BROCHLOR 0.5% W/W EYE DROPS, BROLENE ANTIBIOTIC 0.5% W/V EYE DROPS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Brochlor 0.5% w/v Eye Drops

Brolene Antibiotic 0.5% w/v Eye Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

3 PHARMACEUTICAL FORM

Eye drops.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of acute bacterial conjunctivitis.

4.2 Posology and method of administration

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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6 Fertility, Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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.

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not applicable to topical (ophthalmic) preparation.

5.3

Preclinical safety data does not add anything of further significance.

6.1 List of excipients

Borax

Boric acid

Water for injections

6.2 Incompatibilities

Not known.

6.3 Shelf life

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.

6.4 Special precautions for storage

Protect from light.

Store between 2°C and 8°C.

6.5 Nature and contents of container

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

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd, trading as STADA

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00240/0580

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

12 August 2004