Exocin

  • Name:

    Exocin

  • Company:
    info
  • Active Ingredients:

    Ofloxacin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/05/16

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 11/5/2016
print

Print ViewKeyword Search SmPC

Allergan Ltd

Allergan Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Acular Active Ingredients Ketorolac Trometamol
Medicine Name Alphagan Active Ingredients brimonidine tartrate
Medicine Name Betagan Active Ingredients Levobunolol hydrochloride
Medicine Name Betagan Unit Dose Active Ingredients Levobunolol hydrochloride
Medicine Name BOTOX 100 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 200 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 50 Units Active Ingredients Botulinum Toxin Type A
Medicine Name Celluvisc 0.5% Active Ingredients Carmellose sodium
Medicine Name Celluvisc 1.0% w/v Eye drops, solution Active Ingredients Carmellose sodium
Medicine Name Combigan Active Ingredients brimonidine tartrate, Timolol Maleate
Medicine Name Exocin Active Ingredients Ofloxacin
Medicine Name FML Active Ingredients Fluorometholone
Medicine Name Ganfort Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Ganfort SD Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Lacri-Lube Active Ingredients No Active Ingredients
Medicine Name Liquifilm Tears Active Ingredients Polyvinyl Alcohol
Medicine Name Lumigan 0.1mg/ml Active Ingredients Bimatoprost
Medicine Name Ozurdex Active Ingredients Dexamethasone
Medicine Name Pred Forte Active Ingredients Prednisolone Acetate
Medicine Name Pred Mild Active Ingredients Prednisolone Acetate
Medicine Name Refresh Ophthalmic Active Ingredients Polyvinyl Alcohol, Povidone
Medicine Name Relestat 0.5 mg/ml, eye drops, solution Active Ingredients Epinastine Hydrochloride
Medicine Name Vistabel Active Ingredients Botulinum Toxin Type A
1 - 0 of 23 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11 May 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 May 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4 (Special warnings and precautions for use):  the following warning: "Stevens-Johnson syndrome has been reported in patients receiving topical ophthalmic ofloxacin, however, a causal relationship has not been established" has been revised, i.e. removed from section 4.4 and the adverse reaction "Stevens-Johnson syndrome" has been added in section 4.8 (Undesirable effects) under the SOC "Skin and Subcutaneous Tissue Disorders" with a frequency "not known".

In section 4.8 (Undesirable effects):

-the following adverse reactions have been added under the SOC "Skin and Subcutaneous Tissue Disorders" with a frequency "not known:
Stevens-Johnson syndrome
Toxic epidermal necrolysis

-
under the SOC "Eye disorders" with frequency not known - addition of an adverse reaction "Periorbital oedema (including eyelid oedema)". The "Periorbital oedema" and "Facial oedema" have been removed  from SOC "Skin and Subcutaneous Tissue Disorders" with the frequency "not known"

-under the SOC "Eye Disorders"  with frequency "not known" - "Hypersensitivity (including Eye pruritus and Eyelid pruritus)" has been removed and then added under the SOC "Immune System Disorders" with the frequency "not known"

-under the SOC "Immune System Disorders" the frequency has been changed from "Very rare" to "Not known" for all adverse reactions under this SOC.
-under the SOC "Immune System Disorders" the following text has been removed: "*Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin". This statement is included in section 4.4 (Special warnings and precautions for use).

In section 10 (Date of revision of the text) - the date of revision of the text is April 2016.

Updated on 9 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 March 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Uptade to the ATC code

Updated on 18 December 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

IMB namche change to HPRA

Updated on 3 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to how the medicine works

Updated on 16 December 2013 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications - hypersensitivity paragraph to API and other excipients have been re-phrased

4.4 Special warnings and precautions for use:
- Paragraph proving info on ofloxacin studies in animals have been moved to sec. 5.3
- P
hotosensitivity has beed added
- Paragraph talking about appropriate treatment for neonates with ophthalmia neonatorum have been removed

sec. 4.8 Undesirable effects:
- Very rare and serious and occassionally fatal hypersensitivity have been added
- Hypersensitivity and facial oedema have been moved
- Reporting of suspected adverse reactions have been added

sec. 5.3 Preclinical Data
- Paragraph proving info on ofloxacin studies in animals have been moved from sec. 4.4 (no new data)

 

Updated on 5 December 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 20 November 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated with:

Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including EXOCIN®, in these populations.

Updated on 15 November 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 June 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Summary of Changes to Exocin® IE Summary of Product Characteristics (SPC)

 

The current FML®TM Liquifilm® SPC is dated 7th June 2011

This supersedes SPC dated 26th August 2009

 

 

Section Number

Subject

Change

4.4

Special Warnings and Precautions for Use

Text Added:

 

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 EXOCIN 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 infection worsens, 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.

