis (such as angulation, Peyronie's
disease or cavernosal fibrosis)
if you suffer from priapism, which is a persistent erection lasting 4 hours or more.
This can happen in men with conditions like sickle cell disease, multiple myeloma
or leukaemia
any bleeding disorder or active peptic ulceration
kidney or liver problems
sudden loss of eyesight in one or both eyes
sudden decrease or loss of hearing
spinal cord injury or other neurological disorders.
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 give SPEDRA to women.
Children and adolescents
Do not give SPEDRA to children and adolescents under 18 years of age.
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 SPEDRA may interfere with each other and affect how it works. These
include:
some antibiotics such as erythromycin and rifampicin
medicines called alpha-blockers, used for prostate problems or for lowering your high
blood pressure e.g. terazosin, tamsulosin and prazosin. Concomitant use of SPEDRA
with alpha-blockers may contribute to dizziness or fainting
other antihypertensives e.g. enalapril, amlodipine
some medicines used to treat seizures such as phenytoin, phenobarbitone and carbamazepine
efavirenz, a medicine used to treat HIV
high doses of alcohol
other medicines that may reduce the breakdown of SPEDRA in the body such as amprenavir,
aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil
bosentan, a medicine used to treat pulmonary arterial hypotension
other treatments for erectile dysfunction.
Grapefruit juice should be avoided within 24 hours prior to taking SPEDRA.
These medicines, grapefruit juice or alcohol may be affected by SPEDRA, or may affect
how well SPEDRA works. You may need to use different amounts of your medicine, or
take different medicines.
Your doctor or pharmacist will have a more complete list of medicines to be careful
with or avoid while taking SPEDRA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SPEDRA.
4. How do I take SPEDRA?
How much to take
Your doctor will decide the correct dose for you depending on your condition and response.
The recommended dose is a 100 mg tablet, as needed. Your doctor may increase your
dose to 200 mg or decrease your dose to 50 mg.
Do not take more than one dose of SPEDRA in a 24-hour period.
Swallow the tablet whole with water.
SPEDRA can be taken with or without food. If SPEDRA is taken with food, there may
be a delay in how fast the medicine works compared to taking it on an empty stomach.
When to take SPEDRA
You should take SPEDRA as needed, approximately 15 to 30 minutes before anticipated
sexual activity. Remember that SPEDRA will only help you to get an erection if you
are sexually stimulated.
If you take too much SPEDRA
If you think that you have taken too much SPEDRA, you may need urgent medical attention.
You may experience more side effects than usual and the side effects may be worse.
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 SPEDRA?
Things you should do
If you have emergency treatment for any suspected heart condition, tell the emergency
staff that you are taking SPEDRA.
Remind any doctor, dentist or pharmacist you visit that you are taking SPEDRA.
Things you should not do
Do not use the recreational drug amyl nitrite (also known as poppers, amyl or rush)
while you are taking SPEDRA.
If you get an angina attack do not take nitrate medicines to relieve the pain but
tell your doctor immediately or contact your nearest emergency department.
Make sure your doctor knows you are taking SPEDRA.
While you are taking SPEDRA, do not take certain medicines used to treat HIV or AIDS
such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir; or certain medicines
for fungal infection such as ketoconazole, itraconazole or voriconazole; or certain
antibiotics for bacterial infections such as clarithromycin and telithromycin.
Do not take more than one dose of SPEDRA in a 24-hour period.
If SPEDRA does not help you get an erection, or if your erection does not last long
enough to complete sexual intercourse, tell your doctor.
Do not give your tablets 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 SPEDRA
affects you.
SPEDRA can make you feel dizzy or affect your vision. Dizziness or faintness may be
worse if you are also taking alpha-blockers.
Drinking alcohol
Be careful when drinking alcohol while you are taking this medicine.
Substantial consumption of alcohol in combination with SPEDRA can increase the potential
for symptoms such as increase in heart rate, decrease in standing blood pressure,
dizziness and headache.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Keep your tablets in the blister until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Store it in a cool dry place below 25°C 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.
Keep it where young children cannot reach it.
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 take 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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headache
flushing
dizziness or light-headedness
nasal or sinus congestion, cold, influenza, cough and chest congestion
back pain
indigestion, feeling or being sick in the stomach (nausea), constipation or diarrhoea
rash
joint pain.
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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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allergic reactions such as rash, hives, wheezing, swelling of the face, lips, mouth
or throat which may cause difficulty in swallowing or breathing
angina (chest pain)
irregular heartbeats or palpitations
an erection that will not go away or lasts more than 4 hours (priapism)
blurred vision
sudden decrease or loss of vision in one or both eyes
sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing
in your ears)
nose bleeds (rare).
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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.
7. Product details
This medicine is only available with a doctor's prescription.
What SPEDRA contains
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Active ingredient
(main ingredient)
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avanafil
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Other ingredients
(inactive ingredients)
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mannitol, fumaric acid, hyprolose, calcium carbonate, magnesium stearate and iron
oxide yellow
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Do not take this medicine if you are allergic to any of these ingredients.
SPEDRA does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.
What SPEDRA looks like
SPEDRA 50 mg tablets (AUST R 228474) are pale yellow oval tablets marked '50' on one
side.
SPEDRA 100 mg tablets (AUST R 228475) are pale yellow oval tablets marked '100' on
one side.
SPEDRA 200 mg tablets (AUST R 228476) are pale yellow oval tablets marked '200' on
one side.
SPEDRA is available in blister packs of 1, 2, 4, 8 or 12 tablets*.
* Not all pack sizes are available for all strengths.
Who distributes SPEDRA
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Ave
Chatswood NSW 2067
Medical Information: 1800 644 542
® = Registered Trademark
This leaflet was prepared in January 2023.
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