Consumer medicine information

Lomide Eye Drops 0.1%

Lodoxamide trometamol

BRAND INFORMATION

Brand name

Lomide Eye Drops 0.1%

Active ingredient

Lodoxamide trometamol

Schedule

S2

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

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

This leaflet answers some common questions about Lomide Eye Drops. 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 Lomide Eye Drops against the risks this medicine could have for you.

The information in this leaflet applies to Lomide 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 the medicine.

You may need to read it again.

What LOMIDE is used for

Lomide contains the active ingredient, lodoxamide, which is a "mast cell stabiliser" which works by preventing the allergic response to stimulants (e.g. pollen, dust) that cause conjunctivitis.

This medicine is used for the treatment of the symptoms of seasonal allergic conjunctivitis (itchy, watery or swollen eyes and/or eyelids). It is also used to treat a severe allergic condition of the eye called vernal keratoconjunctivitis or spring catarrh.

Ask your pharmacist or doctor if you have any questions about why this medicine has been given to you.

Your pharmacist or doctor may have given it for another reason.

This medicine is not addictive.

It is available from your pharmacy.

Use in children

Lomide is not recommended for use in children under 4 years.

The safety and effectiveness of Lomide in this age group have not been established.

Before you use LOMIDE

Do not use Lomide Eye Drops if you have an allergy to:

  • Lodoxamide
  • Other ingredients in Lomide that are listed at the end of this leaflet under "Product description" 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 this medicine if the expiry date has passed, the packaging is torn or the seal around the neck area is broken.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you use this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start using Lomide talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if:

  • You have an allergy to any other medicines or any other substances, such as foods, preservatives or dyes
  • You are pregnant, or intend to become pregnant
    Your doctor will discuss the possible risks and benefits of using Lomide during pregnancy
  • You are breastfeeding or intend to breastfeed
    Your doctor will discuss the possible risks and benefits of using Lomide when you are breastfeeding.

If you have not told your doctor about any of the above, tell them before you use Lomide Eye Drops.

Do not put Lomide Eye Drops into your eye(s) while you are wearing contact lenses.

The preservative in Lomide Eye Drops, benzalkonium chloride, may be deposited in contact lenses that may cause irritation to your eyes.

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

Taking or using other medicines

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

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

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using this medicine.

How to use LOMIDE

Carefully follow all directions given to you by your doctor and pharmacist.

Use Lomide Eye Drops only as prescribed by your doctor or pharmacist.

They may differ from the information contained in this leaflet.

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

How much to use

The usual dose for Lomide Eye Drops for adults and children over 4 years of age is one drop in the affected eye(s) four times a day at regular intervals.

After using Lomide Eye Drops wait at least 10 minutes before putting any other eye drops in your eye(s).

If you wear soft contact lenses, remove them before using this medicine. Wait for 15 minutes after using Lomide before reinserting the contact lenses.

The preservative in Lomide Eye Drops can affect the contact lenses.

Follow these steps to use the eye drops:

  1. Wash your hands thoroughly with soap and water.
  2. Immediately before using a bottle for the first time, break the safety seal around the neck area and throw the loose plastic ring away.
  3. Shake the bottle.
  4. Remove the cap from the bottle.
  5. Hold the bottle upside down in one hand between your thumb and middle finger.
  6. While tilting your head back, gently pull down the lower eyelid of your eye to form a pouch/pocket.
  7. Place the tip of the bottle close to your eye. Do not let it touch your eye.
  8. Release one drop into the pouch/pocket formed between your eye and eyelid by gently tapping or pressing the base of the bottle with your forefinger.
  9. 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.
  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 hand again. If you have been using Lomide Eye drops in a child's eye(s) make sure that you wash the child's hands as well.

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.

When to use it

Use Lomide Eye Drops at about the same time every day unless your doctor or pharmacist tells you otherwise.

Using your eye drops at the same time each day will have the best effect in treating your allergic conjunctivitis. It will also help you remember when to use the eye drops.

How long to use it

Continue using your medicine for as long as your doctor or pharmacist tells you.

If you are unsure about when, or how, to stop using Lomide Eye Drops you should talk to your doctor or pharmacist.

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 your medicine as you would normally.

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 what to do ask your pharmacist.

If you use too much (overdose)

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

Some of the symptoms of accidently swallowing lodoxamide in doses of 0.1 mg to 10.0 mg include feeling warm, flushing, nausea, vomiting, sweating and abdominal cramps.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of Lomide, immediately telephone your doctor or the Poisons Information Centre on 13 1126 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 Lomide

Things you must do

Tell your pharmacist or doctor immediately if you become pregnant while using Lomide.

