Consumer medicine information

Flarex Eye Drops 0.1%

Fluorometholone acetate

BRAND INFORMATION

Brand name

Flarex

Active ingredient

Fluorometholone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flarex Eye Drops 0.1%.

What is in this leaflet

Please read this leaflet carefully before you use FLAREX Eye Drops.

This leaflet answers some common questions about Flarex. It does not contain all of 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 from www.novartis.com.au.

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 expected benefits of you using FLAREX against the risks this medicine could 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 need to read it again.

What FLAREX is used for

FLAREX Eye Drops are used to treat the redness, swelling and other symptoms of eye inflammation.

FLAREX Eye Drops contain the active ingredient fluorometholone acetate. Fluorometholone belongs to a class of medicines known as "steroids" or "corticosteroids" which reduce inflammation.

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

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor's prescription.

Use in children

This medicine is not recommended in children.

The safety and effectiveness of FLAREX Eye Drops has not been established in children.

Before you use FLAREX

When you must not use it

Do not use this medicine if you have an allergy to:

  • Fluorometholone
  • Any other similar medicines containing other types of "steroids"
  • 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 FLAREX if:

  • You are suffering from any type of viral infection of the eye
  • You have tuberculosis of the eye
  • You are suffering from any other types of infection including fungal or bacterial infections
  • You have another infection that is not being treated
  • You suffer from raised pressure within your eyes (intraocular pressure) or have been diagnosed with a condition known as "glaucoma".

Do not use this medicine if the expiry date has passed, the packaging is torn or the safety seal around the closure and neck area is broken. If it has expired or is damaged, return it to your pharmacist for disposal.

Do not wear contact lenses while you are using FLAREX Eye Drops.

If you are not sure whether you should start to use FLAREX talk to your doctor.

Before you start to use it

Tell your doctor if:

  • You are pregnant or plan to become pregnant.
    FLAREX is not recommended in pregnant women or women of child bearing potential not using a contraceptive.
  • You are breastfeeding.

Your doctor will discuss the possible risks and benefits of using FLAREX during breast-feeding.

If you have not told your doctor about any of the above, or any other general conditions, tell him or her before you start using this medicine.

Do not put FLAREX Eye Drops into your eye(s) while you are wearing contact lenses. The preservative in FLAREX Eye Drops, benzalkonium chloride, may be deposited in contact lenses.

You can put your contact lenses back into your eyes 15 minutes after you have used FLAREX Eye Drops.

Taking or using other medicines

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

Some medicines and FLAREX Eye Drops may interfere with each other.

These include eye drops or eye ointments which contain non-steroidal anti-inflammatory drugs (NSAIDs).

Tell your doctor if you are using medicines containing ritonavir or cobicistat, as this may increase the amount of FLAREX in the blood.

Using FLAREX

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

Use FLAREX Eye Drops only as prescribed by your doctor.

If you do not understand the instructions on the box ask your doctor or pharmacist for help.

How much to use

The usual dose of FLAREX Eye Drops is one to two drops in the affected eye, or eyes, two to four times a day.

The exact dose that your doctor prescribes for you will depend on the severity of your condition.

Do not use FLAREX Eye Drops more often than your doctor or pharmacist has told you.

Your pharmacist will put the dosing instructions on the bottle or carton of the drops.

It is important to follow your doctor’s directions when using FLAREX Eye Drops.

How to use FLAREX

If you are wearing contact lenses, remove them before putting the drops in your eye.

Follow these steps to use FLAREX Eye Drops:

  1. Wash your hands thoroughly.
  2. Shake the bottle well.
  3. Remove the cap from the bottle.
  4. Hold the bottle upside down in one hand between your thumb and middle finger (see Diagram 1).

  1. While tilting your head back, gently pull the lower eyelid of your eye down using the forefinger of your other hand.
  2. Place the dropper tip close to, but not touching, your lower eyelid and gently tap or press the base of the bottle with your forefinger to release one drop (see Diagrams 2 and 3).

  1. Close your eye gently without blinking.
  2. If necessary, repeat the above steps 1-6 for your other eye.
  3. Place the cap on the bottle and close it tightly.
  4. Wash your hands again.

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

Do not touch the tip of the dropper to your eye or to any other surface. This will help to prevent your eye drops becoming dirty or contaminated.

After using FLAREX 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 FLAREX Eye Drops at the same time each day. Using it at the same time each day will have the best effect. It will also help you remember when to use it.

How long to use it

Do not stop using FLAREX Eye Drops unless your doctor has advised you to.

If you are unsure about when to stop using FLAREX Eye Drops, you should talk to your doctor.

