Consumer medicine information

Ganfort 0.3/5 Eye Drops

Bimatoprost; Timolol

BRAND INFORMATION

Brand name

Ganfort 0.3/5

Active ingredient

Bimatoprost; Timolol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ganfort 0.3/5 Eye Drops.

SUMMARY CMI

GANFORT® 0.3/5 eye drops

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 using GANFORT® 0.3/5 eye drops?

GANFORT® 0.3/5 eye drops contains the active ingredients bimatoprost and timolol (as maleate). GANFORT® 0.3/5 eye drops are used to lower raised pressure in the eye and to treat glaucoma.

For more information, see Section 1. Why am I using GANFORT® 0.3/5 eye drops? in the full CMI.

2. What should I know before I use GANFORT® 0.3/5 eye drops?

Check the list of ingredients at the end of the CMI. Do not use GANFORT® 0.3/5 eye drops if you have ever had an allergic reaction to any of them.

Talk to your doctor before you use this medicine if he/she is not aware that you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use GANFORT® 0.3/5 eye drops? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with GANFORT® 0.3/5 eye drops and affect how it works, or GANFORT® 0.3/5 eye drops may interfere with other medicines and affect how they work.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use GANFORT® 0.3/5 eye drops?

5. What should I know while using GANFORT® 0.3/5 eye drops?

Things you should do
  • Remind any doctor, dentist, pharmacist, or optometrist you visit that you are using GANFORT® 0.3/5 eye drops.
  • Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor tells you to stop. GANFORT® 0.3/5 eye drops helps to control your condition but does not cure it.
  • Keep all your appointments so your condition can be checked.
Things you should not do
  • Do not touch the dropper tip against your eye, eye lid or any surface
  • Do not stop using GANFORT® 0.3/5 eye drops without checking with your doctor.
  • Do not use GANFORT® 0.3/5 eye drops while you are wearing contact lenses.
Driving or using machines
  • Wait until your vision clears after using GANFORT® 0.3/5 eye drops before driving or using machines.
Drinking alcohol
  • There is no information on the effects of using GANFORT® 0.3/5 eye drops with alcohol.
Looking after your medicine
  • Follow all instructions on the carton
  • Store it in a cool dry place, below 25°C, away from moisture, heat, or sunlight.

For more information, see Section 5. What should I know while using GANFORT® 0.3/5 eye drops? in the full CMI.

6. Are there any side effects?

The most common side effects include red, congested eyes, or growth of eyelashes. Note that side effects can occur in other parts of the body, including serious effects on the heart or, blood vessels, decreased blood flow to the brain, serious allergic reaction (anaphylaxis). 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.



FULL CMI

GANFORT® 0.3/5 eye drops (gan-fort)

Active ingredient(s): bimatoprost & timolol (bim-at-oh-prost & tim-oh-lol)

Consumer Medicine Information (CMI)

This leaflet provides important information about using GANFORT® 0.3/5 eye drops. 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 GANFORT® 0.3/5 eye drops.

Where to find information in this leaflet:

1. Why am I using GANFORT® 0.3/5 eye drops?
2. What should I know before I use GANFORT® 0.3/5 eye drops?
3. What if I am taking other medicines?
4. How do I use GANFORT® 0.3/5 eye drops?
5. What should I know while using GANFORT® 0.3/5 eye drops?
6. Are there any side effects?
7. Product details

1. Why am I using GANFORT® 0.3/5 eye drops?

GANFORT® 0.3/5 eye drops contain the active ingredients bimatoprost and timolol (as maleate).

GANFORT® 0.3/5 eye drops are used to lower raised pressure in the eye and to treat glaucoma. It works by decreasing the production of fluid in the eye and by helping the flow of fluid out of the eye.

Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Although GANFORT® 0.3/5 eye drops help control your condition, they will not cure it.

Your doctor may have prescribed this medication for another reason. Ask your doctor if you have any questions about why GANFORT® 0.3/5 eye drops have been prescribed for you.

2. What should I know before I use GANFORT® 0.3/5 eye drops?

Warnings

Do not use GANFORT® 0.3/5 eye drops if:

  • you are allergic to bimatoprost or timolol, or any of the ingredients listed at the end of this leaflet.
  • you have or have had any problems with your lungs, such as asthma, bronchospasm, or a condition called chronic obstructive pulmonary disease (COPD).
  • you have or have had a heart condition, such as a slow heartbeat, irregular heartbeat, or heart failure.
  • The seal around the cap is broken, the bottle/packaging shows signs of tampering, or the product does not look quite right.

