TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle

Main information

  • Trade name:
  • TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173354
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173354

TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

27/07/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle

Product Type

Single Medicine Product

Effective date

5/07/2018

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

TRAVATAN Eye Drops are indicated to decrease elevated intraocular pressure in: - ocular hypertension. - open-angle glaucoma. TRAVATAN Eye Drops

may be used: - as first line monotherapy. - as adjunctive therapy.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

2 Years

Store below 30

degrees Celsius

Not recorded

Discard 4 weeks after

opening

Bottle

2 Years

Store below 30

degrees Celsius

Not recorded

Discard 4 weeks after

opening

Pack Size/Poison information

Pack Size

Poison Schedule

2.5 mL x 3

(S4) Prescription Only Medicine

2.5 mL x 1

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Eye Drops, solution

Route of Administration

Ophthalmic

Visual Identification

Clear colourless, sterile and preserved solution

Active Ingredients

travoprost

40 microgram/mL

Public Summary

Page 1 of

Produced at 23.05.2019 at 06:56:07 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

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Public Summary

Page 2 of

Produced at 23.05.2019 at 06:56:07 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

TRAVATAN

TRAVATAN

®

Eye Drops 0.004%

travoprost

CONSUMER MEDICINE INFORMATION

What is in this leaflet

Read this leaflet carefully before

you start to use Travatan Eye

Drops.

This leaflet answers some common

questions about Travatan Eye Drops.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak

to your pharmacist or doctor to

obtain the most up to date

information on the medicine.

You can also download the most up

to date leaflet in Australia from

www.novartis.com.au or

www.medsafe.govt.nz in New

Zealand.

The updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using Travatan

against the expected benefits it will

have for you.

The information in this leaflet applies

to Travatan Eye Drops only. This

information does not apply to similar

products, even if they contain the

same ingredients.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What TRAVATAN is

used for

Travatan Eye Drops contain the

active ingredient travoprost, which

belongs to a class of medicines

known as "prostaglandins".

Travatan Eye Drops are used, either

alone or in combination with other

eye drops/medicines, to lower raised

pressure in the eye and to treat

glaucoma.

Glaucoma is usually caused by a

build-up of the fluid which flows

through the eye, leading to an

increase in the pressure within the

eye; some people with glaucoma

may, however, have normal pressure

within the eye.

Travatan Eye Drops lower the

pressure within the eye by increasing

the outflow of fluid from the eye.

Although Travatan Eye Drops help to

control your glaucoma, it does not

cure it.

Before prescribing Travatan Eye

Drops for you, your doctor will have

examined your eye(s) and decided

that Travatan Eye Drops is the right

medicine.

Your doctor may have prescribed

Travatan Eye Drops for another

reason. Ask your doctor if you have

any questions about why Travatan

Eye Drops have been prescribed for

you.

Travatan Eye Drops are not

addictive.

For more information about

glaucoma contact Glaucoma

Australia on 1800 500 880 or

Glaucoma New Zealand on 09 373

8779.

Use in children

This medicine is not recommended in

children.

The safety and effectiveness of

Travatan Eye Drops has not been

established in children.

Before you use

TRAVATAN

When you must not use it

Do not use Travatan Eye Drops if

you have an allergy to:

travoprost or 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 use Travatan Eye Drops if

you are pregnant or intend to

become pregnant.

Do not use this medicine if:

the foil overwrap pouch appears

damaged in any way (it is

TRAVATAN

possible that the foil overwrap

pouch may have been removed by

your pharmacist)

the bottle/packaging shows signs

of tampering

the expiry date on the

bottle/carton has passed. If you

use this medicine after the expiry

date has passed, it may not work

as well.

If it has expired or is damaged, return

it to your pharmacist for disposal.

Do not use Travatan Eye Drops

while you are wearing contact

lenses.

You can put your contact lenses into

your eyes 15 minutes after you have

used Travatan Eye Drops.

If you are not sure whether you

should start using Travatan Eye

Drops talk to your doctor.

