FULL CMI

APOHEALTH Chloramphenicol Eye Drops

Active ingredient(s): chloramphenicol

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH Chloramphenicol Eye Drops. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using this medicine.

Where to find information in this leaflet:

1. Why am I using APOHEALTH Chloramphenicol Eye Drops?
2. What should I know before I use APOHEALTH Chloramphenicol Eye Drops?
3. What if I am taking other medicines?
4. How do I use APOHEALTH Chloramphenicol Eye Drops?
5. What should I know while using APOHEALTH Chloramphenicol Eye Drops?
6. Are there any side effects?
7. Product details

1. Why am I using APOHEALTH Chloramphenicol Eye Drops?

APOHEALTH Chloramphenicol Eye Drops contain the active ingredient chloramphenicol. APOHEALTH Chloramphenicol Eye Drops is a topical antibiotic eye drop.

APOHEALTH Chloramphenicol Eye Drops are used to treat bacterial conjunctivitis, which is a bacterial infection involving the mucous membrane of the surface of the eye.

The most common symptom is the presence of a sticky yellow-white discharge with mucus and pus (or glued eyes, especially in the morning on waking). Other symptoms include a gritty sensation in the eye, redness, irritation and watering of the eyes. The infection usually starts in one eye and then spreads to the other.

2. What should I know before I use APOHEALTH Chloramphenicol Eye Drops?

Warnings

Do not use APOHEALTH Chloramphenicol Eye Drops if:

• you are allergic to chloramphenicol, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  Some symptoms of an allergic reaction may include irritation, pain and swelling of the eye, skin rashes, blister and fever.
• the packaging is torn, broken or shows signs of tampering.
• after the expiry date (EXP.) printed on the pack.

This medicine should not be used in children under 2 years of age unless advised by your doctor or optometrist.

Check with your doctor or pharmacist if:

• you or your family have blood disorders (e.g. anaemia) or problems with bone marrow
• you have an injury to the cornea. Eye preparations may inhibit the healing of the wound
• you wear contact lenses
  contact lens wear - contact lenses should not be worn during chloramphenicol treatment. If you wear hard or disposable contact lenses, you can start using your contact lenses again after successfully completing the course of treatment. If you wear soft contact lenses, you should wait 24 hours after successfully completing the course of treatment before starting to use your lenses again.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor, optometrist or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Purchased without prescription

If you have bought this medicine without a prescription and without prior consultation from a doctor or optometrist, it is important to check the following list.

Speak to your doctor or optometrist if any apply before you start to use APOHEALTH Chloramphenicol Eye Drops:

• you are allergic to any other antibiotic eye drops or ointments
• you are using other eye drops or eye ointments
• you have pain within your eye (rather than just feeling sore or gritty)
• swelling around the eye
• blurred vision or sensitivity to light
• limited eye movement
• abnormal pupil (the black circle in the centre of the eye)
• your eye looks cloudy
• there is copious yellow-green purulent discharge that accumulates after being wiped away
• you have injured your eye or there is a foreign body in the eye
• you have been welding without eye protection immediately before your eye symptoms appeared
• you have glaucoma
• you have dry eye syndrome
• you have had similar symptoms in the past
• you have had eye surgery or laser treatment in the past six months
• you have recently travelled overseas
• you are allergic to any other medicines or any foods, dyes or preservatives
• you have surgery (including dental surgery) using a general anaesthetic
• you feel unwell
• you have any other medical conditions.

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

3. What if I am taking other medicines?

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

Some medicines may interfere with APOHEALTH Chloramphenicol Eye Drops and affect how it works. These include other eye drops and eye ointments.

These medicines may reduce or increase the effectiveness of APOHEALTH Chloramphenicol Eye Drops, reduce its own effectiveness and/or react with APOHEALTH Chloramphenicol Eye Drops resulting in untoward or sometimes dangerous side effects.

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

4. How do I use APOHEALTH Chloramphenicol Eye Drops?

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

How much to use

• The dose of may be different for each person and their medical condition. Your doctor, optometrist or pharmacist will recommend the right dose for you.
  Do not use in children under 2 years of age except on doctor's advice.
• The usual recommended doses are:
  For adults and children (2 years and over): Instil 1 or 2 eye drops in the affected eye(s) every two to six hours for up to 5 days or as directed by your doctor, optometrist or pharmacist.
• Do not exceed the recommended dosage.
• If the symptoms of your condition do not improve after 2 days, or if they become worse, seek medical advice.