If you have been using FLAREX Eye Drops for more than a few days your doctor will slowly reduce the number of drops before you complete your treatment.

If you forget to use

If you forget to use FLAREX Eye Drops, you should put the drops that you missed in as soon as you remember and then go back to using them normally. If it is almost time for your next dose, skip the dose that you missed and take your next dose when you are due to.

Never use double the dose to make up for the one that you missed.

If you are not sure what to do, contact your doctor or pharmacist.

If you use too much (overdose)

If you accidentally put too many drops in your eye(s), immediately rinse your eye(s) with warm water.

If anyone accidentally swallows FLAREX Eye Drops, immediately telephone the nearest Poisons Information Centre on 13 11 26, or call your doctor, or go to Accident and Emergency at the nearest hospital.

While you are using FLAREX

Things you must do

If you become pregnant while using this medicine tell your doctor immediately.

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are using FLAREX Eye Drops.

Tell any other doctor, dentist or pharmacist that you are using this medicine.

If you are going to have surgery tell your surgeon or anaesthetist that you are using FLAREX Eye Drops.

Tell your doctor if you experience swelling around the trunk and in the face area with weight gain. This may occur when ophthalmic corticosteroids such as FLAREX eye drops become absorbed into your blood after intensive or long-term continuous treatment. These risks are especially important in predisposed patients, including children and patients treated with medicines containing ritonavir or cobicistat.

Things you must not do

Do not stop using FLAREX Eye Drops without first asking your doctor.

Do not use FLAREX Eye Drops to treat other complaints unless your doctor or pharmacist tells you to.

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

Do not let children handle FLAREX Eye Drops. If a child accidentally swallows any of the drops read the instructions under "If you use too much (overdose)".

Things to be careful of

Be careful of driving or operating machinery until you know how FLAREX 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 and use machinery in some people. If blurred vision occurs when you use your drops, wait until your vision is clear before driving.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using FLAREX Eye Drops.

This medicine helps most people but it may have some unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Most side effects from FLAREX Eye Drops occur in, or around, the eye. These include:

  • Blurred vision
  • Eye pain, discomfort or irritation
  • Eye redness
  • A feeling that something is in the eye
  • Increased pressure within the eye(s). If this continues, damage to the optic nerve and loss of vision may occur.
  • An increased likelihood of experiencing eye infections
  • A small puncture in the membranes surrounding the eye.
    This side effect is usually due to the presence of a viral infection in the eye which may weaken the membranes surrounding the eye.
  • Increased tearing

Occasionally, some people notice unwanted effects in the rest of their body as a result of using FLAREX Eye Drops. These include:

  • Change in taste sensation

Tell your doctor or pharmacist if you notice anything that is making you unwell.

Other side effects not listed above may also occur in some people.

After using FLAREX

Storage

Keep your eye drops in a cool, dry place where the temperature stays below 25°C. Do not refrigerate or freeze.

Put the top back on the bottle right away after use to avoid contaminating the eye drops. Do not leave the top off the bottle for any length of time.

Do not leave FLAREX Eye Drops in the car, in the bathroom or in other warm, damp places. Heat and humidity 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.

Disposal

Throw out each bottle of FLAREX Eye Drops 4 weeks after opening.

Write the date on the bottle when you first open the drops to help you remember when to throw it out.

Product description

What it looks like

FLAREX Eye Drops are a sterile ophthalmic suspension that come in 5 mL or 10 mL dropper bottle.

Storage

Store below 25°C.

Shake well before use.

Ingredients

The active ingredient in FLAREX Eye Drops 0.1% is fluorometholone acetate (equivalent to 1 mg/mL fluorometholone).

FLAREX Eye Drops also contain:

  • benzalkonium chloride 0.1 mg/mL as a preservative
  • sodium biphosphate
  • tyloxapol
  • disodium edetate
  • sodium chloride
  • hyetellose
  • hydrochloric acid/sodium hydroxide used to adjust pH
  • purified water.

Supplier

This product is supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1-800-671-203.

Web site: www.novartis.com.au

Australian registration number

AUST R 25278.

Date of preparation

This leaflet was prepared in November 2023.

™ Trademark

Internal document code:
(fla131123c) based on PI (fla131123i)

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Flarex

Active ingredient

Fluorometholone acetate

Schedule

S4

 

1 Name of Medicine

Fluorometholone acetate.

2 Qualitative and Quantitative Composition

The active ingredient in Flarex Eye Drops is fluorometholone acetate 1 mg/mL (0.1%).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, suspension. It is a sterile ophthalmic suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Fluorometholone Acetate Ophthalmic Suspension is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye.

4.2 Dose and Method of Administration

Shake well before use.
One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. Care should be taken not to discontinue therapy prematurely.

