REVATIO®

REVATIO®

Active ingredient(s): Sildenafil (as citrate)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using REVATIO. 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 REVATIO.

Where to find information in this leaflet:

1. Why am I using REVATIO?
2. What should I know before I use REVATIO?
3. What if I am taking other medicines?
4. How do I use REVATIO?
5. What should I know while using REVATIO?
6. Are there any side effects?
7. Product details

1. Why am I using REVATIO?

REVATIO contains the active ingredient sildenafil (present as sildenafil citrate). Sildenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

REVATIO is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs). Revatio lowers the blood pressure by relaxing these vessels.

REVATIO is not for use in children under 18 years of age.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

2. What should I know before I use REVATIO?

Warnings

Do not use REVATIO if:

• you are taking nitrite or nitrate medications.
• you are being treated for angina (chest pain), or other heart conditions with medicines called nitrates.
  Nitrate medicines include glyceryl trinitrate (also called nitroglycerin).
  Common tradenames for glyceryl trinitrate tablets include Anginine and Lycinate.
  Common tradenames for glyceryl trinitrate patches include Nitro-Dur, Transiderm-Nitro, Nitroderm TTS and Minitran.
  Common tradenames for glyceryl trinitrate sprays include Nitrolingual and Glytrin.
  Tradenames for glyceryl trinitrate injections include Glyceryl Trinitrate Concentrate and Glyceryl Trinitrate.
  Common tradenames for other nitrate preparations include Imdur Durules, Monodur Durules, Sorbidin, Isordil, Imtrate, Duride, Isomonit, Ikorel and Sodium Nitroprusside.
  There may be other tradenames not listed here.
• you are taking guanylate cyclase stimulators (GCS), such as Adepmas (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, CTEPH) or narrowing of the vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension or PAH).
• 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 low and is not effectively treated
• an eye disease called retinitis pigmentosa
• loss of vision in one or both eyes from an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION).
• you are taking certain medicines used to treat fungal infections including ketoconazole and itraconazole.
• you are taking ritonavir, a treatment for HIV infection.
• 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 use this medicine.
• the packaging is torn or shows signs of tampering.
• the expiry date on the pack has passed.

Before treatment with REVATIO, check with your doctor if you:

• have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
• have previously had sudden loss of eyesight in one or both eyes.
• have any of the following medical conditions:
  – heart or blood vessel problems
  – high blood pressure
  – diabetes, especially if you also have eye problems
  – leukaemia (cancer of the blood cells)
  – multiple myeloma (a cancer of the bone marrow)
  – any bleeding disorder such as haemophilia or problems with nose bleeds
  – stomach ulcer
  – a disease of the blood called sickle cell anaemia
  – pulmonary veno-occlusive disease (blockage or narrow vein in the lung)
  – any disease or deformity of your penis
  – you are receiving any treatment for male erectile dysfunction (impotence) including Viagra which contains the same medicine, sildenafil, as REVATIO. There are other tradenames for sildenafil containing medicines that are not listed here. Other medicines used to treat impotence include Cialis and Levitra
  – you are receiving other treatments for your condition
  – you previously experienced sudden decrease or loss of hearing.

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

Check with your doctor if you are pregnant or intend to become pregnant.

REVATIO should not be used during pregnancy. Your doctor will discuss the risks with you.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

You should not breastfeed while being treated with REVATIO.

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 use REVATIO if you are using nitrate medicines for angina.

Do not use REVATIO if you are taking guanylate cyclase stimulators (GCS), such as Adepmas (riociguat).

Tell your doctor if you are taking any other medicines for pulmonary arterial hypertension.

These medicines include Tracleer (bosentan), Flolan (epoprostenol) or Ventavis (Iloprost).

You may need to take different medicines or take different amounts of your medicine.

Some medicines and REVATIO may interfere with each other. These include:

• medicines called alpha-blockers. These are used to treat high blood pressure or prostate problems
• some medicines used to treat epilepsy such as phenytoin, carbamazepine and phenobarbital
• St John’s wort that may be used to treat mild anxiety
• Rifampicin used to treat leprosy or tuberculosis
• An antibiotic called erythromycin
• Saquinavir, a medicine used to treat HIV infection
• Cimetidine for stomach ulcers.

You may need to take different medicines or different amounts of your medicine. 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 you are being treated with REVATIO.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect REVATIO.

Avoid drinking grapefruit juice. It may increase the level of sildenafil in your blood.

4. How do I use REVATIO?

How much to take REVATIO

• Take REVATIO tablets 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.
• The usual dose is one 20 mg tablet taken three times a day (taken 6-8 hours apart).