When to take use

Use APOHEALTH Chloramphenicol Eye Drops at about the same time each day.

Using it at the same time each day will have the best effect and will also help you remember when to use it.

How to use

• wash hands thoroughly before and after use
• open the eye, tilt head back and look upwards
• gently pull down the lower lid to form a pouch
• approach the eye from the side and hold the bottle dropper near the lid, but do not let the tip of the dropper touch the eye, eyelids or lashes
• apply one drop into the pouch
• close the eyes (do not rub them) and try not to blink for a short time
• apply gentle pressure for a few minutes with a finger to the bridge of the nose to prevent the medicine being drained from the eye
• blot excess solution around the eye with a tissue
• if instilling more than one drop in an eye, separate each installation by several minutes to avoid washing drops out of the eye
• to minimise contamination, do not allow the dropper to contact the surface of the eye.

Vision may be temporarily blurred. Avoid activities that require good visual ability until vision clears.

How long to use APOHEALTH Chloramphenicol Eye Drops

APOHEALTH Chloramphenicol Eye Drops should be used for up to 5 days or as directed by your doctor, optometrist or pharmacist.

If you forget to use APOHEALTH Chloramphenicol Eye Drops

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 it as soon as you remember, and then go back to using it as you would normally.

If you are unsure about whether to use your next dose, speak to your doctor, optometrist or pharmacist.

Do not use a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you use too much APOHEALTH Chloramphenicol Eye Drops

Accidental ingestion of the drug in adults is unlikely to cause any toxicity due to the low content of antibiotic but consult your doctor or Poisons Information Centre.

If the eye drops are accidentally ingested by infants or young children, you should immediately: You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using APOHEALTH Chloramphenicol Eye Drops?

Things you should do

• Use APOHEALTH Chloramphenicol Eye Drops exactly as directed.
• Tell all doctors, dentists, optometrists or pharmacists who are treating you that you are using APOHEALTH Chloramphenicol Eye Drops.
• Tell your doctor or pharmacist if your infection does not start to improve within 48 hours.
• Stop using chloramphenicol eye drops and tell your doctor or pharmacist if irritation occurs or you experience an allergic reaction.
• Tell your doctor immediately if you become pregnant while you are using APOHEALTH Chloramphenicol Eye Drops.
• Always discuss with your doctor, optometrist or pharmacist any problems or difficulties during or after using this medicine.
• Tell your doctor, optometrist or pharmacist if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, they may think that it was not effective and change your treatment unnecessarily.

Things you should not do

• Do not use APOHEALTH Chloramphenicol Eye Drops for a longer time than your doctor, optometrist or pharmacist has prescribed.
• Do not increase the dose, without first checking with your doctor, optometrist or pharmacist.
• Do not use this medicine to treat any other complaints without checking with your doctor, optometrist or pharmacist
• Do not give this medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APOHEALTH Chloramphenicol Eye Drops affects you.

APOHEALTH Chloramphenicol Eye Drops may distort your vision temporarily. Make sure you know how you react to it before you drive a car, operate machinery or do anything else that could be dangerous.

Looking after your medicine

• Store unopened bottles at between 2-8°C in a refrigerator. Do not freeze. Protected from light.
• After opening, store at room temperature (below 25°C). Protect from light.
• Discard 4 weeks after opening

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

When to discard your medicine

APOHEALTH Chloramphenicol Eye Drops should be discarded 4 weeks after opening.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side affects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH Chloramphenicol Eye Drops contains

Do not take this medicine if you are allergic to any of these ingredients.

What APOHEALTH Chloramphenicol Eye Drops look like

APOHEALTH Chloramphenicol Eye Drops are in a 10 mL plastic dropper bottle (Aust R 222547).

Who distributes APOHEALTH Chloramphenicol Eye Drops

Arrotex Pharmaceuticals Pty Ltd
15 -17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in October 2024.

Published by MIMS December 2024

1 Name of Medicine

Chloramphenicol.

