APO-Latanoprost

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

latanoprost
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about this medicine. 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 taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What this medicine is used for

APO-LATANOPROST 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 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. 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.

How APO-LATANOPROST works

APO-LATANOPROST belongs to a family of medicines called prostaglandin agonists.
It lowers the pressure in the eye by allowing more fluid to flow out from within your eye.
Although APO-LATANOPROST helps control your glaucoma it does not cure it. So, you must keep using it until your doctor tells you to stop.
APO-LATANOPROST is used, either alone or in combination with other eye medicines, to lower raised pressure within your eye.
Ask your doctor if you have any questions about why APO-LATANOPROST has been prescribed for you.
Your doctor may have prescribed it for another reason.
APO-LATANOPROST is not addictive.

Use in Children

APO-LATANOPROST is not recommended for use in children. The safety and effectiveness of APO-LATANOPROST in children have not been established.

Before you use APO-LATANOPROST

When you must not use it

Do not take this medicine if you have an allergy to:
any medicine containing latanoprost
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine after the expiry date printed on the pack or if the bottle or packaging 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 APO-LATANOPROST, talk to your doctor.

Before you start to take it

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 medical conditions such as severe asthma, or any other types of glaucoma or eye conditions.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start taking 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.
Some medicines and APO-LATANOPROST may interfere with each other. These include:
eye drops which contain an ingredient called thiomersal. If using such eye drops as well as APO-LATANOPROST, you should wait at least 5 minutes between using these eye drops and APO-LATANOPROST
some other eye drops that contain a prostaglandin. The use of two or more prostaglandin eye drops at the same time is not recommended.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

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

The usual dose of APO-LATANOPROST is one drop into the affected eye, or eyes, once daily.
Use APO-LATANOPROST every day, at about the same time each day, preferably in the evening, 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.

How to use it

If you are wearing soft contact lenses, remove them before putting the drops in your eye.
The preservative in APO-LATANOPROST (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 APO-LATANOPROST.
If using other eye drops in addition to APO-LATANOPROST, wait at least 5 minutes before putting any other drops in your eye(s).
Be careful not to touch the dropper tip against your eye, eyelid or anything else.
Touching the dropper tip against something may contaminate the eye drops and give you an eye infection.
You may find it easier to put drops in your eye while you are sitting or lying down.

1. Wash your hands well with soap and water.

2. Twist off the protective overcap from the bottle.

3. Unscrew the inner cap.

4. Use your finger to gently pull down the lower eyelid of your affected eye.

5. Tilt your head back and look up.

6. Place the tip of the bottle close to but not touching your eye. Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.

Close your eye. Do not blink or rub your eye.

7. 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.

8. Screw the inner cap back on the bottle.

9. Wash your hands again with soap and water to remove any residue.

You may feel a slight burning sensation in the eye shortly after using the eye drops.
If this persists, or is very uncomfortable, contact your doctor or pharmacist.

How long to use it

Continue using APO-LATANOPROST every day for as long as your doctor prescribes.
APO-LATANOPROST helps control your condition but does not cure it.

If you forget to use it

If you miss a dose, skip the dose you missed and use your next dose when you are meant to.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several drops in your eye, immediately rinse your eye with warm water.
If you think that you or anyone else may have swallowed APO-LATANOPROST, immediately telephone your doctor or the Australian Poisons Information Centre (telephone 131 126) for advice or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using this medicine

Things you must do

To make sure APO-LATANOPROST is working properly, have your eye pressure checked regularly.
Have your eyes checked regularly for any other changes, including a change in eye colour.
A slow change in eye colour, which may be permanent, has been reported to occur in some patients who use APO-LATANOPROST. Your doctor will decide whether you should continue using APO-LATANOPROST.
If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.
Your doctor may tell you to use a new container of APO-LATANOPROST because of possible contamination of the old one or may advise you to stop your treatment with APO-LATANOPROST.
If you become pregnant while using APO-LATANOPROST, tell your doctor immediately.
If you are about to be started on any new medicine tell your doctor and pharmacist that you are using APO-LATANOPROST.
Tell all doctors and pharmacists who are treating you that you are using APO-LATANOPROST.

Things you must not do

Do not give APO-LATANOPROST to anyone else, even if they have the same condition as you.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not stop using APO-LATANOPROST without first talking to your doctor.
If you stop using your eye drops, your eye pressures may rise again and damage to your eye may occur.

Things to be careful of

Be careful driving or operating machinery until you know how APO-LATANOPROST affects you.
APO-LATANOPROST generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause blurred vision in some people. Make sure you know how you react to APO-LATANOPROST or that your vision is clear before driving a car or operating machinery.

Side effects

Check with your doctor as soon as possible if you have any problems while using APO-LATANOPROST, even if you do not think the problems relate to the medicine or are not listed in this leaflet.
Like other medicines, APO-LATANOPROST can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
a slow change in eye colour over a period of time.
The iris may become browner in colour and appear darker. This change may be permanent and more noticeable if you are only being treated in one eye.
blurred vision, double vision or other visual problems
irritation or feeling of having something in the eye.
This may be worse during the first two or three days of using APO-LATANOPROST.
eye pain
redness, burning or watering of the eye(s)
discharge, itching of the eye(s), crusty eyelashes
darkening, thickening, lengthening or an increase in the number of eye lashes and the fine hair on the eyelids
misdirected eyelashes sometimes causing eye irritation
darkening of the skin of the eyelids
crusting, redness, thickening, itching or burning of the eyelids
sensitivity to light
skin rash
headache
muscle/joint pain
painful, urgent or frequent urination.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
chest pain
you notice strong, rapid or irregular heartbeats
dizziness
white deposits or plaque in the cornea causing the transparent front part of your eye to look white or cloudy
symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

Storage and Disposal

Storage

Before opening APO-LATANOPROST, keep the bottle in its box in a refrigerator (2°C - 8°C) protected from light.
After opening APO-LATANOPROST, keep the bottle in its box in a cool place where the temperature stays below 25°C. You do not need to keep it refrigerated. Keep the box properly closed and protected from light.
Do not store this 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 it 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.
Put the top back on the bottle right away after use to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks.
Open a new bottle every 4 weeks.
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.
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 remaining solution.

Product description

What it looks like

APO-LATANOPROST eye drops come in a plastic bottle with a dropper and screw cap inside a protective overcap. Remove this overcap before use.
When you first receive your APO-LATANOPROST bottle, it will appear half full. This corresponds to 2.5 mL of eye drop solution, giving a minimum of 80 drops. This volume is enough to last 4 weeks if used in both eyes. AUST R 291496.

Ingredients

The active ingredient in APO-LATANOPROST eye drops is latanoprost. Each 1 mL of APO-LATANOPROST contains 50 micrograms of latanoprost. Each drop contains about 1.5 micrograms of latanoprost.
This medicine also contains the following:
sodium chloride
sodium phosphate monobasic monohydrate
sodium phosphate dibasic anhydrous
water for injections
benzalkonium chloride (as a preservative).

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Tel: (02) 8877 8333
Web: www1.apotex.com/au
This leaflet was prepared in September 2018.