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

Tell any other doctors, dentists or pharmacists who treat you that you are using this medicine.

Things you must not do

Do not use Lomide to treat any other complaints unless your pharmacist or doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how Lomide affects you.

This medicine may cause blurred vision in some people.

If you have this symptom do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are using Lomide.

This medicine helps most people with allergic conjunctivitis but may have 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 attention 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 pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

  • Burning, stinging or discomfort
  • Itching of the eye
  • Blurred vision or dimmed vision
  • Crusting of the eye lid margins
  • Dry eyes
  • Tearing
  • Redness of the eye
  • Discomfort or a feeling of having something in your eye
  • Pain in the eye
  • Discharge from the eye
  • Swelling of the eye or eye lid
  • Dim vision
  • Tired eyes
  • Inflammation of the eye.

These are the most common side effects of your medicine. They are usually mild and short lived.

Occasionally some people notice unwanted effects in the rest of their body as a result of using Lomide Eye Drops.

These effects may include:

  • Feeling warm
  • Headache
  • Nausea
  • A feeling of discomfort in the stomach
  • Dizziness
  • Sleepiness
  • Dry nose
  • Sneezing
  • Rash

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.

After using Lomide

Storage

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

Do not store Lomide Eye Drops or any other medicine in the car, bathroom, window sill or in other warm, damp places.

Heat and dampness can destroy some medicines.

Keep it out of the sight or reach of children.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

This eye drop contains 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 you need to continue treatment get a new bottle of drops, even if there is some left in the old bottle.

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 as the drops may not keep well.

Disposal

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

Lomide is a sterile solution containing lodoxamide and is available in a 10 mL Drop-tainer bottle.

Ingredients

Lomide contains the active ingredient lodoxamide (as trometamol) 1.06 mg in 1 mL.

Lomide also contains:

  • Benzalkonium chloride (as a preservative)
  • Mannitol
  • Hypromellose
  • Sodium citrate
  • Citric acid monohydrate
  • Tyloxapol
  • Disodium edetate
  • Sodium hydroxide and hydrochloric acid to adjust pH
  • Purified water

Supplier

Lomide is supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 16054 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1-800-671-203
Web site: www.novartis.com.au

Date of preparation

This leaflet was prepared in August 2017.

Australian registration numbers

Aust R No. 54275

® Registered Trademark

© Novartis Pharmaceuticals Australia Pty Limited 2017

Internal document code: (lom130617c) based on PI (lom130617i)

BRAND INFORMATION

Brand name

Lomide Eye Drops 0.1%

Active ingredient

Lodoxamide trometamol

Schedule

S2

 

Name of the medicine

Lodoxamide trometamol.

Excipients.

Mannitol, hypromellose, sodium citrate, citric acid monohydrate, tyloxapol, disodium edetate, benzalkonium chloride, hydrochloric acid, sodium hydroxide and purified water.

Description

Chemical names: N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid (lodoxamide) and 2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol). Molecular formula: C19H28O12N5Cl. MW: 553.91. CAS: 63610-09-3. Lodoxamide trometamol is a white crystalline powder, freely soluble in water.
Lomide Eye Drops contain lodoxamide trometamol 1.78 mg/mL (≡ lodoxamide 1.0 mg/mL), a mast cell stabilising agent, in a sterile solution for topical application to the eye.

Pharmacology

Pharmacodynamics.

Lodoxamide trometamol is a mast cell stabiliser that inhibits the in vivo type I, IgE mediated (immediate) hypersensitivity reaction. Lodoxamide inhibits the increase in cutaneous vascular permeability that is associated with reagin or IgE and antigen mediated reactions.
In vitro studies have demonstrated the ability of lodoxamide to stabilise rodent mast cells and prevent antigen stimulated release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e. SRS-A, slow reacting substances of anaphylaxis also known as the peptidoleukotrienes) and inhibits eosinophil chemotaxis. Although lodoxamide's precise mechanism of action is unknown, the drug has been reported to prevent calcium influx into mast cells upon antigen stimulation.
Lodoxamide has no intrinsic vasoconstrictor, antihistaminic, cyclooxygenase inhibition or other anti-inflammatory activity.

Pharmacokinetics.

The disposition of 14C-lodoxamide was studied in six healthy adult volunteers receiving a 3 mg (50 microCi) oral dose of lodoxamide. Urinary excretion was the major route of elimination (83%). The elimination half-life of 14C-lodoxamide was estimated from urinary excretion data to be 8.5 hours.
The administration of Lomide Eye Drops to twelve healthy adult volunteers (one drop in each eye four times per day for ten days) resulted in only 3 plasma samples (from a total of 108) with detectable levels of lodoxamide (level of detection 2.5 nanogram/mL). It is, therefore, possible that minute amounts of lodoxamide might be absorbed systemically in some patients.

