Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking VIAGRA?
VIAGRA contains the active ingredient sildenafil. VIAGRA is used to treat erectile
dysfunction, more commonly known as impotence, in men. For more information, see Section
1. Why am I taking VIAGRA? in the full CMI.
2. What should I know before I take VIAGRA?
Do not use if you have ever had an allergic reaction to VIAGRA or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section
2. What should I know before I take VIAGRA? in the full CMI.
3. What if I am taking other medicines?
4. How do I take VIAGRA?
Take VIAGRA exactly as your doctor has prescribed.
Your doctor will decide the correct dose for you depending on your condition and response.
5. What should I know while taking VIAGRA?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking VIAGRA.
Stop taking VIAGRA if you have sudden vision problems including blurred, decreased
or distorted vision, objects appear smaller or further away than they are, changes
to colour vision, loss of eyesight in one or both eyes, experience loss of hearing
or have an erection that persists for more than 4 hours. Seek medical attention urgently.
If you are about to start taking any new medicines, especially nitrates, or riociguat,
tell your doctor and pharmacist that you are taking VIAGRA.
|
|
Things you should not do
|
Do not use drugs containing amyl nitrite (sometimes called "poppers") while you are
taking VIAGRA.
If you get an angina attack, do not take nitrate medicines to relieve the pain but
tell your doctor immediately.
Do not give VIAGRA to anyone else, even if they have the same condition as you.
|
|
Driving or using machines
|
If you experience changes in vision, or dizziness when taking VIAGRA, you should not
drive or operate machinery.
|
|
Drinking alcohol
|
Be careful drinking alcohol while taking VIAGRA.
|
|
Looking after your medicine
|
Keep VIAGRA in a cool, dry place where the temperature stays below 30°C.
Keep this medicine where children cannot reach it.
|
6. Are there any side effects?
Tell your doctor or pharmacist if you notice any of the following and they worry you: headache, dizziness, flushing, hot flushes, indigestion, heartburn, nasal or sinus
congestion, swelling of your nose, diarrhoea, rash, tightness in your throat, feeling
hot or irritable, redness in your mouth or tongue.
Tell your doctor or go straight to the Emergency Department if you notice any of the
following: unusual heartbeat, persistent headache or fainting, bleeding from the nose, pain
or tingling in your hands, toes or feet, red eye(s), swollen, puffy or pain in or
around the eye(s), blood in the urine, sudden vision problems, changes to your normal
vision, shortness of breath, wheezing or difficulty breathing, swelling of the face,
lips, tongue or other parts of the body, chest pain, increased heart rate, seizures,
fits or convulsions or your erection is increased, painful or persists for longer
than four hours.
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):
sildenafil (as citrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking VIAGRA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking VIAGRA.
Where to find information in this leaflet:
1. Why am I taking VIAGRA?
VIAGRA contains the active ingredient sildenafil (as citrate). VIAGRA belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
VIAGRA is used to treat erectile dysfunction, more commonly known as impotence, in
men. This is when a man cannot get, or keep, a hard erect penis suitable for sexual activity.
It works by relaxing the blood vessels in your penis when you are sexually excited.
This allows blood to flow into your penis, allowing you to get an erection in the
natural way.
VIAGRA will not increase your sex drive and will work only if you are sexually excited.
VIAGRA is not for use in women.
2. What should I know before I take VIAGRA?
Warnings
YOU MUST NOT TAKE VIAGRA IF YOU ARE TAKING NITRATES OR NITRITE MEDICATIONS. IT MAY
LEAD TO A SEVERE DROP IN YOUR BLOOD PRESSURE, WHICH MAY BE DIFFICULT TO TREAT.
BECAUSE SEXUAL ACTIVITY MAY PLACE A STRAIN ON YOUR HEART, YOUR DOCTOR WILL NEED TO
CHECK WHETHER YOU ARE FIT ENOUGH TO TAKE VIAGRA.
Do not take VIAGRA if:
you are allergic to sildenafil or similar medicines, or any of the ingredients listed
at the end of this leaflet.
An allergic reaction can include:
hives, itching or skin rash
swelling of the face, lips or tongue which may lead to difficulty swallowing or breathing.
Always check the ingredients to make sure you can take this medicine.
you are being treated for angina (chest pain) or other heart conditions with medicines
called nitrates.