Check with your doctor if:

  • your eye(s) is/are inflamed
  • you have fluid build-up in the light-sensitive layer at the back of the eye, known as the macula
  • you have had eye surgery
  • you have a diabetes-related eye condition, such as diabetic retinopathy or blockage of a retinal vein
  • your eye does not have a lens or your eye has an artificial lens, following cataract surgery
  • the capsule ("bag") that normally holds the eye's lens in place is torn, or ruptured
  • you have had severe allergic reactions (anaphylaxis) to such things as medicines, foods, dyes
  • you have angina or other problems with your heart or blood vessels
  • you have low blood pressure
  • you have or have had problems with your liver or kidneys
  • you have an overactive thyroid
  • you have diabetes
  • you are about to have surgery under general anaesthetic
  • you have muscle weakness
  • you have problems with your circulation, such as Raynaud's syndrome
  • you have any disease that affects the surface of the eye (cornea)
  • you take any medicines for any other condition.
  • you have had an allergy to any medicines or any other substances, such as foods, preservatives or dyes

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

Make sure your doctor is aware that you are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed.

Cosmetic effects

Before you start using GANFORT® 0.3/5 eye drops your doctor should tell you that some changes to your eyes may occur which may be permanent.

During treatment, GANFORT® 0.3/5 eye drops may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken, your upper eyelid to droop, the skin around your eye to tighten and the lower white part of your eye to become more visible. The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop using GANFORT® 0.3/5 eye drops.

Eyelashes may also grow longer and thicker, and eyelashes, the skin around the eye and the coloured part of the eye (iris) may become darker. If only one eye is being treated the cosmetic differences between the eyes may be noticeable. None of these changes affect vision. If you have any concerns, ask your doctor or pharmacist.

Hair may grow where GANFORT® 0.3/5 eye drops contact the skin. It is important to use as directed.

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 may interfere with GANFORT® 0.3/5 eye drops and affect how it works, while GANFORT® 0.3/5 eye drops may affect how other medicines work.

Medicines where GANFORT® 0.3/5 eye drops may increase their effect include:

  • medicines for high blood pressure
  • some medicines used to treat diabetes
  • some medicines used to treat heart conditions, such as for irregular heart beats
  • medicines used to expand blood vessels (vasodilator drugs).
  • medicines to treat depression

These medicines may be affected by GANFORT® 0.3/5 eye drops, or affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect GANFORT® 0.3/5 eye drops.

4. How do I use GANFORT® 0.3/5 eye drops?

Follow all directions given to you by your doctor carefully. The directions may differ from the information contained in this leaflet.

How much to use

  • Your doctor will tell you how many drops you need to use each day. Use GANFORT® 0.3/5 eye drops only as prescribed by your doctor.
  • The usual dose of GANFORT® 0.3/5 is one drop in your affected eye(s), according to your doctor's instructions.

When to use GANFORT® 0.3/5 eye drops

  • Use the drops each morning.

Use GANFORT® 0.3/5 eye drops every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your eye pressure. It will also help you remember when to use the eye drops.

In some instances, GANFORT® 0.3/5 eye drops need to be used with other eye drops. Your doctor will let you know which drops, how to use them, and how long to use them.

Wait at least 5 to 10 minutes after using GANFORT® 0.3/5 eye drops before using other eye drops. If you are also using an eye ointment, instill the eye ointment last.

If you are being changed from one eye drop to another, follow your doctor's instructions carefully as to when to stop the old drops and when to start the new drops.

How to use GANFORT® 0.3/5 eye drops

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in GANFORT® eye drops (benzalkonium chloride) may be deposited in soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used GANFORT® eye drops.

These drops are for use in your eyes only.

You may find it easier to put drops in your eye while you are sitting or lying down.

To open a new bottle of GANFORT® 0.3/5 eye drops first tear off the protective seal from the bottle. The contents are sterile if the seal is intact.

The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Remove the lid/cap.
  3. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  4. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  5. Tilt your head back and look up.
  6. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  7. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  8. Close your eye. Do not blink or rub your eye.
  9. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
  10. Replace the lid/cap, sealing it tightly.
  11. Wash your hands again with soap and water to remove any residue.

If a drop misses your eye, try again. Wipe off any excess that runs down the cheek.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

If you forget to use GANFORT® 0.3/5 eye drops

It is important that you use GANFORT® 0.3/5 eye drops at the same time each day.

If you miss using your drops and it is almost time for your next dose, use GANFORT® 0.3/5 eye drops at the usual time the next day.

If you miss using your drops and remember during the day, use the drops as soon as you remember and go back to using them at your usual time the next day.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the number of drops to make up for the dose you missed.

If you use too much GANFORT® 0.3/5 eye drops

Immediately rinse your eyes with warm water.

If GANFORT® 0.3/5 eye drops are accidentally swallowed

You should immediately:

  • phone the Poisons Information Centre
    (13 11 26 in Australia or
    0800 POISON (0800 764 766) in New Zealand    ), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there appear to be no signs of discomfort or poisoning.

5. What should I know while using GANFORT® 0.3/5 eye drops?

Things you should do

  • Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor tells you to stop. GANFORT® 0.3/5 eye drops help to control your condition but does not cure it.
  • Keep all your doctor's appointments so that your condition can be monitored, and your eye pressure can be checked.
  • Tell your doctor if you think your condition is not improving while using GANFORT® 0.3/5 eye drops.

