Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Optrex Infected Eye Drops
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chloramphenicol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Optrex Infected 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 this condition, 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.
What you need to know before you take it
e Optrex Infected Eye Drops
Optrex Infected 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 see a doctor. Do not use this product if you
- are allergic to chloramphenicol or any of the ingredients shown under section 6 'Contents of the pack and other information'
- have ever had problems with your blood (in particular very low numbers of blood cells) during previous treatment with chloramphenicol
- have bone-marrow depression or a family
history of blood problems such as low white blood cell, red blood cell, or platelet counts Do not use this product and seek advice from your doctor if
- 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 ever 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. Soft contact lenses should not be replaced for 24 hours after completing the treatment.
- you are using any other eye drops or eye ointment
- you have had eye surgery or laser treatment in the last 6 months. Tell your pharmacist before using this product if you
- are taking any other medicines
- suffer from any other eye problems. Taking other medicines If you are taking bone marrow depressant drugs (drugs 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 Breastfeeding If you are pregnant, planning to become pregnant or breastfeeding speak to your doctor or pharmacist before using this product. Driving and operating machinery 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. Important information about some of the ingredients in Optrex Infected Eye Drops Contains phenylmercuric nitrate which may cause allergic reactions.
How to take it
Optrex Infected Eye Drops Applying the drops To be used in the eye(s) only. 1. Check the seal is not broken before first use. 2. Wash and dry your hands.
Please turn over
5,5 mm
SENSO DI LETTURA READING SIDE
3. Remove the plastic cap from the eye drop tip. 4. Tilt your head back while seated or lie down on your back. 5. Gently pull the lower eyelid downwards and look up. 6. 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. 7. Close your eye for a moment. 8. When both eyes are to be treated, repeat for the other eye 9. Replace the cap straight away.
Whilst applying the drops, do not
- breathe on or touch the dropper nozzle
- touch the eyes or eyelids with the dropper nozzle
- share your eye drops with anyone else. For external use only. Dose Adults, children aged over 2 years, and elderly: Apply one drop to the affected eye(s) every 2 hours for the first two days and 4 hourly 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 Optrex Infected Eye Drops for more than 5 days without consulting your doctor. Discard any remaining eye drops after the 5 day course of treatment. Do not use in children under 2 years of age. If you take more medicine than you should: Wash your eyes with plenty of water and speak to your doctor or pharmacist. Symptoms of local overdose may include eye irritation, pain, swelling, tears in the eye, sensitivity to light. 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 you missed the dose some time ago and it is nearly time for your next dose, just put in the next dose of drops at the right time. Never double up on a dose to make up for the one you have missed.
- The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor.
- blurred vision, eye irritation or mild burning or stinging when you put the drops in.
- 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 phenyl mercuric nitrate. Reporting of 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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using the product and seek medical help immediately if you experience:
- allergic reactions such as itching, rashes, fever, swelling, hives, wheezing, difficulty breathing, systemic inflammatory reactions and other.
- changes in blood (anaemia) leading to severe tiredness or easy bruising. Other side effects may include:
- Discolouration or clouding of the eye surface (cornea) or lens due to the preservative. 00000000
How to store it
Optrex Infected 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 'use by' date shown on the bottle. Discard any unused product within 28 days of opening. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Contents of the pack and other information
Each pack contains 10ml of the drops. The drops contain 0.5% w/v chloramphenicol, which is equivalent to 5mg of chloramphenicol per millilitre. They also contain purified water, boric acid, borax and phenylmercuric nitrate. Further information If you have any questions or are not sure about anything, ask your pharmacist or doctor. They can obtain more information about this medicine if needed. Licence holder: Optrex Limited, Slough, SL1 3UH, UK. Manufacturer: Tubilux Pharma, Via Costarica, 20/22. 00071 Pomezia (Roma) – Italia PL 00062/0051. Leaflet revised April 2024
Frequently asked questions about Optrex Infected Eye Drops
How do I take Optrex Infected Eye Drops?
Optrex Infected Eye Drops comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Optrex Infected Eye Drops?
The active substance in Optrex Infected Eye Drops is chloramphenicol.
Are there equivalent medicines to Optrex Infected Eye Drops?
Medicines with the same active substance, strength and form include: Clorogen Eye Drops 0.5% w/v, Minims Chloramphenicol 0.5%, Eye drops solution, Chloramphenicol Eye Drops BP 0.5% W/V. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Optrex Infected Eye Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Optrex Infected Eye Drops without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: chloramphenicol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of acute bacterial conjunctivitis.
4.2. Posology and method of administration
Posology
Adults:
One drop instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. The course of treatment is 5 days. Treatment should continue for 5 days even if symptoms improve.
