SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Chlormytol 1% w/w Eye Ointment

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Chloramphenicol 1.0% w/w.

1 g of ointment contains 10 mg chloramphenicol For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Eye ointment.

A smooth uniform translucent greasy ointment contained in a multi-laminate tube.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of acute bacterial conjunctivitis.

Chloramphenicol is indicated in both adults and children.

4.2    Posology and method of administration

Posology

Adults, children and elderly

The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone

The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve.

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

Topical administration to the eye only.

4.3 Contraindications

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

Chlormytol eye ointment must not be administered to patients with/who:

•    have experienced myelosuppression during previous exposure to chloramphenicol.

•    a family history of blood dyscrasias.

4.4 Special warnings and precautions for use

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).

In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.

The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor.

Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and emergence of resistant organisms.

Do not use for more than 5 days without consulting your doctor.

The label 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

•    Do not use if you are allergic to chloramphenicol or any of the ingredients

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

For external use only.

Keep all medicines out of the sight and reach of children.

Patients should be referred to a doctor if any of the following apply:

•    Disturbed vision

•    Any significant 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 with caution in patients with a 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

If you wear contact lenses, seek advice either from your optometrist, contact lens practitioner 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 ointment.

4.5 Interaction with other medicinal products and other forms of interaction

Bone marrow depressant drugs

4.6 Fertility, pregnancy and lactation

The safety of Chlormytol eye ointment during pregnancy and lactation has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.

In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

Chloramphenicol has minor influence on the ability to drive and use machines. Blurring of vision can occur with the ointment and patients should be warned not to drive or operate machinery unless their 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*
General disorders and administration site conditions Not known	Pain (stinging sensation), pyrexia*
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*

*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

In view of the relatively small amount of chloramphenicol in chlormytol eye ointment, overdosage with this product is unlikely to constitute a hazard.

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 opthalmological examination should be considered.

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotic ATC code: D06AX02

Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts its effects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Escherichia coli, Haemophilus influenzae, Staphyloccus aureus, Streptococcus haemolyticus, Morax anenfeld, Klebsiella/Enterobacter species and others. Entrobacteriaceae are variably resistant while Pseudomonas and Mycobacteria are usually resistant.

5.2    Pharmacokinetic properties

Absorption

Chloramphenicol enters the aqueous humour following topical application. Distribution

Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF, giving concentrations of about 50% of those existing in the blood even in the absence of inflamed meninges; it diffuses across the placenta into the fetal circulation, into breast milk, and into the aqueous and vitreous humour of the eye. Up to about 60% in the circulation is bound to plasma protein. The halflife of chloramphenicol has been reported to range from 1.5 to 4 hours; the half-life is prolonged in patients with severe hepatic impairment and is also much longer in neonates. Renal impairment has relatively little effect on the half-life of the active drug, due to its extensive metabolism, but may lead to accumulation of the inactive metabolites. Chloramphenicol is excreted mainly in urine.

Biotransformation/Elimination

The absorption, metabolism, and excretion of chloramphenicol are subject to considerable interindividual variation, especially in infants and children, making monitoring of plasma concentrations necessary to determine pharmacokinetic in a given patient.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6.1    List of excipients

Liquid Paraffin

Polyethylene in Mineral Oil (Plastibase 50W)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Unopened: 4 years After first opening; 28 days

Although the shelf life once opened is 28 days, patients will be advised to discard the medicine after a 5 day course of treatment.

6.4    Special precautions    for    storage

Do not store above 25 °C.

6.5    Nature and contents of container

Supplied in a polyethylene tube laminated with aluminium and fitted with a white polyethylene nozzle and screw cap containing 4g of ointment.

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 12762/0400

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/06/2011

10 DATE OF REVISION OF THE TEXT

27/09/2016