Call your doctor straight away if you:

  • develop any problems with your eye(s), such as, trauma, change of vision, infection in the eye or eyelid, or have eye surgery.
  • become pregnant while using GANFORT® 0.3/5 eye drops.

Remind any doctor, dentist, pharmacist or optometrist you visit that you are using GANFORT® 0.3/5 eye drops.

Things you should not do

  • Do not touch the dropper tip against your eye, eyelid or anything else, to avoid contaminating the eye drops.
  • Do not stop using GANFORT® 0.3/5 eye drops without checking with your doctor. Your eye pressure can rise again and may cause damage to your eye.
  • Do not give GANFORT® 0.3/5 eye drops to anyone else, even if they have the same condition as you.

Driving or using machines

Your vision may be blurred after using GANFORT® 0.3/5 eye drops. Wait until your vision clears before driving or using machines.

Looking after your medicine

Follow the instructions on 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
  • do not store it in the car or on window sills.

Ensure the lid is closed tightly after each use.

Keep it where young children cannot reach it.

When to discard your medicine

Discard the bottle 28 days after first opening it.

Getting rid of any unwanted medicine

If your doctor advises that you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date has passed.

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 effectsWhat to do
Effects on the eye(s):
  • red, congested eyes
  • growth of eyelashes
  • darkening of eyelash colour
  • burning and/or stinging in the eye
  • itching or irritation of the eyes
  • small lesions on the eye surface
  • eye dryness
  • the feeling of having something in the eye or discomfort in the eye
  • watery eyes
  • redness or swelling in the eye or area around the eye
  • excessive sensitivity to bright light
  • red, swollen, itching eyelids
  • inflamed eyelids
  • darkening of the coloured part of the eye (iris)
  • darkening of skin around the eye
  • abnormal hair growth
  • misdirected upper or lower eyelashes that turn inward towards the eye
  • loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken eye, drooping eyelid, tightening of the skin around your eye, and the lower white part of your eye to become more visible.
  • decreased sensation to the front of the eye
Effects on the body as a whole
  • headache
  • ringing in the ear
  • symptoms of a cold such as runny nose or nasal congestion
  • cough
  • increased colour or pigment on the face around the eye
  • feeling tired
  • reduced interest in sex or sexual dysfunction
  • allergic skin reaction (rash, itching, hives) and eye allergy
  • changes in your taste sensation
  • dry mouth
  • inability to sleep, nightmares, anxiety, confusion, hallucinations or memory loss.
  • loss of appetite
  • muscle pain
  • excessive or abnormal hair growth in areas where the product repeatedly comes into contact with the skin
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Effects on the eye(s):
  • eye pain
  • discharge from the eye
  • small spots on the eye surface
  • changes to vision, double vision
  • macular edema (build-up of fluid at the back of the eye, which causes vision to become blurry)
  • spasm of the eyelids where there is uncontrolled blinking and squeezing of the eyelid
Effects on the body as a whole:
  • slow heartbeat
  • shortness of breath
  • asthma or worsening of asthma
  • high blood pressure
  • feeling weak and tired, nauseous, dizzy
  • depression (low mood, feelings of worthlessness)
  • low blood sugar
  • diarrhoea, stomach pain, vomiting, indigestion
  • red, scaly patches on the skin, rash or hair loss.
Call your doctor straight away, if you notice any of these serious side effects.
Effects on the body as a whole:
  • severe allergic reaction, including swelling of the eye, tongue, lips and throat, difficulty breathing
  • symptoms suggestive of decreased blood flow to the brain, such as symptoms of a stroke, fainting, tingling or numbness, muscle weakness
  • severe chest pain, heart beating slowly or irregularly, low blood pressure
  • swelling or coldness in your hands or feet, pain or tiredness in the legs.
Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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 in Australia or to nzphvc.otago.ac.nz/reporting in New Zealand. 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 GANFORT® 0.3/5 eye drops contains

Active ingredients
(main ingredients)
  • bimatoprost 0.3 mg/mL
  • timolol (as maleate) 5.0 mg/mL
Other ingredients
(inactive ingredients)
  • benzalkonium chloride
  • citric acid monohydrate
  • dibasic sodium phosphate heptahydrate
  • hydrochloric acid
  • sodium chloride
  • sodium hydroxide
  • purified water

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

What GANFORT® 0.3/5 eye drops look like

GANFORT® 0.3/5 eye drops are a sterile, clear to slightly yellow solution. It is supplied in a 3mL bottle which is packed inside a carton. (AUST R 147830).

Who distributes GANFORT® 0.3/5 eye drops?

GANFORT® 0.3/5 eye drops are distributed in Australia by:

AbbVie Pty Ltd
241 O'Riordan Street
Mascot NSW 2020
Australia

GANFORT® 0.3/5 eye drops are distributed in New Zealand by:

AbbVie Limited
6th Floor, 156-158 Victoria St
Wellington, 6011
New Zealand

This leaflet was prepared in Aug 2023.