If symptoms persist or worsen after 48 hours, or have not resolved within 5 days, consult a healthcare professional.
Paediatric Population:
Children aged 2 years and over: As above for adults.
Children under 2 years: this product is not recommended for children under 2 years of age.
Elderly:
No dosage adjustments are required for elderly
Method of administration:
For ocular use.
4.3. Contraindications
Chloramphenicol eye drops must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the drops.
• Patients with pre-existing bone-marrow depression or patients who have experienced myelosuppression during previous exposure to chloramphenicol.
• Patients with a family history of blood dyscrasias.
4.4. Special warnings and precautions for use
Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).
In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.
The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor.
Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and emergence of resistant organisms.
Do not use for more than 5 days without consulting your doctor.
Toxic epidermal necrolysis have been reported very rarely in association with the use of chloramphenicol (see section 4.8).
The label will state:
• If symptoms do not improve within 48 hours talk to your doctor
• Seek further immediate medical advice at any time if symptoms worsen
• Do not use if you are allergic to chloramphenicol or any of the ingredients
• Discard any remaining eye drops after the five day course of treatment
For external use only.
Keep all medicines out of the sight and reach of children.
Phenylmercuric nitrate may cause allergic reactions. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
Patients should be referred to a doctor if any of the following apply:
• Disturbed vision
• Severe pain within the eye
• Photophobia
• Eye inflammation associated with a rash on the scalp or face
• The eye looks cloudy
• The pupil looks unusual
• Suspected foreign body in the eye
Patients should also be referred to their doctor if any of the following in his/her medical history apply:
• Previous conjunctivitis in the recent past
• Glaucoma
• Dry eye syndrome
• Eye surgery or laser treatment in the last 6 months
• Eye injury
• Current use of other eye drops or eye ointment
• Contact lens use
If this product is used following advice from a contact lens practitioner or doctor contact lenses should not be worn during the course of treatment. Soft contact lenses should not be replaced for 24 hours after completing the treatment.
4.5. Interaction with other medicinal products and other forms of interaction
Bone marrow depressant drugs
4.6. Fertility, pregnancy and lactation
Pregnancy
The safety of chloramphenicol eye drops during pregnancy has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.
Breast-feeding
In view of the fact that chloramphenicol/metabolites are excreted in human milk and effects have been shown in breastfed newborns/ infants of treated women, the product should not be used during lactation.
Fertility
No data on human fertility are available.
4.7. Effects on ability to drive and use machines
Blurring of vision can occur with the drops and patients should be warned not to drive or operate machinery unless their vision is clear.
4.8. Undesirable effects
Adverse events which have been associated with topical chloramphenicol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Blood and Lymphatic System Disorders
Not known
Bone marrow failure1, aplastic anaemia1,2
Immune System Disorders
Not known
Hypersensitivity3
Eye Disorders
Not known
Vision blurred, eye pain, eye swelling, eye irritation
Skin and Subcutaneous Tissue Disorders
Not known
Rash vesicular, rash maculo-papular
Description of Selected Adverse Reactions:
1 Bone marrow failure, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.
2 This can include neutropenia and thrombocytopenia.
3 This can include rashes, fever, angioedema, urticaria and anaphylaxis. Treatment must be discontinued immediately in such cases.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9. Overdose
Symptoms
In view of the relatively small amount of chloramphenicol in chloramphenicol eye drops, overdosage with this product is unlikely to constitute a hazard. Localised symptoms such as eye irritation, pain or swelling, lacrimation or photophobia may occur.
Management
If excess product is applied to the eye the eye should be washed out with water and symptomatic treatment given.
💬 Ask about this leaflet
Ask anything about Optrex Infected Eye Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Chloramphenicol
- Brolene Antibiotic 0.5%w/v Eye Drops
- Chloramphenicol 1.0% w/w Antibiotic Eye Ointment
- Chloramphenicol 10% w/v Ear Drops
- Chloramphenicol 5% w/v Ear Drops
- Chloramphenicol 5% w/v Ear Drops (FAMAR)
- Chloramphenicol Antibiotic 0.5%w/v Eye Drops
- Chloramphenicol Capsules BP 250 mg
- Chloramphenicol Eye Drops BP 0.5% W/V
- Clorogen Eye Drops 0.5% w/v
- Eykappo (Chloramphenicol) 5mg/ml Eye Drops
- Minims Chloramphenicol 0.5%, Eye drops solution
- Mollifeye 5mg/ml Eye Drops, Solution
- Optrex Bacterial Conjunctivitis 1% w/w Eye ointment