Refresh Ophthalmic
- Name:
Refresh Ophthalmic
- Company:
Allergan Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only

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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Allergan Ltd

Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name Acular | Active Ingredients Ketorolac Trometamol |
Medicine Name Alphagan | Active Ingredients brimonidine tartrate |
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 |
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 4.5 amend to no known drug interactions
In section 4.8 addition of undesirable effects • Conjunctival hyperaemia • Lacrimation increased
Updated on 10 December 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 10 December 2015 SPC
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 4.5 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
|
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
To avoid contamination
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
|
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
|
10 |
DATE OF REVISION OF THE TEXT |
July 2009 replaces June 2009 |
Updated on 11 August 2009 SPC
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
|
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
To avoid contamination
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
|
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
|
10 |
DATE OF REVISION OF THE TEXT |
July 2009 replaces June 2009 |
Updated on 21 July 2009 SPC
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 SPC
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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only