© 2023 AbbVie. All rights reserved.
GANFORT and its design are trademarks of Allergan, Inc., an AbbVie company.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Ganfort 0.3/5

Active ingredient

Bimatoprost; Timolol

Schedule

S4

 

1 Name of Medicine

Bimatoprost and timolol (as maleate).

2 Qualitative and Quantitative Composition

Bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL.

Excipient with known effect.

Benzalkonium chloride (used as preservative).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.
Clear and colourless to slightly yellow solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Ganfort 0.3/5 eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

4.2 Dose and Method of Administration

The recommended dose is one drop of Ganfort 0.3/5 in the affected eye(s) once daily, administered in the morning.
In order to minimise systemic absorption of Ganfort 0.3/5 eye drops, apply pressure to the tear duct immediately following administration of the drug (see Section 4.4 Special Warnings and Precautions for Use).
As with all eye drops containing benzalkonium chloride as a preservative, there is potential for incompatibility with other topical ophthalmic medications. If more than one topical ophthalmic medicinal product is to be used, other eye drops should not be used within five to ten minutes of using Ganfort 0.3/5 eye drops.

Information for patients.

Use with contact lenses.

The preservative in Ganfort 0.3/5 eye drops, benzalkonium chloride, may be absorbed by and cause discolouration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove them prior to administration and wait at least 15 minutes after instilling Ganfort 0.3/5 eye drops before reinserting soft contact lenses.
Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops. Discard contents 4 weeks after opening the bottle.

4.3 Contraindications

Ganfort 0.3/5 eye drops are contraindicated in patients with hypersensitivity to any component of this medication, in patients with bronchospasm, bronchial asthma or patients with a history of bronchial asthma, or severe chronic obstructive pulmonary disease, in patients with sinus bradycardia, sick sinus syndrome, sino-atrial nodal block, second or third degree atrioventricular block not controlled with a pacemaker, overt cardiac failure or cardiogenic shock.

4.4 Special Warnings and Precautions for Use

Ganfort 0.3/5 should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Patients should be advised that if they develop an intercurrent ocular condition (e.g. trauma, ocular surgery or infection) or any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their doctor's advice concerning the continued use of the product.
Ganfort 0.3/5 has not been studied in patients with inflammatory ocular conditions, neovascular glaucoma, inflammatory glaucoma, angle closure glaucoma, congenital glaucoma or narrow angle glaucoma.
Ganfort 0.3/5 should not be used alone in the treatment of acute angle closure glaucoma.
In bimatoprost 0.03% (multidose) studies in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP lowering effect. Patients using bimatoprost ophthalmic solutions with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Cystoid macular oedema has been reported with Ganfort 0.3/5, however, it has been uncommonly reported (> 0.1% to < 1%) following treatment with bimatoprost. Therefore, Ganfort 0.3/5 should be used with caution in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy) or in aphakic patients and pseudophakic patients with a torn posterior lens capsule).
During treatment with Ganfort 0.3/5, darkening of the eyelid skin and gradual increased eyelash growth (lengthening, darkening and thickening) with no consequent untoward ocular effects have been observed.
Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation since these have been observed during treatment with bimatoprost. Some of these changes may be permanent and may lead to impaired field of vision and differences in appearance between the eyes if only one eye is treated (see Section 4.8 Adverse Effects (Undesirable Effects)).
There is the potential for hair growth to occur in areas where Ganfort 0.3/5 solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Ganfort 0.3/5 solution as instructed and to avoid it running onto the cheek or other skin areas.
Like other topically applied ophthalmic agents, Ganfort 0.3/5 may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed.

Identified precautions.

Due to the beta-adrenergic component, timolol, adverse reactions typical of systemic beta-adrenoceptor blocking agents may occur and include the following.

Anaphylaxis.

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Cardiac disorders.

Although rare, cardiac reactions have been reported, including death due to cardiac failure. Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension. Cardiac failure should be adequately controlled before beginning Ganfort 0.3/5 therapy. Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked. Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. Due to the negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Beta-blockers may cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and rarely, death in association with cardiac failures have been reported following administration of timolol maleate.

Respiratory disorder.

Respiratory reactions have been reported, including death, due to bronchospasm. Patients with chronic obstructive pulmonary diseases of mild or moderate severity, should in general, not receive products containing beta-blockers, including Ganfort 0.3/5; however, if Ganfort 0.3/5 is deemed necessary in such patients, it should be administered with caution in such patients and only if the potential benefit outweighs the potential risk.

Liver and renal function.

Ganfort 0.3/5 has not been studied in patients with hepatic or renal impairment. Therefore caution should be used in treating such patients.
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months. There are no known adverse reactions of ocular timolol on liver function.

Hyperthyroidism.

Beta-blockers may also mask the signs of hyperthyroidism.

Other beta-blocking agents.