Clinical Trials

The safety (915 patients) and efficacy (723 patients) of Lomide Eye Drops in the treatment of allergic ocular disorders were studied in a series of nine clinical studies; 336 of the patients evaluated for safety were treated for seasonal allergic conjunctivitis while 389 of the patients evaluated for safety were treated for vernal keratoconjunctivitis. Patients four years of age and older were enrolled, with no upper age limit. The demographic features of the study population reflected the expected age-sex distribution of the conditions studied.
Fifty six patients were treated up to 12 months, with no evidence of rebound exacerbation of disease on cessation of therapy or tachyphylaxis.

Seasonal allergic conjunctivitis.

Lomide Eye Drops were demonstrated to be at least as efficacious as sodium cromoglycate 2% and 4% in the treatment of seasonal allergic conjunctivitis with significant improvement in many symptoms and signs occurring within the first three to seven days of treatment. Treatment effect continued to increase up to 4 weeks after initiation of therapy.

Vernal keratoconjunctivitis.

Lomide Eye Drops were shown to be superior to placebo and sodium cromoglycate 2% and 4% in the treatment of vernal keratoconjunctivitis with resolution of some of the major clinical signs (corneal papillae, follicles and corneal staining) of this condition. In a 7 week study Lomide Eye Drops significantly reduced the need for adjunctive topical steroid therapy in patients with moderate to severe vernal keratoconjunctivitis in comparison to sodium cromoglycate 2% (week 3-week 7 of the study).

Indications

Seasonal allergic conjunctivitis and vernal keratoconjunctivitis in adults and children four years of age and older.
Prophylactic use of Lomide Eye Drops may help in the management of seasonal allergic conjunctivitis and assist in reducing the allergic symptoms.

Contraindications

Known hypersensitivity to lodoxamide or any excipient.

Precautions

Lomide Eye Drops are not for injection.

Information for the patient.

Patients should be advised that effect of therapy with lodoxamide eye drops is dependent upon administration at regular intervals. The recommended frequency of administration should not be exceeded.
In situations where the condition does not improve within a few days, or unmanageable symptoms occur during treatment, the patient should be advised to consult a doctor or pharmacist.
Patients should also be advised that instillation of eye drops may cause discomfort or transient burning or stinging initially. Should these symptoms persist, the patient should be advised to contact a doctor, optometrist or pharmacist.
Due to the severe nature of the disease, patients should be advised not to wear contact lenses while being treated for vernal keratoconjunctivitis. In the event that a patient does wear soft contact lenses, the lenses should be removed prior to instillation of the drops and should not be reinserted earlier than 15 minutes after dosing.
Lodoxamide eye drops should not affect a patient's ability to drive or to use machinery.

Effects on fertility.

No evidence of impairment of reproductive function was shown in laboratory animal studies.
There is no data available on the effect of lodoxamide on fertility in humans.

Use in pregnancy.

(Category B1)
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have not shown evidence of an increased occurrence of foetal damage.
Reproduction studies with lodoxamide trometamol administered orally to rats and rabbits in doses of 100 mg/kg/day produced no evidence of developmental toxicity. There are no or a limited amount of data from the use of Lomide Eye Drops in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Because animal reproductive studies are not always predictive of human response, lodoxamide eye drops should only be used in pregnancy if clearly needed.

Use in lactation.

It is not known whether lodoxamide is excreted in human milk. There is insufficient information on the excretion of lodoxamide from Lomide Eye Drops in animal milk. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/ abstain from Lomide Eye Drops therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Paediatric use.

The safety and effectiveness of Lomide Eye Drops in children below the age of four years have not been established.

Use in the elderly.

There are no special precautions to be followed in prescribing Lomide Eye Drops for the elderly.

Genotoxicity, carcinogenicity.

A long-term study with lodoxamide trometamol in rats (two year oral administration) showed no neoplastic or tumourigenic effects at doses up to 100 mg/kg/day (more than 5,000 times the proposed human clinical dose). No evidence of mutagenicity or genetic damage was seen in assays for gene mutations and chromosomal damage. In the BALB/c-3T3 cells transformation assay, some increase in the number of transformed foci was seen at high concentrations.

Contact lenses.

Lomide Eye Drops contain benzalkonium chloride which may cause eye irritation and are known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of Lomide Eye Drops and wait at least 15 minutes before reinsertion.

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 the vision clears before driving or using machinery.