2 Qualitative and Quantitative Composition

APOHealth Chloramphenicol eye drops contain chloramphenicol 5 mg/mL.

Excipients with known effect.

3 Pharmaceutical Form

Eye drops.
A bright colourless to faint yellow aqueous solution, practically clear.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of bacteria conjunctivitis. For use under medical supervision only in the treatment of other superficial ocular infections caused by chloramphenicol sensitive organisms.

4.2 Dose and Method of Administration

Dosage.

Adults and children 2 years of age and over.

Instructions to patients.

4.3 Contraindications

History of hypersensitivity and/or toxic reaction to chloramphenicol or any other component of the medication.

4.4 Special Warnings and Precautions for Use

Discontinue promptly if sensitisation or irritation occurs.
Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. Chloramphenicol should be used with caution in patients who have been identified as having an individual or family history of blood disorders.
Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
Ophthalmic agents may retard corneal wound healing.
The use of this antibiotic, as with other antibiotics, may result in the overgrowth of non-susceptible organisms, including fungi. If infections caused by non-susceptible organisms appear during therapy, its use should be discontinued and appropriate measures should be taken. In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication.
APOHealth Chloramphenicol should not be recommended for OTC use under the following circumstances:
Photophobia;
Severe pain in the eye or pain and swelling around the eye;
Loss of, reduced or blurred vision;
Restriction of eye movement;
Cloudy cornea;
Copious yellow-green purulent discharge that accumulates after being wiped away;
Contact lens wear;
Abnormal pupils;
Injury to the eye or suspicion of a foreign body in the eye;
History of welding without eye protection immediately prior to onset of symptoms;
Glaucoma;
Dry eye syndrome;
Patient is using other eye preparations at the time of presentation;
Patient has had eye surgery or laser treatment in the past six months;
Individual or family history of bone marrow problems;
Recent overseas travel;
Patient has had similar symptoms in the past;
Patient feels unwell;
Children under the age of 2 years except on medical advice;
Use for longer than 5 days unless on medical advice.
In these cases, referral to a doctor or optometrist is required.

Contact lens wearers.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Systemically absorbed/administered forms of chloramphenicol have been known to interact with certain drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

This medicine may distort vision temporarily. It is recommended that patients using this medicine understand how it may affect them before driving a motor vehicle, or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Dose related toxicity following a single ocular exposure is unlikely.
The following clinical adverse experiences have been observed with the use of chloramphenicol. More serious side effects (indicated by *) have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. The adverse reactions are listed by system organ class and frequency (Common: ≥ 1% and < 10%, Uncommon: ≥ 0.1% and < 1%, Not known: Cannot be estimated from available data).

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

Accidental ingestion of the drug is unlikely to cause any toxicity due to the low content of antibiotic.
Each mL of Chloramphenicol eye drops contains 19 mg of borax/boric acid as buffer. It is advisable to keep medication out of reach of children. If accidentally ingested by infants or young children, a local Poisons Information Centre should be contacted. As there is individual variability in the pharmacokinetics of chloramphenicol in infants and children, monitor plasma levels. Levels exceeding 25 microgram/mL are frequently considered toxic.
If irritation, pain, swelling, lacrimation or photophobia occurs after undesired eye contact, the exposed eye(s) should be irrigated with copious amounts of room temperature water for at least 15 minutes. If symptoms persist after 15 minutes of irrigation, an ophthalmological examination should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye. Chloramphenicol is rapidly absorbed from the gastrointestinal tract when given by mouth and widely distributed throughout most body tissues and fluids. It is inactivated primarily in the liver by glucuronyl transferase and excreted mainly in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections; boric acid; borax; phenylmercuric nitrate as the preservative.

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

Unopened.

Opened.

6.5 Nature and Contents of Container

APOHealth Chloramphenicol eye drops 5 mg/mL; 10 mL (plastic dropper bottle with lid to pierce the bottle on the initial use).

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

Chloramphenicol is a white to greyish white or yellowish white, fine crystalline powder or fine crystals, needles or elongated plates. Soluble 1:400 of water, 1:2.5 of alcohol, and 1:7 of propylene glycol; freely soluble in acetone and ethyl acetate; slightly soluble in ether. A 2.5% suspension in water has a pH of 4.5 to 7.5.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes