Acular

  • Name:

    Acular

  • Company:
    info
  • Active Ingredients:

    Ketorolac Trometamol

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/06/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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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 14 June 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 14 June 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 2 (qualitative and quantitative composition), "with known effect" was added.

In section 4.3 (contraindications), hypersensitivity to the active substance(s) or to any excipients listed in section 6.1. 

In section 4.8 (undesirable effects), ulcerative keratitis, eye swelling, ocular hyperaemia, face oedema and swelling face were included as undesirable effects with not known frequency.

In section 10 (date of revision of the text), the date was updated to 06/2019.

 

 

Updated on 1 October 2014 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 October 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To update the container closure system for the finished product.

Updated on 9 September 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 September 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 4 September 2014 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

To update SPC and PIL in line with ADR Reporting Statement and CSP v2.0.

Updated on 26 August 2014 PIL

Reasons for updating

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

Updated on 17 March 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been updated in line with CCDS V3: sec.4.2; 4.4; 4.5; 4.8 and 10.

Updated on 11 March 2014 PIL

Reasons for updating

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

Updated on 14 March 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Summary of Changes to Acular® Irish Summary of Product Characteristics (SPC)

 

The current Acular® SPC is dated March 2011

This supersedes SPC dated June 2009

 

 

Section Number

Subject

Change

1.0

Name of medicinal product

Text Removed:

Acular®

 

2.0

Qualitative and quantitative composition

Text Added/ Removed:

Ketorolac trometamol 0.5% w/v. 5 mg/mL

 

Contains Excipients: benzalkonium chloride 0.01% w/v. 0.1mg/mL

 

4.1

Therapeutic indications

For the prophylaxis and reduction of inflammation following cataract surgery.

Acular is indicated in adults.

 

4.2

Posology and method of administration

Text Added:

 

Posology

Post-operative inflammation:

One drop instilled into the eye three times daily starting 24 hours before surgery and continuing for three to four weeks.

 

Paediatric population

There is no relevant use of Acular in the paediatric population in the indication:  For the prophylaxis and reduction of inflammation following cataract surgery.

 

Method of administration

Ocular use.

Instil one drop of the solution into the inferior conjunctival sac of the eye to be treated, while pulling the lower eyelid gently downwards and looking upwards.

 

4.3

Contraindications

Text Added/ Removed:

ACULAR® is contraindicated in individuals hypersensitive Hypersensitivity to the active substance or to any of the excipients. any component of the medication.

 

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. ACULAR ® is contraindicated in individuals who have previously exhibited sensitivities to these drugs.

ACULAR® is not recommended for use in children due to insufficient data on safety and efficacy.

 

4.4

Special warnings and precautions for use

Text Unchanged:

 

It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

 

In common with other anti-inflammatory drugs, ACULAR may mask the usual signs of infection.

 

Text Added:

 

All non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay wound healing.  Concomitant use of NSAIDs and topical steroids can increase the potential for healing problems.  Concomitant use of ACULAR and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.

 

Use of topical NSAIDS may result in keratitis.  In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.  These events may be sight threatening.  Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

 

Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.

 

Post marketing experience with topical NSAIDs also suggest that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events

 

The preservative in ACULAR, benzalkonium chloride, may cause eye irritation.  Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion.  Benzalkonium chloride is known to discolour soft contact lenses.  Contact with soft contact lenses must be avoided.

 

There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma associated with the use of ACULAR, which may be contributory.  Caution is recommended in the use of ACULAR in these individuals (see section 4.8).

 

Text Removed:

 

Concomitant use of ACULAR® and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.

Use of topical NSAIDS may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.

Post marketing experience with topical NSAIDs also suggest that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

ACULAR® contains benzalkonium chloride as a preservative and should not be used in patients continuing to wear soft (hydrophilic) contact lenses (since benzalkonium chloride is known to discolour this lens-type). 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.

 

4.5

Interactions with other medicinal products and other forms of interaction

Text Added/ Deleted:

No interaction studies have been performed.

ACULAR® has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics local anaesthetics and cycloplegics.

ACULAR® may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing problems (see section 4.4).

If ACULAR® is used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications.

 

4.6

Pregnancy Fertility, pregnancy and lactation

Text Added:

Pregnancy
There are no or a limited amount of data from the use of ketorolac trometamol in pregnant women.  Animal studies are insufficient with respect to reproductive toxicity .  ACULAR is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Breastfeeding

ACULAR should not be used during breast-feeding.  Ketorolac trometamol is excreted in human milk after systemic administration.

 

Fertility:

There are no adequate data from the use of ketorolac trometamol on fertility in humans.

Text Removed:

There are no adequate data from the use of ACULAR® in pregnant women.

Lactation

ACULAR® is not recommended for nursing mothers. Ketorolac trometamol is secreted in human milk after systemic administration.

 

4.7

Effects on ability to drive and use machinery

Text Added:

 

ACULAR has no or negligible influence on the ability to drive and use machines.

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

 

4.8

Undesirable effects

The most frequent adverse events reported with the use of ACULAR are transient stinging and burning on instillation.

 

The frequency of adverse reactions documented during clinical trials is given below and is defined as follows: 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 available data).

