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.
for Brolene Antibiotic Eye Drops contain a medicine called chloramphenicol. This belongs to a group of medicines called antibiotics. It works by stopping the growth of bacteria, allowing your body to fight off the infection. Brolene Antibiotic Eye Drops are used to treat minor infections of the eye or eyelid caused by bacteria (bacterial conjunctivitis). Signs include sore, red or inflamed eyes, sticky discharge or crust on the lids. 2. Before you use Brolene Antibiotic Eye Drops Do not use this medicine and tell your doctor if: Ñ You are allergic (hypersensitive) to chloramphenicol or any of the other ingredients of Brolene Antibiotic Eye Drops (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid. Ñ You or anyone in your family have had any problems with your blood, including 'aplastic anaemia' Do not use this medicine if the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Drops. Warnings and precautions Take special care with Brolene Antibiotic Eye Drops Check with your doctor before taking your medicine if: You have problems with your eyesight You have severe pain within the eye Your eyes are sensitive to light You have eye inflammation and a rash on your face or scalp Your eye looks cloudy The pupil of your eye looks unusual
You think that you have a foreign object in your eye You have recently had conjunctivitis You have glaucoma Your eyes produce fewer tears (dry eye syndrome) You have had eye surgery or laser treatment in the last 6 months You have an eye injury You are using other eye drops or eye ointment You wear contact lenses. You should not wear contact lenses while using these eye drops and for at least 24 hours after completing your treatment. If you are not sure if the above apply to you, talk to your doctor or pharmacist before using Brolene Antibiotic Eye Drops. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Brolene Antibiotic Eye Drops can affect the way some other medicines work. Also some medicines can affect the way Brolene Antibiotic Eye Drops work. In particular, tell your doctor if you are taking any of the following:
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4. Possible side effects Like all medicines, Brolene Antibiotic Eye Drops can cause side effects, although not everybody gets them. Stop using Brolene Antibiotic Eye Drops and see a doctor as soon as possible if:
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.
Brolene Eye Drops Keep this medicine in a safe place where children cannot see or reach it. Do not use Brolene Antibiotic Eye Drops after the expiry date which is stated on the label and carton.
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If you stop using Brolene Antibiotic Eye Drops Keep using the eye drops for 5 days even if your symptoms improve. Do not stop using Brolene Antibiotic Eye Drops just because your eye(s) feel better. If you stop, your infection may come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Date:
By joannearmitage at 12:11 pm, Dec 23, 2021
The expiry date refers to the last day of that month. Store in the fridge (between 2°C and 8°C) and protect from light. Brolene Antibiotic Eye Drops are sterile when you buy them. Discard any drops remaining after 5 days of use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
What Brolene Antibiotic Eye Drops contains
Brolene Antibiotic 0.5%w/v Eye Drops comes as eye drops containing 0.5%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Brolene Antibiotic 0.5%w/v Eye Drops is chloramphenicol.
Medicines with the same active substance, strength and form include: Chloramphenicol Antibiotic 0.5%w/v Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Brolene Antibiotic 0.5%w/v 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.
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.
For ocular use.
The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only.
Treatment should continue for 5 days, even if symptoms improve.
Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.
Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms.
Do not use for more than 5 days without consulting 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.
Patients should be referred to their 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 treatment.
The labels 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.
• Discard any remaining eye drops after the five day course of treatment.
• Do not use if you are allergic to chloramphenicol or any of the other ingredients.
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
The safety of Chloramphenicol Eye Drops during pregnancy and lactation has not been established.
Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
Chloramphenicol eye drops may cause transient blurring of vision when applied to the eye. Patients should be warned not to drive or operate hazardous machinery unless their vision is clear.
Eye disorders:
Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye.
Blood and lymphatic system disorder:
Bone marrow depression, including irreversible and fatal aplastic anaemia 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 this compound.
Immune system disorders:
Hypersensitivity reactions including angioedema.
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.
Not applicable.
Ask anything about Brolene Antibiotic 0.5%w/v 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.
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