These are available in multiple dosage forms, such as tablets, patches, sprays and
injections. These include but not limited to:
glyceryl trinitrate (also called nitroglycerin)
isosorbide mononitrate, isosorbide dinitrate
nicorandil
sodium nitroprusside.
you are taking guanylate cyclase stimulators (GCS), such as riociguat
GCS is a type of medicine used to treat high blood pressure in the blood vessels in
the lungs caused by blood clots in the lungs (chronic thromboembolic pulmonary hypertension
or CTEPH) or narrowing of the vessels that carry blood from the heart to the lungs
(pulmonary arterial hypertension or PAH).
you have heart or blood vessel problems that make sexual intercourse inadvisable
you have suffered a heart attack or stroke in the last 6 months
you have severe liver problems
you have blood pressure that is unusually high or low or is not effectively treated
you have sudden vision problems including loss of vision in one or both eyes from
an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION)
you have an eye disease called retinitis pigmentosa
the packaging is torn or shows signs of tampering, or does not look quite right even
if the tablets may look alright
the expiry date on the pack has passed
If it has expired or is damaged, return it to your pharmacist for disposal.
Check with your doctor if you:
have any allergies to any other medicines or any other substances such as foods, preservatives
or dyes
have any other heart or blood vessel problems
have previously had sudden vision problems including blurred, decreased or distorted
vision, objects appear smaller or further away than they are, changes to colour vision,
loss of eyesight in one or both eyes
have any of the following medical conditions:
diabetes, especially if you also have eye problems
kidney or liver problems
leukaemia (cancer of the blood cells)
multiple myeloma (a cancer of the bone marrow)
any disease or deformity of your penis
any bleeding disorder such as haemophilia
stomach ulcer
a disease of the blood called sickle cell anaemia
colour vision problems
previously experienced sudden decrease or loss of hearing
are taking or using any other treatment for impotence
are taking any medicines to treat high blood pressure in the vessels of the lungs
(pulmonary arterial hypertension) including bosentan or Revatio which also contains
sildenafil
have any other medical conditions.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking VIAGRA.
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?
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.
Do not take VIAGRA if you are taking or using nitrate medicines for angina.
Do not take VIAGRA if you are taking guanylate cyclase stimulators (GCS), such as
riociguat.
Some medicines and VIAGRA may interfere with each other. These include:
cimetidine, a medicine used to treat ulcers
some medicines used to treat fungal infections including ketoconazole and itraconazole
some antibiotics including erythromycin and rifampicin
some protease inhibitors such as ritonavir and saquinavir for the treatment of HIV
infection
medicines called alpha-blockers. These are used to treat high blood pressure or prostate
problems
bosentan, a medicine used to treat high blood pressure in the vessels of the lungs.
You may need different amounts of your medicine or you may need to take different
medicines. Your doctor or pharmacist can tell you what to do if you are taking any
of these medicines. They also have a more complete list of medicines to be careful
with or avoid while taking VIAGRA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VIAGRA.
4. How do I take VIAGRA?
Take VIAGRA exactly as your doctor has prescribed.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
Your doctor will decide the correct dose for you depending on your condition and response.
This can be either one 25 mg tablet, one 50 mg tablet, or one 100 mg tablet per day.
Do not take more than one dose of VIAGRA a day.
How to take it
Swallow the tablet whole with a full glass of water.
When to take VIAGRA
Take your dose of VIAGRA about one hour before you intend to have sex.
The amount of time VIAGRA takes to start working varies from person to person, but
it normally takes between half an hour and one hour.
You may find VIAGRA takes longer to work if you take it with a heavy meal.
VIAGRA will work only if you are sexually excited.
If you take too much VIAGRA
If you think that you or anyone else may have taken too much VIAGRA, urgent medical
attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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 VIAGRA?
Things you should do
Stop taking VIAGRA if you have sudden vision problems including blurred, decreased
or distorted vision, objects appear smaller or further away than they are, changes
to colour vision, loss of eyesight in one or both eyes, experience loss of hearing
or have an erection that persists for more than 4 hours. Seek medical attention urgently.
If VIAGRA does not help you get an erection or if your erection does not last long
enough to complete sexual intercourse, tell your doctor.
In these cases, your doctor may decide that you need a higher dose.
If you are about to start taking any new medicines, especially nitrates, or riociguat,
tell your doctor and pharmacist that you are taking VIAGRA.
