APO-Bimatoprost

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

Bimatoprost
Consumer Medicine Information
 

What is in this leaflet

This leaflet answers some common questions about bimatoprost. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for

Bimatoprost is used to lower raised pressure in the eye and to treat glaucoma.
Glaucoma is a condition in which the pressure of fluid in the eye may be higher than normal. It 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, causing the pressure 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.
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.

How it works

Bimatoprost belongs to a group of medicines called prostaglandin analogues. It lowers the pressure in the eye by helping the flow of fluid out of the eye chamber.
Bimatoprost eye drops can be used alone or together with other medicines to lower the pressure within your eyes.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is not enough information to recommend the use of this medicine in children.

Before you use this medicine

When you must not use it

Do not use this medicine if you have an allergy to:
bimatoprost
any of the ingredients listed at the end of this leaflet.
Do not use the medicine after the expiry date printed on the bottle or if the seal around the bottle is broken or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Before you start using bimatoprost eye drops your doctor should tell you that some changes to your eyes may occur which may be permanent.
Eyelashes may grow longer and thicker, and eyelashes, the skin around the eye and the coloured part of the eye may become darker. If only one eye is being treated the cosmetic differences between the eyes may be noticeable. None of these changes should affect vision. If you have any concerns, ask your doctor.
Do not put the eye drops into your eye(s) while you are wearing soft contact lenses.
The preservative in bimatoprost 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 the eye drops.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
breathing problems
liver or kidney problems
hypotension (low blood pressure)
bradycardia (low heart rate)
other heart conditions
eye disorders
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Do not use this medicine until you and your doctor have discussed the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start using this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

How to use this medicine

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to use

Your doctor will tell you how many drops you need to use each day.
The usual dose is one drop in the affected eye(s) once daily, given in the evening.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.
If you are wearing soft contact lenses, remove them before putting the drops in your eye.
To open a new bottle of bimatoprost eye drops, break off the protective seal from the bottle and place in the bin. The contents are sterile if the seal is intact.

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.

Wait 5 minutes before using any other topical eye medication.
Wait 15 minutes before replacing your contact lenses.
Be careful not to touch the bottle tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

When to use it

Use bimatoprost eye drops at about the same time each day.
Using your eye drops at the same time each day will have the best effect. It will also help you remember when to use your eye drops.

How long to use it

Continue bimatoprost eye drops for as long as your doctor tells you.
Bimatoprost eye drops help to control your condition, but do not cure it.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.
Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not administer a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

If you accidentally put several drops in your eye(s), immediately rinse your eye(s) with warm water.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accidental and Emergency at your nearest hospital, if you think that you or anyone else may have swallowed any or all of the contents of a bottle of bimatoprost eye drops. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you use this medicine.
Tell your doctor if you develop an eye infection, receive an eye injury, or have eye surgery.
Your doctor may tell you to use a new bottle of bimatoprost eye drops because of possible contamination of the old bottle.
If you become pregnant, tell your doctor immediately.
Hair may grow where bimatoprost contacts the skin.
If you wear soft contact lenses, remove them before using bimatoprost eye drops. Leave your lenses out for at least 15 minutes after putting in the eye drops.
Keep all of your doctor's appointments so that your progress can be checked.
Tell your doctor if your condition gets worse or does not get better while using bimatoprost eye drops.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use your medicine to treat any other complaint unless your doctor tells you to.
Do not stop using your medicine or change the dosage without first checking with your doctor.

Things to be careful of

Your vision may blur for a short time after you put in your eye drops. If this happens you should wait until you can see well again before you drive or use machinery.
Bimatoprost eye drops are not expected to cause any problems with your ability to drive a car or operate machinery. However, as a general precaution, be careful driving or operating machinery until you know how bimatoprost eye drops affect you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using this medicine.
This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
red, congested eyes
darkening or growth of eyelashes
itching, pain or irritation of eye/s
discharge from the eye, discomfort or dryness
tears, inflamed areas around eye/s
allergic effects or burning feeling on eye and surrounding eyelid
feeling of something in the eye
sensitivity to light
an increase in colouring or pigment of area around eye
blurred vision, visual changes
darkening of the coloured part of the eye
swelling of the back of the eye
other eye related problems such as spasm of the eye where there is uncontrolled blinking and squeezing of the eyelid, swelling of the eyelid, inflammation of the coloured part of eye, bleeding in the eye chamber, eyelid retraction, small lesions or erosions on the eye surface
effects on the body such as headache, weakness, dizziness, depression, infection, nausea, high blood pressure, skin pigmentation and abnormal hair growth.
The above list includes some side effects that may require medical attention.
If you think you are having an allergic reaction to bimatoprost, stop using this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep your eye drops in a cool dry place where the temperature will stay below 25°C.
Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Throw out any remaining solution after four weeks from the date of opening.
Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.
If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any medicine left over.

Product description

What it looks like

Clear, colourless solution in bottles containing 3 mL of solution.
AUST R 204398

Ingredients

APO- Bimatoprost eye drops contain 0.3 mg/mL of bimatoprost.
They also contain the following:
benzalkonium chloride
anhydrous citric acid
sodium chloride
dibasic anhydrous sodium phosphate
purified water
sodium hydroxide or hydrochloric acid for pH adjustment
This medicine does not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
Australia
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in October 2018.