Viagra

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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?

Some medicines may interfere with VIAGRA and affect how it works. 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 VIAGRA?

Take VIAGRA exactly as your doctor has prescribed.
Your doctor will decide the correct dose for you depending on your condition and response.
More instructions can be found in Section 4. How do I take VIAGRA? in the full CMI.

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 a 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.
For more information, see Section 5. What should I know while taking VIAGRA? in the full CMI.

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, changes to your normal vision, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts, 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
Nitrate medicines include glyceryl trinitrate (also called nitroglycerin) which are available in multiple dosage forms such as tablets, patches, sprays and injections.
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 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 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.
Tell your doctor if you 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 used 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 a 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.
See " 2. What should I know before I take VIAGRA? " for a list of common nitrate medications.
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:
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
Other ingredients
(inactive ingredients)
microcrystalline cellulose
calcium hydrogen phosphate
croscarmellose sodium
magnesium stearate
hypromellose
titanium dioxide
lactose monohydrate
triacetin
indigo carmine
PF0102 (ARTG PI No: 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 film-coated, rounded diamond-shaped tablets, marked PFIZER on one side and VGR 25 on the other. (AUST R 64434)
50 mg - blue film-coated, rounded diamond-shaped tablets, marked PFIZER on one side and VGR 50 on the other. (AUST R 64435)
100 mg - blue film-coated, rounded diamond-shaped tablets, marked PFIZER on one side and VGR 100 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 December 2023.
VIAGRA® is a Viatris company trade mark
VIAGRA_cmi\Dec23/00