When to take REVATIO

• Take REVATIO tablets at the same times each day.
  Taking REVATIO tablets at the same times each day will have the best effect. It will also help you to remember when to take it. REVATIO tablets can be taken with or without food.

How to take REVATIO

• Swallow the REVATIO tablet whole with a full glass of water.

How long to take REVATIO

• You must take REVATIO tablets every day. Continue taking your medicine for as long as your doctor tells you.

If you forget to use REVATIO

If you forget to take REVATIO tablets, take a dose as soon as you remember, then continue to take your tablets at the usual times.

Do not take a double dose to make up for the dose you missed.

REVATIO Solution for Injection

REVATIO Solution for Injection is given as an injection into a vein by a doctor or trained nurse.

Your doctor will determine your dose and how long you need to be given REVATIO Solution for Injection.

The usual dose of is 10 mg three times a day (given 6-8 hours apart).

REVATIO Solution for Injection is given when you are unable to take REVATIO tablets.

A dose of 10 mg REVATIO Solution for Injection is predicted to provide an effect of sildenafil equivalent to a 20 mg oral dose.

REVATIO Solution for Injection will be given to you under close medical supervision. It is unlikely that a dose would be missed.

However, tell your doctor or nurse if you think that a dose has been forgotten.

If you use too much REVATIO

If you think that you have used too much REVATIO, you are more likely to experience side effects.

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.

As your doctor will supervise how much REVATIO injection you are given, you are unlikely to have an overdose.

5. What should I know while using REVATIO?

Things you must do

You must stop treatment with REVATIO if you have a loss of eyesight in one or both eyes, or have an erection that lasts more than 4 hours. Seek medical attention urgently.

If you are about to start taking any new medicines, especially nitrates or Adepmas (riociguat), tell your doctor and pharmacist that you are being treated with REVATIO.

See “Before treatment with REVATIO” for a list of common nitrate medications.

Tell any other doctors, dentists and pharmacists who are treating you that you being treated with REVATIO.

Things you must not do

Do not use drugs containing amyl nitrite (sometimes called “poppers”) while you are on REVATIO.

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 being treated with REVATIO.

Do not take or use REVATIO to treat any other conditions unless your doctor says so.

Do not give REVATIO to anyone else, even if they have the same condition as you.

Driving or using machines

REVATIO can cause dizziness and effects on vision. You should be aware of how you react to REVATIO before you drive or operate machinery.

• If you experience changes in vision, or dizziness, when on
• REVATIO, you should not drive or operate machinery.

Drinking alcohol

You may feel lightheaded if you drink alcohol while you are using REVATIO.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 30°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.

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.

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.

REVATIO Solution for Injection will be stored in the pharmacy or in the hospital ward and is kept below 30°C.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking REVATIO tablets or if the medicine has passed its expiry date, ask your pharmacist what to do with any left over.

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

Less serious side effects	What to do
headache dizziness flushing indigestion stuffy nose muscle aches, back or limb pain rash diarrhoea or upset stomach a numbness or tingling skin sensation breathlessness or coughing fever or flu like symptoms nose bleeds difficulty sleeping hayfever prolonged erection.	Tell your doctor or pharmacist if you notice any of the following and they worry you.

Serious side effects

Serious side effects	What to do
Rarely men have lost vision in one or both eyes sometime after taking drugs such as Viagra, Cialis or Levitra to treat impotence (known as erectile dysfunction). A small number of people have reported a loss of hearing, which may include a ringing or other persistent noise in the ears and dizziness, while being treated with REVATIO. It is not known whether hearing loss is related to REVATIO.	If you lose sight 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 while on REVATIO, seek medical attention urgently. If you experience any loss of hearing, tell your doctor as soon as possible.

Tell your doctor 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 REVATIO tablet contains

Active ingredient (main ingredient)	sildenafil (as citrate) equivalent to 20 mg sildenafil.
Other ingredients (inactive ingredients)	microcrystalline cellulose calcium hydrogen phosphate croscarmellose sodium magnesium stearate hypromellose titanium dioxide lactose monohydrate triacetate
Potential allergens	lactose

What REVATIO Solution for Injection contains

Active ingredient (main ingredient)	sildenafil (as citrate) equivalent to 10 mg sildenafil
Other ingredients (inactive ingredients)	glucose monohydrate water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What REVATIO tablet looks like

REVATIO tablets are white to off-white, round biconvex, debossed, film-coated tablets (AUST R 119102).

The tablets are available in blister packs containing 90 tablets in each box.

REVATIO Solution for Injection is clear, colourless solution in a glass vial. (AUST R 171474).

Who distributes REVATIO

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in April 2023.

REVATIO^® is a Viatris company trade mark

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