 

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.

 

Use in the elderly: No comparative data are available with topical dosing in elderly versus other groups.

 

The following precautions are relevant for the systemic absorption of oxoquinolone antibacterial agents. However, the plasma levels of ofloxacin following absorption from topically applied EXOCIN eye drops are minimal.

 

Persons with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions with systemically absorbed oxoquinolone antibacterial agents.

 

Patients with pre-existent significant renal or hepatic disorders should be carefully monitored to detect any deterioration in function. Dosage reduction may be required.

 

EXOCIN should be administered with caution to persons with existent central nervous system disorders, epilepsy, hepatic or renal insufficiency, or severe dehydration. Photosensitivity reactions may be induced. Evidence of CNS irritability has been reported particularly in the elderly, leading occasionally to psychosis.

 

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.

 

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.

 

Caution should be taken when using fluoroquinolones, including EXOCIN, in patients with known risk factors for prolongation of the QT interval such as, for example:

 

- Congenital long QT syndrome

 

- Concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)

 

- Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)

 

- Elderly

 

- Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

 

(see section 4.2 elderly, section 4.5, section 4.8, section 4.9)

 

EXOCIN contains the preservative benzalkonium chloride which may cause ocular irritation and discolour 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

 

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.

 

Mineral antacids used simultaneously may effect systemic absorption. Concomitant use of systemic quinolones with some phenylproprionic acid derived non-steroidal anti-inflammatory drugs may lead to toxicity possibly because of renal effects.

 

A study of concurrent administration with a coumarin anticoagulant showed no interaction.

 

EXOCIN, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4)

 

4.8

Undesirable effects

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, adverse events reported with systemic use could possibly occur.

 

Frequency categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).

 

Immune System Disorders:

Not known: Hypersensitivity (including Eye allergy)

 

Nervous System Disorders:

Not known: Dizziness

Headache

Hypoaesthesia

 

Eye Disorders:

Common: Eye irritation

Ocular discomfort

Not known:  Keratitis,

        Conjunctivitis,

        Vision blurred,

        Photophobia,

        Eyelid oedema,

        Foreign body sensation in eyes,

        Lacrimation increased,

        Dry eye,

        Eye pain,

        Eye/Eyelids pruritus,

        Ocular hyperaemia

 

Cardiac disorders:

Not known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see section 4.4 and 4.9)

 

Gastrointestinal Disorders

Not known: Nausea

 

Skin and Subcutaneous Tissue Disorders

Not known: Periorbital oedema

 

General Disorders and Administrative Site Conditions

Not known: Facial oedema

 

4.9

Overdose

Text Added

 

No case of overdose has been reported.

 

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

 

In the event of an overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

10

DATE OF REVISION OF TEXT

Text Removed/Added

26th August 2009 07 June 2011

 

 

 

Key:

Unchanged text appears as follows: eg Benzalkonium Chloride
Added text appears as follows: eg EXOCIN

Deleted (Removed) text appears as follows: eg Not applicable

 

Updated on 20 June 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 14 September 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section Number

Subject

Change

4.4

Special Warnings and Precautions for Use

The following text was added:

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

 

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

 

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.

 

Text has been amended as follows:

Exocin The multidose eye drop presentation contains the preservative benzalkonium chloride which may cause eye ocular irritation and discolour soft contact lenses.

 

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.

 

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

The following text was added:

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.

 

4.7

Effects on the ability to Drive and Use Machines

The following text was added:

No studies on the effects on the ability to drive and use machines have been performed.

 

4.8

Undesirable Effects

Text has been amended as follows:

a) The most frequently reported ADR is eye irritation which was reported with an incidence of 1.6% in clinical trials.

 

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, adverse events reported with systemic use could possibly occur

 

Frequency categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).

 

b) Immune System Disorders:

                        Rare Not known:Hypersensitivity (including Eye allergy)

 

            Nervous System Disorders:

                        UncommonNot known:Dizziness

                        Rare                           Headache

                                                          Hypoaesthesia

 

            Eye Disorders:

                        Common:          Eye irritation (includes ocular burning)

                                                                             Ocular discomfort

                                                    Uncommon:      Eye pain (includes eye stinging)

                                                    Rare Not known Ocular / Conjunctival hyperaemia

                                                    Keratitis,

Conjunctivitis,

Vision blurred,

Photophobia,

Eyelid oedema,

Foreign body sensation in eyes, 

Lacrimation increased,

Dry eye,

Eye pain (includes eye stinging)

Eye/Eyelids pruritus,

Ocular hyperaemia

 

 

            Gastrointestinal Disorders

                        Rare Not known Nausea

 

Skin and Subcutaneous Tissue Disorders

Not known:        Periorbital oedema

 

General Disorders and Administrative Site Conditions

Not known:        Facial oedema

c)         Not applicable

 

d)         Since ofloxacin is systemically absorbed after topical administration, side effects reported with systemic use could possibly occur. These include vasculitis, gastrointestinal disturbances, abnormal liver function tests.

