Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about chloramphenicol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

CHEMISTS’ OWN Clorah is a topical antibiotic eye drop used to treat bacterial conjunctivitis.

How it works

Bacterial conjunctivitis is a highly contagious bacterial infection involving the mucous membrane of the surface of the eye.

Common symptoms include sticky yellow-white discharge with mucous and pus, a gritty sensation in the eye, irritation and redness of the eye and watery eyes. The infection usually starts in one eye and then spreads to the other.

Chloramphenicol works by stopping the growth of the bacteria causing your infection.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Your doctor or pharmacist may have recommended this medicine for another reason.

This medicine is not addictive.

Before you use this medicine

When you must not use it

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

• chloramphenicol
• 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, throat or other parts of the body
• rash, itching or hives on the skin

This medicine should not be used in children under 2 years of age unless on medical advice.

Do not use this medicine after the expiry date printed on the pack or the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should use this medicine, talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have any of the following:

• aversion to light, severe pain or swelling in the eye
• loss of, reduced or blurred vision, restricted eye movement
• 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
• injury to the eye or foreign object in the eye
• history of welding without eye protection immediately prior to onset of symptoms
• glaucoma
• dry eye syndrome
• eye surgery or laser treatment in the past six months
• history or family history of bone marrow problems or blood disorders

Tell your doctor if you are pregnant or breastfeeding. Your doctor will discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

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

Other eye preparations may interfere with how well chloramphenicol works. You must separate the dose of chloramphenicol eye drops from your other eye drops by 5 minutes and separate from eye ointments by 10 minutes.

Other medicines not listed above may also interact with chloramphenicol.

How to use this medicine

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to use

Place one or two drops in the affected eye(s) every 2 to 6 hours for 2 to 3 days. The interval between doses may then be increased.

How to use it

To keep the medicine as germ free as possible, do not touch the tip of the bottle to the eye or any surface.

• Wash your hands.
• Tilt your head back and pull the lower lid away from your eye to make a pouch and drop the medicine into this space. Let go of your eyelid and gently close your eyes. Try not to blink for a short time as this can stop the medication from working properly.
• Apply gentle pressure to the inner corner of the eye (the tear duct) for approximately 1 minute immediately after placing the drops in the eye. This will reduce the amount of medicine absorbed into the blood stream or other parts of the body.
• Keep your eyes closed for 1 to 2 minutes to allow the medicine to come into contact with the infection.

When to use it

Use this medicine 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 long to use it for

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

Normally treatment is continued for at least 2 days after the eye appears to be back to normal. Do not use for more than 5 days in total except on medical advice.

If you forget to use it

If it is almost time to administer your next dose, skip the missed dose and use your medicine at the usual time.

Otherwise, use it as soon as you remember and then go back to using your medicine as you would normally.

Do not administer a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints to help you remember.

If you use too much (overdose)

Rinse your eye with large amounts of water for at least 15 minutes if pain, swelling, excessive tears or an uncomfortable sensitivity to the light is experienced after application of chloramphenicol eye drops.

Contact your doctor or pharmacist if symptoms are still present after thoroughly rinsing your eye.

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice if you think that you or anyone else may have accidentally swallowed this medicine. Do this even if there are no signs of discomfort or poisoning.

While you are using this medicine

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are using this medicine.

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor or pharmacist.

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.

Things you must not do

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

Do not use your medicine to treat any other condition unless your doctor tells you to.

Do not stop using your medicine or lower the dosage without checking with your doctor or pharmacist. If you do not complete the full course prescribed by your doctor or pharmacist, the infection may not be completely cured. The bacteria may grow again, and your symptoms may return.

Things to be careful of

Be careful driving or operating machinery until you know how it affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause blurred vision. If your vision is affected, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using chloramphenicol eye drops.

This medicine helps most people with bacterial conjunctivitis, but it may unwanted side effects in a few 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 lists of 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 and they worry you:

• temporary itching, burning or stinging eyes

Tell your doctor as soon as possible if you notice any of the following.

• eye soreness, redness or swelling that was not present before treatment or that worsens after treatment
• skin rash, itching or swelling
• fever
• unusual tiredness, weakness, bleeding or bruising more easily than normal

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital:

• symptoms of an allergic reaction including shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

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

Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep the unopened bottles in the refrigerator, where the temperature stays between 2°C and 8°C and where children cannot reach it. The top shelf of the refrigerator at the back is a good place to store this medicine.

After opening, keep your eye drops in a cool dry place where the temperature stays below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep your eye drops in the bottle until it is time to use them. If you remove the eye drops out of the bottle they may not keep well.

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

CHEMISTS’ OWN Clorah Eye Drops should be discarded within one month after opening.

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What CHEMISTS’ OWN Clorah eye drops looks like

CHEMISTS’ OWN Clorah eye drops are in 10 mL plastic dropper bottle. AUST R 222549.

Ingredients

Each 1 mL of CHEMISTS’ OWN Clorah eye drops contains 5 mg of chloramphenicol.

It also contains the following:

• phenylmercuric nitrate as a preservative
• boric acid
• borax
• water for injections

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 -17 Chapel Street
Cremorne VIC 3121

www.arrotex.com.au

This leaflet was last updated in April 2024.

Published by MIMS May 2024

1 Name of Medicine

Chloramphenicol.

2 Qualitative and Quantitative Composition

Chemists' Own Clorah 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.
Chemists' Own Clorah 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: store below 2°C and 8°C. Refrigerate, do not freeze. Opened: store below 25°C for up to a month.

6.5 Nature and Contents of Container

Chemists' Own Clorah 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