Tell any other doctors, dentists and pharmacists who are treating you that you are
taking VIAGRA.
Things you should not do
Do not use drugs containing amyl nitrite (sometimes called "poppers") while you are
taking VIAGRA.
If you get an angina attack do not take nitrate medicines to relieve the pain but
tell your doctor immediately. Make sure your doctor knows you are taking VIAGRA.
Do not give VIAGRA to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or take any machines or tools until you know how VIAGRA
affects you.
If you experience changes in vision, or dizziness when taking VIAGRA, you should not
drive or operate machinery.
Drinking alcohol
Be careful drinking alcohol while taking VIAGRA.
Drinking alcohol can temporarily impair the ability to get an erection.
Do not drink large amounts of alcohol before sexual activity.
Looking after your medicine
Store below 30°C
Keep the tablets in their pack until it is time to take them. If you take your tablets
out of the pack, they will not keep as well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool 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 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 take this medicine after the expiry date.
6. Are there any side effects?
While VIAGRA helps most people, it can cause some unwanted side effects in a few people.
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking VIAGRA.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects.
You may not get any of them.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Nervous system related:
headache
dizziness
Vascular related:
flushing
hot flushes
Gastrointestinal related:
indigestion
heartburn
diarrhoea
dry mouth or dry throat
Respiratory related:
nasal congestion
sinus congestion
dry nose
Skin related:
rash
Eye related:
dry eyes
Other side effects:
swelling of your nose
tightness in your throat
feeling hot or irritable
redness in your mouth or tongue
|
Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Heart related:
unusual heartbeat
Urogenital related:
urinary tract infection (stinging or burning urine, more frequent need to pass urine)
blood in the urine
Nervous system related:
persistent headache or fainting
pain or tingling in your hands, toes or feet
decreased sensitivity or numbness in your mouth
Eye related:
irritation or feeling of having something in the eye
swollen or puffy eye(s)
fatigue, pain in or around the eyes
"red eye" due to swollen blood vessels in the white part of the eye and in the eyelids
Other side effects:
bleeding from the nose
|
Call your doctor straight away if you notice any of these serious side effects.
|
More serious side effects
|
More serious side effects
|
What to do
|
|
Allergy related:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts
Heart related:
chest pain
increased heart rate
Nervous system related:
seizures, fits or convulsions
Urogenital related:
your erection is increased, painful or persists for longer than usual
If your erection continues for four hours, or sooner if there is pain, you should
seek medical attention urgently.
Eye related:
sudden vision problems
blurred, decreased or distorted vision
objects appear smaller or further away than they are
changes to colour vision
changes to your normal vision such as:
red or yellow colour tinges to your vision or colourless objects appear coloured
you see a halo around lights, sparks or lights when your eyes are closed
Rarely, men have lost eyesight after taking drugs to treat erectile dysfunction. If
you lose eyesight in one or both eyes or experience changes in vision such as blurring,
a blue colour to your vision or a greater awareness of light, seek medical attention
urgently.
Other side effects:
sudden decrease or loss of hearing
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these more serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell or if you don't understand anything in this list.
This is not a complete list of all possible side effects. 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 VIAGRA contains
|
Active ingredient
(main ingredient)
|
sildenafil (as citrate) equivalent to 25 mg, 50 mg or 100 mg sildenafil per tablet
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
calcium hydrogen phosphate
croscarmellose sodium
magnesium stearate
hypromellose
titanium dioxide
lactose monohydrate
triacetin
indigo carmine
PF0102 (ID 3329)
|
|
Potential allergens
|
lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What VIAGRA looks like
25 mg - blue, rounded diamond shaped film coated tablets, debossed with “VGR 25” on
one side and “VIAGRA” on the other. (AUST R 64434)
50 mg - blue, rounded diamond shaped film coated tablets, debossed with “VGR 50” on
one side and “VIAGRA” on the other. (AUST R 64435)
100 mg - blue, rounded diamond shaped film coated tablets, debossed with “VGR 100”
on one side and “VIAGRA” on the other. (AUST R 64436)
All strengths are available in a box of 4 tablets. The 100 mg tablets are also available
in a box of 12 tablets.
Who distributes VIAGRA
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2024.
VIAGRA® is a Viatris company trade mark
VIAGRA_cmi\Oct24/00