Before you start to use it

Tell your doctor if you have any

allergies to any other medicines,

preservatives or dyes.

Tell your doctor if you are

breastfeeding or intend to

breastfeed.

Your doctor will discuss the possible

risks and benefits of using Travatan

Eye Drops when breastfeeding.

Tell your doctor if you suffer from

dry eyes, inflammation of the eye

or any diseases of the cornea.

If you have not told your doctor

about any of the above, tell him/ her

before you use Travatan Eye Drops.

Using other medicines

Tell your doctor or pharmacist if you

are taking any other medicines,

including medicines that you buy at a

pharmacy or health food shop

without a doctor's prescription.

Some medicines and Travatan Eye

Drops may interfere with each other.

Tell your doctor if you are

currently taking or using any other

medicines to treat glaucoma or if

you are using any other type of eye

drops.

These medicines may be affected by

Travatan Eye Drops or may affect

how well it works. You may need

different amounts of your medicine,

or you may need to use other

different medicines.

Your doctor or pharmacist will be

able to tell you what to do when

using Travatan Eye Drops with other

medicines.

How to use

TRAVATAN

Carefully follow all directions

given to you by your doctor and

pharmacist.

They may differ from the

information contained in this leaflet.

If you are being changed from one

medicine to another, follow your

doctor's instructions carefully as to

when to stop the old medicine and

when to start the new eye drops.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for

help.

How much to use

The usual dose of Travatan Eye

Drops is one drop in the affected

eye(s) once each day. The dosing

instructions will be printed on the

label your pharmacist puts on the

bottle or carton.

How to use it

It is important to use Travatan Eye

Drops exactly as your doctor or

pharmacist has told you. If you use it

less often than you should, it may not

work as well and the eye problem

may not improve. Using it more

often than you should may not

improve the eye problem any faster

and may cause increased side effects.

If you are wearing soft contact

lenses, remove them before putting

the drops in your eye.

Follow these steps to use Travatan

Eye Drops:

Wash your hands thoroughly with

soap and water.

Immediately before using a bottle

for the first time, tear off the

overwrap pouch and take the

bottle out (see Diagram1).

Diagram 1

Shake the bottle.

Remove the cap from the bottle.

Hold the bottle upside down in

one hand between your thumb

and first finger (see Diagram 2).

Diagram 2

While tilting your head back,

gently pull down the lower eyelid

of your eye to form a pouch /

pocket.

Place the tip of the bottle close to

your eye. Do not let it touch your

eye.

Release one drop into the

pouch/pocket formed between

your eye and eyelid by gently

squeezing the sides of the bottle

(see Diagram 3).

TRAVATAN

Diagram 3

Close your eye. Do not blink or

rub your eye.

10. 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. This will also reduce the

unpleasant taste sensation that

some people experience when

using these drops.

11. If necessary, repeat the above

steps for the other eye.

12. Your eyelids can only hold less

than one drop at a time, so it is

normal for a small amount of the

eye drop to spill onto your cheek.

You should wipe away any

spillage with a tissue.

13. Replace the cap on the bottle,

closing it tightly.

14. 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.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else.

This will help prevent the drops

becoming dirty or contaminated.

If you have trouble knowing whether

you have placed your drops correctly,

you may want to store them in the

fridge. Some people find it easier to

feel the drops in the eye if they are

cold.

After using Travatan Eye Drops, wait

at least 5 minutes before putting any

other eye drops in your eye(s).

Wait 15 minutes before replacing

your contact lenses.

When to use it

Use Travatan 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(s) each day will have

the best effect on your eye pressure.

It will also help you remember when

to use the eye drops.

Travatan Eye Drops work most

effectively if used during the

evening, before going to bed.

How long to use it

Your doctor or pharmacist will tell

you how long to use Travatan Eye

Drops.

Travatan Eye Drops help control

your condition but do not cure it.

Therefore, Travatan Eye Drops must

be used every day. Continue using

Travatan Eye Drops for as long as

your doctor prescribes.

