Allergan Ltd

Section Number

Subject

Change

1.0

Name of Medicinal Product

Text Added

EXOCIN 3 mg/ml Eye Drops, Solution.

2.0

Qualitative and Quantitative Composition

Text Added

One millilitre contains 3 mg Oofloxacin 0.3 w/v.

For a full list of excipients, see section 6.1.

3.0

Pharmaceutical Form

Text Added

Eye drops, solution.

Clear, pale to light yellow-green solution, practically free from visible particles.

4.1

Therapeutic indications

Text Added/ Removed

 ExocinXOCIN is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) in adults and children caused by ofloxacin - sensitive organisms. Safety and efficacy in the treatment of ophthalmia neonatorum has not been established.

4.3

Contraindications

Text Added/ Removed

ExocinXOCIN is contra-indicated in patients individuals sensitive who have shown hypersensitivity to ofloxacin or any of its other components excipients.

4.4

Special Warnings and Precautions for Use

Text Added/ Removed

EXOCIN is not for injection.

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching.

If an allergic reaction to ofloxacin occurs, discontinue the drug. Use EXOCIN with caution in patients who have exhibited sensitivities to other quinolones antibacterial agents.

When using ExocinXOCIN eye drops the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms.

If worsening infection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.

Stevens-Johnson syndrome has been reported in patients receiving topical ophthalmic ofloxacin, however, a causal relationship has not been established.

Use ExocinXOCIN with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents.

Corneal precipitates have been reported during treatment with topical ophthalmic ofloxacin. However, a causal relationship has not been established.

Long-term, high-dose use of other fluoroquinolones in experimental animals has caused lenticular opacities. However, this effect has not been reported in human patients, nor has it been noted following topical ophthalmic treatment with ofloxacin for up to six months in animal studies including studies in monkeys.

The multidose eye drop presentation contains the preservative benzalkonium chloride, which may cause eye irritation ExocinXOCIN contains the preservative benzalkonium chloride, which may be absorbed by cause ocular irritation soft contact lenses and discolour them soft contact lenses.

Use of contact lenses is not recommended in patients receiving treatment for an eye infection.

4.5

Interaction with other medicinal products and other forms of interactions

Text Added/ Removed:

None Known. No interaction studies have been performed.

It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Drug interaction studies conducted with systemic ofloxacin have demonstrated that metabolic clearance of caffeine and theophylline are not significantly affected by ofloxacin.

Although there have been reports of an increased prevalence of CNS toxicity with systemic dosing of fluoroquinolones when used concomitantly with systemic nonsteroidal anti-inflammatory drugs (NSAIDs), this has not been reported with the concomitant systemic use of NSAIDs and ofloxacin.

4.6

Pregnancy and lactation

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Use in pregnancy: There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that ExocinXOCIN not be used in pregnant women only if the potential benefit justifies the potential risk to the foetus.

4.7

Effects on ability to drive and use machines

Text Added/ Removed

None known. No studies on the effects on the ability to drive and use machines have been performed.

Transient blurring of vision may occur on instillation of eye drops. Do not drive or operate hazardous machinery unless vision is clear.

4.8

Undesirable effects

Text Removed

Adverse reactions: Transient ocular irritation (burning, stinging, redness, itching or photophobia) has been reported. Extremely low incidence of dizziness, with numbness and nausea and of headache were reported from clinical trials.

Text Added:

General

Serious reactions after use of systemic ofloxacin are rare and most symptoms are reversible. Since a small amount of ofloxacin is systemically absorbed after topical administration, side-effects reported with systemic use could possibly occur.

Frequency categories: Very common (³1/10); Common (³1/100 to <1/10); Uncommon (³1/1,000 to <1/100); Rare (³1/10,000 to <1/1,000); Very rare (<1/10,000) and not known (cannot be estimated from the available data):

Immune System Disorders:

Not known: Hypersensitivity (including Eye allergy)

Nervous System Disorders

Not known: Dizziness

Eye Disorders

Common: Eye irritation; Ocular discomfort

Not known: Keratitis; Conjunctivitis; Vision blurred; Photophobia; Eye oedema; Foreign body sensation in eyes; Lacrimation increased; Dry eye; Eye pain; Eye pruritus; Eyelids pruritus; Ocular hyperaemia

Gastrointestinal Disorders

Not known: Nausea

Skin and Subcutaneous Tissue Disorders

Not Known: Periorbital oedema

General Disorders and Administration Site Conditions

Not known: Facial oedema

4.9

Overdose

Text Added

No case of overdose has been reported.

In the event of a topical overdosage, flush the eye with water.

5.1

Pharmacodynamic properties

Text Added

Pharmacotherapeutic group: Ophthalmologicals, anti-infectives, quinolones

ATC code: S 01 AX 11.

Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically in ophthalmic infections. Clinical trial evidence of the efficacy of ExocinXOCIN against S. pneumoniae was based on a limited number of isolates.

6.1

List of excipients

Text Added

Benzalkonium chloride (EP)         0.005% w/v

Sodium chloride (EP)         0.9% w/v

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Purified water (EP)             

6.3

Shelf Life

Text Added/ Removed

24 months 2 years unopened.

Discard 28 days after first opening

6.5

Nature and contents of container

Text Added/ Removed

5 ml or 10 ml low density polyethylene (LDPE) bottles with LDPE tip and medium or high impact polystyrene cap. A bottle and an applicator tip of low density polyethylene (LDPE) and medium or high impact polystyrene cap.

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Text Added/ Removed

Discard bottle 28 days after opening. There is no special requirement for disposal.

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

9.0

Date of First Authorisation/ Renewal of the Authorisation

Text Added

Date of first authorisation: 26^th October 1992

Date of last renewal: 8^th November 2004

Section Number

Subject

Change

4.4

Special warnings and precautions for use

Text Updated

The following heading was deleted:

Precuations

Text Added

Data are very limited to establish efficacy and safety of ofloxacin eye drops 0.3% in the treatment of conjunctivitis in neonates. The use of ofloxacin eye drops in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended as it has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomatis or Neisseria gonorrhoeae.

Clinical and non-clinical publications have reported the occurrence of corneal perforation in patients with pre-existing corneal epithelial defect or corneal ulcer, when treated with topical fluoroquinolone antibiotics. However, significant confounding factors were involved in many of these reports, including advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs. Nevertheless, it is necessary to advise caution regarding the risk of corneal perforation when using product to treat patients with corneal epithelial defects or corneal ulcers.

The multidose eye drop presentation contains the preservative benzalkonium chloride, which may cause eye irritation. Exocin contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and discolour them. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Text deleted

Exocin contains benzalkonium chloride and should not be used in patients continuing to wear hydrophilic (soft) contact lenses.

10

Date of Partial Revision of the Text

Text Updated

4^th August 2008 replaces 24^th November 2006