Refresh Ophthalmic

Summary of Product Characteristics last updated on medicines.ie: 10/12/2015
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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 10 December 2015 PIL

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
  • Improved electronic presentation
  • Change to improve clarity and readability

Free text change information supplied by the pharmaceutical company

In section 4.4 addition of possible eye injury; addition of advice on using other ophthalmic products; addition of advice  not to use if solution changes colour or becomes cloudy.

In section 4.5 amend to no known drug interactions

In section 4.8 addition of undesirable effects • Conjunctival hyperaemia • Lacrimation increased

Updated on 10 December 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 10 December 2015 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
  • Improved electronic presentation
  • Change to improve clarity and readability

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 addition of possible eye injury; addition of advice on using other ophthalmic products; addition of advice  not to use if solution changes colour or becomes cloudy.

In section 4.5 amend to no known drug interactions

In section 4.8 addition of undesirable effects • Conjunctival hyperaemia • Lacrimation increased

Updated on 11 August 2009 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Eye irritation
  • Eye pain
  • Ocular hyperaemia
  • Vision blurred
  • Eye pruritus
  • Foreign body sensation
  • Eye discharge
  • Hypersensitivity

Free text change information supplied by the pharmaceutical company



4.3

Contraindications

Hypersensitivity to the active substances or any of the other excipients replaces Hypersensitivity to any component of the formulation.

 

4.4

Special warnings and precautions for use

Text edited as follows:

If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment considered use and consult a doctor.

 

To avoid contamination Tthe dropper tip should not be allowed to touch the eye or any other surface.

 

Contact lenses should be removed before each application and may be reinserted after 15 minutes.

 

4.7

Effects on ability to drive and use machines

Text edited as follows:

Refresh Ophthalmic has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision.  Do not drive or use hazardous machinery unless vision is clear.

 

4.8

Undesirable effects

The following text was added:

The frequency of the following undesirable effects is not known (cannot be estimated from the available data).

 

Eye disorders

  • Eye irritation
  • Eye pain
  • Ocular hyperaemia
  • Vision blurred
  • Eye pruritus
  • Foreign body sensation
  • Eye discharge
  • Hypersensitivity

 

4.9

Overdosage

The following text was added:

No case of overdose has been reported

5.1

Pharmacodynamic properties

The following text was added:

Pharmacotherapeutic group: Artificial tears and other indifferent preparations – S01XA20

 

6.3

Shelf life

Text edited as follows:

After first opening the container: Use immediately after opening. Discard any unused contents solution.

 

10

DATE OF REVISION OF THE TEXT

July 2009 replaces June 2009

 

 

Updated on 11 August 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Eye irritation
  • Eye pain
  • Ocular hyperaemia
  • Vision blurred
  • Eye pruritus
  • Foreign body sensation
  • Eye discharge
  • Hypersensitivity

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company



4.3

Contraindications

Hypersensitivity to the active substances or any of the other excipients replaces Hypersensitivity to any component of the formulation.

 

4.4

Special warnings and precautions for use

Text edited as follows:

If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment considered use and consult a doctor.

 

To avoid contamination Tthe dropper tip should not be allowed to touch the eye or any other surface.

 

Contact lenses should be removed before each application and may be reinserted after 15 minutes.

 

4.7

Effects on ability to drive and use machines

Text edited as follows:

Refresh Ophthalmic has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision.  Do not drive or use hazardous machinery unless vision is clear.

 

4.8

Undesirable effects

The following text was added:

The frequency of the following undesirable effects is not known (cannot be estimated from the available data).

 

Eye disorders

  • Eye irritation
  • Eye pain
  • Ocular hyperaemia
  • Vision blurred
  • Eye pruritus
  • Foreign body sensation
  • Eye discharge
  • Hypersensitivity

 

4.9

Overdosage

The following text was added:

No case of overdose has been reported

5.1

Pharmacodynamic properties

The following text was added:

Pharmacotherapeutic group: Artificial tears and other indifferent preparations – S01XA20

 

6.3

Shelf life

Text edited as follows:

After first opening the container: Use immediately after opening. Discard any unused contents solution.

 

10

DATE OF REVISION OF THE TEXT

July 2009 replaces June 2009

 

 

Updated on 21 July 2009 SmPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Summary of Changes to Refresh Ophthalmic® Irish Summary of Product Characteristics (SPC)

 

The current SPC is dated June 2007

This supersedes SPC dated June 2009

 

 

Section Number

Subject

Change

1

Name of the Medicinal Product

Name amended from REFRESH OPHTHALMIC to read Refresh Ophthalmic 1.4% w/v + 0.6% w/v

2

Qualitative and quantitative composition

Text expanded to read “For a full list of excipients, see section 6.1.

6.1

List of excipients

Phrase “(for pH adjustment)” added to 2 of the excipients.

6.2

Incompatibilities

Text deleted “None known” and replaced with “In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products

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

Section subject heading amended from “Instructions for use and handling”

9

Date of first authorization / renewal of the authorization

Amended from7th March 1989 / 7th March 2004 to read 7th March 1989 / 7th March 2009.

10

Date of revision of the text

Amended from 20th June 2007 to read 25th June 2009.

 

Updated on 21 July 2009 PIL

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Summary of Changes to Refresh Ophthalmic® Irish Summary of Product Characteristics (SPC)

 

The current SPC is dated June 2007

This supersedes SPC dated June 2009

 

 

Section Number

Subject

Change

1

Name of the Medicinal Product

Name amended from REFRESH OPHTHALMIC to read Refresh Ophthalmic 1.4% w/v + 0.6% w/v

2

Qualitative and quantitative composition

Text expanded to read “For a full list of excipients, see section 6.1.

6.1

List of excipients

Phrase “(for pH adjustment)” added to 2 of the excipients.

6.2

Incompatibilities

Text deleted “None known” and replaced with “In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products

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

Section subject heading amended from “Instructions for use and handling”

9

Date of first authorization / renewal of the authorization

Amended from7th March 1989 / 7th March 2004 to read 7th March 1989 / 7th March 2009.

10

Date of revision of the text

Amended from 20th June 2007 to read 25th June 2009.

 

Updated on 22 August 2008 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

Section Number

Subject

Change

10

Date of revision of text

Changed from 18June2007 to 20June2007

Updated on 22 August 2008 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Section Number

Subject

Change

10

Date of revision of text

Changed from 18June2007 to 20June2007

Updated on 30 August 2007 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Free text change information supplied by the pharmaceutical company

 

3

Pharmaceutical Form

Text removed – to very slightly yellow and sterile

10

Date of revision of text

Changed from 8th April 2005 to 18th June 2007

All

 

REFRESH OPTHALMICTM  replaced by Refresh Ophthalmic throughout document

Updated on 30 August 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

3

Pharmaceutical Form

Text removed – to very slightly yellow and sterile

10

Date of revision of text

Changed from 8th April 2005 to 18th June 2007

All

 

REFRESH OPTHALMICTM  replaced by Refresh Ophthalmic throughout document

Updated on 15 August 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Updated on 15 August 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 27 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only