Do not use Travatan Eye Drops

longer than your doctor tells you.

If you use Travatan Eye Drops longer

than your doctor or pharmacist tells

you, the chance of side effects may

increase.

If you are unsure about when or how

to stop using Travatan Eye Drops,

you should talk to your doctor or

pharmacist.

If you forget to use it

If you forget to use Travatan Eye

Drops, you should put the drops that

you missed in the eye(s) as soon as

you remember and then go back to

using them as recommended by your

doctor. If it is almost time for the

next dose, skip the dose that you

missed and continue using them as

recommended.

Do not use double the amount to

make up for the dose that you

missed.

Using multiple doses may cause

unwanted side effects.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

If you have trouble remembering to

use the 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.

If you think that you or anyone

else may have swallowed any or all

of the contents of a bottle of

Travatan Eye Drops, immediately

telephone your doctor, or the

Poisons Information Centre in

Australia on 13 1126 or the

National Poisons Centre in New

Zealand on 0800 POISON or 0800

764 766 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

TRAVATAN

Things you must do

Tell all doctors and pharmacists

who are treating you that you are

using Travatan Eye Drops.

Tell your doctor if, for any reason,

you have not used Travatan Eye

Drops exactly as prescribed.

Otherwise your doctor may think that

it was not effective and change the

treatment unnecessarily.

You should have your eye pressure

checked when your eye specialist

says, to make sure that Travatan

Eye Drops are working.

TRAVATAN

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 bottle of Travatan Eye Drops

because of possible contamination of

the old one or may advise you to stop

treatment with Travatan Eye Drops.

If you become pregnant while

using Travatan Eye Drops, tell

your doctor immediately.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are using

Travatan Eye Drops.

Things you must not do

Do not:

let children handle Travatan Eye

Drops

stop using Travatan Eye Drops

without first asking your doctor

give this medicine to anyone else,

even if they appear to have the

same condition as you

use Travatan Eye Drops to treat

other complaints unless your

doctor or pharmacist tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Travatan Eye Drops affect you and

your vision.

As with any eye medicines,

temporary blurred vision or other

visual disturbances may affect the

ability to drive or use machinery in

some people. If blurred vision occurs

when you use your drops, wait until

your vision is clear before driving or

operating machinery.

Side effects

Tell your doctor as soon as possible

if you do not feel well while you are

using Travatan Eye Drops.

This medicine helps most people to

lower raised blood pressure in the

eye or to treat glaucoma, but may

have unwanted side effects in some

people. All medicines can have side

effects. Sometimes they are serious,

however most of the time they are

not. You may need to seek medical

treatment if you get some of the side

effects.

Do not be alarmed by the following

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 if you notice any of

the following effects in the eye(s)

and the eye area, and they worry you:

redness of the eye

inflammation inside the eye

eye pain or swelling

eye strain

eye irritation

eye discharge

sunken eyes

sensitivity to light

blurred, reduced or abnormal

vision

dry or itchy eye

discomfort in or around the eye

increased tear production

abnormal or decreased eye

sensation

eyelid abnormality, irritation,

itching, redness, pain, swelling or

crusting

eczema eyelids

discolouration of the eyelashes

increased or decreased growth or

number of eyelashes

changes in the colour of the iris.

Travatan Eye Drops may gradually

change the colour of the eye (s); this

is due to an increase in pigment

within the iris (coloured portion of

the eye). This change in eye colour is

most frequently seen in eyes with

mixed colours (e.g. blue-brown,

grey-brown), however, it may also

occur with single coloured eyes. This

change in eye colour may be

permanent.

These are the most common side

effects of your medicine. They are

usually mild and short-lived.

Additional side effects that are

noticed more rarely in the eye

include:

inflammation or infection of the

conjunctiva

inflammation of the back of the

corneal disorder

eye allergy

tired eyes

eye herpes simplex

ingrowth or introversion of the

eyelashes

cataract.