4.3 Contraindications

Mycobacterial ocular infections.
Herpes simplex keratitis.
Vaccinia, varicella and most other viral diseases of the cornea and conjunctiva.
Tuberculosis of the eye.
Fungal diseases of ocular structures.
Acute untreated infections.
Hypersensitivity to the constituents of this medication.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Employment of steroid medication in the treatment of stromal keratitis or uveitis caused by herpes simplex requires great caution; periodic slit lamp microscopy is essential. Prolonged use may result in ocular hypertension and/or glaucoma, damage to the optic nerve, defects in visual acuity and visual field, posterior subcapsular cataract formation, and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host responses.
Acute infections of the eye may be masked or exacerbated by the presence of steroid medications. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the chronic use of topical steroids.
It is advisable that the intraocular pressure be checked frequently. This is especially important in paediatric patients, as the risk of corticosteroid induced ocular hypertension may be greater in children and may occur earlier than in adults. Flarex is not approved for use in paediatric patients. The risk of corticosteroid induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).
Systemic corticosteroid side-effects may occur after intensive or long-term continuous ophthalmic corticosteroid therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (e.g. ritonavir and cobicistat).
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Fungal infections of the cornea are particularly prone to develop coincidentally with long term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use and corticosteroid therapy should be discontinued if fungal infection occurs.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Contact lenses.

No contact lenses should be worn under Flarex treatment. Additionally, this product contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness in children have not been established.
It is advisable that the intraocular pressure be checked frequently. This is especially important in paediatric patients, as the risk of corticosteroid induced ocular hypertension may be greater in children and may occur earlier than in adults. Flarex is not approved for use in paediatric patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems.
Co-treatment with CYP3A4 inhibitors, including ritonavir and cobicistat, may increase systemic exposure resulting in increased risk of systematic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no data regarding the effects of Flarex on male or female fertility.
(Category B3)
There are no or limited amount of data from the use of Flarex Eye Drops in pregnant women. Flarex Eye Drops is not recommended during pregnancy and in women of childbearing potential not using contraception.
Animal reproduction studies have not been conducted with Fluorometholone Acetate Ophthalmic Suspension. Animal studies with corticosteroids have shown reproductive toxicity. It is also not known whether Fluorometholone Acetate Ophthalmic Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, other steroids have been found to be teratogenic. Fluorometholone Acetate Ophthalmic Suspension should be given to a pregnant woman only if clearly needed.
 It is not known whether this drug and its metabolites are excreted in human milk. Systemic corticosteroids are excreted into human milk. A risk to the suckling child cannot be excluded. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, use only when considered essential by the physician.

4.7 Effects on Ability to Drive and Use Machines

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response and perforation of the globe may occur.

Post marketing experience.

The following adverse reactions have been reported following use of fluorometholone topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Adverse reactions are presented in order of decreasing seriousness.

Eye disorders.

Intraocular pressure increased, vision blurred (see Section 4.4 Special Warnings and Precautions for Use), eye pain, ocular discomfort, foreign body sensation in eyes, eye irritation, ocular hyperaemia, lacrimation increased.

Gastrointestinal disorders.

Dysgeusia.

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

An ocular overdose of Flarex Eye Drops is not likely to be associated with toxicity. Accidental ingestion is also unlikely to be associated with toxicity. Treatment of suspected ingestion 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: ophthalmological, anti-inflammatory agents, corticosteroids. ATC code: S01BA07.

Mechanism of action.

Corticosteroids suppress the inflammatory response to a variety of agents.

Clinical trials.

Clinical studies demonstrate that fluorometholone acetate is significantly more efficacious than fluorometholone for the treatment of external ocular inflammation. Corticosteroids cause a rise in intraocular pressure in susceptible individuals. In clinical studies, Fluorometholone Acetate Ophthalmic Suspension was demonstrated to raise intraocular pressure more slowly but ultimately to the same extent as dexamethasone phosphate.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each mL contains benzalkonium chloride, sodium biphosphate, tyloxapol, disodium edetate, sodium chloride, hyetellose, hydrochloric acid/sodium hydroxide to adjust pH, purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.
Shake well before use.

6.5 Nature and Contents of Container

As a sterile ophthalmic suspension in 5 mL and 10 mL opaque LDPE bottles.

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

Chemical structure.

Its chemical name is 9α-fluoro-11β-17α dihydroxy-6α-methyl pregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of fluorometholone acetate is presented below:
Fluorometholone acetate, a corticosteroid, is a white to creamy white powder with an empirical formula of C24H31FO5 and a molecular weight of 418.5.

CAS number.

426-13-1.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes