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GOLDEN EYE ANTIBIOTIC 0.5% W/V EYE DROPS, CHLORAMPHENICOL EYE DROPS BP 0.5% W/V - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - GOLDEN EYE ANTIBIOTIC 0.5% W/V EYE DROPS, CHLORAMPHENICOL EYE DROPS BP 0.5% W/V

Chloramphenicol Eye Drops BP 0.5% w/v

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
  • You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.

  • 1. What Chloramphenicol Eye Drops are and what they are used for

  • 2. What you need to know before you use Chloramphenicol Eye Drops

  • 3. How to use Chloramphenicol Eye Drops

  • 4. Possible side effects

  • 5. How to store Chloramphenicol Eye Drops

  • 6. Contents of the pack and other information

  • 1. WHAT CHLORAMPHENICOL EYE DROPS ARE AND WHAT ARE THEY USED FOR

Chloramphenicol Eye Drops contain an antibiotic called chloramphenicol. It is used to treat bacterial infections that affect the front surfaces of the eye.

The most common type of infection in this area is called acute bacterial conjunctivitis. When you have acute bacterial conjunctivitis the white part of one or both of your eyes will be red and /or your eyelids will be red or swollen. There will be a sticky discharge, which can make the eye difficult to open in the morning and the eye may feel ‘gritty’ or ‘irritated’.

Chloramphenicol Eye Drops are not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper, more serious infections.

2. what you need to know before you use chloramphenicol eye drops

Chloramphenicol Eye Drops are recommended for use in children aged 2 years and over , in adults and the elderly. A child below the age of 2 years with an eye infection should be seen by a doctor. Do not use this product if you:

  • are allergic to Chloramphenicol or any of the ingredients of this medicine (listed in section 6).
  • have ever had problems with your blood (in particular very low number of blood cells) during previous treatment with chloramphenicol
  • have a family history of blood problems such as low white blood cell, red blood cell, or platelet counts
  • your eyesight is affected (loss of sight, reduced vision, blurred vision or halos around lights)
  • you have pain within the eye
  • your eye has suffered a blow or other injury
  • your eye is inflamed and you have a rash on the scalp or face
  • the pupil of your eye looks unusual or your eye looks cloudy

  • your eyes are sensitive to light

  • you have (or think you have) a foreign body in your eye, which has not been removed
  • you have recently had an eye infection
  • you suffer from or have suffered from glaucoma or dry eye syndrome
  • you wear contact lenses. If you wear contact lenses and your contact lens practitioner or doctor has advised you to use this product, do not wear your lenses during the course of treatment. Wear your glasses instead. Soft contact lenses should not be used for 24 hours after completing treatment.
  • you are using any other eye drops or eye ointment
  • you have had eye surgery or laser treatment in the last 6 months

  • are taking any other medicines.

  • suffer from any other eye problems.

Other medicines and Chloramphenicol Eye Drops

If you are taking bone marrow depressant medicines (medicines which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or are receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

After using the drops, you may temporarily get blurred vision. Do not drive or operate machinery until your vision is clear. If in doubt, talk to your pharmacist or doctor.

Chloramphenicol Eye Drops contains phenylmercuric nitrate

Phenylmercuric nitrate may cause allergic reactions.

3. how to use chloramphenicol eye drops

Instructions for use

To be used in the eye(s) only

  • Check that the seal is not broken before the first use.
  • Wash and dry your hands
  • Tilt your head back while seated or lie down on your back
  • Gently pull the lower eyelid downwards and look up
  • Place the tip of the bottle close to your eye. Squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye. Take care that the tip of the bottle does not touch your eye, the skin around your eye or your fingers.
  • Close your eye for a moment.
  • When both eyes are to be treated, repeat for the other eye
  • Replace and tighten the cap immediately after use. Whilst applying the drops, do not
  • breathe on or touch the dropper nozzle
  • touch the eyes or eyelids (or any other surface) with the tip of the bottle
  • share your eye drops with anyone else.

For external use only.

Dose

Apply one drop to the affected eye(s) every 2 hours for the first two days and every 4 hours thereafter. Use during waking hours only. Length of treatment

The course of treatment is 5 days. Keep using these eye drops for 5 days. Do not stop just because you feel better, this could make your condition worse.

If your symptoms do not improve within 48 hours , consult your doctor. If your symptoms get worse seek medical advice at once.

Do not use Chloramphenicol Eye Drops for more than 5 days without consulting doctor. Dispose of any remaining eye drops appropriately after the 5 day course of treatment (see section 5).

If you forget to use your drops

If you have only just missed a dose and it is a long time before the next dose is due, put in the missed dose of drops straight away. If it is nearly time for your next dose, skip the missed dose and just put in the next dose of drops at the usual time. Do not take a double dose to make up for a forgotten dose.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may get one or more of these side effects. Some effects happen straight away but do not last long – others may only happen after several days of use.

  • Allergic reactions such as itching or rashes.

If you get a severe reaction, with swelling or breathing problems get medical help straight away.

  • Changes in the blood (anaemia) leading to severe tiredness or easy bruising. If you experience these effects, stop using the drops immediately and tell your doctor.
  • Discolouration or clouding of the eye surface (cornea) or lens due to preservative.
  • The use of topical Chloramphenicol may occasionally result in the over growth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor.
  • Blurred vision or mild burning or stinging when you put the drops in. These should subside quickly.
  • Irritation of the skin around the eyes, mercurialentis (brown discolouration of the lens) and atypical band keratopathy (appearance of calcium on the cornea). These may be due to the preservative in the drops called phenylmercuric nitrate.

If you do not feel well or are worried about your health, talk to a pharmacist or doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at

By reporting side effects you can help provide more information on the safety of this medicine. ________

5. how to store chloramphenicol eye drops

Replace the cap securely after use. Store at 2°C to 8°C. This is the temperature of most domestic refrigerators.

Keep this and all medicines out of the sight and reach of children.

Do not use after the expiry date which is stated on the bottle and on the carton the bottle is packed in. Dispose of any medicine left at the end of a 5 day course of treatment.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Chloramphenicol Eye Drops contains

  • – The active substance is Chloramphenicol 0.5% w/v.

  • – The other ingredients are: borax, boric acid, phenyl mercuric nitrate (as preservative)

What Chloramphenicol Eye Drops looks like and contents of the pack

Each bottle contains 10 ml of drops.

The drops contain 0.5% w/v chloramphe­nicol, which is equivalent to 5 mg of chloramphenicol per millilitre. Chloramphenicol Eye Drops is a clear, colourless, sterile solution.

Marketing Authorisation Holder

Medicom Healthcare Ltd

Lynton House, 7–12 Tavistock Square,

Kings Cross, London, WC1H 9LT, U.K.

Manufacturer Distributed by

Excelvision, 27, AAH Pharmaceuticals Ltd,

rue de la Lombardiere, BP 131, Coventry, CV2 2TX 07100 Annonay, Fran­ce

PL number: 18956/0004

Hard to see or read the leaflet?

Call +44 (0) 1489 574119 for help

This leaflet was last revised in 02/2020 COLDP-42-GB-PV2

V4–160105


Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Golden Eye Antibiotic 0.5% w/v eye drops used for?

Golden Eye Antibiotic eye drops are primarily used to treat bacterial infections of the eye, such as conjunctivitis.

How does Chloramphenicol work in these eye drops?

Chloramphenicol works by stopping the growth of bacteria, thus helping to treat the infection in your eyes.

Are there any common side effects of using Golden Eye Antibiotic drops?

Common side effects may include temporary blurred vision, stinging, or redness upon application. If you experience severe discomfort, consult your doctor.

Can I use Golden Eye Antibiotic drops if I wear contact lenses?

It's advisable to remove contact lenses before using these eye drops and wait at least 15 minutes before reinserting them.

How often should I apply Golden Eye Antibiotic eye drops?

Typically, you should use the drops as directed by your healthcare provider, but it is often recommended to use them every few hours during the day.

What should I do if I miss a dose of Golden Eye Antibiotic drops?

If you miss a dose, apply it as soon as you remember. If it's almost time for your next dose, skip the missed one and continue with your regular schedule.

Can children use Golden Eye Antibiotic 0.5% eye drops?

Yes, children can use these eye drops; however, dosing may differ based on age and weight. Always consult a pediatrician first.

Is it safe to use Golden Eye Antibiotic during pregnancy?

Consult with your healthcare provider before using any medication, including Golden Eye Antibiotic drops, during pregnancy.

How should I store Golden Eye Antibiotic eye drops?

Store the eye drops in a cool dry place away from direct sunlight and keep them out of reach of children.

What should I do if my symptoms don’t improve after using the drops?

If you don’t notice improvement within 48 hours or if your symptoms worsen, contact your healthcare provider for further evaluation.

Can I use Golden Eye Antibiotic if I'm allergic to penicillin?

Yes, Chloramphenicol is not related to penicillin; however, inform your doctor about all allergies you have before starting any medication.

How long can I use Golden Eye Antibiotic eye drops?

It is usually recommended to use these eye drops for no longer than 7-10 days unless directed otherwise by your healthcare professional.

Are there any foods or drinks I should avoid while using these eye drops?

There are no specific foods or drinks that need to be avoided while using Golden Eye Antibiotic drops.

Can I drive after using Golden Eye Antibiotic 0.5% w/v eye drops?

Be cautious as these drops may cause temporary blurred vision. Wait until your vision clears before driving or operating machinery.

Is Golden Eye Antibiotic effective against viral infections?

No, Golden Eye Antibiotic is specifically designed for bacterial infections and will not be effective against viral infections like conjunctivitis caused by viruses.

What should I do if the bottle of eye drops is damaged or opened before my first use?

Do not use damaged products. Instead, return it to the pharmacy for a replacement or consult with a healthcare provider.

Are there any interactions with other medications when using these eye drops?

Inform your doctor about all medications you are taking so they can check for potential interactions with Chloramphenicol.

Can I share my Golden Eye Antibiotic 0.5% w/v eye drops with someone else?

No, sharing prescription medications can lead to complications and infections; always keep it personal.

What happens if someone accidentally ingests the eye drop solution?

If swallowed, seek medical attention immediately and take the product container with you to help identify it for proper treatment.