SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Chloromytol 0.5% w/v Eye Drops

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1ml of the drops contains 5mg of Chloramphenicol Excipient with known effect: Phenylmercuric nitrate- 0.002 % w/v For the full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Eye Drops

A bright, colourless to faint yellow aqueous solution, practically clear and practically free from particles.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of acute bacterial conjunctivitis.

Chloramphenicol is indicated in both adults and children.

4.2.    Posology and method of administration

Posology

Adults and Children:

The recommended dosage is for adults, and children.

One drop to be applied to the infected eye every 2 hours for the first 48 hours and then every 4 hours thereafter. Treatment should be continued for 5 days.

Elderly

As for adults. Chloramphenicol has been used successfully at recommended dosages in elderly patients.

Paediatric population

Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.

Method of administration

For topical administration to the eye only. To be used during waking hours only. The recommended period of treatment is 5 days.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Chloramphenicol eye drops should not be administered to patients with/who:

•    have experienced myelosuppression during previous exposure to chloramphenicol.

•    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 (see section 4.8).

In severe infection and where it is not confined to the conjunctivae, the patient should be referred to the doctor in case the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears during treatment or symptoms worsen, the patient should consult a doctor immediately.

This product must not be used for more than 5 days. It should be discarded thereafter or returned to the Pharmacy for safe disposal.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.

Chloromytol 0.5% w/v Eye Drops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

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

•    Discard any remaining eye drops after the five day course of treatment

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

Chloramphenicol should be used in caution in patients with a medical history of:

•    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

Contact lens wearers should only use Chloromytol 0.5% w/v eye drops on the advice of a doctor or contact lens practitioner. Contact lenses should not be worn during treatment. Soft contact lenses should not be worn until 24 hours after the course of treatment has finished.

This medicine contains phenylmercuric nitrate which is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

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 topical chloramphenicol 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 has minor influence on the 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 the vision is clear.

4.8.    Undesirable effects

Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below. The frequencies correspond with:

Not known (cannot be estimated from the available data)

Blood & lymphatic system disorders Not known	Aplastic anaemia*, bone marrow failure*
Immune system disorders Not known	Anaphylactic reaction*
Nervous system disorders Not known	Burning sensation
Skin + subcutaneous tissue disorders Not known	Angioedema*, dermatitis* (including vesicular & maculopapular dermatitis) urticaria*
General disorders and administration site conditions Not known	Pain (stinging sensation), pyrexia*

*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 MHRA Yellow Card Scheme: www.mhra.gov.uk/yellowcard

4.9 Overdose

Accidental ingestion of Chloromytol 0.5% w/v Eye Drops 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

Pharmacotherapeutic group: Antibiotic ATC code: S01AA01

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 well established antibiotic and the successful use of the eye drops is well documented. Chloramphenicol is found in measurable amounts in the aqueous humor 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.

6.3    Shelf life

Unopened shelf-life is 24 months. Opened shelf-life 28 days, but the patient is advised to discard any remaining drops after the 5 day course of treatment.

6.4    Special precautions for storage

Store in a refrigerator (2°C - 8°C). Replace cap securely after use and keep the bottle in the outer carton in order to protect from light.

6.5    Nature and contents of container

10ml Flexible polyethylene bottles incorporating a polyethylene plug and cap assembly.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Mercury Pharmaceuticals Ltd, Capital House,

85 King William Street, London EC4N 7BL, UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 12762/0037

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13 February 2001 Date of last renewal: 1 April 2009

10    DATE OF REVISION OF THE TEXT

28/10/2016