4.9

Overdose

The following text was added:

No case of overdose has been reported.

 

5.1

Pharmacodynamic properties

The following text was added:

Pharmacotherapeutic group: Ophthalmologicals, anti-infectives, quinolones

 

ATC code: S 01 AX 11

 

6.6

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Text has been amended as follows:

No special requirements.

 

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

 

Due to the nature of Benzalkonium chloride, EXOCIN should not be used by soft (hydrophilic) contact lens wearers.

 

Contact lenses should not be worn during instillation of the drug. After instillation there should be an interval of at least 15 minutes before reinsertion

10

Date of revision of text

26th August 2009 replaces 28th October 2006

Updated on 8 September 2009 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 12 February 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.2

Posology and Method of Administration

Text Added: Adults only

4.3

Contraindications

Text Added: Exocin is not recommended for use in children or adolescents before epiphyseal closure

Updated on 10 November 2008 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 6 November 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Summary of Changes to Exocin Irish Summary of Product Characteristics (SPC)

 

The current Exocin SPC is dated 28th October 2008 

This supersedes SPC dated 19th December 2006

 

 

Section Number

Subject

Change

4.2

Posology and method of administration

Text deleted:

Adults only

4.3

Contraindications

Text deleted:

EXOCIN is not recommended for use in children or adolescents before epiphyseal closures.

 

4.4

Special warnings and precautions for use

Text added:

When using Exocin eye drops the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered

 

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.

 

Text deleted:

Toxicological studies have shown the administration of oxoquinolone antibacterial agents at doses higher than the therapeutic range can produce erosions of the cartilage in weight bearing joints in the immature animals of some species. No such lesions have been shown to occur in man to date. This product should not be prescribed for children. Safety and efficacy in the treatment of ophthalma neonatorum has not been established.

 

EXOCIN contains benzalkonium chloride and should not be used while patients are wearing hydrophilic (soft) contact lenses.

 

Text added:

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.

 

10

Date of revision of text

Text added:

28th October 2008

 

Replaces:

19th December 2006

 

 

Updated on 12 March 2007 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Change to side-effects

Updated on 12 March 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section Number

Subject

Change

1

Name of the medicinal Product

 

added - w/v Eye Drops Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Added text in red

 

Ofloxacin 0.3% w/v (3 mg/ml)

 

Benzalkonium chloride (preservative) 0.005% w/v (0.05 mg/ml)

 

For full list of excipients, see section 6.1

 

3

PHARMACEUTICAL FORM

 

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

 

4.4

Special Warnings and Precautions for Use

Removed “Special” before precautions in heading

 

ADDED

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.

 

4.5

Interaction with other

medicinal products and

other forms of interactions

 

Replaced “medicaments” with “medicinal products”

4.7

Effects on ability to drive and Use Machines

ADDED

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

COMPLETELY REWRITTEN

a)The most frequently reported ADR is eye irritation

which was reported with an incidence of 1.6% in clinical

 trials.

 

b)Immune System Disorders:

Rare:    Hypersensitivity (including Eye allergy)

 

Nervous System Disorders:

Uncommon:    Dizziness

Rare:                Headache, Hypoaesthesia

 

Eye Disorders:

Common: Eye irritation (includes ocular burning)

                 Uncommon: Eye pain (includes eye stinging)

                  Rare: Ocular / Conjunctival hyperaemia

                           Photophobia

                           Eye / Eyelid pruritus

                           Eyelid oedema

 

Gastrointestinal Disorders

Rare:    Nausea

 

c)Not applicable

 

d)Since ofloxacin is systemically absorbed after topical administration, side effects reported with systemic

            use could possibly occur. These include vasculitis,

            gastrointestinal disturbances, abnormal liver

            function tests.

 

6.1

List of excipients

Added text in red

 

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

 

6.6

Special precautions for

disposal of a used

medicinal product or

waste materials derived

 from such medicinal

product and other

handling of the product

 

Changed from Instructions for Use/Handling

Updated on 1 September 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 August 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2003 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)