Tears Naturale * Pharmacy Only: Non-prescription
Company:
Alcon Laboratories Ireland LimitedStatus:
DiscontinuedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 February 2020
File name
ie-pl-clean_1581091447.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 02 January 2020
File name
ie-pl-clean_1577975453.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 02 January 2020
File name
ie-spc-clean_1577975323.pdf
Reasons for updating
- Other
Legal category:Supply through pharmacy only
Updated on 11 December 2019
File name
ie-pl-clean_1576058408.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
Updated on 10 December 2019
File name
ie-spc-clean_1576000906.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through pharmacy only
Updated on 25 October 2018
File name
PIL Tears Naturale eye drops solution IE V1 (002)_1540456030.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 25 October 2018
File name
Tears Naturale Eye Drops Solution V1_1540455974.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through pharmacy only
Updated on 20 August 2018
File name
REG_SPC_Tears Naturale Eye Drops Solution_PF180232_clean_1534771926.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
MAT transfer to Novartis Ireland
Updated on 30 May 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 30 May 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
Updated on 17 May 2017
File name
PIL_9074_874.pdf
Reasons for updating
- New PIL for new product
Updated on 17 May 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 17 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Updated on 16 December 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 08 October 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 07 October 2013
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 29 November 2011
Reasons for updating
- Change due to harmonisation of PIL
Updated on 18 February 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- 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
In Section 1, Name of the medicinal product, ‘(Dextran 70 0.1% w/v, Hypromellose 0.3% w/v)’ is added next to the name of the product.
In Section 2, Qualitative and quantitative composition, ‘Also contains Benzalkonium Chloride Solution 0.01% w/v.’ has been added.
In Section 4.3, Contraindications, ‘This product contains benzalkonium chloride and should not be used when soft contact lenses are being worn.’ has been replaced with ‘Hypersensitivity to dextran 70, hypromellose or to any of the excipients.’
In Section 4.4, Special warnings and precautions for use, special warnings about ocular use, presence of benzalkonium chloride and any undesired reactions are listed.
In Section 4.5, Interaction with other medicinal products and other forms of interaction, ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’ is added.
In Section 4.6, Pregnancy and lactation, further information about the use of Tears Naturale during pregnancy and breast-feeding is added.
In Section 4.7, Effects on ability to drive and use machines, ‘Tears Naturale has no or negligible influence on the ability to drive or use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.’ is added.
In Section 4.8, Undesirable effects, a summary of the safety profile of the product and a tabulated list of adverse reactions is added.
In Section 4.9, Overdose, ‘No case of overdose has been reported. An overdose of Tears Naturale can easily be washed out of the eye with lukewarm tap water.’ is added.
In Section 6.1, List of excipients, solution is added against benzalkonium chloride, concentrated and ‘for PH adjustment’ is added against Sodium hydroxide and/or Hydrochloric acid.
In Section 6.3, Shelf life, ‘1 month’ has been replaced with ‘4 weeks’
In Section 6.4, Special precautions for storage, ‘Discard one month after opening’ is replaced with ‘Discard 4 weeks after opening’
In Section 9, Date of first authorisation/Renewal of authorisation, Date of last renewal is revised to 13th March 2010.
In Section 10, Date of revision of the text, the date of revision has been updated to January 2011.
Updated on 29 October 2010
Reasons for updating
- Change to date of revision
- Change due to harmonisation of PIL
Updated on 28 October 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 6.1 - List of excipients
- 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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In Section 1, the header is amended in lines with the QRD template, and '(Dextran 70 0.1% w/v, Hypromellose 0.3% w/v)' is added against the product name.
In Section 2, ‘For excipients, see - 6.1.’ is replaced with ‘For a full list of excipients, see section 6.1.’ and ‘Also contains Benzalkonium Chloride Solution 0.01% w/v.’ is added.
In Section 4.4, the header is amended in lines with the QRD template.
In Section 4.5, the header is amended in lines with the QRD template.
In Section 6.1, (for pH adjustment) is added against ‘Sodium hydroxide and/or Hydrochloric acid’
In Section 6.3, ‘1 month’ is replaced with ‘4 weeks’
In Section 6.5, ‘polystyrene or polypropylene cap’ is replaced with ‘polypropylene cap’
In Section 6.6, the header is amended in lines with the QRD template
In Section 7, the header is amended in lines with the QRD template
In Section 9, date of last renewal has been updated
In Section 10, date of revision of text has been updated
Updated on 13 August 2010
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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 6.2 - 'Not applicable' is replaced with 'None known'.
Section 6.5 - 'polystyrene or polypropylene cap' replaced with 'polypropylene cap'.
Section 9 - Date of last renewal updated.
Section 10 - Date of revision updated.
Updated on 16 August 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 18 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 28 October 2004
Reasons for updating
- New PIL for new product
Updated on 27 August 2003
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Supply through pharmacy only
Updated on 20 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only