Patients who are already receiving a beta-adrenergic blocking agent orally and who are given timolol should be closely observed for a potential additive effect either on the IOP or on the known systemic effects of beta-blockade. The use of two topical beta-adrenergic blocking agents is not recommended.

Choroidal detachment.

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.

Diabetes mellitus.

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycemia.

Surgical anaesthesia.

Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anaesthesia in surgical procedures. In patients undergoing elective surgery, it may be necessary to gradually withdraw the beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists. The anaesthetist must be informed if the patient is using Ganfort 0.3/5.

Muscle weakness.

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis, and generalised weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

Vascular disorders.

Patients with severe peripheral circulatory disturbance/ disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.

Corneal diseases.

Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.

Use in the elderly.

See Section 5.2 Pharmacokinetic Properties.

Paediatric use.

Safety and effectiveness in paediatric patients have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Specific drug interaction studies have not been conducted with Ganfort 0.3/5 eye drops.
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when eye drops containing timolol are administered concomitantly with oral calcium channel blockers, guanethidine, or beta-blocking agents, antiarrhythmics, digitalis glycosides or parasympathomimetics.
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Potentiated systemic beta-blockade (e.g. decreased heart rate) has been reported during combined treatment with quinidine and timolol, possibly because quinidine inhibits the metabolism of timolol via the P450 enzyme, CYP2D6.
Although timolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol and epinephrine has been reported occasionally.
Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycaemia.
Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine depleting drugs such as reserpine because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Bimatoprost did not affect fertility in male or female rats at oral doses up to 0.6 mg/kg/day corresponding to 30-50 times the expected human exposure (based on blood AUC calculated from total blood concentration).
Reproductive toxicity studies of timolol in rats showed no adverse effects on male or female fertility at oral doses up to 100 mg/kg/day.
(Category C)
There are no adequate data on the use of Ganfort 0.3/5 in pregnant women.

Bimatoprost.

Bimatoprost and/or its metabolites crossed the placenta in rats. In embryofetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost of 0.3 and 0.6 mg/kg/day, respectively, resulting in exposures 15 and 34 times the expected human exposure (based on blood AUC calculated from total blood concentration). Bimatoprost was not teratogenic at up to 0.6 mg/kg/day in mice or rats. At doses of ≥ 0.3 mg/kg/day PO in rats, approximately 20 times the expected human exposure, the gestation length was reduced, embryofetal losses and peri- and postnatal pup mortality were increased, and pup bodyweights were reduced.

Timolol.

Timolol was not teratogenic in mice, rats or rabbits at oral doses up to 50 mg/kg/day (over 600 times the maximum recommended clinical dose on a "mg/m2" basis), although delayed fetal ossification was observed at this dose in rats. At higher doses, there were increases in resorptions and fetal variations (14 ribs and hypoplastic sternebrae) in mice (1000 mg/kg/day), increased resorptions in rabbits (≥ 90 mg/kg/day), and a decreased number of caudal vertebral bodies and arches as well as an increase in hypoplastic sternebrae in rats (500 mg/kg/day).
Epidemiological studies suggest that owing to their pharmacological effects beta-blockers may reduce placental perfusion, which may result in intrauterine growth retardation, premature delivery, or fetal death. In addition, undesirable effects (e.g. bradycardia and hypoglycaemia) may occur in the fetus and the neonate. There is also an increased risk of cardiac and pulmonary complications in a neonate that has been exposed to a beta-blocker.
Consequently, Ganfort 0.3/5 should not be used during pregnancy unless clearly necessary.

Bimatoprost.

Bimatoprost was excreted in rat milk following PO administration. Increased pup mortality and depressed pup growth occurred when dams were treated PO with bimatoprost from gestation day 7 to lactation day 20 at ≥ 0.3 mg/kg/day, corresponding to exposures approximately 20 times the expected human exposure (based on blood AUC calculated from total blood concentration).
There are no data on the excretion of bimatoprost into human milk or on the safety of bimatoprost exposure in infants.

Timolol.

Timolol is excreted in human milk and there is potential for serious adverse reactions from timolol in breastfed infants. Therefore, nursing women who use Ganfort 0.3/5 should stop breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

Ganfort 0.3/5 has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

The majority of ADRs were ocular, mild in severity and none were serious.
Based on 12 month clinical data, the most commonly reported ADR in the Ganfort 0.3/5 group was conjunctival hyperaemia in approximately 26% of patients and led to a discontinuation rate of 1.5% in patients. The conjunctival hyperaemia was mostly trace to mild and thought to be of a noninflammatory nature.
In the 12 month studies, discontinuations due to adverse events occurred in 6.9% of patients in the Ganfort 0.3/5 group compared with 9.8% in the bimatoprost group and 3.4% in the timolol group.
The following adverse drug reactions were reported during clinical trials with Ganfort 0.3/5 eye drops.

Ocular effects.