Interactions

No specific drug interaction studies, either with ophthalmic or systemic medications, have been conducted. Limited concomitant medications, however, were permitted during the clinical studies and no interactions were observed. Concomitant medications included: corticosteroids (systemic and ophthalmic), naphazoline, antazoline, ketorolac, ciprofloxacin, gentamicin, sulfacetamide, tetracycline, tobramycin, timolol and dipivefrine.
Patients should be advised to wait 10 minutes after instilling Lomide Eye Drops before instilling any other eye drops.

Adverse Effects

Lomide Eye Drops were well tolerated in clinical studies with no significant changes in visual acuity, colour vision, intraocular pressure or signs of local toxicity or irritation. No serious adverse events were reported with the use of Lomide Eye Drops in these studies. Side effects were mild and self limiting, resolving within minutes without further intervention. The incidence of side effects was similar to other topical medications such as sodium cromoglycate, and only slightly greater than when the vehicle was used alone.
During clinical studies, the most frequently reported ocular adverse experiences were transient burning, stinging or discomfort upon instillation, which occurred in 13% of patients. Other ocular events occurring in 1 to 3.5% of the patients included ocular pruritus (3.5%), blurred vision (1.8%), lid margin crusting (1.6%), dry eye (1.3%), tearing (1.2%) and hyperaemia (1.2%). Events that occurred in less than 1% of the patients included foreign body sensation, ocular pain, discharge, ocular oedema, ocular fatigue, ocular warming sensation, lid oedema, chemosis, anterior chamber cells, epitheliopathy, keratopathy/ keratitis, blepharitis, sticky sensation, corneal erosion, dim vision, corneal abrasion and allergy.
Nonocular events are rare and reported at incidences less than 0.5%. These included a temporary warm sensation, headache, nausea, stomach discomfort, dizziness, somnolence, dry nose, sneezing and rash.

Postmarketing experience.

The following adverse reactions are classified by MedDRA system organ class according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and postmarketing experience for lodoxamide eye drops.

Immune system disorders.

Rare: drug hypersensitivity.

Nervous system disorders.

Uncommon: dizziness, headache.
Rare: somnolence, dysgeusia.

Eye disorders.

Very common: ocular discomfort.
Common: vision blurred, dry eye, eye pruritus, lacrimation increased, ocular hyperaemia.
Uncommon: eye pain, eye oedema, asthenopia, corneal deposits, conjunctival oedema, abnormal sensation in eye, foreign body sensation in eyes, eye discharge, eye irritation.
Rare: corneal erosion, corneal scar, corneal abrasion, anterior chamber cell, corneal epithelium defect, keratitis, blepharitis, visual impairment, eyelid oedema, conjunctival disorder.

Respiratory, thoracic and mediastinal disorders.

Rare: nasal dryness, sneezing.

Gastrointestinal disorders.

Uncommon: nausea.
Rare: abdominal discomfort.

Skin and subcutaneous tissue disorders.

Uncommon: eyelid exfoliation.
Rare: rash.

General disorders and administration site conditions.

Uncommon: drug intolerance, feeling hot.
Additional adverse reactions identified from postmarketing surveillance include the following. Frequencies cannot be estimated from the available data. Within each system organ class adverse reactions are presented in order of decreasing seriousness.

Cardiac disorders.

Palpitation.

Dosage and Administration

Adults and children 4 years and older.

One drop in each eye four times a day at regular intervals.
Patients who experience regular symptoms associated with seasonal allergic conjunctivitis should be advised to begin treatment with Lomide Eye Drops about one week prior to the expected onset of the allergy season(s). Treatment should be continued for the duration of the allergy season.
Patients should be advised that the effect of therapy with Lomide Eye Drops is dependent upon its administration at regular intervals, as directed.
Improvements in signs and symptoms in response to therapy with Lomide Eye Drops (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/ swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, however, longer treatment for up to four weeks is sometimes required. Further, continued treatment may result in ongoing improvement in signs and symptoms for at least 3 months. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.
Patients should be advised to wait 10 minutes after instilling Lomide Eye Drops before instilling any other eye drops.

Overdosage

Due to the characteristics of this preparation, toxic effects are unlikely following an ocular overdose of this product. In the event of an ocular overdose, flush from the eye with lukewarm water.
In case of accidental ingestion of doses of 0.1 mg to 10.0 mg of lodoxamide, the following adverse effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping. Transient elevations of systolic and diastolic blood pressure have been noted with doses of 3.0 and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse effects after an oral overdose are headache, dizziness, fatigue and loose stools.
If accidentally ingested, efforts to decrease further absorption may be appropriate.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

Presentation

Eye drops (clear, colourless, sterile solution), 0.1% w/v: 10 mL (LDPE, Drop-Tainer dispenser).

Storage

Store below 25°C. Do not freeze.
Discard 28 days after opening.

Poison Schedule

S2.