Occasionally, some people notice

unwanted effects in the rest of the

body as a result of using Travatan

Eye Drops. These effects may

include:

discolouration of the skin around

the eye(s)

shortness of breath, asthma or

worsening of asthma

increased or decreased blood

pressure

irregular, increased or decreased

heart rate

chest pain

viral infection

generalized weakness

cough, throat pain or irritation,

dry or stuffy nose, nasal

discomfort, voice changes

increased allergic symptoms

abdominal pain, gastrointestinal

discomfort, ulcer, constipation,

diarrhoea, vomiting, nausea

skin inflammation, redness,

itching, discolouration

increased body hair

hair colour changes

shoulder pain

bad taste

TRAVATAN

dry mouth

headache, dizziness, ringing in

ears

depression, anxiety

increased prostate antigen

body weakness

muscular or joint pain

painful or inability to control

passing of urine.

Stop using Travatan Eye Drops

and tell your doctor immediately

or go to Accident and Emergency

at your nearest hospital if any of

the following happen:

skin rash

swelling of the face, hands or feet

wheezing, difficulty in breathing

shortness of breath (dyspnoea,

heart failure)

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash.

These hypersensitivity reactions can

be very serious side effects. You may

need urgent medical attention or

hospitalisation. These side effects are

very rare.

Other side effects not listed above

may also occur in some patients. Let

your doctor know if you observe any

unwanted effects while using

Travatan Eye Drops, even if they do

not appear in the list above.

After using

TRAVATAN

Storage

Store Travatan Eye Drops in a cool

dry place.

Travatan Eye Drops preserved

with polyquaternium-1 should be

stored at temperatures below 30°C.

Travatan Eye Drops preserved

with benzalkonium chloride*

should be stored at temperature

below 25°C.

It is not necessary to store

Travatan Eye Drops in the

refrigerator, but it is acceptable if

you prefer to instil cold drops.

Do not freeze.

Do not leave Travatan Eye Drops

in the car, in the bathroom or in

other warm, damp places.

Heat and temperature can destroy

some medicines.

Do not leave the top off the bottle for

any length of time, to avoid

contaminating the eye drops.

Keep Travatan Eye Drops, and all

other medicine in a safe place.

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.

Disposal

Discard each bottle of Travatan

Eye Drops 4 weeks after it has

been opened.

Write the date when it was opened on

the bottle label to remind you when

to discard the bottle.

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 then be used.

If your doctor tells you to stop

using Travatan Eye Drops or it has

passed the expiry date, ask your

pharmacist what to do with any

that is left over.

Product description

What it looks like

Travatan Eye Drops is a colourless to

pale yellow liquid that comes in a 2.5

mL oval DROP-TAINER

dispenser.

Ingredients

The active ingredient in Travatan

Eye drops is travoprost 40 mcg in 1

Travatan Eye Drops also contain:

polyquaternium-1, as a

preservative

polyoxylene hydrogenated castor

boric acid

mannitol

sodium chloride

propylene glycol

purified water

sodium hydroxide and/or

hydrochloric acid (to adjust pH).

Travatan Eye Drops preserved with

benzalkonium chloride* also contain:

polyoxylene hydrogenated castor

disodium edetate

boric acid

trometamol

mannitol

purified water.

Supplier

Travatan Eye Drops is supplied in

Australia by:

Novartis Pharmaceuticals Australia

Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone No. 1800 671 203

www.novartis.com.au

Travatan Eye Drops is supplied in

New Zealand by:

Novartis New Zealand Limited

109 Carlton Gore Road

Newmarket

Auckland 1023.

PO Box 99102

Newmarket

Auckland 1149

New Zealand

TRAVATAN

Free Phone: 0800 354 335.

Australian Registration

Number

AUST R: 173354

Date of Preparation

This leaflet was prepared in January

2018.

© Novartis Pharmaceuticals

Australia Pty Limited 2018

® Registered Trademark

* This formulation is not available in

Australia or New Zealand.

Internal document code

(tra040717c_v2) based on PI

(tra040717i)