Very common (> 1/10): conjunctival hyperaemia, growth of eyelashes.
Common (> 1/100, < 1/10): burning sensation, eye pruritus, superficial punctate keratitis, eye dryness, foreign body sensation, stinging sensation in the eye, eyelid erythema, photophobia, eye pain, eye discharge, eyelid pruritus, visual disturbance, corneal erosion.
Uncommon (> 1/1000, < 1/100): eye irritation, blepharitis, epiphora, iritis, eyelid oedema, eyelid pain, conjunctival oedema, asthenopia, trichiasis, visual acuity worsened.

Nervous system disorders.

Uncommon (> 1/1000, < 1/100): headache.

Respiratory, thoracic and mediastinal disorders.

Uncommon (> 1/1000, < 1/100): rhinitis.

Skin and subcutaneous tissue disorders.

Common (> 1/100, < 1/10): blepharal pigmentation. Uncommon (> 1/1000, < 1/100): hirsutism.

Post-marketing experience.

In addition to what has been observed in clinical trials, the following adverse reactions have been identified during postmarketing use of Ganfort 0.3/5. Because postmarketing reporting is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions.

Cardiac disorders.

Bradycardia.

Eye disorders.

Cystoid macular oedema, eye swelling, lid sulcus deepened (enophthalmos), iris hyperpigmentation, vision blurred, ocular discomfort.

General disorders and administration site conditions.

Fatigue.

Immune system disorders.

Hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy.

Nervous system disorders.

Dizziness, dysgeusia.

Psychiatric disorders.

Insomnia, nightmare.

Respiratory, thoracic and mediastinal disorders.

Asthma, dyspnoea.

Skin and subcutaneous tissue disorders.

Alopecia, skin hyperpigmentation (periocular), skin discolouration (periocular).

Vascular disorders.

Hypertension.

Additional adverse events.

Additionally adverse events that have been seen with either one of the components may potentially occur also with Ganfort 0.3/5.
Bimatoprost.

Ocular effects.

Ocular pruritus, allergic conjunctivitis, eyelash darkening, ocular burning, ocular dryness, ocular irritation, pigmentation of periocular skin, tearing, blepharospasm, retinal haemorrhage and eye discharge; prostaglandin analogue periorbitopathy.

Systemic effects.

Nausea, hypertension, asthenia, headache, infection (primarily colds and upper respiratory tract infections), depression and vertigo.

Description of selected adverse reactions.

Prostaglandin analogue periorbitopathy (PAP).

Prostaglandin analogues including Ganfort can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show. Changes are typically mild, can occur as early as one month after initiation of treatment with Ganfort, and may cause impaired field of vision even in the absence of patient recognition. PAP is also associated with periocular skin hyperpigmentation or discoloration and hypertrichosis. All changes have been noted to be partially or fully reversible upon discontinuation or switch to alternative treatments.

Iris hyperpigmentation.

Increased iris pigmentation is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long-term effects of increased iris pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish. Neither naevi nor freckles of the iris appear to be affected by the treatment. At 12 months, the incidence of iris hyperpigmentation with bimatoprost 0.1 mg/mL eye drops, solution was 0.5%. At 12 months, the incidence with bimatoprost 0.3 mg/mL eye drops, solution was 1.5% and did not increase following 3 years treatment.
Timolol.

Ocular effects.

Decreased corneal sensitivity, diplopia, ptosis, pseudopemphigoid, refractive changes, signs and symptoms of ocular irritation including conjunctivitis, keratitis and choroidal detachment following filtration surgery.

Systemic effects.

See Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use for additional information on the susceptible patient populations.
Arrhythmia, atrioventricular block, hypotension, syncope, heart block, cerebrovascular accident, cerebral ischaemia, cardiac arrest, cardiac failure, palpitations, worsening of angina pectoris, pulmonary oedema, claudication, Raynaud's phenomenon, cold hands and feet, bronchospasm (predominantly in patients with pre-existing bronchospastic disease) (uncommon, see Section 4.4 Special Warnings and Precautions for Use), exacerbation of asthma, respiratory failure, upper respiratory infection, nasal congestion, cough, chest pain, alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash, signs and symptoms of allergic reactions including anaphylaxis, angioedema, pruritus, urticaria, localised and generalised rash, anxiety, confusion, depression, disorientation, hallucinations, nervousness, somnolence, memory loss, increase in signs and symptoms of myasthenia gravis, paraesthesia, abdominal pain, anorexia, dry mouth, nausea, vomiting, diarrhoea, dyspepsia, decreased libido, Peyronie's disease, retroperitoneal fibrosis, sexual dysfunction, systemic lupus erythematosus, hypoglycaemia, myalgia, and tinnitus.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No case of overdose has been reported with Ganfort 0.3/5 and is unlikely to occur after ocular administration.

Bimatoprost.

Systemic overdose resulting from accidental ingestion. If Ganfort 0.3/5 is accidentally ingested, the following information may be useful: in two week oral rat and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 70 times higher than the accidental dose of one bottle of Ganfort 0.3/5 in a 10 kg child.

