SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Chloromycetin 0.5 % w/v Redidrops Eyedrops Chloramphenicol 0.5% w/v Eye Drops

2.    Qualitative and Quantitative Composition

Each 1 ml of the drops contains 5mg of chloramphemcol Ph Eur.

3.    Pharmaceutical Form

Eye drops.

Clinical Particulars

4.1. Therapeutic Indications

Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chioramphenicol susceptible organisms including: Escherichia coil, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-axenfeld, Klebsiella/Enterobacter species and others.

4.2. Posology and Method of Administration

Topical administration to the eye only.

Adults, children and infants:

The recommended dosage for adults, children and infants of all age groups is two drops to be applied to the affected eye every 3 hours or more frequently if required. Treatment should be continued for at least 48 hours after the eye appears normal.

Elderly (over 65 years):

As for adults. Chloramphenicol has been used successfully at normal dosages in elderly patients. The pattern and incidence of adverse effects does not appear to differ from younger adults.

4.3 Contraindications

Chloromycetin Redidrops should not be administered to:

•    Patients hypersensitive to chloramphenicol or any other component of the drops.

•    Patients with a known personal or family history of blood dyscrasias including aplastic anaemia.

4.4 Special warnings and precautions for use

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 Chloromycetin Redidrops 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 any haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.

Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. iIf any new infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only in infections for which it is specifically indicated.

Chloromycetin Redidrops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

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 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 using the eye drops.

The packaging will convey the following information:

•    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

Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

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 Pregnancy and lactation

The safety of topical chloramphenicol in 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

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

Transient burning or stinging sensations may occur with the use of Chloromycetin Redidrops. 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.

4.9. Overdose

Accidental ingestion of Chloromycetin Redidrops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product. 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.

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, including Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus viridans, Moraxella species and Enterobacteriaceae, the main pathogens responsible for acute bacterial conjunctivitis. Chloramphenicol exerts its antibacterial effect by reversibly binding to bacterial ribosomes thereby inhibiting bacterial protein synthesis.

5.2. Pharmacokinetic Properties

Chloramphenicol is an extremely well established antibiotic and the successful use of the eye drops is well documented. Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye.

5.3. Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients Borax Boric acid

Phenylmercuric nitrate and Water for Injection

6.2. Incompatibilities

None known.

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SUMMARY OF PRODUCT CHARACTERISTICS

6.3 Shelf Life 24 Months

Chloromycetin Redidrops/UK/ Var/ reduction of shelf life/12.06

6.4.    Special Precautions for Storage

Store between 2° C and 8° C. Discard remaining contents 28 days after opening. Protect from light.

6.5.    Nature and Contents of Container

A flexible polyethylene bottle incorporating a polyethylene plug and cap assembly. Pack sizes: 5ml and 10ml.

6.6. Instruction for Use/Handling

None.

7    MARKETING AUTHORISATION HOLDER

Mercury Pharmaceuticals Ltd,

Capital House,

85 King William Street,

London EC4N 7BL, UK 8.    Marketing Authorisation Number

PL 12762/0206

DATE OF REVISION OF THE TEXT

21/03/2014