Brolene

Brochlor 0.5% w/v Eye Drops

Brolene Antibiotic 0.5% w/v Eye Drops

Chloramphenicol 0.5% w/v

Excipients with known effect

Borax: 40 mg per 10mL

Boric acid: 150 mg per 10mL

For the full list of excipients, see section 6.1

Eye drops.

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.

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms.

Not applicable to a topical (ophthalmic) preparation.

Preclinical safety data does not add anything of further significance.

Borax

Boric acid

Water for injections

Not known.

24 months from the date of manufacture. The in-use shelf life is 28 days, however the patient should be advised to discard any remaining contents after the 5-day course of treatment.

Protect from light. Store between 2°C and 8°C.

A flexible polypropylene bottle incorporating a polyethylene plug and cap assembly. The bottles contain 10ml.

None.

Aventis Pharma Limited, trading as Sanofi

410 Thames Valley Park Drive,

Reading,

Berkshire,

RG6 1PT,

United Kingdom.

PL 04425/0366

July 2004

18/08/2021