Timolol.

Symptoms of systemic timolol overdose are: dizziness, headache, shortness of breath, bradycardia, hypotension, bronchospasm, and cardiac arrest. A study of patients showed that timolol did not dialyse readily.
If overdosage occurs, treatment should be symptomatic and supportive.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ophthalmologicals; beta-blocking agents. ATC code: S01ED51.

Mechanism of action.

Ganfort 0.3/5 consists of two active substances: bimatoprost and timolol maleate. These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. Ganfort 0.3/5 has a rapid onset of action.

Bimatoprost.

Bimatoprost is a synthetic prostamide analogue with potent ocular hypotensive activity. It selectively mimics the effects of a naturally occurring substance, prostamide. Prostamide is biosynthesised from anandamide by a pathway involving COX-2 but not COX-1, suggesting a new pathway that leads to the synthesis of endogenous lipid amides that lower IOP. Bimatoprost and prostamides differ from prostaglandins (PGs) in that prostamides are biosynthesised from a different precursor, anandamide; bimatoprost does not stimulate any previously described prostanoid receptor; it is not mitogenic; it does not contract the human uterus; and it is electrochemically neutral.
Bimatoprost reduces IOP in man by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. Reduction of the IOP starts approximately 4 hours after the first administration and maximum effect is reached within approximately 8 to 12 hours. The duration of effect is maintained for at least 24 hours.
Clinical studies have shown mean IOP decreases of up to 9 mmHg.

Timolol.

Timolol maleate is a nonselective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant or local anaesthetic (membrane stabilising) activity. Timolol maleate combines reversibly with a part of the cell membrane, the beta-adrenergic receptor, and thus inhibits the usual biological response that would occur with stimulation of that receptor. The specific competitive antagonism blocks stimulation of the beta-adrenergic receptors by catecholamines having beta-adrenergic stimulating (agonist) activity, whether these originate from an endogenous or exogenous source. Reversal of this blockade can be accomplished by increasing the concentration of the agonist, which will restore the usual biological response.
The precise mechanism of action of timolol maleate in lowering IOP is not clearly established at this time, although a fluorescein study and tonography studies indicate that its predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed.

Clinical trials.

Elevated IOP presents a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and glaucomatous visual field loss. Bimatoprost has the action of lowering IOP with no clinically relevant effects on heart rate and blood pressure observed in clinical trials. Timolol decreases aqueous humour production with little or no significant effect on episcleral venous pressure, outflow facility or uveoscleral outflow.
In four well controlled, double blind, 3 arm, parallel group studies the IOP reducing effect of Ganfort 0.3/5 was compared with bimatoprost and timolol monotherapy. The mean decreases from the baseline in IOP were statistically significant within each treatment group at all timepoints (p < 0.01). In the pooled analysis of 2 studies, identical in design, decreases of up to 9.6 mmHg are seen in the Ganfort 0.3/5 group compared with a maximum 8.8 mmHg in the bimatoprost group.
Responder rates using 18 mmHg as the reference point showed statistically significantly more patients treated with Ganfort 0.3/5 achieved mean diurnal IOP < 18 mmHg at all visits throughout the 12 month study period when compared with bimatoprost monotherapy and with timolol monotherapy (see Table 1).
The IOP lowering effect of Ganfort 0.3/5 was maintained over a 12 month period.

5.2 Pharmacokinetic Properties

Ganfort 0.3/5.

Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the monotherapy treatments to Ganfort 0.3/5 treatment in healthy subjects. Systemic absorption of the individual components was minimal and not affected by coadministration in a single formulation.
In two 12 month studies where systemic absorption was measured, no accumulation was observed with either of the individual components.

Bimatoprost.

Absorption.

Bimatoprost penetrates the human cornea and sclera in vitro.
After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 nanogram/mL) within 1.5 hours after dosing. Mean bimatoprost Cmax values were similar on days 7 and 14 at 0.0721 and 0.0822 nanogram/mL respectively. The mean AUC0-24hr values were also similar on days 7 and 14 at 0.0742 and 0.096 nanogram.hr/mL respectively, indicating that a steady systemic exposure to bimatoprost was reached during the first week of ocular dosing. The systemic exposure of bimatoprost is very low with no accumulation over time.

Distribution.

Bimatoprost is moderately distributed into body tissues with a steady-state systemic volume of distribution in humans of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. The plasma protein binding of bimatoprost is approximately 90%.
Data from in vitro studies showed that the overall extent of melanin binding was not dependent on concentration and the binding was reversible.

Metabolism.

Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing in humans. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.

Excretion.

Bimatoprost is eliminated primarily by renal excretion. Up to 67% of an intravenous dose of radiolabelled bimatoprost administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The elimination half-life, determined after intravenous administration, was approximately 45 minutes, the total blood clearance of unchanged bimatoprost was 1.5 L/hr/kg.
After twice daily dosing, the mean AUC0-24hr value of 0.0634 nanogram.hr/mL for bimatoprost in the elderly (subjects 65 years or older) was statistically significantly higher than that of 0.0218 nanogram.hr/mL in young healthy adults, suggesting the existence of an age effect. However, this finding is not clinically relevant as systemic exposure for elderly and young subjects remained very low from ocular dosing. There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.

