Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
e Chloramphenicol Antibiotic Eye Ointment Chloramphenicol 1.0% w/w Eye ointment is recommended for Children over 2 years, adults and the elderly. It is recommended that any child below the age of two years with an eye infection should be seen by a doctor. Do not use the ointment if:
Chloramphenicol eye ointment is used by placing a small amount (about 1cm) in the space between the lower eyelid and the eye. Always follow your pharmacist's instructions. To be used in the eye(s) only.
When using the ointment
4. Possible side effects Like all medicines, Chloramphenicol Eye Ointment 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. Stop using your medicine and tell your doctor or pharmacist immediately if you experience the following side effects:
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non susceptible organisms including funghi. If any new infection appears during treatment you should tell your doctor.
Chloramphenicol Antibiotic Eye Ointment 4. Possible side effects 5. How to store Chloramphenicol Antibiotic Eye Ointment 6. Contents of the pack and other information
1. What Chloramphenicol Antibiotic Eye Ointment is and what it is used for Chloramphenicol belongs to a group of medicines called antibiotics. Antibiotics are used for infections caused by bacteria. Chloramphenicol eye ointment is for simple eye infections called "acute bacterial conjunctivitis". This is sometimes known as "red eye" because the white part of the affected eye(s) will be red and/or the eyelid(s) will be red or swollen. There may also 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 ointment is 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 and more serious infections.
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. By reporting side effects you can help provide more information on the safety of this medicine.
Chloramphenicol Antibiotic Eye Ointment Keep out of the sight and reach of children. Do not use Chloramphenicol Antibiotic Eye Ointment after the expiry date printed on the crimp seal of the tube. The expiry date refers to the last day of that month. Once the tube is open use within 28 days. You are advised to dispose of the tube once you have finished your 5 day course of treatment. This medicine needs to be stored below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. The measures will help to protect the environment.
What Chloramphenicol Antibiotic Eye Ointment contains The name of this medicine is Chloramphenicol 1.0% w/w Antibiotic Eye Ointment. This medicine contains the active ingredient Chloramphenicol 1.0 w/w.Other ingredients are Liquid Paraffin and White Soft Paraffin. Each tube contains 4 grams of yellowish-white eye ointment. Manufacturer: Tubilux Pharma S.p.A., Via Costarica 20/22, 00071 Pomezia (RM), Italy Marketing Authorisation Holder: Martindale Pharmaceuticals Ltd., Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom This leaflet was last revised in: March 2022
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Chloramphenicol 1.0% w/w Antibiotic Eye Ointment comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Chloramphenicol 1.0% w/w Antibiotic Eye Ointment is chloramphenicol.
Medicines with the same active substance, strength and form include: Optrex Bacterial Conjunctivitis 1% w/w Eye ointment. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Chloramphenicol 1.0% w/w Antibiotic Eye Ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of acute bacterial conjunctivitis in adults and children aged 2 years and over.
Posology
Adults (including elderly people) and children aged 2 years and over:
If using just the eye ointment, apply about 1 cm of ointment to the affected eye(s) 3 to 4 times a day.
If using chloramphenicol eye drops during the day and the eye ointment at night - apply the ointment at night, before going to bed.
The course of treatment is 5 days.
Method of administration
For topical ocular use.
The ointment is applied into the space between the lower eyelid and the eye.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients who have experienced myelosuppression during previous exposure to chloramphenicol.
Family or personal history of blood dyscrasias including aplastic anaemia.
Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure.
Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of the compound. Where Chloramphenicol antibiotic eye ointment is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect haemopoietic abnormalities.
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.
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Prolonged use of chloramphenicol eye drops is not advisable, as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.
Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.
Chloramphenicol eye ointment should not be used for more than 5 days at a time except on the advice of a doctor.
Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.
The label will state:
• Do not use this ointment if you are allergic to chloramphenicol or anything else in the ointment.
• If you do not get better within 48 hours talk to a doctor.
• If your eyes get worse see a doctor straight away.
• After 5 days, throw away any ointment left.
For external use only
Keep all medicines out of the sight and reach of children.
Chloramphenicol eye ointment should not be recommended under the following circumstances (in these circumstances patients should be referred to their doctor):
• Severe pain within the eye
• Disturbed vision
• Photophobia
• Eye inflammation associated with a rash on the scalp or face
• The pupil looks unusual
• The eye looks cloudy
• 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:
• Associated pain or swelling around the eye or face
• The patient has had conjunctivitis previously in the recent past
• The patient has glaucoma
• The patient has dry eye syndrome
• The patient has an eye injury
• The patient is already using other eye ointments or eye drops
The patient has had eye surgery or laser treatment in the last 6 months
If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished the eye ointment.
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
The safety of topical chloramphenicol in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician.
Chloramphenicol may be absorbed systemically following the use of the eye ointment. Chloramphenicol does cross the placenta and enter breast milk. Therefore, chloramphenicol eye ointment should not be used during pregnancy and breastfeeding.
May cause transient blurring of vision on instillation of the ointment. User should not drive or operate hazardous machinery unless vision is clear.
Transient burning or stinging sensations may occur with the use of Chloramphenicol Antibiotic Eye Ointment. More serious side effects include bone marrow depression and rarely aplastic anaemia, angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported and are causes for discontinuation.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store
Accidental ingestion of Chloramphenicol Antibiotic Eye Ointment is unlikely to cause systemic toxicity due to the low content of the antibiotic. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered.
Ask anything about Chloramphenicol 1.0% w/w Antibiotic Eye Ointment. 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.
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