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:

 

Immune system disorders

Common:                    Hypersensitivity including localised allergic reactions

 

Nervous system disorders

Uncommon:                Headache

 

Eye Disorders

Very Common:            Eye irritation (including burning sensation)

                                    Eye pain (including stinging)

 

Common:                    Superficial (punctate) keratitis

                                    Eye and/or eyelid oedema

                                    Ocular pruritus

                                    Conjunctival hyperaemia

                                    Eye infection

                                    Eye inflammation

 

Uncommon:                Corneal ulcer

Corneal infiltrates

Blurred and/or diminished vision

Eye dryness

Epiphora

Iritis

 

Not known:                  Corneal damage, e.g. thinning, erosion, epithelial breakdown and                                               perforation*

 

Respiratory, thoracic and mediastinal disorders

Not known:                  Bronchospasm or exacerbation of asthma**

 

                       

*Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received.  These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity (see section 4.4).

 

**There have been post-marketing reports of bronchospasm or exacerbation of asthma, in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma, associated with the use of ACULAR which may be contributory.

 

None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.

 

Text Deleted:

a) The most frequent adverse events reported with the use of ACULAR® are transient stinging and burning on instillation. The events below are classified according to their incidence in clinical trials.

b) Very Common (>1/10):

 

Ocular stinging or burning

Common (>1/100, <1/10):

 

Superficial (punctate) keratitis

 

Eye pain

 

Localised allergic reaction

 

Eye and/or eyelid oedema

 

Ocular irritation

 

Ocular pruritus

 

Conjunctival hyperaemia

Rare (>1/10,000, <1/1,000):

 

Corneal ulcer

 

Corneal infiltrates

 

Blurred and/or diminished vision

 

Headache

 

Eye dryness

 

Epiphora

Since ACULAR® has been marketed globally a few spontaneous reports of urticaria and rash have been received.

c) Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received. These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity. See warnings and precautions section 4.4.

d) None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.

 

4.9

Overdose

No case of overdose has been reported.  Overdose is unlikely to occur via the recommended method of administration.

If accidentally ingested, drink fluids to dilute.

5.3

Preclinical safety

Text Added:

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

 

Text Deleted:

 

Acute, subacute and chronic studies of ACULAR® in experimental animals have established the safety of the drug. In addition, octoxinol 40 was separately evaluated for its ocular safety. ACULAR® was found to be non-irritating, it did not demonstrate a local anaesthetic effect, it did not influence the healing of experimental corneal wounds in rabbits, it did not enhance the spread of experimental ocular infections of Candida albicans, Herpes simplex virus type one, or Pseudomonas aeruginosa in rabbits, and it did not increase the ocular pressure of normal rabbit eyes.

 

 

10

Date of the revision of the text

Text Added:

 

March 2011

 

 

 

Key:

Unchanged text appears as follows: eg sodium hydroxide

Added text appears as follows: eg Acular

Deleted text appears as follows: eg Not applicable

 

Updated on 10 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 June 2009 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.4 Special precautions for storage
Store below 25C replace old text 'This medicinal product does not require any special storage conditions'
Section 10 Date of reviseion of text
02June099 replace old text April 2007

Updated on 12 June 2009 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 30 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 

2

Qualitative and Quantitative Composition

Text added

Contains benzalkonium chloride 01.01% w/v

Text updated

For a full list of excipients, see section 6.1 replaces old text For excipients, see 6.1

4.3

Contraindications

Text added

Acular® is not recommended for use in children due to insufficient data on safety and efficacy.

 

4.4

Special warnings and precautions for use

Heading updated

Special warnings and precautions for use replaces Special warning and Special Precautions for use

Text added

Use of topical NSAIDS may result in keratitis.  In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.  These events may be sight threatening.  Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

 

Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.

 

Post marketing experience with topical NSAIDs also suggest that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

Text removed

Safety and effectiveness of ACULAR® in children have not been established

4.6

Pregnancy and lactation

Subheadings added

Pregnancy and Lactation

Text updated – Pregnancy section

There are no adequate data from the use of Acular® in pregnant women replaces Safety of use in pregnant women has not been established

4.8

Undesirable effects

Section b

Text updated

Localised allergic reaction replaces Allergic reaction

Text added

Since Acular® has been marketed globally a few spontaneous reports of urticaria and rash have been received

4.9

Overdose

Text updated

No case of overdose has been reported replaces There is no experience by the ophthalmic route

5.1

Pharmacodynamic properties

Text added

Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids

5.3

Preclinical safety data

Text updated

Octoxinol replaces octoxynol

6.3

Shelf life

Text added

Unopened

6.4

Special precautions for storage

Text updated

This medicinal product does not require any special storage conditions replaces No special precautions for storage

6.5

Nature of contents of container

Text updated

Low density polyethylene dropper bottles (with LDPE dropper tips) containing 3ml, 5ml or 10ml of solution. The drop size is 35 microlitres. Each bottle has a medium impact polystyrene (MIPS) screw-cap.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

Heading changed

Special precautions for disposal and other handling replaces Instructions for use/handling

Text updated

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements replaces None

7

Marketing Authorisation Holder

Heading changed

Marketing Authorisation Holder  replaces Name and Address of the holder of the marketing authorization

Text deleted

Ireland

8

Marketing Authorisation Number

Heading updated

Authorisation replaces Authorization

9

Date of first authorisation/renewal of the authorisation

Heading updated

Date of first authorisation/renewal of the authorisation replaces Date of first authorization/Renewal of authorization

Text added

Date of last renewal: 27 July 2006

10

Date of revision of text

Heading updated

Date of revision of text replaces Date of (partial) revision of text

Text updated

April 2007 replaces 6th March 2003

 

 

Updated on 28 August 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change to appearance of the medicine
  • Change to marketing authorisation holder
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 August 2003 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)