Timolol.

After ocular administration of a 0.25% eye drop to humans, peak timolol concentration in the aqueous humour was 1.56 microgram/mL at 1 hour postdose. The half-life of timolol in plasma is about 7 hours. Timolol is partially metabolised by the liver with timolol and its metabolites excreted by the kidney. Timolol is not extensively bound to plasma.

5.3 Preclinical Safety Data

Ganfort 0.3/5.

Repeated dose toxicity studies on bimatoprost and timolol in combination showed no special additional hazard for humans. The ocular and systemic safety profile of the individual components is well established.

Bimatoprost.

Ocular administration of bimatoprost in monkeys at concentrations of 0.03% or 0.1% once or twice daily for 6 months to 1 year caused an increase in iris pigmentation and reversible dose related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure. No associated increase in melanocyte number was observed with the pigmentation. It appears that the mechanism of increased iris pigmentation is due to increased stimulation of melanin production in melanocytes and not to an increase in melanocyte number.
Periocular effects were also observed in an intravenous toxicity study at systemic exposures at least 235-fold higher than that observed in humans after ocular administration. No functional or microscopic changes related to the periocular effects were observed. The mechanism of action for the observed periocular changes is unknown.

Genotoxicity.

Bimatoprost was not mutagenic or clastogenic in a bacterial mutation assay, in a mouse lymphoma test in vitro or in a mouse micronucleus test. Both in vitro and in vivo studies (Ames test, neoplastic cell transformation assay, cytogenetic assay and micronucleus test in mice) showed no genotoxicity of timolol.

Carcinogenicity.

Bimatoprost.

Long-term studies in mice and rats revealed no evidence of carcinogenicity following oral (by gavage) administration of bimatoprost at doses up to 2 and 1 mg/kg/day, respectively. These doses resulted in systemic bimatoprost levels 85-95 times the maximum anticipated human exposure (based on blood AUC). In the rat carcinogenicity study, a dose related increase in vacuolated corpora lutea was observed. The clinical relevance of this ovarian effect is unclear.

Timolol.

In a two year study of timolol maleate in rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats dosed orally at 300 mg/kg/day, but not at 100 mg/kg/day (approximately 2000 times the maximum recommended dose in humans on a "mg/m2" basis). In a long-term study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumours, benign uterine polyps and mammary adenocarcinomas in female mice dosed orally at 500 mg/kg/day, but not at 50 mg/kg/day (approximately 600 times the maximum recommended ophthalmic dose in humans on a "mg/m2" basis).
In a subsequent study in female mice, in which postmortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumours was again observed at 500 mg/kg/day. The increased occurrence of mammary adenocarcinomas in female mice was associated with elevations in serum prolactin. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumours has been established in humans. In adult women who received oral treatment with timolol maleate at doses up to 60 mg (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, dibasic sodium phosphate heptahydrate, citric acid monohydrate; and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

6.2 Incompatibilities

The preservative in Ganfort 0.3/5 eye drops, benzalkonium chloride, may be absorbed by and cause discolouration of soft contact lenses (see Section 4.2 Dose and Method of Administration, Information for patients).

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
To avoid contamination of the solution, keep container tightly closed. Contents are sterile if seal is intact.

6.5 Nature and Contents of Container

Ganfort 0.3/5 (bimatoprost) 0.3 mg/mL and (timolol) 5.0 mg/mL eye drops are supplied in white opaque low density polyethylene (LDPE) bottles with polystyrene screw caps. Each bottle has a fill volume of 3 mL; pack size: 1 x 3 mL bottles in a carton.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Bimatoprost is a synthetic prostamide analogue for ophthalmic use. It is a white to off-white powder and is very soluble in ethyl alcohol, methyl alcohol and slightly soluble in water.
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. It is a white, odourless, crystalline powder which is soluble in water, methanol and alcohol.

Chemical structure.

Bimatoprost.


Chemical name: (Z)-7-[(1R,2R,3R,5S) -3,5-dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl] cyclopentyl]-N-ethyl-5-heptenamide.
Molecular weight: 415.58.
Empirical formula: C25H37NO4.

Timolol maleate.


Chemical name: (S)-1-(tert-butylamino)-3- [(4-morpholino-1,2,5-thiadiazol-3-yl) oxy] -2-propanol maleate (1:1) (salt).
Molecular weight: 432.50 as the maleate salt.
Empirical formula: C13H24N4O3S.C4H4O4.

CAS number.

Bimatoprost.

155206-00-1.

Timolol maleate.

26921-17-5.

7 Medicine Schedule (Poisons Standard)

S4, prescription only medicine.

Summary Table of Changes